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SRPS EN ISO 11607-2:2017

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)

Dec 25, 2017
95.99   Withdrawal of Standard   Jun 22, 2020

General information

95.99     Jun 22, 2020

ISS

Z076

European Norm

11.080.30  

English  

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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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 11607-2:2017
95.99 Withdrawal of Standard
Jun 22, 2020

REVISED BY

PUBLISHED
SRPS EN ISO 11607-2:2020

Related project

Adopted from EN ISO 11607-2:2017

Adopted from ISO 11607-2:2006 IDENTICAL

Adopted from ISO 11607-2:2006/Amd 1:2014 IDENTICAL