NBN 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)

WITHDRAWN

About this standard

Languages
English and French
Type
NBN
Standards committee
CEN/TC 102
Status
WITHDRAWN
Publication date
23 August 2017
ICS Code
11.080.30 (Sterilized packaging)
Withdrawn Date
07 March 2023
Price
€ 50,00

About this training

Summary

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.