GB/T 36983-2018Porous tantalum material for surgical implant applications (English PDF)
外科植入物用多孔钽材料
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
December 28, 2018
Implementation date
January 1, 2021
Scope
GB/T 36983-2018 is the English-translated version of 外科植入物用多孔钽材料.
GB/T 36983-2018 specifies the requirements and test methods for porous tantalum materials used in surgical implants. It covers the chemical composition, mechanical properties and microstructure of the material, and defines porous tantalum, pore size, macropores (pores larger than 10 µm) and micropores (not larger than 10 µm).
It applies to porous tantalum made by physical or chemical methods, and refers to standards on biological evaluation of medical devices, pore size distribution and porosity, X-ray CT inspection of porous metals for implants and grain size measurement.
It is intended for implant material producers, device manufacturers and testing laboratories. It was issued on 28 December 2018 and has applied since 1 January 2021.
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Document preview — GB/T 36983-2018
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 35
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
- 5 Test method
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the chemical composition, mechanical properties and microstructure requirements and test methods of porous tantalum materials for surgical implants.
This standard applies to porous tantalum materials for surgical implants produced by physical or chemical methods.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing in the process of risk management
GB/T 21650.1 Determination of pore size distribution and porosity of solid materials - Part 1
GB/T 36984 X-ray CT detection method for porous metal materials for surgical implants
YY/T 0966 Surgical Implant Metal Material Pure
SY/T 0988.14 Surgical implant coatings - Part 14
ISO 13175-3 Surgical implant calcium phosphate Part 3. Hydroxyapatite and beta-tricalcium phosphate substitutes (Implants for surgery - Calcium phosphates - Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes)
ISO 13383-1 Fine ceramics (advanced ceramics, advanced process ceramics) - Microstructures - Part 1: Grain size and particle size Determination of cloth [Fine ceramics (advanced ceramics, advanced technical ceramics) - Microstructural characterization - Part 1: Determination of grain size and size distribution]
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Porous tantalum
A porous structure base metal material having three-dimensional connected pores.
3.2 Pore size
The hole width (such as the diameter of a circular hole or the distance between two pairs of walls of a slit hole) is a representative of the spatial size properties of porous materials. Sex value.
3.3 Macropore
A pore having a pore diameter greater than 10 µm.
3.4 Micropore
A hole having a pore diameter of not more than 10 µm.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 21650.1Evaluation of pore size distribution and porosity of solid materials by mercruy poresimetry and gas adsorption - Part 1: Mercury porosimetry
- GB/T 36984X-ray CT testing method of the porous metal materials for surgical implant applications
- YY/T 0966Implants for surgery - Metallic materials - Unalloyed tantalum
SY/T 0988.14 · ISO 13175-3 · ISO 13383-1
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.10-2024 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization
GB/T 16886.11-2021 — Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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