YY/T 1809-2021 English PDFUS$159.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1809-2021: (Medical additive manufacturing powder bed molding metal powder molding and effect verification) Status: Valid
Basic dataStandard ID: YY/T 1809-2021 (YY/T1809-2021)Description (Translated English): (Medical additive manufacturing powder bed molding metal powder molding and effect verification) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C30 Word Count Estimation: 8,831 Issuing agency(ies): State Drug Administration YY/T 1809-2021: (Medical additive manufacturing powder bed molding metal powder molding and effect verification)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. (Medical additive manufacturing powder bed molding metal powder molding and effect verification) ICS 11.040.40 C30 People's Republic of China Pharmaceutical Industry Standard Powder Bed Fusion Forming Process for Medical Additive Manufacturing Metal powder cleaning and cleaning effect verification method Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration directory Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Common cleaning process for residual metal powder 1 5 Cleaning effect verification method 2 Reference 4 forewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of China National Institute for Food and Drug Control. This standard was drafted by. Medical Device Technology Evaluation Center of the State Drug Administration, China National Institute for Food and Drug Control, Sichuan University Science, Wuxi City Product Quality Supervision and Inspection Institute/National Additive Manufacturing Product Quality Supervision and Inspection Center (Jiangsu), South China University of Technology Medical Devices Research and Testing Center, Dabo Medical Technology Co., Ltd., Beijing Aikang Yicheng Medical Equipment Co., Ltd., Yiqiangu (Beijing) Medical Technology Ltd. The main drafters of this standard. Guo Yajuan, Wang Jian, Ding Jinju, Wu Jing, Wang Yaning, Han Qianqian, Mao Xin, Wang Chunren, Mao Yuyi, Zeng Da, Xu Xinrong, Wang Caimei, Deng Xiang, Xu Baodong.IntroductionAdditive 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. Powder Bed Fusion Forming Process for Medical Additive Manufacturing Metal powder cleaning and cleaning effect verification method1 ScopeThis 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 referencesThe following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. 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 Four3 Terms and DefinitionsGB/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 powder4.1 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. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1809-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1809-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 1809-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1809-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. |
