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  • OVE/ONORM EN 60601-1 : 2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)

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    Superseded date:  23-01-2023

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    Published date:  12-01-2013

    Publisher:  Osterreichisches Normungsinstitut/Austrian Standards

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    Abstract - (Show below) - (Hide below)

    Diese ÖVE/ÖNORM gilt für die BASISSICHERHEIT und die WESENTLICHEN LEISTUNGSMERKMALE von MEDIZINISCHEN ELEKTRISCHEN GERÄTEN und MEDIZINISCHEN ELEKTRISCHEN SYSTEMEN, nachfolgend als ME-GERÄTE und ME-SYSTEME bezeichnet. Diese Norm kann auch auf Geräte angewendet werden, die zur Kompensation oder Linderung einer Krankheit, Verletzung oder Behinderung verwendet werden. In-vitro-Diagnosegeräte, die in der Normenreihe IEC 61010 (alle Teile) behandelt werden, fallen nicht unter den Begriff ME-GERÄTE. Diese Norm gilt nicht für die in der Normenreihe ISO 14708-1 behandelten implantierbaren Teile von aktiven implantierbaren medizinischen Geräten.

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    Document Type Standard
    Publisher Osterreichisches Normungsinstitut/Austrian Standards
    Status Superseded
    Superseded By

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

    ONORM EN ISO 10993-17 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
    ONORM EN ISO 10993-7 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    ONORM EN ISO 13857 : 2008 SAFETY OF MACHINERY - SAFETY DISTANCES TO PREVENT HAZARD ZONES BEING REACHED BY UPPER AND LOWER LIMBS
    ISO 23529:2016 Rubber General procedures for preparing and conditioning test pieces for physical test methods
    ISO 9614-1:1993 Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points
    ONORM EN ISO 7010 : 2015 AMD 7 2017 GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011 + AMD 1:2012 + AMD 2:2012 + AMD 3:2012 + AMD 4:2013 + AMD 5:2014)
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    ONORM EN ISO 10993-12 : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
    IEC 60079-5:2015 RLV Explosive atmospheres - Part 5: Equipment protection by powder filling "q"
    ONORM EN ISO 10993-11 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ONORM EN ISO 10993-9 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ONORM EN ISO 10993-18 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    ONORM EN ISO 10993-15 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
    ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ONORM EN ISO 10993-10 : 2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
    ONORM EN ISO 10993-2 : 2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    IEC 60695-11-10:2013 Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods
    IEC 60079-6:2015 Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o"
    IEC 60079-0:2011 Explosive atmospheres - Part 0: Equipment - General requirements
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 13857:2008 Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs
    ISO 2878:2017 Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance
    ONORM EN ISO 10993-1 : 2011 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 1853:2011 Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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