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EVS-EN ISO 11135:2014/A1:2019

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 (ISO 11135:2014/Amd 1:2018)

General information

Valid from 02.12.2019
Base Documents
ISO 11135:2014/Amd 1:2018; EN ISO 11135:2014/A1:2019

Standard history

Status
Date
Type
Name
Main
prEN ISO 11135
02.12.2019
Amendment
04.08.2014
Main
ISO 11135 describes requirements for the ethylene oxide sterilization process for medical devices in both industrial and healthcare facility settings. Compliance with ISO 11135 ensures products that meet the defined requirements for sterile products with a high degree of confidence. EN ISO 11135:2014/A1:2019 modifies the European standard EN ISO 11135:2014. The main text and the amendment can be found in the standard’s history.

In this amendment you can find the following:

— Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices,
— Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 93/42/EEC on medical devices,
— Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices,
— Relationship between EN ISO 11135 and the General Safety and Performance Requirements of Regulation (EU) 2017/745,
— Relationship between EN ISO 11135 and the General Safety and Performance Requirements of Regulation (EU) 2017/746,
— Annex E (which specifies the release of a product from a single batch sterilization process).

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