PREN 868-2 : DRAFT 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
02-01-2017
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Superseded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 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 (ISO 9237:1995) |
| EN 21974:1994 | Paper - Determination of tearing resistance (Elmendorf method) (ISO 1974:1990) |
| ISO 2758:2014 | Paper Determination of bursting strength |
| EN 20535:1994 | Paper and board - Determination of water absorptiveness - Cobb method (ISO 535:1991) |
| 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 13938-1:1999) |
| 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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