This Standard specifies the technical requirements, test methods, product classification, marks, labels, packaging, transport and storage for plasma sprayed hydroxyapatite coated - titanium dental implant. This Standard is applicable to the plasma sprayed hydroxyapatite coated - titanium dental implant that is implanted in jawbone after the loss of a teeth.
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C33
Classification of International Standard
11.060.10
Word Count Estimation
10,175
Date of Issue
2009-12-30
Date of Implementation
2011-06-01
Older Standard (superseded by this standard)
YY 0304-1998
Quoted Standard
GB/T 13810-2007; GB/T 16886.1; YY/T 0268; YY/T 0313-1998; ISO 13779.3-2008; ISO 13779.4-2002; ISO 14801-2007
Adopted Standard
ISO 13779.2-2000, IDT; ISO 13779.3-2008, IDT; ISO 13779.4-2002, IDT;
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the plasma sprayed hydroxyapatite coating titanium-based dental implants technical requirements, test methods, product classification, marking, labeling, packaging, transportation and storage requirements. This standard applies to dental implants jaw after missing a plasma sprayed hydroxyapatite coating titanium-based dental implants bone.
