NF EN 60601-1 : 2007-01
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MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
Published date
01-01-2007
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La présente Norme internationale s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS ELECTROMEDICAUX et des SYSTEMES ELECTROMEDICAUX, désignés ci-après sous le terme APPAREILS EM et SYSTEMES EM. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM OU uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. LeS DANGERS inhérents à la fonction physiologique prévue de L'APPAREIL EM Ou des SYSTEMES EM dans le cadre du domaine d'application de la présente norme ne sont pas couverts par des exigences spécifiques contenues dans la présente norme, à l'exception de 7.2.13 et 8.4.1. La présente norme peut également être appliquée aux appareils utilisés pour l'atténuation d'une maladie, la compensation ou l'atténuation d'une blessure ou d'une incapacité. Les appareils de diagnostic in vitro qui n'entrent pas dans la définition des APPAREILS EM Sont couverts par la série CEI 61010. La présente norme ne s'applique pas aux parties implantables des dispositifs médicaux implantables actifs couverts par l'ISO 14708-1.
| DevelopmentNote |
Indice de classement: C74-011 PR NF EN 60601-1 June 2002 (08/2002) PR NF EN 60601-1 July 2004. (07/2004) 1991 version along with its amendments is still active. (02/2007) Supersedes NFC 74 010. (10/2014)
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Standard
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Amendment 11 is available separately, see AMD 11 TO NF EN 60601-1. (Brij 07/2012) AMD 1 is available separately, see AMD 1 TO NF EN 60601-1. (Brij 04/2014) Supersedes NFC 74 010. (Brij 10/2014) 1991 version along with its amendments is still active and is available at price 202.50 Euro. (Brij 01/2015) AMD 12 is available separately, see AMD 12 TO NF EN 60601-1. (Brij 08/2016)
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Association Francaise de Normalisation
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Current
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| Standards | Relationship |
| IEC 60601-1:2005+AMD1:2012 CSV | Identical |
| NBN EN 60601-1 : 2007 AMD 2/COR 15 | Identical |
| SN EN 60601-1 : 2006 AMD 11 2011 | Identical |
| I.S. EN 60601-1:2006&A1:2013&AC:2014&A12:2014 | Identical |
| BS EN 60601-1 : 2006 | Identical |
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| NF EN 60068-2-2 : 2007 | ENVIRONMENTAL TESTING - PART 2-2: TESTS - TESTS B: DRY HEAT |
| 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 |
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| NF EN 60529 : 92 AMD 2 2014 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) |
| IEC 60851-6:2012 | Winding wires - Test methods - Part 6: Thermal properties |
| IEC 60851-5:2008+AMD1:2011 CSV | Winding wires - Test methods - Part 5: Electrical properties |
| NF EN 60112 : 2003 AMD 1 2010 | METHOD FOR THE DETERMINATION OF THE PROOF AND THE COMPARATIVE TRACKING INDICES OF SOLID INSULATING MATERIALS |
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| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
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| IEC 61558-1:2017 | Safety of transformers, reactors, power supply units and combinations thereof - Part 1: General requirements and tests |
| IEC 60447:2004 | Basic and safety principles for man-machine interface, marking and identification - Actuating principles |
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| IEC 60068-2-2:2007 | Environmental testing - Part 2-2: Tests - Test B: Dry heat |
| IEC 60695-11-10:2013 | Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC 60079-0:2011 | Explosive atmospheres - Part 0: Equipment - General requirements |
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| NF EN ISO 9614-1 : 2009 | ACOUSTICS - DETERMINATION OF SOUND POWER LEVELS OF NOISE SOURCES USING SOUND INTENSITY - PART 1: MEASUREMENT AT DISCRETE POINTS |
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| IEC 60730-1:2013+AMD1:2015 CSV | Automatic electrical controls - Part 1: General requirements |
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