ISO 11607-2:2019

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

Publication date: Jan 31, 2019

General information

Current stage: 60.60 Effective date: Jan 31, 2019

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

ICS: 11.080.30

Languages: English French

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Status: Published

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Scope

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

Life cycle

PREVIOUSLY

Revises
ISO 11607-2:2006

Revises
ISO 11607-2:2006/Amd 1:2014

NOW

PUBLISHED
ISO 11607-2:2019
60.60 Standard published
Jan 31, 2019

CORRIGENDA / AMENDMENTS

Amended by
ISO 11607-2:2019/DAmd 1

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