I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
03-07-2006
English
01-01-1997
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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
Gives the requirements and test methods for packaging materials and systems which are used for packaging of medical devices which are to be terminally sterilised; and which are intended to maintain sterility of the device.
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 868-1 : 1997 | Identical |
| NF EN 868-1 : 1997 | Identical |
| EN 868-1 : 1997 | Identical |
| DIN EN 868-1:1997-05 | Identical |
| UNE-EN 868-1:1997 | Identical |
| NEN EN 868-1 : 1997 | Identical |
| SN EN 868-1 : 1997 | Identical |
| UNI EN 868-1 : 1999 | Identical |
| BS EN 868-1:1997 | Identical |
| NS EN 868-1 : 1ED 1997 | Identical |
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