I.S. EN 376:2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
Hardcopy , PDF
12-29-2009
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.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirement for labels
4.1 Outer container
4.2 Immediate container
5 Requirement for instructions for use
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other
provisions of EU Directives
Bibliography
Gives requirements for the information supplied by the manufacturer of in vitro diagnostic reagents for use in self-testing.
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NEN EN 376 : 2002 | Identical |
| NF EN 376 : 2002 | Identical |
| DIN EN 376:2002-06 | Identical |
| BS EN 376:2002 | Identical |
| SN EN 376 : 2002 | Identical |
| EN 376 : 2002 | Identical |
| NS EN 376 : 2002 | Identical |
| NBN EN 376 : 2002 | Identical |
| UNI EN 376 : 2002 | Identical |
| UNE-EN 376:2002 | Identical |
| EN 592 : 2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| EN 375 : 2001 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| EN 28601 : 1992 | DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES |
| ISO 3864:1984 | Safety colours and safety signs |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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