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About This Item

 

Full Description

Provides requirements and guidance

Cross References:
BS 5750:Part 0:Section 0.1
BS 5750:Part 1
BS EN 46001
BS EN 46002
EN 1174-1
EN 29002
BS 5750:Part 0:Section 0.2
BS EN 550
BS EN 554
AAAMI RS-3
ANSI/AAMI ST 31
ANSI/AAMI ST 32
90/385/EEC
93/42/EEC


Replaced by BS EN ISO 11137-1:2006, BS EN ISO 11137-2:2007 and BS EN ISO 11137-3:2006 but remains current.

Incorporates the following:
AMD 10623 published 15 August 1999
AMD 13085 published 15 June 2001
 

Document History

  1. 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

    • Most Recent
  2. BS EN ISO 11137-1:2015


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

    • Historical Version
  3. BS EN ISO 11137-1:2006+A1:2013


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

    • Historical Version
  4. BS EN ISO 11137-1:2006


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

    • Historical Version
  5. BS EN 552:1994

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    Sterilization of medical devices. Validation and routine control of sterilization by irradiation

    • Historical Version