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: Gällande

· Tillägg: 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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Omfattning
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.

Ämnesområden

Sterilisering och desinficering allmänt (11.080.01)


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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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Pris: 3 026 SEK
standard ikon pdf

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Pris: 3 026 SEK
standard ikon

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Produktinformation

Språk: Engelska

Framtagen av: ISO

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

Artikelnummer: STD-917577

Utgåva: 2

Fastställd: 2014-07-07

Antal sidor: 78

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