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I.S. EN 376:2002

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 SELF-TESTING
Available format(s)

Hardcopy , PDF

Superseded date

12-29-2009

Language(s)

English

Published date

01-01-2002

Publisher

National Standards Authority of Ireland

Preview

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 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Superseded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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Hardcopy - English
PDF - English
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