Phone: +1 758-453-0049
E-mail: info@slbs.org
Bisee, Saint Lucia LC04301

ISO 11607-1:2019

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

Jan 31, 2019

General information

60.60     Jan 31, 2019

ISO

ISO/TC 198

International Standard

11.080.30  

English   French  

Buying

Published

Language in which you want to receive the document.

Scope

This document specifies 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

Life cycle

PREVIOUSLY

Revises
ISO 11607-1:2006

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

NOW

PUBLISHED
ISO 11607-1:2019
60.60 Standard published
Jan 31, 2019

CORRIGENDA / AMENDMENTS

Amended by
ISO 11607-1:2019/CD Amd 1

Amended by
ISO 11607-1:2019/DAmd 1

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.

Login