Name: UNI EN 868-5 : 2009
Brand: UNI

UNI EN 868-5 : 2009

Superseded

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS

Superseded date

09-05-2019

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
Annex A (informative) Details of significant technical
        changes between this European Standard and the
        previous edition
Annex B (normative) Method for the determination of
        resistance to the intended sterilization process
Annex C (normative) Method for the determination of
        pinholes in plastic laminate
Annex D (normative) Method for the determination of
        the strength of the seal joint for pouches and
        reel material
Annex E (normative) Method for the determination of
        peel characteristics of paper/plastic laminate
        products
Annex F (normative) Method for the determination of
        fibre orientation
Bibliography

Supplies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 used as 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
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN 868-5 : 2019
Supersedes	UNI EN 868-5 : 2002

Standards	Relationship
SN EN 868-5 : 2009	Identical
NBN EN 868-5 : 2009	Identical
NS EN 868-5 : 2009	Identical
NF EN 868-5 : 2009	Identical
I.S. EN 868-5:2009	Identical
ONORM EN 868-5 : 2009	Identical
DIN EN 868-5:2009-09	Identical
EN 868-5:2009	Identical
UNE-EN 868-5:2009	Identical
BS EN 868-5:2009	Identical
NEN EN 868-5 : 2009	Identical
EN 868-5:2018	Identical

EN ISO 14937:2009	Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
EN 868-6:2017	Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN 14180:2014	Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 868-2:2017	Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-3:2017	Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
EN ISO 11140-1:2014	Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
ISO 11140-1:2014	Sterilization of health care products Chemical indicators Part 1: General requirements
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO 8601:2004	Data elements and interchange formats Information interchange Representation of dates and times
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN 868-7:2017	Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
EN 1422:2014	Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 13060:2014	Small steam sterilizers