1 Scope
This standard specifies the classification, requirements, test methods, inspection rules, marking, use instructions, packaging, transportation and storage of metal nail of neck fixation of femur.
This standard is applicable to metal nail of neck fixation of femur (hereinafter referred to as nail of femur neck) which is used for the internal fixation for fracture of neck of femur in orthopedic surgery.
2 Normative References
The following documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding any corrigendum), or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. For any undated references, the latest edition of the document referred to applies
GB/T 191 Packaging - Pictorial Marking for Handling of Goods
GB/T 4234 Stainless Steel for Surgical Implants
GB/T 4340 Metallic Materials - Vickers Hardness Test
GB/T 13810 Wrought Titanium and Titanium Alloy for Surgical Implants (GB/T 13810-1997, eqv ISO 5832-2:1993)
YY 0018 Implants for Osteosynthesis - Metallic Bone Screws
YY/T 1074 Implants for Surgery - Measuring Method for Pitting Corrosion Potential on Stainless Products
YY 0341 General Technological Requirements for Non-active Metallic Surgical Implants for Osteosynthesis
3 Classification
Foreword i
1 Scope
2 Normative References
3 Classification
4 Requirements
5 Test Methods
6 Inspection Rules
7 Marking and Use Instructions
8 Packaging, Transportation and Storage
9 Use Requirements
