Standard ISO standard · ISO 11135:2014

Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices

Status: Valid

· Amended by: ISO 11135:2014/Amd 1:2018
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Standard ISO standard · ISO 11135:2014

Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
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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 ISO standard · ISO 11135:2014

Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
Subscribe on standards - Read more Dölj
Price: 3 026 SEK
standard ikon pdf

PDF

Price: 3 026 SEK
standard ikon

Paper

Show more Show less

Product information

Language: English

Written by: ISO

International title:

Article no: STD-917577

Edition: 2

Approved: 7/7/2014

No of pages: 78

Replaces: ISO 11135-1:2007 , ISO/TS 11135-2:2008