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STN EN ISO 11607-2

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Electronic version (pdc file)

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Name: STN EN ISO 11607-2
Validity: Valid
Number of pages: 24
Language:
EN
Paper: 14,10€
Electronic version a) Only read (without ability to print and copy) 12,69€
b) Without ability to print, with ability to copy (printscreen) 14,10€
c) With ability to print and copy (printscreen) 18,33€
Slovak title Obaly na sterilizované zdravotnícke pomôcky. Časť 2: Požiadavky validácie na procesy tvarovania, spájania a skladania (ISO 11607-2: 2019)
English title Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Release Date: 01. 04. 2020
Date of withdrawal:
ICS: 11.080.30
Sorting character/National clasification code 85 6543
Level of incorporation: idt EN ISO 11607-2:2020, idt ISO 11607-2:2019
Official Journal 03/20
Amendments Zmena A11 V 08/22, Zmena A1 V 12/23
Replaced by:
Repleces: STN EN ISO 11607-2:2018-03 (85 6543)
Note in Official Journal:
Subject of the standard: 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.
Preview: Náhľad normy (PDF)