PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Publisher

National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (informative) - Details of significant technical
        changes between this European Standard and the
        previous edition
Annex B (normative) - Method for the determination of
        water repellency
Annex C (normative) - Method for the determination of
        pore size
Annex D (informative) - Repeatability and reproducibility
        of test methods
Bibliography

Defines test methods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

DocumentType	Standard
Pages	24
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN 868-6:2009

Standards	Relationship
NBN EN 868-6 : 2009	Identical
SN EN 868-6 : 2017	Identical
BS EN 868-6:2017	Identical
DIN EN 868-6:2015-08 (Draft)	Identical
NEN EN 868-6 : 2017	Identical
UNI EN 868-6 : 2009	Identical
EN 868-6:2017	Identical
NF EN 868-6 : 2017	Identical
NS EN 868-6 : 2017	Identical
UNE-EN 868-6:2009	Identical
DIN EN 868-6:2017-05	Identical
UNE-EN 868-6:2017	Identical

ISO 1974:2012	Paper — Determination of tearing resistance — Elmendorf method
ISO 5636-3:2013	Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 6588-2:2012	Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction
EN 21974 : 1994	PAPER - DETERMINATION OF TEARING RESISTANCE (ELMENDORF METHOD)
ISO 2758:2014	Paper Determination of bursting strength
EN 20535 : 1994	PAPER AND BOARDS - DETERMINATION OF WATER ABSORPTIVENESS - COBB METHOD
ISO 187:1990	Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ISO 9197:2016	Paper, board and pulps Determination of water-soluble chlorides
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
EN ISO 1924-2:2008	Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008)
EN ISO 536:2012	Paper and board - Determination of grammage (ISO 536:2012)
ISO 8601:2004	Data elements and interchange formats Information interchange Representation of dates and times
ISO 1924-2:2008	Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (20 mm/min)
EN 20187:1993	Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990)
ISO 3781:2011	Paper and board — Determination of tensile strength after immersion in water
ISO 536:2012	Paper and board Determination of grammage
ISO 3689:1983	Paper and board — Determination of bursting strength after immersion in water
EN ISO 2758:2014	Paper - Determination of bursting strength (ISO 2758:2014)
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 535:2014	Paper and board — Determination of water absorptiveness — Cobb method
ISO 9198:2001	Paper, board and pulp Determination of water-soluble sulfates

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I.S. EN 868-6:2017

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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