MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

Published date

12-01-2013

Publisher

AVANT-PROPOS
SECTION UN - GÉNÉRALITÉS
1 Domaine d'application et objet
2 Terminologie et définition
3 Prescriptions générales
6 Identification, marquage et documentation
SECTION DEUX - CONDITIONS D'ENVIRONNEMENT
10 Conditions d'environnement
SECTION TROIS - PROTECTION CONTRE LES RISQUES DE CHOCS
                ÉLECTRIQUES
16 ENVELOPPES et CAPOTS DE PROTECTION
17 Séparation
19 COURANTS DE FUITE permanents et COURANT AUXILIAIRE
   PATIENT
SECTION QUATRE - PROTECTION CONTRE LES RISQUES MÉCANIQUES
22 Parties en mouvement
SECTION CINQ - PROTECTION CONTRE LES RISQUES DUS AUX
               RAYONNEMENTS NON DéSIRÉS OU EXCESSIFS
SECTION SIX - PROTECTION CONTRE LES RISQUES D'IGNITION DE
              MÉLANGES ANESTHÉSIQUES INFLAMMABLES
SECTION SEPT - PROTECTION CONTRE LES TEMPÉRATURES
               EXCESSIVES ET AUTRES RISQUES
44 Débordements, renversement, fuite, humidité,
   pénétration de liquides, nettoyage, stérilisation,
   désinfection et compatibilité
49 Coupure de l'alimentation
SECTION HUIT - PRÉCISION DES CARACTÉRISTIQUES DE
               FONCTIONNEMENT ET PROTECTION CONTRE LES
               CARACTÉRISTIQUES DE SORTIE PRÉSENTANT DES
               RISQUES
SECTION NEUF - FONCTIONNEMENT ANORMAL ET CONDITIONS DE
               DÉFAUT; ESSAIS D'ENVIRONNEMENT
52 Fonctionnement anormal et conditions de défaut
SECTION DIX - REGLES DE CONSTRUCTION
56 Composants et ensembles
57 PARTIES RELIÉES AU RÉSEAU, composants et montage
58 Mise à la terre de protection - Bornes et raccordement
59 Construction et montage
Annexe AAA (informative) Guide général et justification
Annexe BBB (informative) Exemples d'associations
           d'APPAREILS ELECTROMEDICAUX et d'appareils
           électriques non médicaux
Annexe CCC (normative) Références normatives
Annexe DDD (informative) Bibliographie
Annexe EEE (normative) Prescriptions relatives aux SOCLES
           MOBILES A PRISES MULTIPLES
Annexe FFF (informative) Exemples d'application des
           SOCLES MOBILES A PRISES MULTIPLES

Describes the safety requirements for medical electrical systems to give protection for the patient, the operator and surroundings. Coverage includes environmental conditions, protection against electric shock hazards, protection against mechanical hazards, protection against hazards from unwanted or excessive radiation, protection against hazards of ignition of flammable anaesthetic mixtures, protection against excessive temperatures and other safety hazards, accuracy of operating data and protection against hazardous output, abnormal operation and fault conditions, and constructional requirements. Also includes annexes and diagrams.

DevelopmentNote	Indice de classement: C74-013. (01/2002) Supersedes NFC 74 013 (05/2005)
DocumentType	Standard
PublisherName	Association Francaise de Normalisation
Status	Current
Supersedes	NFC 74 006 : 1990 NFC 74 013 : 1999 PR

Standards	Relationship
DIN EN 60601-1-1 : 2002	Identical
EN 60601-1-1:2001	Identical
UNE-EN 60601-1-1:2002	Identical
I.S. EN 60601-1-1:2001	Identical
BS EN 60601-1-1:2001	Identical
SN EN 60601-1-1 : 2001	Identical
IEC 60601-1-1:2000	Identical

NF EN ISO 16201 : 2007	TECHNICAL AIDS FOR PERSONS WITH DISABILITY - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING
NF EN ISO 11608-4 : 2007	PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
NF EN 60601 2-13 : 2007 AMD 1 2007	MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
NF EN 60601-1-4 : 1999 AMD 1 2005	MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
NF EN 60601-2-40 : 2000	MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENTS
NF EN ISO 17510-1 : 2009	SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT

IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV	Plugs and socket-outlets for household and similar purposes - Part1: General requirements
NF EN 60529 : 92 AMD 2 2014	DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE)
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV	Degrees of protection provided by enclosures (IP Code)
IEC 60989:1991	Separating transformers, autotransformers, variable transformersand reactors.

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NF EN 60601-1-1 : 2001

MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

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