Non-active surgical implants - General requirements (ISO 14630:2008/DAM 1:2010); German version EN ISO 14630:2009/prA1:2010
Project begin
2010-04-12
WI
00285109
Planned document number
DIN EN ISO 14630
Abstract
This Standard specifies general requirements for non-active surgical implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses.
With regard to safety, this document gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are given or referred to in Level 2 and Level 3 Standards.
The amendment was initiated by CEN/TC 285 "Non-active surgical implants" to address the additional essential requirement contained in the European directive 2007/47/EC.
Responsible Committee
NA 027-02-17 AA Implants for surgery
Notice of supersedure
Vorgesehen als Änderung von DIN EN ISO 14630:2009-08
Draft standard
Previous Document(s)
Search in NA 027
Contact
Dipl.-Ing. (FH)
Elisabeth Leitner
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