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BS EN 592:2002

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Instructions for use for in vitro diagnostic instruments for self-testing
Available format(s)

Hardcopy , PDF

Superseded date

02-28-2010

Language(s)

English

Published date

05-03-2002

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Form and presentation of the instructions for use
5 Requirements for the content of the instructions for
  use
6 Requirements for supplementary information
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

Defines the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments.

Committee
CH/212
DevelopmentNote
Supersedes 99/565689 DC (05/2002) Supersedes 91/57328 DC. (03/2006)
DocumentType
Standard
Pages
14
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
DIN EN 592:2002-05 Identical
I.S. EN 592:2002 Identical
NBN EN 592 : 2002 Identical
UNE-EN 592:2002 Identical
NS EN 592 : 2002 Identical
NF EN 592 : 2002 Identical
EN 592 : 2002 Identical
NEN EN 592 : 2002 Identical
SN EN 592 : 2002 Identical
UNI EN 592 : 2002 Identical
DIN EN 592:1994-11 Identical

EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS 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 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO/IEC Guide 2:2004 Standardization and related activities General vocabulary
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
EN 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
EN 980:2008 Symbols for use in the labelling of medical devices

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