UNI EN 375 : 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
23-07-2013
01-01-2002
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 |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| SN EN 375 : 2001 | Identical |
| NBN EN 375 : 2001 | Identical |
| NF EN 375 : 2001 | Identical |
| BS EN 375:2001 | Identical |
| NS EN 375 : 2001 | Identical |
| NEN EN 375 : 2001 | Identical |
| I.S. EN 375:2001 | Identical |
| EN 375 : 2001 | Identical |
| UNE-EN 375:2001 | Identical |
| DIN EN 375:2001-06 | Identical |
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