Standard

SN EN ISO 11607-1:2018

Jan 2018 Withdrawn

Note: Latest version: SN EN ISO 11607-1:2020

Existing or new amendments and versions must be purchased separately.

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Abstract

ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

Products specifications

Standard from INB
Published: January 1 2018
Withdrawn: July 1 2020
Effective: January 1 2018
Document type: EN
Pages
ISBN:

ICS: 11.080.30
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 171
European TC: CEN/TC 102
International TC: ISO/TC 198

Product Relations

Replaced by: SN EN ISO 11607-1:2020
Replaces: SN EN ISO 11607-1:2009
Adopted from: ISO 11607-1:2006 , IDT

SN EN ISO 11607-1:2018

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SN EN ISO 11607-1:2020