Standards Library

1-500 of 536 results for "AAMI"

AAMI NS15
Title: Implantable peripheral nerve stimulators
Organization: AAMI
Year: 1995
Status: Inactive
AAMI TIR15843
Title: STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT FAMILIES AND SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS, AND FREQUENCY OF STERILIZATION...
Organization: AAMI
Year: 2000
Status: Inactive
SP10
Title: Electronic or Automated Sphygmomanometers
Organization: AAMI
Year: 2002
Status: Inactive
AAMI II36
Title: Medical electrical equipment, Part 2: Particular requirements for safety of baby incubators
Organization: AAMI
Year: 2004
Status: Inactive
RD61
Title: Concentrates for hemodialysis
Organization: AAMI
Year: 2006
Status: Inactive
AAMI TIR13
Title: Principles of Industrial Moist Heat Sterilization
Organization: AAMI
Year: 1997
Status: Inactive
SP10 AMD 2
Title: Amendment 2 to ANSI/AAMI SP10:2002, Manual, electronic and automated sphygmomanometers
Organization: AAMI
Year: 2006
Status: Inactive
AAMI ST66
Title: STERILIZATION OF HEALTHCARE PRODUCTS - CHEMICAL INDICATORS - PART 2 : CLASS 2 INDICATORS FOR AIR REMOVAL TEST SHEETS AND PACKS
Organization: AAMI
Year: 1999
Status: Inactive
AAMI DF2
Title: Cardiac Defibrillator Devices
Organization: AAMI
Year: 1996
Status: Inactive
TAR10-331
Title: Hemodialyzer Reuse: Issues and Solutions
Organization: AAMI
Year: 1985
Status: Inactive
AAMI NS14
Title: Implantable spinal cord stimulators
Organization: AAMI
Year: 1995
Status: Inactive
AAMI II51
Title: Transport Infant Incubators
Organization: AAMI
Year: 2004
Status: Inactive
TIR19 AMD 1
Title: Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical deices—Part 7: Ethylene oxide sterilization residuals Amendment
Organization: AAMI
Year: 1999
Status: Inactive
TIR7
Title: Chemical sterilants and high level disinfectants: A guide to selection and use
Organization: AAMI
Year: 1999
Status: Inactive
STBK8-3-331
Title: Part 3: Industrial Process Control
Organization: AAMI
Year: 1999
Status: Inactive
AAMI ST46
Title: Steam Sterilization and Sterility Assurance in the Health Care Facilities
Organization: AAMI
Year: 2002
Status: Inactive
BIOT2 PT 11
Title: Part 11: Tests for Systemic Toxicity
Organization: AAMI
Year: 1998
Status: Inactive
AAMI 15223
Title: Medical Devices - Symbols to be used with medical device labels, labeling and information to be supplied.
Organization: AAMI
Year: 2000
Status: Inactive
AAMI TIR10993-20
Title: Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
Organization: AAMI
Year: 2006
Status: Active
BIOT2 PT 6
Title: Part 6: Tests for Local Effects After Implantation
Organization: AAMI
Year: 1998
Status: Inactive
AAMI ST33
Title: Guidelines for the Selection and Use of Reusable Rigid Container Systems for Ethylene Oxide Sterilization and Steam Sterilization in Health Care Facilities
Organization: AAMI
Year: 1996
Status: Inactive
BIOT2 PT 2
Title: Part 2: Animal Welfare Requirements
Organization: AAMI
Year: 1998
Status: Inactive
AAMI TIR26
Title: Ventricular assist and heart replacement systems
Organization: AAMI
Year: 2000
Status: Inactive
AAMI SW68
Title: Medical Device Software - Software Life Cycle Processes
Organization: AAMI
Year: 2001
Status: Inactive
AAMI ST59
Title: STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL
Organization: AAMI
Year: 1999
Status: Inactive
AAMI ST21
Title: Biological Indicators for Ethylene Oxide Sterilization Process in Health Care Facilities
Organization: AAMI
Year: 1986
Status: Inactive
TIR6
Title: Reuse of Hemodialyzer Blood Tubing
Organization: AAMI
Year: 1990
Status: Inactive
DSBK8-331
Title: Volume 3: Dialysis
Organization: AAMI
Year: 1998
Status: Inactive
AAMI ST63
Title: Sterilization of health care products—Requirements for the development, validation, and routine control of an industrial sterilization process for medical devices—Dry heat
Organization: AAMI
Year: 2002
Status: Inactive
AAMI TIR11
Title: Selection and use of protective apparel and surgical drapes in health care facilities
Organization: AAMI
Year: 2005
Status: Active
BIOT2 PT 3
Title: Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
Organization: AAMI
Year: 1998
Status: Inactive
AAMI ST45
Title: BIER/Steam Vessels
Organization: AAMI
Year: 1992
Status: Inactive
AAMI TIR20
Title: PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION
Organization: AAMI
Year: 2001
Status: Inactive
AAMI HE48
Title: Human Factors Engineering Guidelines and Preferred Practices for the Design of Medical Devices
Organization: AAMI
Year: 1993
Status: Inactive
AAMI DF39
Title: Automatic External Defibrillators and Remote-Control Defibrillatiors
Organization: AAMI
Year: 1993
Status: Inactive
BIOT2 PT 4
Title: Part 4: Selection of Tests for Interactions with Blood
Organization: AAMI
Year: 1998
Status: Inactive
AAMI TIR25
Title: Chemical indicators— Guidance for the selection, use, and interpretation of results
Organization: AAMI
Year: 1999
Status: Inactive
BIOT9
Title: BIOLOGICAL EVALUATION OF MEDICAL DEVICES, SUPPLEMENT 2
Organization: AAMI
Year: 2000
Status: Inactive
ST21
Title: Sterilization of health care products— Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization
Organization: AAMI
Year: 1999
Status: Inactive
AAMI HFMD
Title: An Introduction to Human Factors in Medical Devices
Organization: AAMI
Year: 1996
Status: Inactive
HF18 ERTA
Title: Electrosurgical Devices
Organization: AAMI
Year: 2001
Status: Inactive
AAMI 13488
Title: Quality systems—Medical devices—Particular requirements for the application of ISO 9002
Organization: AAMI
Year: 1996
Status: Inactive
AAMI 11134
Title: Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization
Organization: AAMI
Year: 1993
Status: Inactive
AAMI TIR10993-19
Title: Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
Organization: AAMI
Year: 2006
Status: Active
AAMI ST19
Title: Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization
Organization: AAMI
Year: 1999
Status: Inactive
AAMI 11737-3
Title: Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data
Organization: AAMI
Year: 2004
Status: Inactive
TIR3
Title: Selection and Use of Chemical Indicators for Steam Sterilization Monitoring in Health Care Facilities
Organization: AAMI
Year: 1989
Status: Inactive
WQD-331
Title: Current Concepts in Hemodialyzer Reprocessing; Water Quality for Dialysis
Organization: AAMI
Year: 1998
Status: Inactive
ST34
Title: Guideline for the Use of Ethylene Oxide and Steam Biological Indicators in Industrial Sterilization Processes
Organization: AAMI
Year: 1991
Status: Inactive
AAMI 11137
Title: Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization
Organization: AAMI
Year: 1994
Status: Inactive
STBK8-1-331
Title: Part 1: Sterilization in Health Care Facilities
Organization: AAMI
Year: 1998
Status: Inactive
ST1134
Title: Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization
Organization: AAMI
Year: 1994
Status: Inactive
AAMI TIR60878
Title: Graphical symbols for electrical equipment in medical practice
Organization: AAMI
Year: 2003
Status: Active
BIOT2 PT 7
Title: Part 7: Ethylene Oxide Sterilization Residuals
Organization: AAMI
Year: 1998
Status: Inactive
TIR19218
Title: Medical devices - Coding structure for adverse event type and cause
Organization: AAMI
Year: 2005
Status: Inactive
TIR8
Title: Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices
Organization: AAMI
Year: 1991
Status: Inactive
AAMI ST37
Title: Flash Sterilization - Steam Sterilization of Patient Care Items for Immediate Use
Organization: AAMI
Year: 1996
Status: Inactive
BIOT2 PT 12
Title: Part 12: Sample preparation and Reference Materials
Organization: AAMI
Year: 1998
Status: Inactive
AAMI TIR27
Title: Sterilization of Health Care Products - Radiation Sterilization Substantiation of 25kGy as a Sterilization Dose Method VD Max
Organization: AAMI
Year: 2001
Status: Inactive
BIOT2 PT 9
Title: Part 9: Degradation of Medical Devices Related to Biological Testing
Organization: AAMI
Year: 1998
Status: Inactive
PAC49
Title: Pacemaker Emergency Intervention System
Organization: AAMI
Year: 1993
Status: Inactive
AAMI TIR13409
Title: Sterilization of Health Care Products-Radiation Sterilization-Substantiation of 25 kGy as a Sterilization Dose for Small or Infrequent Production Batches
Organization: AAMI
Year: 1996
Status: Inactive
AAMI TIR14969
Title: Medical devices—Quality management systems— Guidance on the application of ISO 13485:2003
Organization: AAMI
Year: 2004
Status: Inactive
AAMI ES1
Title: Safe Current Limits for Electromedical Apparatus
Organization: AAMI
Year: 1993
Status: Inactive
AAMI 10993-8
Title: Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
Organization: AAMI
Year: 2000
Status: Inactive
BIOT2 PT 1
Title: Part 1: Guidance on Selection of Tests
Organization: AAMI
Year: 1998
Status: Inactive
AAMI TIR4
Title: Apnea monitoring by means of thoracic impedance pneumography
Organization: AAMI
Year: 1989
Status: Inactive
MDS-331
Title: Developing Safe, Effective, and Reliable Medical Software
Organization: AAMI
Year: 1991
Status: Inactive
AAMI ST42
Title: Steam Sterilization and Sterility Assurance in Table-Top Sterilizers in Office-Based, Ambulatory Care, Medical, Surgical, and Dental Facilities
Organization: AAMI
Year: 1998
Status: Inactive
ECAR
Title: Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms
Organization: AAMI
Year: 1987
Status: Inactive
AAMI TIR11139
Title: Sterilization of health care products — Vocabulary
Organization: AAMI
Year: 2006
Status: Inactive
BIOT2 PT 10
Title: Part 10: Tests for Irritation and Sensitization
Organization: AAMI
Year: 1998
Status: Inactive
AAMI TIR33
Title: Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax
Organization: AAMI
Year: 2005
Status: Inactive
STBK8-2-331
Title: Part 2: Sterilization Equipment
Organization: AAMI
Year: 1998
Status: Inactive
TIR15844
Title: Sterlization of Health Care Products - Radiation Sterlization - Selection of a Sterilization Dose for a Single Production Batch
Organization: AAMI
Year: 1998
Status: Inactive
VP20
Title: Cardiovascular Implants - Vascular Graft Prosthesis
Organization: AAMI
Year: 1994
Status: Inactive
BIOT2 PT 5
Title: Part 5: Tests for Cytotoxicity: In Vitro Methods
Organization: AAMI
Year: 1998
Status: Inactive
SP9
Title: Non-Automated Sphygmomanometers
Organization: AAMI
Year: 1994
Status: Inactive
AAMI TIR16142
Title: Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
Organization: AAMI
Year: 2005
Status: Inactive
AAMI WQD
Title: Water Quality for Dialysis, Second Edition
Organization: AAMI
Year: 1993
Status: Inactive
ST44
Title: BIER/EO Gas Vessels
Organization: AAMI
Year: 2002
Status: Inactive
TIR19
Title: Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
Organization: AAMI
Year: 1998
Status: Inactive
HE
Title: Human Factors Engineering Guidelines and Preferred Practices for the Design of Medical Devices, Second Edition *NOT CURRENT DOCUMENT
Organization: AAMI
Year: 1988
Status: Inactive
AAMI ST60
Title: Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements
Organization: AAMI
Year: 1996
Status: Inactive
BIO8-331 BOOK
Title: Volume 4 - Biological Evaluation of Medical Devices
Organization: AAMI
Year: 1997
Status: Inactive
11607
Title: Packaging for Terminally Sterilized Medical Devices
Organization: AAMI
Year: 2000
Status: Inactive
ST43
Title: Good Hospital Practice: Ethylene Oxide Gas - Ventilation Recommendations and Safe Use
Organization: AAMI
Year: 1993
Status: Inactive
AAMI HF18
Title: Electrosurgical Devices
Organization: AAMI
Year: 2001
Status: Inactive
ST1135-331
Title: Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
Organization: AAMI
Year: 1994
Status: Inactive
VOL 2.1
Title: Biomedical Equipment Part 1: General Safety and Design; Equipment for Therapy and Surgery 1995 Edition
Organization: AAMI
Year: 1995
Status: Inactive
AAMI ST35
Title: Good Hospital Practice: Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical Settings
Organization: AAMI
Year: 2003
Status: Inactive
AAMI RD16
Title: Cardiovascular implants and artificial organs-Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators
Organization: AAMI
Year: 2007
Status: Inactive
AAMI RD17
Title: Cardiovascular implants and artificial organs—Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters
Organization: AAMI
Year: 2007
Status: Inactive
AAMI 11135-1
Title: Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Organization: AAMI
Year: 2007
Status: Inactive
AAMI EC11
Title: Diagnostic electrocardiographic devices
Organization: AAMI
Year: 1991
Status: Inactive
PC69
Title: Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
Organization: AAMI
Year: 2007
Status: Inactive
AAMI EC13
Title: Cardiac monitors, heart rate meters, and alarms
Organization: AAMI
Year: 2002
Status: Inactive
AAMI TIR36
Title: Validation of software for regulated processes
Organization: AAMI
Year: 2007
Status: Inactive
PC69 ERTA
Title: Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers and implantable cardioverter
Organization: AAMI
Year: 2008
Status: Inactive
AAMI RD5
Title: Hemodialysis Systems
Organization: AAMI
Year: 2003
Status: Inactive
AAMI EC38
Title: Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
Organization: AAMI
Year: 2007
Status: Inactive
AAMI TIR11135-2
Title: Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
Organization: AAMI
Year: 2008
Status: Inactive
AAMI BE78
Title: Biological evaluation of medical devices— Part 10: Tests for irritation and delayed-type hypersensitivity
Organization: AAMI
Year: 2002
Status: Inactive
AAMI 14155-1
Title: Clinical investigation of medical devices for human subjects - Part 1: General requirements
Organization: AAMI
Year: 2003
Status: Inactive
AAMI 14155-2
Title: Clinical investigation of medical devices for human subjects—Part 2: Clinical investigation plans
Organization: AAMI
Year: 2003
Status: Inactive
AAMI TIR31
Title: PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARD FACILITIES
Organization: AAMI
Year: 2008
Status: Active
AAMI 15882
Title: Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
Organization: AAMI
Year: 2008
Status: Active
AAMI TIR22
Title: Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices— Part 1 and Part 2:2006
Organization: AAMI
Year: 2007
Status: Inactive
AAMI TIR62296
Title: Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
Organization: AAMI
Year: 2009
Status: Active
AAMI RD62
Title: Water treatment equipment for hemodialysis applications
Organization: AAMI
Year: 2006
Status: Inactive
AAMI 14161
Title: Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results
Organization: AAMI
Year: 2009
Status: Inactive
AAMI TIR80002-1
Title: Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
Organization: AAMI
Year: 2009
Status: Active
AAMI TIR62354
Title: General testing procedures for medical electrical equipment
Organization: AAMI
Year: 2009
Status: Active
AAMI HE74
Title: Human factors design process for medical devices
Organization: AAMI
Year: 2001
Status: Inactive
AAMI 14708-5
Title: Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
Organization: AAMI
Year: 2010
Status: Inactive
AAMI 5840
Title: Cardiovascular implants— Cardiac valve prostheses
Organization: AAMI
Year: 2005
Status: Inactive
AAMI DF80
Title: Medical electrical equipment—Part 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators)
Organization: AAMI
Year: 2003
Status: Inactive
AAMI RD52
Title: Dialysate for hemodialysis
Organization: AAMI
Year: 2004
Status: Inactive
AAMI TIR18
Title: Guidance on electromagnetic compatibility of medical devices in healthcare facilities
Organization: AAMI
Year: 2010
Status: Active
AAMI 7198
Title: Cardiovascular implants—Tubular vascular prostheses
Organization: AAMI
Year: 1998
Status: Active
AAMI 8638
Title: Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
Organization: AAMI
Year: 2010
Status: Inactive
AAMI 15223-2
Title: Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 2: Symbol development, selection and validation
Organization: AAMI
Year: 2010
Status: Active
AAMI 80001-1
Title: Application of risk management for IT Networks incorporating medical devices — Part 1: Roles, responsibilities and activities
Organization: AAMI
Year: 2010
Status: Active
AAMI 18472
Title: Sterilization of health care products—Biological and chemical indicators—Test equipment
Organization: AAMI
Year: 2006
Status: Inactive
AAMI TIR12417
Title: Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products
Organization: AAMI
Year: 2011
Status: Inactive
AAMI 27186
Title: Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
Organization: AAMI
Year: 2010
Status: Inactive
CEC
Title: The Clinical Engineering Collection
Organization: AAMI
Year: 2010
Status: Active
AAMI STBK-3
Title: Sterilization Part 3: Industrial Process Control
Organization: AAMI
Year: 2010
Status: Inactive
AAMI TIR43
Title: Ultrapure dialysate for hemodialysis and related therapies
Organization: AAMI
Year: 2011
Status: Active
AAMI 10993-14
Title: Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
Organization: AAMI
Year: 2001
Status: Active
AAMI BE83
Title: Biological evaluation of medical devices—Part 18: Chemical characterization of materials
Organization: AAMI
Year: 2006
Status: Active
AAMI 14708-4
Title: Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps
Organization: AAMI
Year: 2008
Status: Active
AAMI 10993-15
Title: Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
Organization: AAMI
Year: 2000
Status: Active
AAMI ID54
Title: Enteral feeding set adapters and connectors
Organization: AAMI
Year: 1996
Status: Inactive
AAMI 14160
Title: Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, develop...
Organization: AAMI
Year: 2011
Status: Active
AAMI TIR61289
Title: High frequency surgical equipment – Operation and maintenance
Organization: AAMI
Year: 2011
Status: Active
AAMI 27185
Title: Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements
Organization: AAMI
Year: 2012
Status: Active
AAMI 10993-7
Title: Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
Organization: AAMI
Year: 2008
Status: Active
AAMI SW87
Title: Application of quality management system concepts to medical device data systems
Organization: AAMI
Year: 2012
Status: Inactive
AAMI 13022
Title: Medical products containing viable human cells - Application of risk management and requirements for processing practices
Organization: AAMI
Year: 2012
Status: Active
AAMI 25539-3
Title: Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
Organization: AAMI
Year: 2011
Status: Active
AAMI 11140-3
Title: Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
Organization: AAMI
Year: 2007
Status: Active
AAMI 11140-4
Title: Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
Organization: AAMI
Year: 2007
Status: Active
AAMI 11140-5
Title: Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
Organization: AAMI
Year: 2007
Status: Active
AAMI PB70
Title: Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
Organization: AAMI
Year: 2012
Status: Active
AAMI 10993-12
Title: Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Organization: AAMI
Year: 2012
Status: Active
AAMI 11658
Title: Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
Organization: AAMI
Year: 2012
Status: Active
AAMI TIR80001-2-1
Title: Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples
Organization: AAMI
Year: 2012
Status: Active
AAMI 60601-2-16
Title: Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment
Organization: AAMI
Year: 2012
Status: Active
AAMI TIR80001-2-2
Title: Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
Organization: AAMI
Year: 2012
Status: Active
AAMI TIR19218-2
Title: Medical devices - Hierarchal coding structure for adverse events - Part 2: Evaluation codes
Organization: AAMI
Year: 2012
Status: Inactive
AAMI TIR62348
Title: Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition
Organization: AAMI
Year: 2012
Status: Active
AAMI 10993-17
Title: Biological evaluation of medical devices - Part 17: Methods for the establishment of allowable limits for leachable substances
Organization: AAMI
Year: 2002
Status: Active
AAMI ES60601-1
Title: Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
Organization: AAMI
Year: 2005
Status: Active
AAMI ST15883-2
Title: Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glass...
Organization: AAMI
Year: 2013
Status: Active
AAMI ST15883-3
Title: Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
Organization: AAMI
Year: 2012
Status: Active
AAMI EQ56
Title: Recommended practice for a medical equipment management program
Organization: AAMI
Year: 2013
Status: Active
AAMI 25539-2
Title: Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
Organization: AAMI
Year: 2012
Status: Active
AAMI BF64
Title: Leukocyte reduction filters
Organization: AAMI
Year: 2012
Status: Inactive
AAMI BF7
Title: Blood transfusion microfilters
Organization: AAMI
Year: 2012
Status: Inactive
AAMI 8637
Title: Cardiovascular implants and extracorporeal systems-Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators Amendment 1 Revision to Figure 2: Main fitting dimensions of dialysis fluid inlet...
Organization: AAMI
Year: 2010
Status: Inactive
AAMI TIR44
Title: Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact
Organization: AAMI
Year: 2012
Status: Active
AAMI 5840-3
Title: Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
Organization: AAMI
Year: 2013
Status: Active
AAMI TIR80001-2-4
Title: Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations
Organization: AAMI
Year: 2012
Status: Active
AAMI 81060-1
Title: Non-invasive sphygmomanometers - Part 1: Requirements and test methods for nonautomated measurement type
Organization: AAMI
Year: 2007
Status: Active
AAMI TIR80001-2-3
Title: Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for Wireless Networks
Organization: AAMI
Year: 2012
Status: Active
AAMI AT6
Title: Autologous transfusion devices
Organization: AAMI
Year: 2013
Status: Inactive
AAMI 13408-6
Title: Aseptic processing of health care products - Part 6: Isolator systems
Organization: AAMI
Year: 2005
Status: Active
AAMI 10993-5
Title: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Organization: AAMI
Year: 2009
Status: Active
AAMI EC71
Title: Standard communications protocol for computer-assisted electrocardiography
Organization: AAMI
Year: 2001
Status: Inactive
AAMI 14937
Title: Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical d...
Organization: AAMI
Year: 2009
Status: Active
AAMI TIR19218-1
Title: Medical devices - Hierarchal coding structure for adverse events - Part 1: Event-type codes
Organization: AAMI
Year: 2011
Status: Inactive
AAMI 17665-1
Title: Sterilization of health care products-Moist heat-Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
Organization: AAMI
Year: 2006
Status: Active
AAMI ID26
Title: Medical electrical equipment-Part 2: Particular requirements for the safety of infusion pumps and controllers
Organization: AAMI
Year: 2004
Status: Inactive
AAMI 60601-1-8
Title: MEDICAL ELECTRICAL EQUIPMENT – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical...
Organization: AAMI
Year: 2006
Status: Active
AAMI DUG
Title: Dialysis Water and Dialysate Recommendations: A User Guide
Organization: AAMI
Year: 2014
Status: Inactive
AAMI SPVVQ
Title: Basic Concepts in Sterilization Processes Verification, Validation, And Qualification
Organization: AAMI
Year: 2014
Status: Inactive
AAMI BFTF
Title: Building for the Future Construction and Renovation of Sterile Processing Facilities
Organization: AAMI
Year: 2013
Status: Inactive
AAMI 62366
Title: Medical devices – Application of usability engineering to medical devices
Organization: AAMI
Year: 2007
Status: Inactive
AAMI 60601-1-2
Title: MEDICAL ELECTRICAL EQUIPMENT – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Organization: AAMI
Year: 2014
Status: Active
AAMI INDEX
Title: AAMI RESOURCE CATALOG
Organization: AAMI
Status: Inactive
AAMI RS
Title: PROCESS CONTROL GUIDELINES FOR GAMMA RADIATION STE
Organization: AAMI
Status: Inactive
AAMI BEBK3
Title: STANDARDS AND RECOMMENDED PRACTICES
Organization: AAMI
Status: Inactive
AAMI HE
Title: HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
Organization: AAMI
Status: Inactive
AAMI ST32
Title: GUIDELINES FOR GAMMA RADIATION STERILIZATION
Organization: AAMI
Status: Inactive
AAMI ST27
Title: GUIDELINE FOR INDUSTRIAL ETHYLENE OXIDE STERILIZATION OF MEDICAL DEVICES
Organization: AAMI
Status: Inactive
AAMI ST29
Title: RECOMMENDED PRACTICE FOR DETERMINING RESIDUAL ETHYLENE OXIDE IN MEDICAL DEVICES
Organization: AAMI
Status: Inactive
AAMI GVR-058
Title: GOOD HOSPITAL PRACTICE: ETHYLENE OXIDE GAS - VENTILATION RECOMMENDATIONS AND SAFE USE
Organization: AAMI
Status: Inactive
AAMI TIR8
Title: MICROBIOLOGICAL METHODS FOR GAMMA IRRADIATION STERELIZATION OF MEDICAL DEVICES
Organization: AAMI
Status: Inactive
AAMI BP23
Title: INTERCHANGEABILITY AND PERFORMANCE OF RESISTIVE BRIDGE TYPE BLOOD PRESSURE TRANSDUCERS
Organization: AAMI
Status: Inactive
AAMI VP20
Title: CARDIOVASCULAR IMPLANTS - VASCULAR GRAFT PROSTHESES
Organization: AAMI
Status: Inactive
AAMI SP9
Title: NON-AUTOMATED SPHYGMOMANOMETERS
Organization: AAMI
Status: Inactive
AAMI ST30
Title: DETERMINING RESIDUAL ETHYLENE CHLOROHYDRIN AND ETHYLENE GLYCOL IN MEDICAL DEVICES
Organization: AAMI
Status: Inactive
AAMI ST1135
Title: MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDESTERILIZATION
Organization: AAMI
Status: Inactive
AAMI ST11135
Title: MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDESTERILIZATION
Organization: AAMI
Status: Inactive
AAMI ST43
Title: GOOD HOSPITAL PRACTICE: ETHYLENE OXIDE GAS - VENTILATION RECOMMENDATIONS AND SAFE USE
Organization: AAMI
Status: Inactive
AAMI SP10
Title: MANUAL, ELECTRONIC, OR AUTOMATED SPHYGMOMANOMETERS
Organization: AAMI
Status: Inactive
AAMI STBK9-3
Title: STERILIZATION STANDARDS BOOKS PART 3: INDUSTRIAL PROCESS CONTROL 1999 EDITION
Organization: AAMI
Status: Inactive
AAMI TAR2
Title: ISSUES IN HEMODIALYSIS - SYSTEM PERFORMANCE WATER PURITY AND TREATMENT COST REIMBURSEMENT AND REGULATION
Organization: AAMI
Status: Inactive
AAMI MDS
Title: DEVELOPING SAFE, EFFECTIVE, AND RELIABLE MEDICAL SOFTWARE
Organization: AAMI
Status: Inactive
AAMI ST34
Title: GUIDELINE FOR THE USE OF ETHYLENE OXIDE AND STEAM BIOLOGICAL INDICATORS IN INDUSTRIAL STERILIZATION PROCESSES
Organization: AAMI
Status: Inactive
AAMI MIR2
Title: GUIDELINE FOR ADMINISTERING MEDICAL INSTRUMENTATION MAINTENANCE
Organization: AAMI
Status: Inactive
ISO CD 10993-18
Title: BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
Organization: AAMI
Status: Inactive
AAMI TIR7
Title: CHEMICAL STERILANTS AND HIGH-LEVEL DISINFECTANTS: A GUIDE TO SELECTION AND USE
Organization: AAMI
Status: Inactive
AAMI TIR19
Title: GUIDANCE FOR ANSI/AAMI/ISO 10993-7:1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
Organization: AAMI
Status: Inactive
AAMI PC69
Title: ACTIVE IMPLANTABLE MEDICAL DEVICES - ELECTROMAGNETIC COMPATIBILITY- EMC TEST PROTOCOLS FOR IMPLANTABLE CARDIAC PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Organization: AAMI
Status: Inactive
AAMI RD61
Title: CONCENTRATES FOR HEMODIALYSIS
Organization: AAMI
Status: Inactive
AAMI ST44
Title: BIER/EO GAS VESSELS
Organization: AAMI
Status: Inactive
AAMI 11607
Title: PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES
Organization: AAMI
Status: Inactive
AAMI TIR19218
Title: MEDICAL DEVICES - HIERARCHAL CODING STRUCTURE FOR ADVERSE EVENTS -PART 1: EVENT TYPE CODES
Organization: AAMI
Status: Inactive
AAMI PAC49
Title: PACEMAKER EMERGENCY INTERVENTION SYSTEM
Organization: AAMI
Status: Inactive
AAMI SYMBOLS
Title: MEDICAL EQUIPMENT SYMBOLS & SAFETY SIGNS CLIP ART COLLECTION
Organization: AAMI
Status: Inactive
AAMI TIR15844
Title: STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SELECTION OF A STERILIZATION DOSE FOR A SINGLE PRODUCTION BATCH
Organization: AAMI
Status: Inactive
AAMI STD
Title: AAMI STANDARDS ON CD - THE COMPLETE COLLECTION
Organization: AAMI
Status: Active
AAMI HE75 / 62366 SET
Title: HANDBOOK OF HUMAN FACTORS IN MEDICAL DEVICE DESIGN (KIT) - INCLUDES AAMI HE75 AND AAMI 62366
Organization: AAMI
Status: Inactive
AAMI HE75 / 62366 SET CD
Title: HUMAN FACTORS COLLECTION CD (INCLUDES AAMI HE75 AND AAMI 62366)
Organization: AAMI
Status: Inactive
AAMI QUALITY SYSTEM CD
Title: QUALITY SYSTEM COLLECTION CD
Organization: AAMI
Status: Inactive
AAMI TIR37
Title: Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products
Organization: AAMI
Year: 2013
Status: Active
AAMI 11663
Title: Quality of dialysis fluid for hemodialysis and related therapies
Organization: AAMI
Year: 2014
Status: Inactive
AAMI 13958
Title: Concentrates for hemodialysis and related therapies
Organization: AAMI
Year: 2014
Status: Inactive
AAMI 13959
Title: Water for hemodialysis and related therapies
Organization: AAMI
Year: 2014
Status: Inactive
AAMI 23500
Title: Guidance for the preparation and quality management of fluids for hemodialysis and related therapies
Organization: AAMI
Year: 2014
Status: Inactive
AAMI 5841-2
Title: Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
Organization: AAMI
Year: 2014
Status: Inactive
AAMI 26722
Title: Water treatment equipment for hemodialysis and related therapies
Organization: AAMI
Year: 2014
Status: Inactive
AAMI TIR58
Title: Water testing methodologies
Organization: AAMI
Year: 2014
Status: Active
AAMI TIR16775
Title: Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
Organization: AAMI
Year: 2014
Status: Active
AAMI 10993-3
Title: Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
Organization: AAMI
Year: 2014
Status: Active
AAMI 14708-1
Title: Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Organization: AAMI
Year: 2014
Status: Active
AAMI TIR17137
Title: Cardiovascular implants and extracorporeal systems – Cardiovascular absorbable implants
Organization: AAMI
Year: 2014
Status: Inactive
AAMI 10993-2
Title: Biological evaluation of medical devices - Part 2: Animal welfare requirements
Organization: AAMI
Year: 2006
Status: Active
AAMI 10993-9
Title: Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Organization: AAMI
Year: 2009
Status: Active
AAMI 11737-2
Title: Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Organization: AAMI
Year: 2009
Status: Active
AAMI 10993-13
Title: Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Organization: AAMI
Year: 2010
Status: Active
AAMI 10993-10
Title: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Organization: AAMI
Year: 2010
Status: Active
AAMI 13408-4
Title: Aseptic processing of health care products - Part 4: Clean-in-place technologies
Organization: AAMI
Year: 2005
Status: Active
AAMI ST15883-1
Title: Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
Organization: AAMI
Year: 2009
Status: Active
CN3
Title: Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
Organization: AAMI
Year: 2014
Status: Inactive
CN20
Title: Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
Organization: AAMI
Year: 2014
Status: Inactive
AAMI 5361
Title: Anaesthetic and Respiratory Equipment-Tracheal Tubes and Connectors
Organization: AAMI
Year: 2012
Status: Inactive
AAMI 5362
Title: Anaesthetic Reservoir Bags
Organization: AAMI
Year: 2006
Status: Inactive
AAMI 5356-1
Title: Anaesthetic and respiratory equipment-Conical connectors-Part 1: Cones and sockets
Organization: AAMI
Year: 2004
Status: Inactive
AAMI 5366-1
Title: Anaesthetic and Respiratory Equipment-Tracheostomy Tubes-Part 1: Tubes and Connectors for Use in Adults
Organization: AAMI
Year: 2000
Status: Inactive
AAMI 5366-3
Title: Anaesthetic and Respiratory Equipment-Tracheostomy Tubes-Part 3: Paediatric Tracheostomy Tubes
Organization: AAMI
Year: 2001
Status: Inactive
AAMI 5364
Title: Anaesthetic and respiratory equipment-Oropharyngeal airways
Organization: AAMI
Year: 2008
Status: Inactive
AAMI 10079-2
Title: Medical Suction Equipment-Part 2: Manually Powered Suction Equipment
Organization: AAMI
Year: 1999
Status: Inactive
AAMI 10079-3
Title: Medical Suction Equipment-Part 3: Suction Equipment Powered from a Vacuum or Pressure Source
Organization: AAMI
Year: 1999
Status: Inactive
AAMI 11195
Title: Gas mixers for medical use-Stand-alone gas mixers
Organization: AAMI
Year: 1995
Status: Inactive
AAMI 14408
Title: Tracheal tubes designed for laser surgery-Requirements for marking and accompanying information
Organization: AAMI
Year: 2005
Status: Inactive
AAMI 10079-1
Title: Medical Suction Equipment-Part I: Electrically Powered Suction Equipment-Safety Requirements
Organization: AAMI
Year: 1999
Status: Inactive
AAMI 10651-4
Title: Lung ventilators-Part 4: Particular requirements for operator-powered resuscitators
Organization: AAMI
Year: 2002
Status: Inactive
AAMI 10651-5
Title: Lung ventilators for medical use-Particular requirements for basic safety and essential performance-Part 5: Gas-powered emergency resuscitators
Organization: AAMI
Year: 2006
Status: Inactive
AAMI 4135
Title: Anaesthetic and Respiratory Equipment-Vocabulary
Organization: AAMI
Year: 2001
Status: Inactive
AAMI TIR37137
Title: Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
Organization: AAMI
Year: 2014
Status: Active
AAMI 11140-1
Title: Sterilization of health care products-Chemical indicators-Part 1: General requirements
Organization: AAMI
Year: 2014
Status: Active
AAMI EQ89
Title: Guidance for the use of medical equipment maintenance strategies and procedures
Organization: AAMI
Year: 2015
Status: Active
AAMI TIR80001-2-5
Title: Application of risk management for ITnetworks incorporating medical devices – Part 2-5: Application guidance – Guidance on distributed alarm systems
Organization: AAMI
Year: 2014
Status: Active
AAMI TIR80001-2-7
Title: Application of risk management for ITnetworks incorporating medical - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to selfassess their conformance w...
Organization: AAMI
Year: 2014
Status: Active
AAMI ST91
Title: Flexible and semi-rigid endoscope processing in health care facilities
Organization: AAMI
Year: 2015
Status: Active
AAMI STBK-1
Title: Sterilization Part 1: Sterilization in Health Care Facilities
Organization: AAMI
Year: 2015
Status: Inactive
AAMI STBKCD
Title: AAMI STANDARDS ON CD - STERILIZATION EDITION (50+ AAMI STANDARDS AND GUIDANCE DOCUMENTS FOR STERILIZATION ON A CD)
Organization: AAMI
Status: Inactive
AAMI STBK-S
Title: AAMI STERILIZATION STANDARDS BOOK COLLECTION
Organization: AAMI
Status: Inactive
AAMI STBKCDXL
Title: AAMI STERILIZATION STANDARDS MULTIMEDIA SET
Organization: AAMI
Status: Inactive
AAMI DIALYSIS CD
Title: DIALYSIS STANDARDS COLLECTION ON CD (CONTAINS: AAMI TIR43, 11663, 23500. 60601-2-16, 13958, 13959, AND 26722)
Organization: AAMI
Status: Inactive
AAMI 80369-20
Title: Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
Organization: AAMI
Year: 2015
Status: Active
AAMI 13408-3
Title: Aseptic processing of health care products - Part 3: Lyophilization
Organization: AAMI
Year: 2006
Status: Active
AAMI HA60601-1-11
Title: MEDICAL ELECTRICAL EQUIPMENT - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical...
Organization: AAMI
Year: 2015
Status: Active
AAMI 13408-5
Title: Aseptic processing of health care products - Part 5: Sterilization in place
Organization: AAMI
Year: 2006
Status: Active
AAMI TIR80001-2-6
Title: Application of risk management for ITnetworks incorporating medical - Application guidance - Part 2-6: Guidance for responsibility agreements
Organization: AAMI
Year: 2014
Status: Active
AAMI 11135
Title: Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
Organization: AAMI
Year: 2014
Status: Active
AAMI TIR48
Title: Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
Organization: AAMI
Year: 2015
Status: Active
AAMI CN6
Title: Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
Organization: AAMI
Year: 2015
Status: Inactive
AAMI 5840-1
Title: Cardiovascular implants-Cardiac valve prostheses-Part 1: General requirements
Organization: AAMI
Year: 2015
Status: Active
AAMI 5840-2
Title: Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
Organization: AAMI
Year: 2015
Status: Active
AAMI TIR65
Title: Sustainability of medical devices-Elements of a responsible product life cycle
Organization: AAMI
Year: 2015
Status: Active
AAMI STBK-2
Title: STERILIZATION PART 2: STERILIZATION EQUIPMENT DESIGN AND USE
Organization: AAMI
Status: Inactive
AAMI TIR23810
Title: Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup
Organization: AAMI
Year: 2012
Status: Active
AAMI 80369-5
Title: Small-bore connectors for liquids and gases in healthcare applications-Part 5: Connectors for limb cuff inflation applications
Organization: AAMI
Year: 2016
Status: Active
AAMI 80369-6
Title: Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
Organization: AAMI
Year: 2016
Status: Active
AAMI 16142-1
Title: Medical devices-Recognized essential principles of safety and performance of medical devices-Part 1: General essential principles and additional specific essential principles for all non-IVD medica...
Organization: AAMI
Year: 2016
Status: Active
AAMI 20857
Title: Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
Organization: AAMI
Year: 2010
Status: Active
AAMI TIR14
Title: Contract sterilization using ethylene oxide
Organization: AAMI
Year: 2016
Status: Active
AAMI 15225
Title: Medical devices-Quality management-Medical device nomenclature data structure
Organization: AAMI
Year: 2016
Status: Inactive
AAMI TIR32
Title: Medical device software risk management
Organization: AAMI
Year: 2004
Status: Inactive
AAMI TIR35
Title: Sterilization of health care products- Radiation sterilization- Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
Organization: AAMI
Year: 2016
Status: Active
TIR35
Title: Sterilization of health care products- Radiation sterilization- Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
Organization: AAMI
Year: 2016
Status: Active
AAMI BP22
Title: Blood pressure transducers
Organization: AAMI
Year: 1994
Status: Active
AAMI 80601-2-58
Title: MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY
Organization: AAMI
Status: Active
AAMI 60601-2-27
Title: Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Organization: AAMI
Year: 2011
Status: Active
AAMI 60601-2-25
Title: Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
Organization: AAMI
Year: 2011
Status: Active
AAMI 60601-2-47
Title: Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
Organization: AAMI
Year: 2012
Status: Active
AAMI TIR80001-2-8
Title: Application of risk management for IT networks incorporating medical devices-Part 2-8: Application guidance-Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
Organization: AAMI
Year: 2016
Status: Active
AAMI 15223-1
Title: Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied- Part 1: General requirements
Organization: AAMI
Year: 2016
Status: Active
AAMI TIR56
Title: Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
Organization: AAMI
Year: 2013
Status: Active
AAMI 15674
Title: Cardiovascular implants and artificial organs - Hard-shell cardiotomy/ venous reservoir systems (with/without filter) and soft venous reservoir bags
Organization: AAMI
Year: 2016
Status: Active
AAMI 15675
Title: Cardiovascular implants and artificial organs-Cardiopulmonary bypass systems-Arterial blood line filters
Organization: AAMI
Year: 2016
Status: Active
AAMI TIR13004
Title: Sterilization of health care products-Radiation-Substantiation of a selected sterilization dose: Method VDmax SD
Organization: AAMI
Year: 2013
Status: Active
AAMI 15676
Title: Cardiovascular implants and artificial organs-Requirements for singleuse tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
Organization: AAMI
Year: 2016
Status: Active
AAMI 18241
Title: Cardiovascular implants and extracorporeal systems-Cardiopulmonary bypass systems-Venous bubble traps
Organization: AAMI
Year: 2016
Status: Active
AAMI 18242
Title: Cardiovascular implants and extracorporeal systems-Centrifugal blood pumps
Organization: AAMI
Year: 2016
Status: Active
AAMI TIR19024
Title: Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
Organization: AAMI
Year: 2016
Status: Active
AAMI ST55
Title: Table-top steam sterilizers
Organization: AAMI
Year: 2016
Status: Active
AAMI 14708-3
Title: Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
Organization: AAMI
Year: 2017
Status: Active
AAMI 5367
Title: Anaesthetic and respiratory equipment - Breathing sets and connectors
Organization: AAMI
Year: 2015
Status: Inactive
AAMI 8836
Title: Suction catheters for use in the respiratory tract
Organization: AAMI
Year: 2015
Status: Inactive
AAMI 26782
Title: Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans
Organization: AAMI
Year: 2015
Status: Inactive
AAMI 11137-1
Title: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
Organization: AAMI
Year: 2006
Status: Active
AAMI TIR28
Title: Product adoption and process equivalence for ethylene oxide sterilization
Organization: AAMI
Year: 2016
Status: Active
AAMI ST81
Title: Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices
Organization: AAMI
Year: 2004
Status: Inactive
AAMI 7199
Title: Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
Organization: AAMI
Year: 2016
Status: Active
AAMI 22442-3
Title: Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Organization: AAMI
Year: 2007
Status: Active
AAMI TIR15
Title: Physical aspects of ethylene oxide sterilization
Organization: AAMI
Year: 2016
Status: Active
AAMI CI86
Title: Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
Organization: AAMI
Year: 2017
Status: Active
AAMI 60601-2-2
Title: Medical electrical equipment-Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Organization: AAMI
Year: 2017
Status: Active
AAMI 13408-1
Title: Aseptic processing of health care products - Part 1: General requirements
Organization: AAMI
Year: 2008
Status: Active
AAMI 25539-1
Title: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
Organization: AAMI
Year: 2017
Status: Active
AAMI TIR22442-4
Title: Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays...
Organization: AAMI
Year: 2011
Status: Active
AAMI TIR17665-3
Title: Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization
Organization: AAMI
Year: 2014
Status: Active
AAMI TIR30
Title: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
Organization: AAMI
Year: 2011
Status: Active
AAMI NS28
Title: Intracranial pressure monitoring devices
Organization: AAMI
Year: 1988
Status: Inactive
AAMI TIR59
Title: Integrating human factors into design controls
Organization: AAMI
Year: 2017
Status: Active
AAMI 16142-2
Title: Medical devices-Recognized essential principles of safety and performance of medical devices-Part 2: General essential principles and additional specific essential principles for all IVD medical de...
Organization: AAMI
Year: 2017
Status: Active
AAMI TIR80002-2
Title: Medical device software - Part 2: Validation of software for medical device quality systems
Organization: AAMI
Year: 2017
Status: Active
AAMI ST90
Title: Processing of health care products-Quality management systems for processing in health care facilities
Organization: AAMI
Year: 2017
Status: Active
AAMI 10993-6
Title: Biological evaluation of medical devices-Part 6: Tests for local effects after implantation
Organization: AAMI
Year: 2016
Status: Active
AAMI TIR29
Title: Guide for process characterization and control in radiation sterilization of medical devices
Organization: AAMI
Year: 2012
Status: Active
AAMI 11138-1
Title: Sterilization of health care products-Biological indicators-Part 1: General requirements
Organization: AAMI
Year: 2017
Status: Active
AAMI 11138-2
Title: Sterilization of health care products-Biological indicators-Part 2: Biological indicators for ethylene oxide sterilization processes
Organization: AAMI
Year: 2017
Status: Active
AAMI 11138-4
Title: Sterilization of health care products-Biological indicators-Part 4: Biological indicators for dry heat sterilization processes
Organization: AAMI
Year: 2017
Status: Active
AAMI 11138-5
Title: Sterilization of health care products-Biological indicators-Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
Organization: AAMI
Year: 2017
Status: Active
AAMI 11138-3
Title: Sterilization of health care products-Biological indicators-Part 3: Biological indicators for moist heat sterilization processes
Organization: AAMI
Year: 2017
Status: Active
AAMI 62304
Title: Medical device software - Software life cycle processes
Organization: AAMI
Year: 2006
Status: Active
AAMI TIR39
Title: Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
Organization: AAMI
Year: 2009
Status: Active
AAMI TIR52
Title: Environmental monitoring for terminally sterilized healthcare products
Organization: AAMI
Year: 2014
Status: Active
AAMI 80369-7
Title: Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications
Organization: AAMI
Year: 2016
Status: Active
AAMI 17664
Title: Processing of health care products-Information to be provided by the medical device manufacturer for the processing of medical devices
Organization: AAMI
Year: 2017
Status: Active
AAMI NS4
Title: Transcutaneous electrical nerve stimulators
Organization: AAMI
Year: 2013
Status: Active
AAMI 22442-1
Title: Medical devices utilizing animal tissues and their derivatives-Part 1: Application of risk management
Organization: AAMI
Year: 2016
Status: Active
AAMI 22442-2
Title: Medical devices utilizing animal tissues and their derivatives-Part 2: Controls on sourcing, collection and handling
Organization: AAMI
Year: 2016
Status: Active
AAMI TIR15499
Title: Biological evaluation of medical devices-Guidance on the conduct of biological evaluation within a risk management process
Organization: AAMI
Year: 2017
Status: Active
AAMI TIR50
Title: Post-market surveillance of use error management
Organization: AAMI
Year: 2014
Status: Active
AAMI TIR51
Title: Human factors engineering – Guidance for contextual inquiry
Organization: AAMI
Year: 2014
Status: Active
AAMI RT2
Title: Radiation therapy readiness check
Organization: AAMI
Year: 2017
Status: Active
AAMI TIR16
Title: Microbiological aspects of ethylene oxide sterilization
Organization: AAMI
Year: 2017
Status: Active
AAMI TIR40
Title: Sterilization of health care products-Radiation- Guidance on dose setting utilizing a Modified Method 2
Organization: AAMI
Year: 2018
Status: Active
AAMI 11137-3
Title: Sterilization of health care products-Radiation-Part 3: Guidance on dosimetric aspects of development, validation and routine
Organization: AAMI
Year: 2017
Status: Active
AAMI 11737-1
Title: Sterilization of health care products-Microbiological methods-Part 1: Determination of a population of microorganisms on products
Organization: AAMI
Year: 2018
Status: Active
AAMI TIR63
Title: Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
Organization: AAMI
Year: 2014
Status: Active
AAMI TIR55
Title: Human factors engineering for processing medical devices
Organization: AAMI
Year: 2014
Status: Active
AAMI EQ93
Title: Medical equipment management - Vocabulary used in medical equipment programs
Organization: AAMI
Year: 2018
Status: Active
AAMI TIR72
Title: Dialysis fluid chemical composition
Organization: AAMI
Year: 2017
Status: Active
AAMI 13408-2
Title: Aseptic processing of health care products-Part 2: Sterilizing filtration
Organization: AAMI
Year: 2018
Status: Active
AAMI TIR34
Title: Water for the reprocessing of medical devices
Organization: AAMI
Year: 2014
Status: Active
AAMI ST41
Title: Ethylene oxide sterilization in health care facilities: Safety and effectiveness
Organization: AAMI
Year: 2008
Status: Active
AAMI ST50
Title: Dry heat (heated air) sterilizers
Organization: AAMI
Year: 2004
Status: Active
AAMI ST40
Title: Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
Organization: AAMI
Year: 2004
Status: Active
AAMI TIR10974
Title: Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
Organization: AAMI
Year: 2018
Status: Active
AAMI TIR17
Title: Compatibility of materials subject to sterilization
Organization: AAMI
Year: 2017
Status: Active
AAMI TIR67
Title: Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
Organization: AAMI
Year: 2018
Status: Active
AAMI TIR45
Title: Guidance on the use of AGILE practices in the development of medical device software
Organization: AAMI
Year: 2012
Status: Active
AAMI 60601-2-21
Title: Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
Organization: AAMI
Year: 2009
Status: Active
AAMI ST58
Title: Chemical sterilization and high-level disinfection in health care facilities
Organization: AAMI
Year: 2013
Status: Active
AAMI ST77
Title: Containment devices for reusable medical device sterilization
Organization: AAMI
Year: 2013
Status: Active
AAMI TIR68
Title: Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
Organization: AAMI
Year: 2018
Status: Active
AAMI 60601-2-50
Title: Medical Electrical Equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
Organization: AAMI
Year: 2009
Status: Active
AAMI 5841-3
Title: Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
Organization: AAMI
Year: 2013
Status: Inactive
AAMI 60601-2-19
Title: Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Organization: AAMI
Year: 2009
Status: Active
AAMI 13408-7
Title: Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
Organization: AAMI
Year: 2012
Status: Active
AAMI TIR21900
Title: Guidance for uncertainty analysis regarding the application of ISO/TS 10974
Organization: AAMI
Year: 2018
Status: Active
AAMI 60601-2-20
Title: Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
Organization: AAMI
Year: 2009
Status: Active
AAMI ST8
Title: Hospital steam sterilizers
Organization: AAMI
Year: 2013
Status: Active
AAMI ST24
Title: Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
Organization: AAMI
Year: 1999
Status: Active
AAMI ST65
Title: Processing of reusable Surgical textiles for use in health care facilities
Organization: AAMI
Year: 2008
Status: Active
AAMI HE75
Title: Human factors engineering - Design of medical devices
Organization: AAMI
Year: 2009
Status: Active
AAMI TIR77
Title: Sorbent-based regenerative hemodialysis systems
Organization: AAMI
Year: 2018
Status: Active
AAMI HIT1000-1
Title: Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
Organization: AAMI
Year: 2018
Status: Active
AAMI SW91
Title: Classification of defects in health software
Organization: AAMI
Year: 2018
Status: Active
AAMI 80601-2-35
Title: MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN ME...
Organization: AAMI
Status: Inactive
AAMI 80601-2-30
Title: Medical electrical equipment-Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
Organization: AAMI
Year: 2018
Status: Active
AAMI TIR38
Title: Medical device safety assurance case report guidance
Organization: AAMI
Year: 2019
Status: Active
AAMI 60601-2-4
Title: Medical electrical equipment-Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
Organization: AAMI
Year: 2010
Status: Active
AAMI 2800-1
Title: Standard for Safety for Medical Device Interoperability
Organization: AAMI
Year: 2019
Status: Active
AAMI 11137-2
Title: Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Organization: AAMI
Year: 2013
Status: Active
AAMI TIR80002-3
Title: Medical device software - Part 3: Process reference model of medical device software life cycle processes
Organization: AAMI
Year: 2016
Status: Active
AAMI 2700-1
Title: Medical Devices and Medical Systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements...
Organization: AAMI
Year: 2019
Status: Active
AAMI TIR102
Title: U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
Organization: AAMI
Year: 2019
Status: Active
AAMI 81060-2
Title: Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
Organization: AAMI
Year: 2019
Status: Active
AAMI TIR9
Title: Evaluation of clinical systems for invasive blood pressure monitoring
Organization: AAMI
Year: 1992
Status: Active
AAMI 11607-1
Title: Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems, and packaging
Organization: AAMI
Year: 2019
Status: Active
AAMI 11607-2
Title: Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing, and assembly processes
Organization: AAMI
Year: 2019
Status: Active
AAMI TIR23
Title: Signal Averaging
Organization: AAMI
Year: 1999
Status: Active
AAMI TIR62
Title: Generating reports for the purpose of submitting defibrillation waveform data for evaluation
Organization: AAMI
Year: 2014
Status: Active
AAMI TIR24
Title: Acquisition and use of physiologic waveform databases for testing of medical devices
Organization: AAMI
Year: 1999
Status: Active
AAMI TIR61
Title: Generating reports for human factors design validation results for external cardiac defibrillators
Organization: AAMI
Year: 2014
Status: Active
AAMI TIR97
Title: Principles for medical device security - Postmarket risk management for device manufacturers
Organization: AAMI
Year: 2019
Status: Active
AAMI TIR60
Title: Common mode rejection in ECG monitoring
Organization: AAMI
Year: 2014
Status: Active
AAMI 13485
Title: Medical devices—Quality management systems—Requirements for regulatory purposes
Organization: AAMI
Year: 2016
Status: Active
AAMI TIR21
Title: Systems used to forecast remaining pacemaker battery service life
Organization: AAMI
Year: 2017
Status: Active
AAMI 10993-1
Title: Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
Organization: AAMI
Year: 2018
Status: Active
AAMI 10993-4
Title: Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
Organization: AAMI
Year: 2017
Status: Active
AAMI 10993-11
Title: Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
Organization: AAMI
Year: 2017
Status: Active
AAMI ST72
Title: Bacterial endotoxins— Test methods, routine monitoring, and alternatives to batch testing
Organization: AAMI
Year: 2019
Status: Active
AAMI RD47
Title: Reprocessing of hemodialyzers
Organization: AAMI
Year: 2020
Status: Active
AAMI ST67
Title: Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
Organization: AAMI
Year: 2019
Status: Active
AAMI 14971
Title: Medical devices— Application of risk management to medical devices
Organization: AAMI
Year: 2019
Status: Active
AAMI QUALITY SYSTEM
Title: THE QUALITY SYSTEM COMPENDIUM: REQ & INDUSTRY PRACTICE
Organization: AAMI
Status: Active
AAMI TIR17665-2
Title: Sterilization of health care products – Moist Heat – Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1
Organization: AAMI
Year: 2009
Status: Active
AAMI 80369-1
Title: Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
Organization: AAMI
Year: 2018
Status: Active
AAMI TIR41
Title: Active implantable medical devices— Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pace...
Organization: AAMI
Year: 2011
Status: Active
AAMI 14117
Title: Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
Organization: AAMI
Year: 2019
Status: Active
AAMI TIR49
Title: Design of training and instructional materials for medical devices used in non-clinical environments
Organization: AAMI
Year: 2013
Status: Active
AAMI SPHC
Title: STERILE PROCESSING IN HEALTHCARE FACILITIES PREPARING FOR ACCREDITATION SURVEYS
Organization: AAMI
Status: Active
AAMI TIR57
Title: Technical Information Report: Principles for medical device security—Risk management
Organization: AAMI
Year: 2016
Status: Active
AAMI 80369-3
Title: SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS
Organization: AAMI
Status: Active
AAMI TIR66
Title: Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
Organization: AAMI
Year: 2017
Status: Active
AAMI 11138-7
Title: Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results
Organization: AAMI
Year: 2019
Status: Active
AAMI CR500
Title: Basic Introduction to the IEC 60601 Series
Organization: AAMI
Year: 2019
Status: Active
AAMI 13485 HDBK
Title: Medical devices — A practical guide
Organization: AAMI
Year: 2016
Status: Active
AAMI 23500-3
Title: Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies
Organization: AAMI
Year: 2020
Status: Active
AAMI 23500-2
Title: Preparation and quality management of fluids for haemodialysis and related therapies—Part 2: Water treatment equipment for haemodialysis applications and related therapies
Organization: AAMI
Year: 2020
Status: Active
AAMI 23500-1
Title: Preparation and quality management of fluids for haemodialysis and related therapies—Part 1: General requirements
Organization: AAMI
Year: 2020
Status: Active
AAMI 23500-4
Title: Preparation and quality management of fluids for haemodialysis and related therapies— Part 4: Concentrates for haemodialysis and related therapies
Organization: AAMI
Year: 2020
Status: Active
AAMI 23500-5
Title: Preparation and quality management of fluids for haemodialysis and related therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies
Organization: AAMI
Year: 2020
Status: Active
AAMI RT3
Title: Radiation therapy machine characterization
Organization: AAMI
Year: 2020
Status: Active
AAMI MP80601-2-49
Title: Medical electrical equipment—Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
Organization: AAMI
Year: 2020
Status: Active
AAMI TIR24971
Title: Medical devices— Guidance on the application of ISO 14971
Organization: AAMI
Year: 2020
Status: Active
AAMI 8637-1
Title: Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Organization: AAMI
Year: 2017
Status: Active
AAMI 8637-2
Title: Extracorporeal systems for blood purification—Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
Organization: AAMI
Year: 2018
Status: Active
AAMI 8637-3
Title: Extracorporeal systems for blood purification—Part 3: Plasmafilters
Organization: AAMI
Year: 2018
Status: Active
AAMI HIT1000-4
Title: Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering
Organization: AAMI
Year: 2020
Status: Active
AAMI TIR20416
Title: Medical devices— Post-market surveillance for manufacturers
Organization: AAMI
Year: 2020
Status: Active
AAMI 62366-1
Title: Medical devices—Part 1: Application of usability engineering to medical devices
Organization: AAMI
Year: 2015
Status: Active
AAMI HIT1000-3
Title: Safety and effectiveness of health IT software and systems - Part 3: Application of risk management
Organization: AAMI
Year: 2019
Status: Active
AAMI TIR75
Title: Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
Organization: AAMI
Year: 2019
Status: Active
AAMI TIR105
Title: Risk management guidance for combination products
Organization: AAMI
Year: 2020
Status: Active
AAMI 80601-2-77
Title: Medical electrical equipment—Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
Organization: AAMI
Year: 2020
Status: Active
AAMI 80601-2-78
Title: Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Organization: AAMI
Year: 2020
Status: Active
AAMI TIR12
Title: Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
Organization: AAMI
Year: 2020
Status: Active
AAMI 10993-16
Title: Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
Organization: AAMI
Year: 2017
Status: Active
AAMI EC53
Title: ECG trunk cables and patient leadwires
Organization: AAMI
Year: 2013
Status: Active
AAMI 14155
Title: Clinical investigation of medical devices for human subjects—Good clinical practice
Organization: AAMI
Year: 2020
Status: Active
AAMI TIR71
Title: Guidance for logging of alarm system data
Organization: AAMI
Year: 2017
Status: Active
AAMI TIR69
Title: Risk management of radio-frequency wireless coexistence for medical devices and systems
Organization: AAMI
Year: 2017
Status: Active
AAMI ST79
Title: Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Organization: AAMI
Year: 2017
Status: Active
AAMI TIR74
Title: Change summary for ISO 11135:2014, Sterilization of health care products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices
Organization: AAMI
Year: 2016
Status: Active
AAMI EC12
Title: Disposable ECG electrodes
Organization: AAMI
Year: 2000
Status: Active
AAMI EC57
Title: Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
Organization: AAMI
Year: 2012
Status: Active
AAMI TIR42
Title: Evaluation of particulate associated with vascular medical devices
Organization: AAMI
Year: 2021
Status: Active
PC76
Title: Active implantable medical devices—Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
Organization: AAMI
Year: 2021
Status: Active
TIR76
Title: Sterilization of health care products—Radiation— Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S
Organization: AAMI
Year: 2021
Status: Active
QUALITY SYSTEM COMPENDIUM
Title: The Quality System Compendium CGMP Requiremements and Industry Practice
Organization: AAMI
Year: 2019
Status: Active
TIR48
Title: Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
Organization: AAMI
Year: 2015
Status: Active
TIR34
Title: Water for the reprocessing of medical devices
Organization: AAMI
Year: 2014
Status: Inactive
CR510
Title: Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
Organization: AAMI
Year: 2021
Status: Active
TIR101
Title: Fluid delivery performance testing for infusion pumps
Organization: AAMI
Year: 2021
Status: Active
CN27
Title: General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
Organization: AAMI
Year: 2021
Status: Active
TIR58
Title: Water testing methodologies
Organization: AAMI
Year: 2021
Status: Active
TIR56
Title: Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
Organization: AAMI
Year: 2013
Status: Active
TIR28
Title: Product adoption and process equivalence for ethylene oxide sterilization
Organization: AAMI
Year: 2016
Status: Active
TIR16
Title: Microbiological aspects of ethylene oxide sterilization
Organization: AAMI
Year: 2017
Status: Active
TIR15
Title: Physical aspects of ethylene oxide sterilization
Organization: AAMI
Year: 2016
Status: Active
TIR14
Title: Contract sterilization using ethylene oxide
Organization: AAMI
Year: 2016
Status: Active
62366-1
Title: Medical devices—Part 1: Application of usability engineering to medical devices
Organization: AAMI
Year: 2015
Status: Active
ST91
Title: Flexible and semi-rigid endoscope processing in health care facilities
Organization: AAMI
Year: 2021
Status: Active
CR34971
Title: Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
Organization: AAMI
Year: 2022
Status: Active
TIR104
Title: Guidance on transferring health care products between radiation sterilization sources
Organization: AAMI
Year: 2022
Status: Active
HIT1000-1
Title: Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements
Organization: AAMI
Year: 2022
Status: Active
TIR67
Title: Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
Organization: AAMI
Year: 2018
Status: Active
TIR68
Title: Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
Organization: AAMI
Year: 2018
Status: Active
2700-2-1
Title: Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requiremen...
Organization: AAMI
Year: 2022
Status: Active
TIR100
Title: End-to-end microbiological quality and sterility assurance
Organization: AAMI
Year: 2021
Status: Active
2800-1
Title: Standard for Medical Device Interoperability
Organization: AAMI
Year: 2022
Status: Active
2800-1-1
Title: Standard for Risk Concerns for Interoperable Medical Products
Organization: AAMI
Year: 2022
Status: Active
2800-1-2
Title: Standard for Interoperable Item Development Life Cycle
Organization: AAMI
Year: 2022
Status: Active
2800-1-3
Title: Standard for Interoperable Item Integration Life Cycle
Organization: AAMI
Year: 2022
Status: Active
TIR11137-4
Title: Sterilization of health care products—Radiation—Part 4: Guidance on process control
Organization: AAMI
Year: 2022
Status: Active
ST98
Title: Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices
Organization: AAMI
Year: 2022
Status: Active
TIR35
Title: Sterilization of health care products— Radiation sterilization— Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
Organization: AAMI
Year: 2016
Status: Active
60601-1-12 REDLINE
Title: Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical sy...
Organization: AAMI
Year: 2016
Status: Active
60601-2-16
Title: Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Organization: AAMI
Year: 2018
Status: Active
TIR43
Title: Ultrapure dialysis fluid for hemodialysis and related therapies
Organization: AAMI
Year: 2021
Status: Active
TIR62354
Title: General testing procedures for medical electrical equipment
Organization: AAMI
Year: 2015
Status: Active
TIR65
Title: Sustainability of medical devices—Elements of a responsible product life cycle
Organization: AAMI
Year: 2015
Status: Active
27185
Title: Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements
Organization: AAMI
Year: 2012
Status: Active
25539-3
Title: Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
Organization: AAMI
Year: 2011
Status: Active
15882
Title: Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
Organization: AAMI
Year: 2008
Status: Active
11140-3
Title: Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
Organization: AAMI
Year: 2007
Status: Active
11140-4
Title: Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
Organization: AAMI
Year: 2007
Status: Active
11140-5
Title: Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
Organization: AAMI
Year: 2007
Status: Active
15223-2
Title: Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied— Part 2: Symbol development, selection and validation
Organization: AAMI
Year: 2010
Status: Active
10993-15
Title: Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
Organization: AAMI
Year: 2019
Status: Active
11737-2
Title: Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Organization: AAMI
Year: 2019
Status: Active
STBK-S
Title: AAMI STERILIZATION STANDARDS BOOK COLLECTION
Organization: AAMI
Year: 2013
Status: Inactive
HE75/62366 SET CD
Title: HUMAN FACTORS COLLECTION CD (INCLUDES AAMI HE75 AND AAMI 62366)
Organization: AAMI
Year: 2013
Status: Inactive
60601-1-2 REDLINE
Title: Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance— Collateral standard: Electromagnetic disturbances—Requirements and tests
Organization: AAMI
Year: 2014
Status: Active
60601-1-8 REDLINE
Title: Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance for alarm systems in medical elec...
Organization: AAMI
Year: 2006
Status: Active
ES60601-1 REDLINE
Title: Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
Organization: AAMI
Year: 2005
Status: Active
HA60601-1-11 REDLINE
Title: Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical sy...
Organization: AAMI
Year: 2015
Status: Active
PB70
Title: Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
Organization: AAMI
Year: 2022
Status: Active
5840-1
Title: Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements
Organization: AAMI
Year: 2022
Status: Active
5840-2
Title: Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
Organization: AAMI
Year: 2022
Status: Active


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