International Standard
ISO 11607-1:2019
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Reference number
ISO 11607-1:2019
Edition 2
2019-02
International Standard
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ISO 11607-1:2019
70799
Published (Edition 2, 2019)
This standard has 1 amendment.

ISO 11607-1:2019

ISO 11607-1:2019
70799
Format
Language
CHF 173
Convert Swiss francs (CHF) to your currency

Abstract

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.

General information

  •  : Published
     : 2019-02
    : International Standard under systematic review [90.20]
  •  : 2
     : 44
  • ISO/TC 198
    11.080.30 
  • RSS updates

 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Application of risk management

Edition 2023

ISO 11607-1:2019/Amd 1:2023
81823
Format
Language
CHF 18
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Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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