EN 868-1 : 1997
Superseded
View Superseded by
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
01-12-2013
04-01-2006
1 Scope
2 Normative references
3 Definitions
4 Requirements
5 Test methods
6 Documentation
7 Information
Annex A (informative) Guidance on clause 4
Annex B (informative) Microbial barrier evaluation scheme
Annex C (informative) Air impermeability - Test methods
Annex D (informative) Microbial barrier properties -
Test methods for materials
Annex E (informative) Microbial barrier properties -
Test methods for permeable closures (filter assembly,
tortuous path)
Annex F (informative) Impermeability and continuity of seals
formed by fusion or adhesion - Test methods
Annex G (informative) Impermeability of seals not formed by
fusion or adhesion - Test methods - Test procedure
for rigid containers
Annex H (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provision
of EU Directives
Defines requirements and methods of test for packaging materials and systems for medical devices for terminal sterilization and for maintenance of sterility of the device.
| Committee |
TC 102
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 868-1 : 1997 | Identical |
| NS EN 868-1 : 1ED 1997 | Identical |
| NF EN 868-1 : 1997 | Identical |
| DIN EN 868-1:1997-05 | Identical |
| AAMI ISO 11607 : 2ED 2000 | Similar to |
| I.S. EN 868-1:1997 | Identical |
| NEN EN 868-1 : 1997 | Identical |
| BS EN 868-1:1997 | Identical |
| UNE-EN 868-1:1997 | Identical |