YY 0120-2002 英文版 骨接合植入物 金属矫形用棒
更多标准英文版信息,请访问www.bzfyw.com
1 Scope
This standard prescribes the classification, requirements, test method, inspection rules, use instruction, labeling, packaging. transportation and storage etc. for metal correctional stick.
This standard is applicable to metal corectional stick (hereinafter referred to as correctional stick), and this product is used for correctional internal fixation for spinal bone lesions or malformation.
2 Normative references
The following normative documents contain provisions which, through reference in the text, constitute provisionsof this national standard. For dated reference, subsequent amendments to, or revisions of, any of thesepublications (excluding contents of corrigenda) do not apply. However, parties to agreements based on thisstandard are encouraged to investigate the possibility of applying the most recent editions of the standardsindicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 228 Metallic tension test method
GB/T 4234 Stainless steel for surgical implants
GB/T 4340 Metallic Vickers hardness test method
GB/T 13810 Wrought titanium and titanium alay for surgical implants (GB/T 138 10- 1997, eqv ISO 5832-2:1993)
YY/T 0343 Liquid penetrant inspection of metallic surgical implants
YY 0341 General technological requirements for non- active metallic surgery implants of osteosynthesis
3 Classification
3.1 Product model example of the correctional stick
4 Requirements
4.1 Material
The correctional stick shall be manufactured with the stainless steel material prescribed in GB/T 4234 or titanium
alloy material prescribed in GB/T 13810.
4.2 Mechanical properties
The hardness or tensile strength of the orrectional stick shall comply with the provisions of Table 4.