NEN-EN 12010:1995 Ontw. en

Niet-actieve chirurgische impantaten - Gewrichtsprothesen - Bijzondere eisen

  • Deze norm is ingetrokken sinds 01-03-1998

23,85 28,86 Incl BTW

Over deze norm

Status Ingetrokken
Aantal pagina's 0
Commissie Chirurgische implantaten
Gepubliceerd op 01-08-1995
Taal Engels
Specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this standard, artificial ligaments and their associated fixing devices are included in the term implant, hereinafter referred to as implants. It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to demonstrate compliance with this standard are contained in or referenced in level 3 standards.


ICS-code 11.040.40
Nederlandse titel Niet-actieve chirurgische impantaten - Gewrichtsprothesen - Bijzondere eisen
Engelse titel Non-active surgical implants - Joint replacement implants - Particular requirements



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