DIN EN 868-1:1997-05
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
01-07-2006
English
12-01-2013
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
This standard is included in DIN Handbook 263. 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
|
| Pages |
24
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 868-1 : 1997 | Identical |
| EN 868-1 : 1997 | Identical |
| UNI EN 868-1 : 1999 | Identical |
| NS EN 868-1 : 1ED 1997 | Identical |
| NF EN 868-1 : 1997 | Identical |
| UNE-EN 868-1:1997 | Identical |
| I.S. EN 868-1:1997 | Identical |
| NEN EN 868-1 : 1997 | Identical |
| SN EN 868-1 : 1997 | Identical |
| BS EN 868-1:1997 | Identical |
| DIN 58946-6:2002-04 | STERILIZATION - STEAM STERILIZERS - PART 6: OPERATING OF LARGE STERILIZERS IN HEALTH CARE FACILITIES |
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