Norm

NEN-EN-ISO 13485:2012 en

Medische hulpmiddelen - Kwaliteitsmanagementsystemen - Bijzondere eisen voor reguleringsdoeleinden

  • Deze norm is ingetrokken sinds 08-03-2016

161,21

Over deze norm

Status Ingetrokken
Aantal pagina's 57
Commissie Medische hulpmiddelen - horizontale onderwerpen
Gepubliceerd op 01-02-2012
Taal Engels
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).

Details

ICS-code 03.120.10
11.040.01
Nederlandse titel Medische hulpmiddelen - Kwaliteitsmanagementsystemen - Bijzondere eisen voor reguleringsdoeleinden
Engelse titel Medical devices - Quality management systems - Requirements for regulatory purposes
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Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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