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SRPS EN ISO 11607-2:2009

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

May 20, 2009
95.99   Withdrawal of Standard   Dec 25, 2017

General information

95.99     Dec 25, 2017

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

Harmonized

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 11607-2:2009
95.99 Withdrawal of Standard
Dec 25, 2017

REVISED BY

WITHDRAWN
SRPS EN ISO 11607-2:2017

Related project

Adopted from EN ISO 11607-2:2006

Adopted from ISO 11607-2:2006 IDENTICAL