Norm

NEN-EN-ISO 22442-2:2015 en

Medische hulpmiddelen waarin dierlijke weefsels en daarvan afgeleide producten zijn gebruikt - Deel 2: Controles op inkoop, verzameling en bewerking

79,70

Over deze norm

Status Definitief
Aantal pagina's 15
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-12-2015
Taal Engels
NEN-EN-ISO 22442-2 specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1. The manufacturers should refer to ISO 22442-3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents. This part of ISO 22442 does not cover the utilization of human tissues in medical devices. This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices. It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO 22442 can form a part of a quality management system conforming to ISO 13485

Details

ICS-code 11.100.99
Nederlandse titel Medische hulpmiddelen waarin dierlijke weefsels en daarvan afgeleide producten zijn gebruikt - Deel 2: Controles op inkoop, verzameling en bewerking
Engelse titel Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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