NF EN 60601-1-1 : 2001
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
12-01-2013
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 |
| 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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