ČSN EN ISO 11135 (855252)

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 1.2.2015


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The information about the standard:

Designation standards: ČSN EN ISO 11135
Classification mark: 855252
Catalog number: 96806
Publication date standards: 1.2.2015
SKU: NS-164475
The number of pages: 76
Approximate weight : 228 g (0.50 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

The category - similar standards:

Sterilization and disinfection in general

Annotation of standard text ČSN EN ISO 11135 (855252):

Tato mezinárodní norma stanovuje požadavky na vývoj, validaci a průběžné řízení postupu sterilizace zdravotnických prostředků ethylenoxidem jak pro průmyslová zařízení, tak i pro poskytovatele zdravotní péče, a bere v úvahu podobnosti i rozdíly mezi těmito dvěma aplikacemi

These changes apply to this standard:

ČSN EN ISO 11135:2015/A1 (855252) Change

Sterilizace výrobků pro zdravotní péči - Sterilizace ethylenoxidem - Požadavky na vývoj, validaci a průběžné řízení sterilizačního postupu pro zdravotnické prostředky.

Change published on 1.5.2020

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