DIN EN ISO 14971:2013-04
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
Hardcopy , PDF
English, German
01-04-2013
29-08-2018
National foreword
National Annex NA (informative) - Bibliography
Foreword
Introduction
1 Scope
2 Terms and definitions
3 General requirements for risk management
4 Risk analysis
5 Risk evaluation
6 Risk control
7 Evaluation of overall residual risk acceptability
8 Risk management report
9 Production and post-production information
Annex A (informative) - Rationale for requirements
Annex B (informative) - Overview of the risk management
process for medical devices
Annex C (informative) - Questions that can be used to
identify medical device characteristics that
could impact on safety
Annex D (informative) - Risk concepts applied to
medical devices
Annex E (informative) - Examples of hazards, foreseeable
sequences of events and hazardous situations
Annex F (informative) - Risk management plan
Annex G (informative) - Information on risk management
techniques
Annex H (informative) - Guidance on risk management for
in vitro diagnostic medical devices
Annex I (informative) - Guidance on risk analysis process
for biological hazards
Annex J (informative) - Information for safety and information
about residual risk
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and Requirements of EU Directive 93/42/EE
on Medical Devices
Annex ZB (informative) - Relationship between this European
Standard and Requirements of EU Directive
90/385/EEC on Active Implantable Medical Devices
Annex ZC (informative) - Relationship between this European
Standard and Requirements of EU Directive 98/79/EC
on In Vitro Diagnostic Medical Devices
This standard is included in DIN Handbook 267-5, 268 and 469.
| DevelopmentNote |
Supersedes DIN EN 1441. (03/2001)
|
| DocumentType |
Standard
|
| Pages |
103
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| BS EN ISO 14971:2012 | Identical |
| EN ISO 14971:2012 | Identical |
| I.S. EN ISO 14971:2012 | Identical |
| NBN EN ISO 14971 : 2012 | Identical |
| NS EN ISO 14971 : 2012 | Identical |
| NEN EN ISO 14971 : 2007 + COR 2012 | Identical |
| ISO 14971:2007 | Identical |
| UNE-EN ISO 14971:2012 | Identical |
| NF EN ISO 14971 : 2009-11 | Identical |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.