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DANSK DS/CEN ISO/TS 11135-2 [ Withdrawn ]

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)

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Full Description

SAME AS ISO TS 11135-2 * DRAFT

This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation.
The exclusions in ISO 11135-1 apply also to this Technical Specification.
For ease of reference, the clause numbering in this Technical Specification corresponds to that in
ISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of ISO 11135-1:2007 and should be used in conjunction with this Technical Specification.
This guidance document is intended for people who have a basic knowledge of the principles of EO
sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1.
This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.

 

Product Details

Edition:
08
Number of Pages:
50
File Size:
1 file , 440 KB
Product Code(s):
DS-ZZZ, DS-ZZZ
 

Document History

  1. DANSK DS/CEN ISO/TS 11135-2

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    Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)

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  2. DANSK DS/CEN ISO/TS 11135-2


    Sterilization of health care products – Ethylene oxide – Part 2: Guidance on the application of ISO 11135-1

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. DANSK DS/CEN ISO/TS 11135-2/AC


    Sterilization of health care products – Ethylene oxide – Part 2: Guidance on the application of ISO 11135-1