Search Within AAMI
SP10
Title:
Electronic or Automated Sphygmomanometers
Organization: AAMI
Year: 2002
Status: Inactive
RD61
Title:
Concentrates for hemodialysis
Organization: AAMI
Year: 2006
Status: Inactive
SP10 AMD 2
Title:
Amendment 2 to ANSI/AAMI SP10:2002, Manual, electronic and automated sphygmomanometers
Organization: AAMI
Year: 2006
Status: Inactive
TAR10-331
Title:
Hemodialyzer Reuse: Issues and Solutions
Organization: AAMI
Year: 1985
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
BIOT2 PT 11
Title:
Part 11: Tests for Systemic Toxicity
Organization: AAMI
Year: 1998
Status: Inactive
BIOT2 PT 6
Title:
Part 6: Tests for Local Effects After Implantation
Organization: AAMI
Year: 1998
Status: Inactive
BIOT2 PT 2
Title:
Part 2: Animal Welfare Requirements
Organization: AAMI
Year: 1998
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
BIOT2 PT 3
Title:
Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
Organization: AAMI
Year: 1998
Status: Inactive
BIOT2 PT 4
Title:
Part 4: Selection of Tests for Interactions with Blood
Organization: AAMI
Year: 1998
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
HF18 ERTA
Title:
Electrosurgical Devices
Organization: AAMI
Year: 2001
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
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
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
BIOT2 PT 12
Title:
Part 12: Sample preparation and Reference Materials
Organization: AAMI
Year: 1998
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
BIOT2 PT 1
Title:
Part 1: Guidance on Selection of Tests
Organization: AAMI
Year: 1998
Status: Inactive
MDS-331
Title:
Developing Safe, Effective, and Reliable Medical Software
Organization: AAMI
Year: 1991
Status: Inactive
ECAR
Title:
Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms
Organization: AAMI
Year: 1987
Status: Inactive
BIOT2 PT 10
Title:
Part 10: Tests for Irritation and Sensitization
Organization: AAMI
Year: 1998
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
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
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
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
PROC
Title:
AAMI STANDARDS PROGRAM National and International (U.S. TAG) Policies and Procedures Manuals
Organization: AAMI
Year: 2007
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
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
CEC
Title:
The Clinical Engineering Collection
Organization: AAMI
Year: 2010
Status: Active
STBK-2
Title:
Sterilization Part 2: Sterilization Equipment Design and Use
Organization: AAMI
Year: 2010
Status: Active
SPHC
Title:
Sterile Processing In Healthcare Facilities Preparing for Accreditation Surveys
Organization: AAMI
Year: 2014
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
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 medi...
Organization: AAMI
Year: 2009
Status: Inactive
80601-2-35 AMD 1
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
Year: 2016
Status: Inactive
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
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
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
5840-3
Title:
Cardiovascular implants-Cardiac valve prostheses-Part 3: Heart valve substitutes implanted by transcatheter techniques
Organization: AAMI
Year: 2022
Status: Active
18472
Title:
Sterilization of health care products-Biological and chemical indicators-Test equipment
Organization: AAMI
Year: 2022
Status: Active
TIR11
Title:
Selection and use of protective apparel and surgical drapes in health care facilities
Organization: AAMI
Year: 2005
Status: Active
TIR40
Title:
Sterilization of health care products-Radiation- Guidance on dose setting utilizing a Modified Method 2
Organization: AAMI
Year: 2018
Status: Active
EQ89
Title:
Guidance for the use of medical equipment maintenance strategies and procedures
Organization: AAMI
Year: 2015
Status: Active
TIR63
Title:
Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
Organization: AAMI
Year: 2014
Status: Active
15223-1
Title:
Medical devices-Symbols to be used with information to be supplied by the manufacturer- Part 1: General requirements
Organization: AAMI
Year: 2022
Status: Active
TIR22456
Title:
Sterilization of health care products-Microbiological methods-Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
Organization: AAMI
Year: 2022
Status: Active
SW96
Title:
Standard for medical device security-Security risk management for device manufacturers
Organization: AAMI
Year: 2023
Status: Active
ST55
Title:
Table-top steam sterilizers
Organization: AAMI
Year: 2016
Status: Active
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, glasswa...
Organization: AAMI
Year: 2013
Status: Active
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
TIR52
Title:
Environmental monitoring for terminally sterilized healthcare products
Organization: AAMI
Year: 2014
Status: Active
ST15883-1
Title:
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
Organization: AAMI
Year: 2009
Status: Active
TIR45
Title:
Guidance on the use of AGILE practices in the development of medical device software
Organization: AAMI
Year: 2023
Status: Active
TIR57
Title:
Principles for medical device security-Risk management
Organization: AAMI
Year: 2016
Status: Active
TIR97
Title:
Principles for medical device security-Postmarket risk management for device manufacturers
Organization: AAMI
Year: 2019
Status: Active
17664-1
Title:
Processing of health care products-Information to be provided by the medical device manufacturer for the processing of medical devices-Part 1: Critical and semi-critical medical devices
Organization: AAMI
Year: 2022
Status: Active
17664-2
Title:
Processing of health care products-Information to be provided by the medical device manufacturer for the processing of medical devices-Part 2: Non-critical medical devices
Organization: AAMI
Year: 2022
Status: Active
TIR34971
Title:
Application of ISO 14971 to machine learning in artificial intelligence-Guide
Organization: AAMI
Year: 2023
Status: Active
11137-3
Title:
Sterilization of health care products-Radiation-Part 3: Guidance on dosimetric aspects of development, validation and routine control
Organization: AAMI
Year: 2017
Status: Active
ST108
Title:
Water for the processing of medical devices
Organization: AAMI
Year: 2023
Status: Active
TIR16775
Title:
Packaging for terminally sterilized medical devices- Guidance on the application of ISO 11607-1 and ISO 11607-2
Organization: AAMI
Year: 2023
Status: Active
TIR21387
Title:
Sterilization of health care products-Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
Organization: AAMI
Year: 2023
Status: Active
11138-8
Title:
Sterilization of health care products-Biological indicators-Part 8: Method for validation of a reduced incubation item for a biological indicator
Organization: AAMI
Year: 2023
Status: Active
10993-11
Title:
Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
Organization: AAMI
Year: 2017
Status: Active
TIR39
Title:
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
Organization: AAMI
Year: 2009
Status: Active
60601-2-39
Title:
Medical electrical equipment-Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Organization: AAMI
Year: 2018
Status: Active
TIR60878
Title:
Graphical symbols for electrical equipment in medical practice
Organization: AAMI
Year: 2015
Status: Active
TIR62366-2
Title:
Medical devices-Part 2: Guidance on the application of usability engineering to medical devices
Organization: AAMI
Year: 2016
Status: Active
TIR17
Title:
Compatibility of materials subject to sterilization
Organization: AAMI
Year: 2017
Status: Active
10993-13
Title:
Biological evaluation of medical devices-Part 13: Identification and quantification of degradation products from polymeric devices
Organization: AAMI
Year: 2010
Status: Active
10993-14
Title:
Biological evaluation of medical devices-Part 14: Identification and quantification of degradation products from ceramics
Organization: AAMI
Year: 2001
Status: Active
10993-3
Title:
Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Organization: AAMI
Year: 2014
Status: Active
10993-5
Title:
Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
Organization: AAMI
Year: 2009
Status: Active
10993-16
Title:
Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables
Organization: AAMI
Year: 2020
Status: Active
TIR11137-4
Title:
Sterilization of health care products-Radiation-Part 4: Guidance on process control
Organization: AAMI
Year: 2022
Status: Active
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
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
TIR62366-2
Title:
Medical devices-Part 2: Guidance on the application of usability engineering to medical devices
Organization: AAMI
Year: 2016
Status: Active