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  • 1

EN 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

Relationship to other standards

Packaging

EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

Identical with ISO 11607-1:2006

EN ISO 11607-2:2006

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

Identical with ISO 11607-2:2006

Packaging

EN 868.2-2009

 Packaging for terminally sterilized medical devices - Part 2 Sterilization wrap - Requirements and test methods

 

EN 868.3-2009

EN 868-3(2009) Packaging for terminally sterilized medical devices - Part 3 Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of

 

EN 868.4-2009

EN 868-4(2009) Packaging for terminally sterilized medical devices -  Part 4 Paper bags - Requirements and test methods

 

Packaging

EN 868.5-2009

EN 868-5(2009) Packaging for terminally sterilized medical devices - Part 5 Sealable pouches and reels of porous materials and plastic film construction - Requirements and test

 

EN 868.6-2009

EN 868-6(2009) Packaging for terminally sterilized medical devices - Part 6 Paper for low temperature sterilization processes - Requirements and test methods

 

EN 868.7-2009

EN 868-7(2009) Packaging for terminally sterilized medical devices - Part 7 Adhesive coated paper for low temperature sterilization processes - Requirements and tesf methods

 

Packaging

EN 868.8-2009

EN 868-8(2009) Packaging for terminally sterilized medical devices -Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods

 

EN 868.9-2009

EN 868-9(2009) Packaging for terminally sterilized medical devices -Uncoated nonwoven materials of polyolefines. Requirements and test methods

 

EN 868.10-2009

EN 868-10(2009) Packaging for terminally sterilized medical devices -Adhesive coated nonwoven materials of polyolefines. Requirements and test methods

 

Sterilization

EN ISO 11135-1:2014

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2014)

Replace EN550

EN 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 11137-1:2006)

Identical with ISO 11137-1:2006 Replace EN552

EN ISO 11137-2:2012

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)

Identical with ISO 11137-2:2012

EN ISO 17665-1:2006

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

Identical with ISO 11137-1:2006 Replace EN554

Sterilization of Medical Devices, Microbiological Method

EN ISO 11737-1:2006

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

Identical with ISO11737-1:2006

EN 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 (ISO 11737-2:2009)

Identical with ISO11737-2:2009