Standard Swedish standard · SS-EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

Status: Valid

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Standard Swedish standard · SS-EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
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Scope
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

Subjects

Sterilization and disinfection in general (11.080.01)


Buy this standard

Standard Swedish standard · SS-EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
Subscribe on standards - Read more Dölj
Price: 1 013 SEK
standard ikon pdf

PDF

Price: 1 013 SEK
standard ikon

Paper

Price: 1 620,80 SEK
standard ikon pdf + standard ikon

PDF + paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80018312

Edition: 1

Approved: 11/28/2019

No of pages: 28

Amendment: SS-EN ISO 11135:2014