NS EN 375 : 2001
Superseded
Superseded
INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
Published date
01-12-2013
Superseded date
03-01-2010
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for labels
4.1 Outer container
4.2 Immediate container
5 Requirements for instructions for use
Annex ZA (informative) Relationship of this document
with EC Directives
Bibliography
Defines the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents that includes reagent products, calibrators, control materials and kits for professional use, hereafter called IVD reagents. Also applicable to accessories.
| DocumentType |
Standard
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Superseded
|
| Standards | Relationship |
| I.S. EN 375:2001 | Identical |
| UNE-EN 375:2001 | Identical |
| BS EN 375:2001 | Identical |
| EN 375 : 2001 | Identical |
| DIN EN 375:2001-06 | Identical |
Summarise
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