BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical devices. Risk analysis
Hardcopy , PDF
03-15-2001
English
03-15-1998
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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
Defines a method for investigation by the manufacturer of the safety of a medical device, including in vitro diagnostic devices or accessories, by identification of hazards and estimation of the risks associated with the device. Particularly helpful in areas where relevant standards are unavailable or unused. Does not define levels of acceptability, or give detailed guidance on management of risks. Nor does it cover decision-making processes regarding assessing the indications and contra-indications for using a particular device.
| Committee |
CH/210/4
|
| DevelopmentNote |
Supersedes 94/506771 DC (03/2001)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN 1441:1998-01 | Identical |
| I.S. EN 1441:1998 | Identical |
| NBN EN 1441 : 1998 | Identical |
| EN 1441 : 1997 | Identical |
| NEN EN 1441 : 1997 | Identical |
| UNE-EN 1441:1998 | Identical |
| UNI EN 1441 : 1998 | Identical |
| SN EN 1441 : 1998 | Identical |
| NS EN 1441 : 1998 | Identical |
| NF EN 1441 : 1998 | Identical |
| PD CR 13694:1999 | Health informatics. Safety and security related software quality standards for healthcare (SSQS) |
| IEC 61025:2006 | Fault tree analysis (FTA) |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| IEC 60812:2006 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| EN 30993-3 : 1993 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| IEC TR 60513:1994 | Fundamental aspects of safety standards for medical electrical equipment |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 60300-3-9:1995 | Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
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