NF EN 60601-1-4 : 1999 AMD 1 2005
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
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
|
| Standards | Relationship |
| UNE-EN 60601-1-4:1997 | Identical |
| EN 60601-1-4:1996/A1:1999 | Identical |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Identical |
| BS EN 60601-1-4:1997 | Identical |
| I.S. EN 60601-1-4:1998 | Identical |
| SN EN 60601-1-4 : 1996 AMD 1 1999 | Identical |
| DIN EN 60601-1-4 : 2001-04 | Identical |
| 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.