I.S. EN 1441:1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MEDICAL DEVICES - RISK ANALYSIS
Hardcopy , PDF
06-07-2001
English
01-01-1998
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.
Foreword
Introduction
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 Acceptability of risk
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 (informative) Guidance on risk analysis procedure for
in vitro diagnostic devices
B (informative) Guidance on risk analysis procedure for
toxicological hazards
C (informative) Examples of possible hazards and
contributing factors associated with medical devices
D (informative) Information on risk analysis techniques
E (Informative) Bibliography
ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions
of EU Directives
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