Back

EVS-EN ISO 11607-1:2017

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)

General information
Withdrawn from 03.02.2020
Base Documents
EN ISO 11607-1:2017; ISO 11607-1:2006; ISO 11607-1:2006/Amd 1:2014
Directives or regulations
None
Standard history
Status
Date
Type
Name
03.02.2020
Main
02.08.2017
Main
04.08.2014
Amendment
EVS-EN ISO 11607-1:2009/A1:2014
07.08.2009
Main
EVS-EN ISO 11607-1:2009
ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.
*
*
*
PDF
19.32 € incl tax
Paper
19.32 € incl tax
Price: 2.40 € incl tax
Standard monitoring
Customers who bought this item also bought
Main

EVS-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Withdrawn from 03.02.2020
Main

EVS-EN ISO 15223-1:2016

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
Newest version Valid from 03.01.2017
Main

EVS-EN 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices
Valid from 07.05.2015
Main + amendment

EVS-EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices
Withdrawn from 17.05.2021