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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS

Available format(s):

Superseded date: 12-07-2006

Language(s):

Published date: 12-01-2013

Publisher: Ente Nazionale Italiano di Unificazione (UNI)

Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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.

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Document Type	Standard
ISBN
Pages
Published
Publisher	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
Superseded By	UNI EN ISO 11607-1 : 2006

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	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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