Standard Technical specification · SIS-CEN ISO/TS 11135-2:2009

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

Status: Withdrawn

· Replaced by: SS-EN ISO 11135:2014
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Standard Technical specification · SIS-CEN ISO/TS 11135-2:2009

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

Subjects

Sterilization and disinfection in general (11.080.01)


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Standard Technical specification · SIS-CEN ISO/TS 11135-2:2009

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1
Subscribe on standards - Read more Dölj
Price: 1 320 SEK
standard ikon pdf

PDF

Price: 1 320 SEK
standard ikon

Paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-69824

Edition: 1

Approved: 6/1/2009

No of pages: 52

Replaced by: SS-EN ISO 11135:2014