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IEEE - ANSI N42.45 - AMERICAN NATIONAL STANDARD FOR EVALUATING THE IMAGE QUALITY OF X-RAY COMPUTED TOMOGRAPHY (CT) SECURITY-SCREENING SYSTEMS Organization: IEEE
Date: 2011-01-01
Description: This standard provides test methods for the evaluation of image quality of computed tomography (CT) security-screening systems. The quality of data for automated analysis is the primary concern.
DS/EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) Organization: DS
Date: 2015-07-06
Description: ISO 11137-1:2006 does not: specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease; detail specified requirements for designating a medical device as sterile; specify a quality management system for the control of all stages of production of medical devices; specify requirements for occupational safety associated with the design and operation of irradiation facilities; specify requirements for the sterilization of used or reprocessed devices.
NBN EN ISO 11137-1 FR - STÉRILISATION DES PRODUITS DE SANTÉ - IRRADIATION - PARTIE 1: EXIGENCES RELATIVES À LA MISE AU POINT, À LA VALIDATION ET AU CONTRÔLE DE ROUTINE D'UN PROCÉDÉ DE STÉRILISATION POUR LES DISPOSITIFS MÉDICAUX (ISO 11137-1:2006, Y COMPRIS AMD 1:2013) Organization: NBN
Date: 2015-07-24
Description: ISO 11137-1:2006 does not:specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;detail specified requirements for designating a medical device as sterile;specify a quality management system for the control of all stages of production of medical devices;specify requirements for occupational safety associated with the design and operation of irradiation facilities;specify requirements for the sterilization of used or reprocessed devices.
NBN - EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) Organization: NBN
Date: 2015-07-24
Description: ISO 11137-1:2006 does not:specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;detail specified requirements for designating a medical device as sterile;specify a quality management system for the control of all stages of production of medical devices;specify requirements for occupational safety associated with the design and operation of irradiation facilities;specify requirements for the sterilization of used or reprocessed devices.
NBN - EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) Organization: NBN
Date: 2015-07-24
Description: ISO 11137-1:2006 does not:specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;detail specified requirements for designating a medical device as sterile;specify a quality management system for the control of all stages of production of medical devices;specify requirements for occupational safety associated with the design and operation of irradiation facilities;specify requirements for the sterilization of used or reprocessed devices.
DIN EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) Organization: DIN
Date: 2015-11-01
Description: NOTE It is not a requirement of this part of ISO 11137 to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4).
ISO/ASTM 52303 - GUIDE FOR ABSORBED-DOSE MAPPING IN RADIATION PROCESSING FACILITIES - FIRST EDITION Organization: ISO
Date: 2015-07-15
Description: Dosimetry is an element of a total quality management system for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.
ASTM E2303 - STANDARD GUIDE FOR ABSORBED-DOSE MAPPING IN RADIATION PROCESSING FACILITIES Organization: ASTM
Date: 2011-07-01
Description: Dosimetry is an element of a total quality management system for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.
ASTM ISO/ASTM 52303 - STANDARD GUIDE FOR ABSORBED-DOSE MAPPING IN RADIATION PROCESSING FACILITIES Organization: ASTM
Date: 2015-02-09
Description: Dosimetry is an element of a total quality management system for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.
ISO 14470 - FOOD IRRADIATION — REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF THE PROCESS OF IRRADIATION USING IONIZING RADIATION FOR THE TREATMENT OF FOOD - FIRST EDITION Organization: ISO
Date: 2011-12-01
Description: This International Standard covers irradiation processes using the radionuclides 60Co or 137Cs, electron beams or X-ray generators. The requirements given in this International Standard are the minimum necessary to control the food irradiation process.
CEN - EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: CEN
Date: 2015-06-01
Description: NOTE It is not a requirement of this part of ISO 11137 to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4).
AAMI - 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS—RADIATION—PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION, AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES - INCORPORATES AMENDMENT 1: 2013 Organization: AAMI
Date: 2006-01-01
Description: NOTE It is not a requirement of this part of ISO 11137 to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4).
CRC - HYBRID SPECT/CT IMAGING I - HYBRID SPECT/CT IMAGING IN CLINICAL PRACTICE Organization: CRC
Date: 2006-05-22
Description: It consisted of a dual-detector gamma camera combined with a single-slice, low-power X-ray CT system. Each modality is imaged separately and sequentially during a single patient examination.

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