Back

Sorry - this product is no longer available

EVS-EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

General information

Withdrawn from 02.08.2017
Base Documents
ISO 11607-1:2006; EN ISO 11607-1:2009
ICS Groups
11.080.30 Sterilized packaging
Directives or regulations
90/385/EEC Active implantable medical devices 93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 90/385/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
02.08.2017
Main
EVS-EN ISO 11607-1:2017
04.08.2014
Amendment
EVS-EN ISO 11607-1:2009/A1:2014
07.08.2009
Main
EVS-EN ISO 11607-1:2009
Main
EVS-EN ISO 11607-1:2006
This part of ISO 11607 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. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. This part of ISO 11607 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. This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.

Required fields are indicated with *

*
*
*
PDF
16.13 € incl tax
Paper
16.13 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 328 KB)

Related products

Main

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)
Withdrawn from 03.02.2020
Main

EVS-EN ISO 11607-1:2020

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Valid from 03.02.2020
Main

EVS-EN ISO 11607-2:2020

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Valid from 03.02.2020
Main

EVS-EN 868-5:2018

Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Newest version Valid from 03.01.2019

Customers who bought this item also bought

Main

EVS-EN ISO 10993-1:2011

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Withdrawn from 31.12.2020
Main

EVS-EN ISO 11135:2014

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
Newest version Valid from 04.08.2014
Main

EVS-EN ISO 10993-11:2009

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Withdrawn from 18.06.2018
Main + corrigendum

EVS-EN ISO 13485:2012

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
Withdrawn from 02.03.2016

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English