| Medical Device Standards |
AAMI RD5
Hemodialysis Systems |
AAMI RD16
Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators |
AAMI RD17
Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters |
AAMI RD47
Reprocessing of hemodialyzers - FDA Recognized |
AAMI RD52
Dialysate for hemodialysis, Amendment 1 - Annex C: Special considerations for home hemodialysis and Amendment 2 - Annex D: Self-assessment of compliance with recommendations for dialysate preparation |
AAMI ST77
Containment devices for reusable medical device sterilization |
AAMI TIR14969
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 |
AAMI TIR12
Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers - 2nd Edition |
ASTM E 2500
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
ASTM F 1980
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
ASTM F 2528
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon |
ASTM F 2567
Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials |
BS EN ISO 22442-3
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 |
BS EN 980
Symbols For Use In The Labelling Of Medical Devices |
BS EN 1041
Information supplied by the manufacturer of medical devices |
BS EN ISO 22442-1
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
BS EN 45502-2-1
Active implantable medical devices Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) - Supersedes BS 6902-1: 1990 and BS 6902-1: Supplement No 1: 1996 |
BS EN 556-1
Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices - CORR 16728: October 31, 2006; Supersedes BS EN 556:1995 |
BS EN ISO 11607-1
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems - Supersedes BS EN 868-1: 1997 |
BS EN ISO 14971
Medical devices - Application of risk management to medical devices |
BS EN ISO 22442-2
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling |
IEC 60601-1
Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance |
IEC 60601-1-2
Medical Electrical Equipment Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests |
IEC 61223-3-1
Evaluation and Routine Testing in Medical Imaging Departments - Part 3-1: Acceptance Tests - Imaging Performance of X-Ray Equipment for Radiographic and Radioscopic Systems - First Edition |
IEC 61223-3-2
Evaluation and routine testing in medical imaging departments – Part 3-2: Acceptance tests – Imaging performance of mammographic X-ray equipment - Edition 2.0 |
IEC 61223-3-3
Evaluation and routine testing in medical imaging departments Part 3-3: Acceptance tests Imaging performance of X-ray equipment for digital subtraction angiography (DSA) |
IEC 61223-3-4
Evaluation and Routine Testing in Medical Imaging Departments - Part 3-4: Acceptance Tests - Imaging Performance of Dental X-Ray Equipment - First Edition |
IEC 62304
Medical Device Software - Software Life Cycle Processes |
IEC 62366
Medical Devices - Application Of Usability Engineering To Medical Devices |
IEEE 1584
Guide For Performing Arc-Flash Hazard Calculations |
ISO 10993-1
Biological evaluation of medical devices Part 1: Evaluation and testing |
ISO 10993-4
Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood |
ISO 10993-6
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation |
ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity |
ISO 10993-11
Biological evaluation of medical devices Part 11: Tests for systemic toxicity |
ISO 10993-12
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Third Edition |
ISO 11135-1
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - First Edition |
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 - First Edition |
ISO 11140-5
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
ISO 11607-1
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems - First edition |
ISO 11607-2
Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
ISO 11737-1
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products |
ISO 11810-2
Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition |
ISO 13485
Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes |
ISO 14971
Medical Devices - Application Of Risk Management To Medical Devices |
ISO 15223-1
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements |
ISO TR 14969
Medical Devices - Quality Management System - Guidance On The Application Of ISO 13485:2003 |