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  • 1

American Standard

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The list of standard on technical service is as follows. Once the new standards are issued by the standardization body, we will update the list. If you have any needs or suggestions, please contact us. Update Time: Mar.18th, 2014.

Category

Standard No.

Standard title

Packaging

ANSI/AAMI/ISO 11607-1:2006/(R)2010

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging

ANSI/AAMI/ISO 11607-2:2006/(R)2010

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

AAMI TIR 22-2007

Guidance for ansi/aami/iso 11607,packaging for terminally sterilized medical devices. Part 1 and part 2:2006 incorporates amendment 1:2008

AAMI TIR17:2008

Compatibility of materials subject to sterilization

Moist heat sterilization

ANSI/AAMI/ISO 17665-1:2006/(R) 2013

Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices.

ANSI/AAMI/ISO TIR17665-2:2009

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1

ANSI/AAMI ST8:2013

Hospital steam sterilizers.

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013

ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, 2nd edition (Incorporates Amendment 1:2010, A2,2011, A3:2012, and A4:2013)

Dry heat sterilization

ANSI/AAMI/ISO 20857:2010

Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices.

EO sterilization

ANSI/AAMI/ISO 11135-1:2007

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

ANSI/AAMI/ISO TIR11135-2:2008

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1

AAMI TIR14:2009

Contract sterilization using ethylene oxide 

AAMI TIR15:2009/(R) 2013

Physical aspects of ethylene oxide sterilization.

AAMI TIR16:2009/(R) 2013

Microbiological aspects of ethylene oxide sterilization.

AAMI TIR28:2009/(R) 2013

Product adoption and process equivalence for ethylene oxide sterilization.

ANSI/AAMI/ISO 10993-7:2008/(R)2012

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

ANSI/AAMI ST24:1999/(R)2013

ST24 Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3rd edition

ANSI/AAMI ST41:2008/(R)2012

ST41 Ethylene oxide sterilization in health care facilities: Safety and effectiveness, 4th edition (Incorporates 2010 Erratum).

Irradiation sterilization

ANSI/AAMI/ISO 11137-1-2006/(R)2010

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ANSI/AAMI/ISO 11137-2:2013

11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

ANSI/AAMI/ISO 11137-3-2006/(R)2010

11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects

AAMI TIR33:2005

TIR33 Sterilization of health care products - Radiation sterilization - Substantiation of a selected sterilization dose - Method VDmax

AAMI TIR35:2006

TIR35 Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits

AAMI TIR37:2007

TIR37 Sterilization of health care products -- Radiation -- Guidance on sterilization of human tissue-based products

AAMI TIR40:2009

TIR40 Sterilization of health care products -- Radiation -- Guidance on dose setting utilizing a Modified Method 2

AAMI TIR29:2012

TIR29 Guide for process control in radiation sterilization

Biological indicator

ANSI/AAMI/ISO 11138-1:2006/(R)2010

11138-1 Sterilization of health care product — Biological indicators — Part 1: General requirements, 2nd edition

ANSI/AAMI/ISO 11138-2:2006/(R)2010

11138-2 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes, 3rd edition

ANSI/AAMI/ISO 11138-3:2006/(R)2010

11138-3 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes, 1st edition

ANSI/AAMI/ISO 11138-4:2006/(R)2010

11138-4 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes, 1st edition

ANSI/AAMI/ISO 11138-5:2006/(R)2010

11138-5 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes, 1st edition

ANSI/AAMI/ISO 14161:2009

14161 Sterilization of health care products — Biological indicators — Guidance for the selection, use, and interpretation of results, 2nd edition

Chemical indicator

ANSI/AAMI/ISO 11140-1:2005/(R)2010

11140-1 Sterilization of health care products—Chemical indicators — Part 1: General requirements

ANSI/AAMI/ISO 11140-3:2007/(R)2012

11140-3 Sterilization of health care products—Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test

ANSI/AAMI/ISO 11140-4:2007/(R)2012

11140-4 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

ANSI/AAMI/ISO 11140-5:2007/(R)2012

11140-5 Sterilization of health care products—Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs

ANSI/AAMI/ISO 15882:2008/(R)2013

15882 Chemical indicators — Guidance for the selection, use, and interpretation of results, 3rd edition

Biological and chemical indicator

ANSI/AAMI/ISO 18472:2006/(R)2010

18472 Sterilization of health care products — Biological and chemical indicators — Test equipment, 1st edition

General requirements for sterilization

ANSI/AAMI/ISO 14937:2009/(R) 2013

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.

ANSI/AAMI ST58:2013

Chemical sterilization and high-level disinfection in health care facilities.

AAMI TIR31:2008

TIR31 Process challenge devices/test packs for use in health care facilities, 1st edition

Sterilization of medical devices Microbiological methods

ANSI/AAMI/ISO 11737-1:2009

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products   

ANSI/AAMI/ISO 11737-2:2009

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process