AAMI Collection
This collection contains documents from the following standards organization(s): Association for the Advancement of Medical Instrumentation 1 2 3 > >
| AAMI 10993-11 | EN-Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | |
| AAMI 10993-12 | EN-Biological evaluation of medical devices - Part 12: Sample preparation and reference materials | |
| AAMI 10993-13 | EN-Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric devices. | |
| AAMI 10993-14 | EN-BIOLOGICAL EVALUATION OF MEDICAL DEVICES PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCT FROM CERAMICS | |
| AAMI 10993-15 | EN-Biological evaluation of medical devices- Part 15: Identification and quantification of degradation products from metals and alloys | |
| AAMI 10993-16 | EN-Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables | |
| AAMI 10993-17 | EN-Biological evaluation of medical devices- Part 17: Methods for the establishment of allowable limits for leachable substances | |
| AAMI 10993-2 | EN-Biological evaluation of medical devices - Part 2: Animal welfare requirements | |
| AAMI 10993-3 | EN-Biological evaluation of medical devices-Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity | |
| AAMI 10993-4 | EN-Biological evaluation of medical devices- Part 4: Selection of tests for interaction with blood-Incorporates Amendment 1: 2006 | |
| AAMI 10993-5 | EN-Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | |
| AAMI 10993-6 | EN-BIOLOGICAL EVALUATION OF MEDICAL DEVICES PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION | |
| AAMI 10993-7 | EN-Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals-Includes Errata: January 22 2010 | |
| AAMI 10993-8 | EN-Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests | |
| AAMI 10993-9 | EN-Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products | |
| AAMI 11134 | EN-Sterilization of health care products?Requirements for validation and routine control?Industrial moist heat sterilization | |
| AAMI 11135-1 | EN-Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development validation and routine control of a sterilization process for medical devices | |
| AAMI 11137 | EN-Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization-Includes Amendment 1: 2002 | |
| AAMI 11137 | EN-Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization | |
| AAMI 11137-1 | EN-Sterilization of health care products-Radiation-Part 1: Requirements for development validation and routine control of a sterilization process for medical devices | |
| AAMI 11137-2 | EN-Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose-Also replaces AAMI ST31 AAMI ST32 AAMI TIR5 and AAMI TIR27 | |
| AAMI 11137-3 | EN-Sterilization of health care products-Radiation-Part 3: Guidance on dosimetric aspects | |
| AAMI 11138-1 | EN-Sterilization of health care products - Biological indicators - Part 1: General requirements | |
| AAMI 11138-2 | EN-Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes | |
| AAMI 11138-3 | EN-Sterilization of health care products-Biological indicators-art 3: Biological indicators for moist heat sterilization processes | |
| AAMI 11138-4 | EN-Sterilization of health care products-Biological indicators-Part 4: Biological indicators for dry heat sterilization processes | |
| AAMI 11138-5 | EN-Sterilization of health care products-Biological indicators-Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes | |
| AAMI 11140-1 | EN-Sterilization of health care products-Chemical indicators-Part 1: General requirements | |
| AAMI 11140-3 | EN-Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test | |
| AAMI 11140-4 | EN-Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration | |
| AAMI 11140-5 | EN-Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests | |
| AAMI 11607 | EN-Packaging for Terminally Sterilized Medical Devices | |
| AAMI 11607-1 | EN-Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging | |
| AAMI 11607-2 | EN-Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming sealing and assembly processes | |
| AAMI 11737-1 | EN-Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products | |
| AAMI 11737-1 | EN-Sterilization of Medical Devices - Microbiological Methods - Part 1: Estimation of the Population of Microorganisms on Product-FDA RECOGNIZED | |
| AAMI 11737-2 | EN-Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition validation and maintenance of a sterilization process | |
| AAMI 11737-3 | EN-Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data-FDA RECOGNIZED | |
| AAMI 13408-1 | EN-Aseptic processing of health care products - Part 1: General requirements | |
| AAMI 13408-2 | EN-Aseptic processing of health care products - Part 2: Filtration | |
| AAMI 13408-3 | EN-Aseptic processing of health care products - Part 3: Lyophilization | |
| AAMI 13408-4 | EN-Aseptic processing of health care products - Part 4: Clean-in-place technologies | |
| AAMI 13408-5 | EN-Aseptic processing of health care products - Part 5: Sterilization in place | |
| AAMI 13408-6 | EN-Aseptic processing of health care products - Part 6: Isolator systems | |
| AAMI 13485 | EN-Medical devices-Quality management systems-Requirements for regulatory purposes | |
| AAMI 13488 | EN-Quality systems-Medical devices-Particular requirements for the application of ISO 9002 | |
| AAMI 14155-1 | EN-Clinical investigation of medical devices for human subjects - Part 1: General requirements | |
| AAMI 14155-2 | EN-Clinical investigation of medical devices for human subjects-Part 2: Clinical investigation plans | |
| AAMI 14160 | EN-Sterilization of single-use medical devices incorporating materials of animal origin-Validation and routine control of sterilization by liquid chemical sterilants | |
| AAMI 14161 | EN-Sterilization of health care products - Biological indicators - Guidance for the selection use and interpretation of results | |
| AAMI 14708-3 | EN-Implants for surgery-Active implantable medical devices-Part 3: Implantable neurostimulators | |
| AAMI 14708-4 | EN-Implants for surgery-Active implantable medical devices-Part 4: Implantable infusion pumps | |
| AAMI 14708-5 | EN-Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices | |
| AAMI 14937 | EN-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 devices | |
| AAMI 14971 | EN-Medical devices - Application of risk management to medical devices | |
| AAMI 14971 ERTA | EN-Medical devices - Application of risk management to medical devices | |
| AAMI 15223-1 | EN-Medical devices - Symbols to be used with medical device labels labeling and information to be supplied - Part 1: General requirements-Incorporates Amendment 1: 2008 | |
| AAMI 15225 | EN-NOMENCLATURE - SPECIFICATION FOA A NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSE OF REGULATORY DATA EXCHANGE-Includes Amendment 1: 2004 | |
| AAMI 15674 | EN-Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags | |
| AAMI 15675 | EN-Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters | |
| AAMI 15882 | EN-Sterilization of health care products - Chemical indicators - Guidance for selection use and interpretation of results | |
| AAMI 17665-1 | EN-Sterilization of health care products - Moist heat - Part 1 Requirements for the development validation and routine control of a sterilization process for medical devices-Former Designation: AAMI ST25 | |
| AAMI 18472 | EN-Sterilization of health care products - Biological and chemical indicators - Test equipment | |
| AAMI 22442-1 | EN-Medical devices utilizing animal tissues and their derivatives-Part 1: Application of risk management | |
| AAMI 22442-2 | EN-Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing collection and handling | |
| AAMI 22442-3 | EN-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 | |
| AAMI 25539-1 | EN-Cardiovascular implants-Endovascular devices-Part 1: Endovascular prostheses Amendment 1: Test methods-Incorporates Amendment 1: 2005 | |
| AAMI 25539-2 | EN-Cardiovascular implants - Endovascular devices - Part 2: Vascular stents | |
| AAMI 5840 | EN-Cardiovascular implants- Cardiac valve prostheses | |
| AAMI 60601-1-2 | EN-Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | |
| AAMI 60601-2-19 | EN-Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | |
| AAMI 60601-2-2 | EN-Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories | |
| AAMI 60601-2-20 | EN-Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators | |
| AAMI 60601-2-21 | EN-Medical Electrical Equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers | |
| AAMI 60601-2-50 | EN-Medical Electrical Equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment | |
| AAMI 62304 | EN-Medical device software - Software life cycle processes | |
| AAMI 7198 | EN-Cardiovascular implants-Tubular vascular prostheses | |
| AAMI 7199 | EN-Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) | |
| AAMI 80601-2-30 | EN-Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers-consolidated reprint C1: 2009 |
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