YY/T 0640-2016Non-active surgical implants - General requirements

YY/T 0640-2016 is the English-translated version of 无源外科植入物 通用要求.

This standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials, trans-endodontic and trans-radicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, it specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer. Identical adoption of ISO 14630:2012.

1. 1.Foreword
2. 2.Introduction
3. 3.1 Scope
4. 4.2 Normative references
5. 5.3 Terms and definitions
6. 6.4 Intended performance
7. 7.5 Design attributes
8. 8.6 Materials
9. 9.7 Design evaluation
10. 10.8 Manufacture
11. 11.9 Sterilization
12. 12.10 Packaging
13. 13.11 Information supplied by the manufacturer
14. 14.Bibliography

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