NBN EN 868-5 : 2009
Current
The latest, up-to-date edition.
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
Annex A (normative) Method for the determination of
resistance to the sterilisation
process
Annex B (normative) Method for the determination of
pinholes in plastic laminate
Annex C (normative) Method for the determination of
peel characteristics of paper/
plastic laminate products
Annex D (normative) Method for the determination of
the strength of the heat seal
joint for pouches and reel
material
Annex E (normative) Method for the determination of
fibre orientation
Annex F (informative) Dimensions and tolerances
Annex G (informative) Bibliography
Gives examples of requirements and test procedures for heat and self-sealable pouches and reels made from paper which complies with EN 868-3 and plastic film. Defined are those suitable for use as packaging for medical devices which are to be terminally sterilized.
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Current
|
| Standards | Relationship |
| EN 868-5:2009 | Identical |
| UNE-EN 868-5:2009 | Identical |
| ONORM EN 868-5 : 2009 | Identical |
| SN EN 868-5 : 2009 | Identical |
| UNI EN 868-5 : 2009 | Identical |
| BS EN 868-5:2009 | Identical |
| NEN EN 868-5 : 2009 | Identical |
| NF EN 868-5 : 2009 | Identical |
| I.S. EN 868-5:2009 | Identical |
| NS EN 868-5 : 2009 | Identical |
| DIN EN 868-5:2009-09 | Identical |
| EN 868-5:2018 | Identical |
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