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  • 1

ISO 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

ISO 11607.1-2006

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

ISO 11607.2-2006

Packaging for terminally sterilized medical devicesPart 2: Validation requirements for forming, sealing and assembly processes

Sterilization

ISO 11135.1-2007

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

ISO/TS 11135.2-2008

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

Sterilization

ISO 11137.1-2006

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

ISO 11137.2-2013

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

ISO 11137.3-2006

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

Sterilization

ISO 17665.1-2006

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

ISO 17665.2-2009

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

Clean Room and Relevant Controlled Environment

ISO 14644.1-1999

Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness

ISO 14644.2-2000

Cleanrooms and associated controlled environments -- Part 2 Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

ISO 14644.3-2005

Cleanrooms and associated controlled environments -- Part 3 Test methods

Clean Room and Relevant Controlled Environment

ISO 14644.4-2001

Cleanrooms and associated controlled environments -- Part 4 Design, construction and start-up

ISO 14644.5-2004

Cleanrooms and associated controlled environments -- Part 5 Operations

ISO 14644.6-2007

Cleanrooms and associated controlled environments -- Part 6 Vocabulary

Clean Room and Relevant Controlled Environment

ISO 14644.7-2004

Cleanrooms and associated controlled environments -- Part 7 Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

ISO 14644.8-2006

Cleanrooms and associated controlled environments -- Part 8 Classification of airborne molecular contamination

ISO 14644.9-2012

Cleanrooms and associated controlled environments -- Part 9: Classification of surface cleanliness by particle concentration

ISO 14644.10-2013

Cleanrooms and associated controlled environments -- Part 10: Classification of surface cleanliness by chemical concentration

Clean Room and Relevant Controlled Environment
Biocontamination Control

ISO 14698.1-2003

Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods

ISO 14698.2-2003

Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data

Sterilization of Medical Devices, Microbiological Method

ISO 11737.1:2006

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

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

Chemical Indicator

ISO 11138.1-2006

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

ISO 11138.2-2006

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

ISO 11138.3-2006

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

ISO 11138.4-2006

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

ISO 11138.5-2006

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

Chemical Indicator

ISO 11140.1-2005

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

ISO 11140.2-1998

Sterilization of health care products - Chemical indicators - Part 2: Test equipment and methods

ISO 11140.3-2007

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

ISO 11140.4-2007

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

ISO 11140.5-2007

Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests