I.S. EN 13641:2002
Current
The latest, up-to-date edition.
ELIMINATION OR REDUCTION OF RISK OF INFECTION RELATED TO IN VITRO DIAGNOSTIC REAGENTS
Hardcopy , PDF
English
01-01-2002
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements related to design and manufacture
5 Information supplied by the manufacturer
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other
provisions of EU Directives
Bibliography
Describes requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents.
DocumentType |
Standard
|
Pages |
10
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Current
|
Standards | Relationship |
EN 13641:2002 | Identical |
UNI EN 13641 : 2003 | Identical |
BS EN 13641:2002 | Identical |
DIN EN 13641:2002-08 | Identical |
UNE-EN 13641:2002 | Identical |
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