BS EN ISO 14971:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical devices. Application of risk management to medical devices
Hardcopy , PDF
English
31-07-2012
15-12-2021
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
Describes a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
| Committee |
CH/210/4
|
| DevelopmentNote |
Supersedes 99/563585 DC & 01/564216 DC (07/2003) Supersedes BS EN 1441 and 05/30140005 DC. (04/2007)
|
| DocumentType |
Standard
|
| Pages |
106
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
| Standards | Relationship |
| DIN EN ISO 14971:2013-04 | 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 |
A newer version of this standard is available.
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