I.S. EN 591:2001
Superseded
View Superseded by
INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
Hardcopy , PDF
English
01-01-2001
01-29-2010
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.
Cooperating organizations
National foreword
Foreword
Specification
1. Scope
2. Definitions
3. Form and presentation of the user manual
4. Content of the user manual
5. Supplementary information
Annex
A. (informative) Bibliography
National annexes
NA. (informative) Committees responsible
NB. (informative) Cross-reference
Covers the requirements for the contents of instruction for use in vitro diagnostic instruments including apparatus, equipment, calibrators and control materials for professional use, hereafter called IVD instruments.
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 591 : 2001 | Identical |
| NF EN 591 : 2001 | Identical |
| BS EN 591:2001 | Identical |
| EN 591 : 2001 | Identical |
| NEN EN 591 : 2001 | Identical |
| NS EN 591 : 2001 | Identical |
| UNE-EN 591:2001 | Identical |
| DIN EN 591:2001-07 | Identical |
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