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美国标准

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  如下标准清单是与本司技术服务相关的部分标准清单,当标准化组织发布新标准后,本司将有专人跟进,随之更新。如您有任何需求或建议,请联系我们。标准清单更新时间:2014/3/18

标准类别

标准号

标准名称

包装类

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

湿热灭菌

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)

干热灭菌

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灭菌

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).

辐照灭菌

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

生物指示剂

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

化学指示剂

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

生物和化学指示剂

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

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

灭菌通用要求

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

医用器械的灭菌 微生物学方法

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