ONORM 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 |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Current
|
| Standards | Relationship |
| EN 868-5:2009 | Identical |
| EN 868-5:2018 | Identical |
| DIN EN 868-5:2009-09 | Identical |
| NS EN 868-5 : 2009 | Identical |
| I.S. EN 868-5:2009 | Identical |
| NF EN 868-5 : 2009 | Identical |
| UNE-EN 868-5:2009 | Identical |
| NBN EN 868-5 : 2009 | Identical |
| BS EN 868-5:2009 | Identical |
| ONORM EN 14180 : 2014 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| ONORM EN 868-7 : 2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS |
| ONORM EN 868-6 : 2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS |
| ONORM EN 868-3 : 2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 3: PAPER FOR USE IN THE MANUFACTURE OF PAPER BAGS (SPECIFIED IN EN 868-4) AND IN THE MANUFACTURE OF POUCHES AND REELS (SPECIFIED IN EN 868-5) - REQUIREMENTS AND TEST METHODS |
| ONORM EN 868-2 : 2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS |
Access your standards online with a subscription
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.