ISO 11607-2:2006

Name: ISO 11607-2:2006
Brand: ISO
SKU: ISO 11607-2:2006
Price: 76.23 EUR
Availability: InStock
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Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

Publication date: Apr 7, 2006

95.99 Withdrawal of Standard Jan 31, 2019

General information

Current stage: 95.99 Withdrawal of Standard Jan 31, 2019

Originator: ISO

Owner: ISO/TC 198 Sterilization of health care products

Type: International Standard

ICS: 11.080.30 Sterilized packaging

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Status: Withdrawn

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Languages: English French

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Scope

ISO 11607-2:2006 specifies the requirements for 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.
ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.
ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11607:2003

NOW

WITHDRAWN
ISO 11607-2:2006
95.99 Withdrawal of Standard
Jan 31, 2019

CORRIGENDA / AMENDMENTS

WITHDRAWN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

REVISED BY

PUBLISHED
ISO 11607-2:2019