I.S. EN 375:2001
Superseded
View Superseded by
INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
Hardcopy , PDF
English
01-01-2001
12-29-2009
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.
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
Provides the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents.
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| 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 |
| EN 375 : 2001 | Identical |
| UNE-EN 375:2001 | Identical |
| DIN EN 375:2001-06 | Identical |