NF EN ISO 11607-2

NF EN ISO 11607-2

January 2018
Standard Cancelled

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

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Main informations

Collections

National standards and national normative documents

Publication date

January 2018

Number of pages

32 p.

Reference

NF EN ISO 11607-2

ICS Codes

11.080.30   Sterilized packaging
55.040   Packaging materials and accessories

Print number

1

European kinship

EN ISO 11607-2:2017
Replaced standards (2)
NF EN ISO 11607-2
July 2006
Standard Cancelled
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

NF EN ISO 11607-2/A1
September 2014
Standard Cancelled
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1

Standard replaced by (1)
NF EN ISO 11607-2
January 2020
Standard Current
Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes

This document specifies requirements for the 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. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

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