BS EN 375:2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 professional use
Hardcopy , PDF
28-02-2010
English
15-03-2001
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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.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 98/564938 DC. (05/2005)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNE-EN 375:2001 | Identical |
| NF EN 375 : 2001 | Identical |
| UNI EN 375 : 2002 | Identical |
| SN EN 375 : 2001 | Identical |
| NBN EN 375 : 2001 | Identical |
| NS EN 375 : 2001 | Identical |
| NEN EN 375 : 2001 | Identical |
| I.S. EN 375:2001 | Identical |
| EN 375 : 2001 | Identical |
| DIN EN 375:2001-06 | Identical |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| EN 591 : 2001 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| 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 |
| ISO 3534-1:2006 | Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
| ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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