Non-active surgical implants - General requirements
Also Known As:
SKU118313568
Published by
Deutsches Institut für Normung
DIN
Publication Date2013-03
Pages CountPages23
This document 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.
Details
| Descriptors | Biological hazards, Checks, Clinical, Construction details, Damage, Data of the manufacturer, Definitions, Design, Evaluations, Fine mechanics, General section, Implants (surgical), Inactive, Information, Labelling, Marking, Materials, Medical devices, Medical equipment, Medical instruments, Medical products, Medical sciences, Packages, Performance, Production, Protection, Residues, Specification (approval), Sterile, Sterility, Sterilization (hygiene), Storage, Surgery, Surgical, Surgical implants, Testing, Transport, Bearings |
| ICS Codes | 11.040.40 - Implants for surgery, prosthetics and orthotics |
| Language(s) | English |
| File Size | 553.0 KB |
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