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NEN EN ISO 11135 : 2014

Current

Current

The latest, up-to-date edition.

STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

Published date

01-12-2013

Defines 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.

DevelopmentNote
Supersedes NEN EN ISO 11135-1 and NEN NPR CEN ISO/TS 11135-2. (07/2014) NEW CHILD AMD 1 2019 IS ADDED
DocumentType
Standard
ProductNote
NEW CHILD AMD 1 2019 IS ADDED
PublisherName
Netherlands Standards
Status
Current
Supersedes

Standards Relationship
EN ISO 11135:2014 Identical
ISO 11135:2014 Identical
PREN ISO 11135 : DRAFT 2011 Identical

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