UNI EN 868-9 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
24-08-2022
01-01-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Materials
4.3 Performance requirements and test methods
4.4 Marking of the protective packaging
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
Supplies 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.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| I.S. EN 868-9:2009 | Identical |
| ONORM EN 868-9 : 2009 | Identical |
| UNE-EN 868-9:2009 | Identical |
| EN 868-9:2018 | Identical |
| NS EN 868-9 : 2009 | Identical |
| BS EN 868-9:2009 | Identical |
| DIN EN 868-9:2009-09 | Identical |
| NBN EN 868-9 : 2009 | Identical |
| SN EN 868-9 : 2009 | Identical |
| NEN EN 868-9 : 2009 | Identical |
| NF EN 868-9 : 2009 | Identical |
| EN 868-9:2009 | 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 |
| 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 |
| EN 21974:1994 | Paper - Determination of tearing resistance (Elmendorf method) (ISO 1974:1990) |
| ISO 2758:2014 | Paper Determination of bursting strength |
| 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) |
| 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 |
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