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BS EN ISO 11607-2:2006+A1:2014现行

Packaging For Terminally Sterilized Medical Devices - Part 2: Validation Requirements For Forming, Sealing And Assembly Processes

出版：British Standards Institution

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基本信息

标准编号： BS EN ISO 11607-2:2006+A1:2014

发布时间：2014/9/30 0:00:00

标准类别：Standard

出版单位：British Standards Institution

标准页数：20

标准简介

Defines the requirements for development and validation of processes for packaging medical devices that are terminally sterilized, it includes forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

标准备注

Supersedes 04/30101215 DC (05/2006) Supersedes 14/30255138 DC. 2006 Edition Re-issued in September 2014 & incorporates AMD 1 2014. (09/2014)

本标准替代的旧标准

BS EN ISO 11607-2:2006

等同采用的国际标准

NF EN ISO 11607-2:2006 - Identical

NBN EN ISO 11607-2:2006 - Identical

DIN EN ISO 11607-2 (2006-07) - Identical

SN EN ISO 11607-2:2006 - Identical

DIN EN ISO 11607-2 (2014-11) - Identical

ONORM EN ISO 11607-2:2014 - Identical

ONORM EN ISO 11607-2:2006 - Identical