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ISO 11607-2:2019

Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes

Üldinfo
Kehtiv alates 31.01.2019
Tegevusala (ICS grupid)
11.080.30 Steriilne pakendamine
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
31.01.2019
Põhitekst
07.07.2014
Muudatus
07.04.2006
Põhitekst
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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Põhitekst

ISO 11607-1:2019

Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
Uusim versioon Kehtiv alates 31.01.2019
Põhitekst

ISO 10993-1:2018

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Uusim versioon Kehtiv alates 17.08.2018
Põhitekst

EVS-EN ISO 10993-11:2018

Meditsiiniseadmete bioloogiline hindamine. Osa 11: Katsed süsteemse toksilisuse hindamiseks
Uusim versioon Kehtiv alates 18.06.2018
Põhitekst

EVS-EN 62366-1:2015

Meditsiiniseadmed. Osa 1: Kasutatavusprojekteerimise rakendamine meditsiiniseadmetele
Kehtiv alates 07.05.2015