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  • EN 1441 : 1997

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s): 

    Superseded date:  15-12-2000

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/CS
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded

    Standards Referenced By This Book - (Show below) - (Hide below)

    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 1970:2000/A1:2005 ADJUSTABLE BEDS FOR DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
    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

    Standards Referencing This Book - (Show below) - (Hide below)

    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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