YY/T 1447-2016Implants for surgery - In vitro evaluation for apatite-forming ability of implant materials (English PDF)
外科植入物 植入材料磷灰石形成能力的体外评估
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1447-2016 is the English-translated version of 外科植入物 植入材料磷灰石形成能力的体外评估.
YY/T 1447-2016 is the Chinese standard "Implants for surgery - In vitro evaluation for apatite-forming ability of implant materials". Its scope clause reads: This standard specifies the method of detecting apatite formed on the surface of a material in simulated body fluids (SBF). Its clauses include normative reference documents; terms and definitions.
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Document preview — YY/T 1447-2016
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C35
Issued by: National Medical Products Administration
Contents
- 1 Scope
- 2 normative reference documents
- 3 terms and definitions
- 3.1 Apatite
- 3.2 Apatite - formingability
- 3.3 Bioactivity
- 3.4 Induction period
- 3.5 Simulated body fluid simulatedbodyfluid (SBF)
- 3.6 Criteria for assessing the formation of apatite standard glass
1 Scope
This standard specifies the method of detecting apatite formed on the surface of a material in simulated body fluids (SBF).
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
ISO 3696. 1987 Analysis of laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specifica- tionandtestmethods)
ISO 14630 Passive Surgical Implants General Requirements (Non-activesurgicalimplants-Generalrequirements)
3 terms and definitions
ISO 14630 and the following terms and definitions apply to this standard.
3.1 Apatite
Calcium phosphate, including bone mineral and the main inorganic constituents that make up bones and teeth, are similar to hydroxyapatite
[Ca10 (PO4) 6 (OH) 2].
Note. Bone minerals also contain ions such as CO32-, F-, Na and Mg2.
3.2 Apatite - formingability
The ability of the surface of the material to form apatite.
3.3 Bioactivity
In the material interface to trigger a specific biological reaction, making the organization and material to form a connection characteristics.
3.4 Induction period
The sample was immersed in the simulated body fluid to detect the time of formation of apatite on the surface of the material.
3.5 Simulated body fluid simulatedbodyfluid (SBF)
An inorganic solution having a plasma composition similar to that of the human body and containing no organic component.
3.6 Criteria for assessing the formation of apatite standard glass
In the SBF and implanted animals show the specific formation of apatite, with a specific chemical composition of the standard glass.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
Normative references
ISO 3696 · ISO 14630
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