NF EN 60601-1-4/A1

April 2005

Standard Cancelled

Medical electrical equipment - Part 1-4 : general requirements for safety - Collateral standard : programmable electrical medical systems

Le présent document apporte des précisions quant aux informations à fournir et à maintenir. Il précise les conditions à remplir pour le cycle de développement et notamment pour la maîtrise de risques. Enfin, abandon de la notion de sécurité absolue. Ce document entre dans le champ d'application de la Directive n° 93/42/CEE du 14/06/1993 relative aux dispositifs médicaux.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2005

Number of pages

11 p.

Reference

NF EN 60601-1-4/A1

ICS Codes

11.040.01 Medical equipment in general

Classification index

C74-015/A1

Print number

1 - 28/04/2005

International kinship

IEC 60601-1-4/A1:1999

European kinship

EN 60601-1-4/A1:1999

Sumary

Medical electrical equipment - Part 1-4 : general requirements for safety - Collateral standard : programmable electrical medical systems

Le présent document apporte des précisions quant aux informations à fournir et à maintenir. Il précise les conditions à remplir pour le cycle de développement et notamment pour la maîtrise de risques. Enfin, abandon de la notion de sécurité absolue. Ce document entre dans le champ d'application de la Directive n° 93/42/CEE du 14/06/1993 relative aux dispositifs médicaux.

Standard replaced by (1)

NF EN 60601-1

January 2007

Standard Current

Medical electrical equipment - Part 1 : general requirements for basic safety and essential performance

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. Ce document entre dans le champ d'application de la Directive n° 93/42/CEE du 14/06/1993 relative aux dispositifs médicaux et de la Directive n° 90/385/CEE relatives aux dispositifs médicaux implantables actifs.

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