YY/T 1809-2021Additive manufacturing for medical applications—Verification methods of cleaning and cleaning effectiveness of metal powder used in powder-bed fusion process (English PDF)
医用增材制造 粉末床熔融成形工艺金属粉末清洗及清洗效果验证方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
September 1, 2022
Scope
YY/T 1809-2021 is the English-translated version of 医用增材制造 粉末床熔融成形工艺金属粉末清洗及清洗效果验证方法.
YY/T 1809-2021 is the Chinese pharmaceutical industry standard that deals with the metal powder left inside a medical implant made by powder bed fusion, the loose and partly sintered powder trapped in its pores and channels.
It gives the methods by which that residual powder is cleaned away and the way the effectiveness of the cleaning is verified, so that a manufacturer can choose a cleaning process and show that it works. Issued on 6 September 2021, it has applied since 1 September 2022.
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Document preview — YY/T 1809-2021
National Standard of the People's Republic of China
- Classification
- C 30
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Common cleaning process for residual metal powder
- 5 Cleaning effect verification method
- Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Introduction
Additive manufacturing technology can realize the manufacture of medical devices with complex macro and micro structures by means of material accumulation, such as topology optimization. components, mesh structures, and especially porous structures. During powder bed fusion additive manufacturing, excess metal powder fills the internal space of the device, It remains in the porous internal structure and is difficult to remove. Partially sintered metal particles are often indistinguishable from unmelted particles, and There may be a risk of separation during use.
This standard provides high-pressure medium cleaning, ultrasonic cleaning, sonic dry cleaning, solid medium jetting, chemical cleaning, etc. for powder bed fusion The common cleaning process of residual metal powder in the additive manufacturing process and the verification method of cleaning effect. Manufacturer (technology provider) in This standard can be referred to when formulating the cleaning process, and other cleaning methods can also be selected according to the characteristics of the product.
1 Scope
This standard specifies the method for cleaning the residual metal powder in the powder bed fusion forming process of medical additive manufacturing and the verification method for the cleaning effect.
This standard applies to the selection of cleaning methods and the effectiveness evaluation of cleaning effects.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 6682-2008 Specifications and test methods for water used in analytical laboratories
GB/T 29070 General Requirements for Nondestructive Testing Industrial Computed Tomography (CT) Testing
GB/T 35351 Additive Manufacturing Terminology Pharmacopoeia of the People's Republic of China 2020 Edition Four
3 Terms and Definitions
GB/T 35351 as well as the following terms and definitions apply to this document.
3.1 Particulate matter
Discrete matter of any shape with different sizes. This standard specifically refers to solid particles remaining after additive manufacturing and post-processing. materials, including raw material powders, blasting media, and other debris.
3.2 Residual metal powder
Powder bed fusion forming process and post-processing process residual metal powder particles in manufactured parts (devices).
4 Common cleaning process for residual metal powder
4.1 General
The manufacturer (technology provider) should follow the source and characteristics of the residual metal powder, according to the product material, structural design characteristics, volume and other related factors. key parameters and its own technical conditions, choose and independently determine the cleaning plan of the metal powder in the powder bed fusion forming process as needed, and choose the appropriate The verification method for evaluating the cleaning effect of the residual metal powder of the corresponding sample is adopted to ensure the effect of removing the residual metal powder. It is not excluded to use other cleaning process.
4.2 Cleaning process
4.2.1 High pressure media cleaning
The surface of the sample and the inside of the pore structure are sprayed by the flowing high-pressure medium to achieve the purpose of cleaning the residual metal powder.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 29070-2012 — Non-destructive testing - Industrial computed tomography (CT) testing - General requirements
GB/T 35351-2025 — Additive manufacturing - Terminology
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
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