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BS EN 375:2001

BS EN 375:2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

Available format(s)

Hardcopy , PDF

Superseded date

28-02-2010

Language(s)

English

Published date

15-03-2001

Publisher

British Standards Institution

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Superseded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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Hardcopy - English
PDF - English
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