NEN EN 868-1 : 1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
05-01-2006
01-12-2013
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.
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Superseded
|
| Standards | Relationship |
| BS EN 868-1:1997 | Identical |
| DIN EN 868-1:1997-05 | Identical |
| I.S. EN 868-1:1997 | Identical |
| EN 868-1 : 1997 | Identical |
| UNI EN 868-1 : 1999 | Identical |
| UNE-EN 868-1:1997 | Identical |
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