I.S. EN 1041:2008+A1:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
Hardcopy , PDF
English
01-01-2008
14-06-2021
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.
Dates of withdrawal of national standards are available from NSAI.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Requirements for provision of information
6 Documentation
Annex A (informative) - Requirements and guidance for
Directives 93/42/EEC and 90/385/EEC, as amended
Annex B (informative) - Guidance on alternative labelling for
instructions for use (IFU)
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EC
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 90/385/EC
Bibliography
Describes requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices.
| Committee |
TC 3
|
| DevelopmentNote |
2008 Edition Re-Issued in October 2013 & incorporates AMD 1 2013. (10/2013)
|
| DocumentType |
Standard
|
| Pages |
29
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN 1041:2013-12 | Identical |
| BS EN 1041 : 2008 | Identical |
| NEN EN 1041 : 2008 + A1 2013 | Identical |
| NBN EN 1041 : 2008 + A1 2013 | Identical |
| EN 1041:2008+A1:2013 | Identical |
| NS EN 1041 : 2008 + A1 2013 | Identical |
| BS EN 1041:2008+A1:2013 | Equivalent |
| EN 1041:2008 | Equivalent |
| DIN EN 1041:2008-11 | Equivalent |
| UNE-EN 1041:2009 | Identical |
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