BS EN 592:2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Instructions for use for in vitro diagnostic instruments for self-testing
Hardcopy , PDF
28-02-2010
English
03-05-2002
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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Superseded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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