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PREN 868-5 : DRAFT 2017

PREN 868-5 : DRAFT 2017

Current

Current

The latest, up-to-date edition.

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

Published date

08-29-2017

Publisher

Comite Europeen de Normalisation

European 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

Describes 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.

Committee
TC 102
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Current

Standards Relationship
17/30360908 DC : 0 Identical
07/30166933 DC : DRAFT AUG 2007 Identical
17/30360908 DC : DRAFT AUG 2017 Identical

BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods

PREN 868-9 : DRAFT 2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
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
ASTM F 88/F88M : 2015 : REDLINE Standard Test Method for Seal Strength of Flexible Barrier Materials
PREN 868-10 : DRAFT 2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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

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