Standard ISO standard · ISO 11137-1:2025

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

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Standard ISO standard · ISO 11137-1:2025

Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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Scope
1.1       This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.


NOTE         Although the scope is limited to medical devices, this document can be applicable to other products and equipment.


This document 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)


Buy this standard

Standard ISO standard · ISO 11137-1:2025

Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Subscribe on standards - Read more Dölj
Price: 2 411 SEK
standard ikon pdf

PDF

Price: 2 411 SEK
standard ikon

Paper

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Product information

Language: English

Written by: ISO

International title:

Article no: STD-82094866

Edition: 2

Approved: 4/2/2025

No of pages: 39

Replaces: ISO 11137-1:2006/Amd 1:2013 , ISO 11137-1:2006 , ISO 11137-1:2006/Amd 2:2018