GB/T 23101.6-2022Implants for surgery - Hydroxyapatite - Part 6: Powders (English PDF)
外科植入物 羟基磷灰石 第6部分：粉末
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Recommended
Issue date
April 15, 2022
Implementation date
May 1, 2023
Scope
GB/T 23101.6-2022 is the English-translated version of 外科植入物 羟基磷灰石 第6部分：粉末.
GB/T 23101.6-2022 is the Chinese standard "Implants for surgery - Hydroxyapatite - Part 6: Powders". Its scope clause reads: This document specifies the requirements for the raw material of hydroxyapatite powder.
This document applies to the production of hydroxyapatite powder raw materials for the production of surgical implants or for the production of surgical implant coatings.
This document does not apply to hydroxyapatite coatings, hydroxyapatite ceramics, glass ceramics, alpha- and beta-tricalcium phosphate or other forms of phosphorus calcium acid. Its clauses include terms and definitions.
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Document preview — GB/T 23101.6-2022
National Standard of the People's Republic of China
- Classification
- C 35
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
- 5 Production Design Requirements
- 6 Certificate of Qualification
- Appendix A (informative) Other possible characterization tests
1 Scope
This document specifies the requirements for the raw material of hydroxyapatite powder.
This document applies to the production of hydroxyapatite powder raw materials for the production of surgical implants or for the production of surgical implant coatings.
This document does not apply to hydroxyapatite coatings, hydroxyapatite ceramics, glass ceramics, alpha- and beta-tricalcium phosphate or other forms of phosphorus calcium acid.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.
GB/T 23101.3 Surgical Implant Hydroxyapatite Part 3.Chemical Analysis and Characterization of Crystallinity and Phase Purity (GB/T 23101.3-2010, ISO 13779-3.2008, IDT)
JC/T 2176 Test method for particle size distribution of fine ceramic powder Laser diffraction method (JC/T 2176-2013, ISO 24235.2007,
MOD)
YY/T 0316 Application of Medical Device Risk Management to Medical Devices (YY/T 0316-2016, ISO 14971.2007 Correction version, IDT)
ISO 2591-1 Screening tests - Part 1.Test methods for screening of woven wire mesh and perforated metal plates (Testsie-
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 atomisation
The process of producing agglomerates of nearly spherical powder particles (atomized powder) by rapidly drying suspended particles.
3.2
alpha-Tricalcium phosphate alphatricalciumphosphate; alpha-TCP Compounds with crystal structures characterized by ICDDPDF09-0348.
Note 1.The chemical formula is Ca3(PO4)2.
Note 2.International Diffraction Data Center Powder Diffraction Card (ICDDPDF).
3.3
beta-tricalcium phosphate; beta-TCP Compounds with crystal structures characterized by ICDDPDF09-0169.
Note 1.The chemical formula is Ca3(PO4)2.
Note 2.International Diffraction Data Center Powder Diffraction Card (ICDDPDF). […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 23101.3Implants for surgery - Hydroxyapatite - Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity
- GB/T 23101.3-2010Implants for surgery - Hydroxyapatite - Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity
- YY/T 0316Medical devices-Application of risk management to medical devices
- YY/T 0316-2016Medical devices-Application of risk management to medical devices
ISO 13779 · ISO 24235.2007 · ISO 14971.2007 · ISO 2591
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Related Standards
GB/T 23101.3-2023 — Implants for surgery - Hydroxyapatite - Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity
YY/T 0316-2003 — Medical devices - Application of risk management to medical devices
YY/T 0316-2008 — Medical devices - Application of risk management to medical devices
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