CSA ISO 14971-1 : 1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MEDICAL DEVICES - RISK MANAGEMENT - APPLICATION OF RISK ANALYSIS TO MEDICAL DEVICES
Hardcopy , PDF
01-09-2001
English
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1 Scope
2 Definitions
3 Procedure
3.1 General
3.2 Identification of qualitative and
quantitative characteristics related to
medical devices
3.3 Identification of possible hazards
3.4 Estimation of the risks for each hazard
3.5 Review of risks
3.6 Risk reduction
3.7 Generation of other hazards
3.8 Evaluation of all identified hazards
3.9 Risk analysis report
4 Review of risk analysis
Annexes
A - Guidance on risk analysis procedure for in vitro
diagnostic devices
B - Guidance on risk analysis procedure for toxicological
hazards
C - Examples of possible hazards and contributing factors
associated with medical devices
D - Information on risk analysis techniques
E - Simplified relationship between risk analysis and
other risk management activities
F - Bibliography
Gives a method for investigating, using available information, the safety of a medical device, including in vitro diagnostic devices (IVD) or accessories, by identifying hazards and estimating the risks associated with the device.
| DocumentType |
Standard
|
| Pages |
29
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| Standards | Relationship |
| ISO 14971-1:1998 | Identical |
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