EN 1441 : 1997
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 ANALYSIS
Superseded date
15-12-2000
Published date
12-01-2013
Publisher
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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 |
CEN/CS
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| DIN EN 1441:1998-01 | Identical |
| BS EN 1441:1998 | Identical |
| I.S. EN 1441:1998 | Identical |
| NBN EN 1441 : 1998 | 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 |
| 02/705544 DC : DRAFT APR 2002 | BS EN ISO 10297 - TRANSPORTABLE GAS CYLINDERS - CYLINDER VALVES - SPECIFICATION AND TYPE TESTING |
| ISO/TR 27809:2007 | Health informatics Measures for ensuring patient safety of health software |
| CSA ISO 14971 : 2007 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CSA Z10535 : 2003 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| S.R. CR 13694:1999 | HEALTH INFORMATICS - SAFETY AND SECURITY RELATED SOFTWARE QUALITY STANDARDS FOR HEALTHCARE (SSQS) |
| AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| DIN EN 737-3:1998-11 | MEDICAL GAS PIPELINE SYSTEMS - PART 3: PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
| CR 13694:1999 | Health Informatics - Safety and Security Related Software Quality Standards for Healthcare (SSQS) |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| EN 13221 : 2000 | HIGH-PRESSURE FLEXIBLE CONNECTIONS FOR USE WITH MEDICAL GASES |
| CEN ISO/TR 12296:2013 | Ergonomics - Manual handling of people in the healthcare sector (ISO/TR 12296:2012) |
| DIN EN 793 : 1998 | PARTICULAR REQUIREMENTS FOR SAFETY OF MEDICAL SUPPLY UNITS |
| I.S. EN 738-3:1999 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| I.S. EN 12218:1999 | RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT |
| 99/124125 DC : DRAFT NOV 1999 | BS EN ISO 15883-1 - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, DEFINITIONS AND TESTS |
| DD ISO/TS 25238:2007 | Health informatics. Classification of safety risks from health software |
| CSA Z10535 : 2003 : R2014 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| S.R. CEN ISO/TR 12296:2013 | ERGONOMICS - MANUAL HANDLING OF PEOPLE IN THE HEALTHCARE SECTOR (ISO/TR 12296:2012) |
| I.S. EN ISO 14971:2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| DIN EN 738-1:2002-07 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES |
| I.S. EN ISO 9703-3:1999 | ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 3: GUIDANCE ON APPLICATION OF ALARMS |
| DIN EN 737-1:1998-02 | MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM |
| DIN EN 1970:2005-10 | ADJUSTABLE BEDS FOR DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| DIN EN 737-3:2000-01 | MEDICAL GAS PIPELINE SYSTEMS - PART 3: PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
| I.S. EN 12442-1:2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| I.S. EN 13220:1999 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| I.S. EN 737-3:1999 | MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
| 02/560165 DC : DRAFT JAN 2002 | BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| PD CEN ISO/TR 12296:2013 | Ergonomics. Manual handling of people in the healthcare sector |
| DD CEN/TS 14507-2:2003 | Inhalational nitric oxide systems Supply systems |
| 03/317861 DC : DRAFT OCT 2003 | EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| CSA Z7396.2 : 2002 | MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| BS EN ISO 14971:2012 | Medical devices. Application of risk management to medical devices |
| BS EN 737-4:1998 | Medical gas pipeline systems Terminal units for anaesthetic gas scavenging systems |
| BS EN ISO 9703-3:1999 | Anaesthetic and respiratory care alarm signals Guidance on application of alarms |
| BS EN 1985:1999 | Walking aids. General requirements and test methods |
| BS EN 12442-1:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk |
| EN 738-4:1998/A1:2002 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT |
| PD ISO/TR 27809:2007 | Health informatics. Measures for ensuring patient safety of health software |
| ISO/TS 25238:2007 | Health informatics Classification of safety risks from health software |
| CEI UNI EN ISO 14971 : 2013 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| I.S. EN 738-2:1999 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - MANIFOLD AND LINE - PRESSURE REGULATORS |
| 02/564996 DC : DRAFT NOV 2002 | BS EN ISO 16201 - TECHNICAL AIDS FOR DISABLED PERSONS - REMOTE CONTROL SYSTEMS |
| MEDDEV 2.5-7 : REV 1 : 1998 | GUIDELINES FOR CONFORMITY ASSESSMENT OF BREAST IMPLANTS ACCORDING TO DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES |
| BS PD ISO/TR 12296 : 2012 | ERGONOMICS - MANUAL HANDLING OF PEOPLE IN THE HEALTHCARE SECTOR |
| UNI CEI EN ISO 14971 : 2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| AAMI ISO 14971 : 2007 : R2010 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| I.S. CEN/TS 14507-2:2003 | INHALATIONAL NITRIC OXIDE SYSTEMS - PART 2: SUPPLY SYSTEMS |
| BS EN 13532:2002 | General requirements for in vitro diagnostic medical devices for self-testing |
| BS EN 737-3:2000 | Medical gas pipeline systems Pipelines for compressed medical gases and vacuum |
| BS EN 12011:1998 | Instrumentation to be used in association with non-active surgical implants. General requirements |
| BS EN 13220:1999 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| BS EN 1970:2000 | Adjustable beds for disabled persons. Requirements and test methods |
| BS EN 13221:2000 | High-pressure flexible connections for use with medical gases |
| BS EN 12523:1999 | External limb prostheses and external orthoses. Requirements and test methods |
| EN 1985:1998 | Walking aids - General requirements and test methods |
| EN 738-2 : 1998 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - MANIFOLD AND LINE - PRESSURE REGULATORS |
| EN 737-4 : 1998 | MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS |
| EN ISO 9703-3 : 1998 | ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 3: GUIDANCE ON APPLICATION OF ALARMS |
| EN 737-2:1998/A1:1999 | MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS |
| EN 738-3:1998/A1:2002 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| EN 737-3:1998/A1:1999 | MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
| EN 793 : 1997 | PARTICULAR REQUIREMENTS FOR SAFETY OF MEDICAL SUPPLY UNITS |
| EN 739:1998/A1:2002 | LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
| I.S. EN 738-4:1999 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT |
| I.S. EN 737-2:1998 | MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS |
| CSA ISO 14971 : 2007 : R2017 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CSA ISO 14971 : 2007 : R2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| BS EN 793:1998 | Particular requirements for safety of medical supply units |
| BS EN 13503-5:2001 | Ophthalmic implants. Intraocular lenses Biocompatibility |
| ISO/TR 12296:2012 | Ergonomics Manual handling of people in the healthcare sector |
| EN 13220 : 1998 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| CEN/TS 14507-2:2003 | Inhalational nitric oxide systems - Part 2: Supply systems |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| EN 12218:1998/A1:2002 | RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT |
| EN 12523 : 1999 | EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| EN 13532:2002 | General requirements for in vitro diagnostic medical devices for self-testing |
| EN 13503-5 : 2001 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY |
| 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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