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NF EN 60601-1-4 : 1999 AMD 1 2005

Current
Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
Published date

12-01-2013

AVANT-PROPOS
INTRODUCTION
SECTION 1: GÉNÉRALITÉS
1 Domaine d'application, objet et référence à d'autres normes
   1.201 Domaine d'application
   1.202 Objet
   1.203 Références à d'autres normes
2 Terminologie et définitions
   2.201 Termes définis
   2.202 Degrés d'exigence et termes divers
6 Identification, marquage et documentation
   6.8 DOCUMENTS D'ACCOMPAGNEMENT
SECTION 9: FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
           ESSAIS D'ENVIRONNEMENT
52 Fonctionnement anormal et conditions de défaut
   52.201 Documentation
   52.202 Plan de gestion des RISQUES
   52.203 CYCLE DE DÉVELOPPEMENT
   52.204 Traitement de la gestion des RISQUES
   52.205 Qualification du personnel
   52.206 Spécification des prescriptions
   52.207 Architecture
   52.208 Conception et réalisation
   52.209 VÉRIFICATION
   52.210 VALIDATION
   52.211 Modification
   52.212 Evaluation
Annexes
AAA Terminologie - Index des termes définis
BBB Justifications
CCC Notion de RISQUE
DDD Modèle de CYCLE DE DÉVELOPPEMENT
EEE Exemples de structures SEMP/SSEP
FFF Bibliographie
ZA Références normatives à d'autres publications
    internationales avec les publications européennes
    correspondantes

Applicable to the safety of medical electrical equipment and medical electrical systems including programmable electronic subsystems (PEMS). Defines requirements for the design process of PEMS and is also the basis of requirements of Particular Standards, which includes serving as a guide to safety requirements for managing and reducing risk.

DevelopmentNote
Indice de classement: C74-015. (11/2003)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Current

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
NFC 74 000 : 1989 MEDICAL RADIOLOGY - TERMINOLOGY
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
EN 29000-3 : 1993 QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - GUIDELINES FOR THE APPLICATION OF ISO 9001 TO THE DEVELOPMENT, SUPPLY AND MAINTENANCE OF SOFTWARE
HD 501 : 200S1 MEDICAL RADIOLOGY - TERMINOLOGY
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
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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