Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

PREN 868-9 : DRAFT 2017

Current
Current

The latest, up-to-date edition.

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
Published date

22-08-2017

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
Bibliography

Defines test methods and values for uncoated nonwoven materials of polyolefines used for 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
17/30360918 DC : 0 Identical
17/30360918 DC : DRAFT AUG 2017 Identical
07/30167333 DC : DRAFT AUG 2007 Identical

17/30360908 DC : 0 BS EN 868-5 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
PREN 868-5 : DRAFT 2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS

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
EN 20811 : 1992 TEXTILES - DETERMINATION OF RESISTANCE TO WATER PENETRATION - HYDROSTATIC PRESSURE TEST
ISO 6588-2:2012 Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction
ISO 2758:2014 Paper Determination of bursting strength
EN ISO 1974:2012 Paper - Determination of tearing resistance - Elmendorf method (ISO 1974:2012)
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)
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 536:2012 Paper and board Determination of grammage
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
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more