NF EN 60601-1-8
NF EN 60601-1-8

NF EN 60601-1-8

July 2007
Standard Current

Medical electrical equipment - Part 1-8 : general requirements for basic safety and essential performance - Collateral Standard : general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Le présent document 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.

Main informations

Collections

National standards and national normative documents

Publication date

July 2007

Number of pages

82 p.

Reference

NF EN 60601-1-8

ICS Codes

11.040.01   Medical equipment in general

Print number

1

European kinship

EN 60601-1-8:2007
Sumary
Medical electrical equipment - Part 1-8 : general requirements for basic safety and essential performance - Collateral Standard : general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Le présent document 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.
Replaced standards (2)
NF EN 60601-1-8
NF EN 60601-1-8
November 2005
Standard Cancelled
Medical electrical equipment - Part 1-8 : general requirements for safety - Collateral standard : general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Le présent document spécifie les exigences applicables aux SYSTEMES D'ALARME et aux SIGNAUX D'ALARME des APPAREILS ET DES SYSTEMES ELECTROMEDICAUX. Il donne également des lignes directrices pour l'application des SYSTEMES D'ALARME. Ce document entre dans le champ d'application de la Directive n° 93/42/CEE du 14/06/1993 relative aux dispositifs médicaux.

NF EN 60601-1-8/A1
NF EN 60601-1-8/A1
September 2006
Standard Cancelled
Medical electrical equipment - Part 1-8 : general requirements for safety - Collateral standard : general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Le présent document modifie l'introduction, l'article 201, le tableau 208 et l'annexe AAA de la norme NF EN 60601-1-8. Ce document entre dans le champ d'application de la Directive n° 93/42/CEE du 14/06/1993 relative aux dispositifs médicaux.

ZOOM ON ... the Requirements department

To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:

  • mandatory clauses to satisfy,
  • non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document "ISO/IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents" as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!


New: UPSELL service
Need to identify, monitor and decipher standards?