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PREN 868-2 : DRAFT 2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
Superseded date

02-01-2017

Published date

08-18-2015

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 draft European Standard
        and the previous edition
Annex B (informative) - Method for the determination of drape
Annex C (normative) - Method for the determination of
        water repellency
Annex D (normative) - Method for the determination
        of pore size
Annex E (informative) - Repeatability and reproducibility
        of test methods
Bibliography

Gives test methods and values for materials 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
Superseded
SupersededBy

Standards Relationship
15/30325855 DC : 0 Identical
07/30166924 DC : DRAFT AUG 2007 Identical

BS EN 867-2:1997 Non-biological systems for use in sterilizers Process indicators (Class A)
BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods

EN 13795-3:2006+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
EN ISO 13937-1:2000/AC:2006 Textiles - Tear properties of fabrics - Part 1: Determination of tear force using ballistic pendulum method (Elmendorf) (ISO 13937-1:2000/Cor.1:2004)
EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
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 13937-1:2000 Textiles — Tear properties of fabrics — Part 1: Determination of tear force using ballistic pendulum method (Elmendorf)
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 9237:1995 Textiles — Determination of the permeability of fabrics to air
EN 1149-1:2006 Protective clothing - Electrostatic properties - Part 1: Test method for measurement of surface resistivity
EN ISO 9073-9:2008 Textiles - Test methods for nonwovens - Part 9: Determination of drapability including drape coefficient (ISO 9073-9:2008)
EN ISO 9237 : 1995 TEXTILES - DETERMINATION OF PERMEABILITY OF FABRICS TO AIR
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 9073-9:2008 Textiles Test methods for nonwovens Part 9: Determination of drapability including drape coefficient
ISO 1924-2:2008 Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (20 mm/min)
EN 29073-3:1992 Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation
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)
EN ISO 13938-1 : 1999 TEXTILES - BURSTING PROPERTIES OF FABRICS - PART 1: HYDRAULIC METHOD FOR DETERMINATION OF BURSTING STRENGTH AND BURSTING DISTENSION
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)
EN 13795-2:2004+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
ISO 13938-1:1999 Textiles Bursting properties of fabrics Part 1: Hydraulic method for determination of bursting strength and bursting distension
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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