02/560165 DC : DRAFT JAN 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
01-14-2004
11-23-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
3.1 Aseptic processing
3.2 Bioburden
3.3 Media Fills
3.4 Medical device
3.5 Sterility
3.6 Sterile
3.7 Terminally-sterilized
3.8 Test for sterility
4 Requirements
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other
provisions of EU Directives
Bibliography
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