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ISO 11137:1995 [ Withdrawn ]

Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization

standard by International Organization for Standardization , 03/01/1995

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Full Description

Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator. Does not cover facility design, licensing, operator training, factors related to radiation safety, the assessment of the suitability of the product for its intended use.
 

Product Details

Edition:
1st
Published:
03/01/1995
Number of Pages:
61
File Size:
1 file , 10 MB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. 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

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  2. ISO 11137:1995

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    Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization

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Amendments, rulings, supplements, and errata

  1. ISO 11137/Amd1:2001


    Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization - Amendment 1: Selection of items for dose setting

  2. ISO 11137/Cor1:1997

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