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BS EN 868-7:2017

Current
Current

The latest, up-to-date edition.

Packaging for terminally sterilized medical devices Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

02-28-2017

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
Annex B (normative) - Method for the determination
        of water repellency
Annex C (normative) - Method for the determination
        of pore size
Annex D (normative) - Method for the determination
        of regularity of seal adhesive coatings on paper
Annex E (normative) - Method for the determination
        of mass per unit area of uncoated paper and
        adhesive coating
Annex F (normative) - Method for the determination
        of seal strength and mode of specimen failure
Annex G (informative) - Repeatability and reproducibility
        of test methods
Bibliography

Defines test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, 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.

This draft European Standard provides test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, 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. The materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization. The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply. The materials specified in this part of EN 868 are intended for single use only.

Committee
CH/198
DevelopmentNote
Supersedes 92/58627 DC. (08/2005) Supersedes 15/30325864 DC. (02/2017)
DocumentType
Standard
Pages
30
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
NBN EN 868-7 : 2009 Identical
I.S. EN 868-7:2017 Identical
SN EN 868-7:2017 Identical
UNE-EN 868-7:2009 Identical
NS EN 868-7 : 2017 Identical
NEN EN 868-7 : 2017 Identical
UNI EN 868-7 : 2009 Identical
EN 868-7:2017 Identical
NF EN 868-7 : 2017 Identical
UNE-EN 868-7:2017 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 ISO 535:2014 Paper and board - Determination of water absorptiveness - Cobb method (ISO 535:2014)
ISO 2758:2014 Paper Determination of bursting strength
ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
EN ISO 1974:2012 Paper - Determination of tearing resistance - Elmendorf method (ISO 1974:2012)
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 2470-2:2008 Paper, board and pulps — Measurement of diffuse blue reflectance factor — Part 2: Outdoor daylight conditions (D65 brightness)
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
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
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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