Standard Swedish standard · SS-EN ISO 11137-1:2015/A2:2019

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

Status: Valid

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Standard Swedish standard · SS-EN ISO 11137-1:2015/A2:2019

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
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Scope
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

This part of ISO 11137 covers radiation processes employing irradiators using,
a) the radionuclide 60Co or 137Cs,
b) a beam from an electron generator
or
c) a beam from an X-ray generator.

Subjects

Sterilization and disinfection in general (11.080.01) Other (11.080.99)


Buy this standard

Standard Swedish standard · SS-EN ISO 11137-1:2015/A2:2019

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
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Price: 875 SEK
standard ikon pdf

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standard ikon

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80018313

Edition: 1

Approved: 11/28/2019

No of pages: 24

Amendment: SS-EN ISO 11137-1:2015