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BS EN ISO 11137-1:2015+A2:2019

Sterilization of health care products. Radiation-Requirements for development, validation and routine control of a sterilization process for medical devices

standard by British Standard / European Standard / International Organization for Standardization , 11/27/2019

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Full Description

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

c) a beam from an X-ray generator.

Cross References:
ISO 11737-1:2018
ISO 11737-2
ISO 11137-2
ISO 13485:2003
ISO 10012-1
ISO 10993-1:2003
ISO 14040:1997
HGB N43.10-2001
ISO 22442-1
IAEA Safety Series No.107
TS 11139:2006
ISO 9000:2005
ISO 11607-1
ISO 22442-2
ISO 11137-3:2006
AAMI ST67:2003
ISO 22442-3
AAMI TIR17:1997
ISO 11607-2
ISO 14001:2004
ISO 9001:2000
ISO 11137:1995
EN 556-1:2001

Incorporates the following:
Amendment, November 2019

Product Details

Published:: 11/27/2019
ISBN(s):: 9780580992896
Number of Pages:: 62
File Size:: 1 file , 2.1 MB
Product Code(s):: 30363660, 30363660, 30363660
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