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UNI EN 868-1 : 1999

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - GENERAL REQUIREMENTS AND TEST METHODS
Superseded date

13-07-2006

Published date

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

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
Ente Nazionale Italiano di Unificazione (UNI)
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Superseded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
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
NS EN 868-1 : 1ED 1997 Identical

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