BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
28-02-2010
English
07-05-2002
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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
Specifies requirements for the labelling of in vitro diagnostic reagents which are meant for use in self-testing. Coverage includes definitions, instructions for use and additional information.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 99/565688 DC (05/2002)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN EN 376 : 2002 | Identical |
| I.S. EN 376:2002 | Identical |
| NF EN 376 : 2002 | Identical |
| DIN EN 376:2002-06 | Identical |
| SN EN 376 : 2002 | Identical |
| EN 376 : 2002 | Identical |
| NS EN 376 : 2002 | Identical |
| NBN EN 376 : 2002 | Identical |
| UNE-EN 376:2002 | Identical |
| UNI 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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