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ISO 11135:2014-ed.2.0
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Automatically translated name:
Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
STANDARD published on 7.7.2014
The information about the standard:
Designation standards: ISO 11135:2014-ed.2.0
Publication date standards: 7.7.2014
SKU: NS-422857
The number of pages: 78
Approximate weight : 234 g (0.52 lbs)
Country: International technical standard
Category: Technical standards ISO
The category - similar standards:
These changes apply to this standard:
ISO 11135:2014-ed.2.0/Amd1:2018
Change
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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
(Stérilisation des produits de santé — Oxyde d´éthylene — Exigences de développement, de validation et de contrôle de routine d´un processus de stérilisation pour des dispositifs médicaux — Amendement 1: Révision de l´Annexe E, Libération d´un lot unique)
Change published on 15.10.2018
Selected format:Show all technical information.
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