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ANSI/AAMI/ISO  Standards:
1ANSI/AAMI/ISO 11134-1993  (Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization
2ANSI/AAMI/ISO 10993-1-2003  Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests
3ANSI/AAMI/ISO 10993-10-1995  Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization
4ANSI/AAMI/ISO 10993-11-1993  Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (included in ANSI/AAMI/ISO 10993-1993: A collection)
5ANSI/AAMI/ISO 10993-12-2002  Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
6ANSI/AAMI/ISO 10993-14-2001  Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics
7ANSI/AAMI/ISO 10993-15-2000  Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys
8ANSI/AAMI/ISO 10993-16-1997  Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design for Degradation Products and Leachables
9ANSI/AAMI/ISO 10993-17-2002  Biological Evaluation of Medical Devices - Part 17: Establishment of Allowable Limits for Leachable Substances
10ANSI/AAMI/ISO 10993-2-1993  Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements (included in ANSI/AAMI/ISO 10993-1993: A collection)
11ANSI/AAMI/ISO 10993-3-2003  Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity (included in ANSI/AAMI/ISO 10993-1993: A collection)
12ANSI/AAMI/ISO 10993-4-2002  Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
13ANSI/AAMI/ISO 10993-5-1999  Biological Evaluation of Medical Devices - Part 5: Test for Cytotoxicity: In Vitro Methods (included in ANSI/AAMI/ISO 10993-1993: A collection)
14ANSI/AAMI/ISO 10993-7-1995  Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
15ANSI/AAMI/ISO 10993-8-2000  Biological Evaluation of Medical Devices - Part 8: Guidance on the Selection and Qualification of Reference Material for Biological Tests
16ANSI/AAMI/ISO 10993-9-1999  Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products
17ANSI/AAMI/ISO 10993-1 to 10993-6 hehao 10993-11-1993  Biological Evaluation of Medical Devices - Parts 1 to 6 hehao 11: A Collection
18ANSI/AAMI/ISO 5840-1996  Cardiovascular Implants - Cardiac Valve Prostheses
19ANSI/AAMI/ISO 25539-1-2003  Cardiovascular Implants - Endovascular Devices - Part 1: Endovascular Prostheses
20ANSI/AAMI/ISO 15675-2001  Cardiovascular Implants and Artificial Organs - Cardiopulmonary Bypass Systems - Arterial Blood Line Filters
21ANSI/AAMI/ISO 15674-2001  Cardiovascular Implants and Artificial Organs - Hard-Shell Cardiotomy/Venous Reservoir System (with/without filter) and Soft Venous Reservoir Bags
22ANSI/AAMI/ISO 7199-1996  Cardiovascular implants and artificial organs- Blood-gas exchangers (oxygenators)
23ANSI/AAMI/ISO 14155-1996  Clinical Investigation of Medical Devices
24ANSI/AAMI/ISO 14155-2-2003  Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
25ANSI/AAMI/ISO 14161-2000  Guideline for the Use of Ethylene Oxide and Steam Biological Indicators in Industrial Sterilization Processes
26ANSI/AAMI/ISO 14971/A1-2000  Medical Devices - Application of Risk Management to Medical Devices - Amendment 1: Annex H - Rationale for the Requirements
27ANSI/AAMI/ISO 14971-2000  Medical Devices - Risk Management - Part 1: Application of Risk Analysis to Medical Devices
28ANSI/AAMI/ISO 11135-1994  Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
29ANSI/AAMI/ISO 15223/A2-2004  Medical devices- Symbols to be used with medical device labels, labelling and information to be supplied - Amendment 2
30ANSI/AAMI/ISO 15225-A1-2004  Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (AMENDMENT 1) pose of Regulatory Data Exchange
31ANSI/AAMI/ISO 11607-1997  Packaging for Terminally Sterilized Medical Devices
32ANSI/AAMI/ISO 13485-2003  Quality Management Systems - Medical Devices - System Requirements for Regulatory Purposes
33ANSI/AAMI/ISO 14969-1999  Quality Systems - Medical Devices - Guidance on the Application of ISO 13485 and ISO 13488
34ANSI/AAMI/ISO 13488-1996  Quality Systems - Medical Devices - Particular Requirements for The Application of ISO 9002
35ANSI/AAMI/ISO 14937-2000  Sterilization of Health Care Products - General Requirements for Characteristics of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process
36ANSI/AAMI/ISO 11737-2-1998  Sterilization of Health Care Products - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process
37ANSI/AAMI/ISO 11137-1994/A1-2002  Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization
38ANSI/AAMI/ISO 11137/A1-2002  Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization
39ANSI/AAMI/ISO 11137-1994  Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization
40ANSI/AAMI/ISO 11737-1-1995  Sterilization of Medical Devices - Microbiological Methods - Part 1: Estimation of the Population of Microorganisms on Product
41ANSI/AAMI/ISO 11737-3-2004  Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data
42ANSI/AAMI/ISO 14160-1998  Sterilization of Medical Devices - Validation and Routine Control of the Sterilization by use of Liquid Chemical Sterilants of Single-Use Medical Devices Incorporating Materials of Animal Origin
43ANSI/AAMI/ISO 7198-2001  Vascular Graft Prostheses
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