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YY/T 1909-2023: Additive manufacturing for medical applications - Requirements for control and validation of metal powder-bed electron beam fusion process
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| YY/T 1909-2023 | English | 299 |
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Additive manufacturing for medical applications - Requirements for control and validation of metal powder-bed electron beam fusion process
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YY/T 1909-2023
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Basic data | Standard ID | YY/T 1909-2023 (YY/T1909-2023) | | Description (Translated English) | Additive manufacturing for medical applications - Requirements for control and validation of metal powder-bed electron beam fusion process | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 15,186 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2024-09-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the general requirements for routine control and process validation of powder bed fusion additive manufacturing processes for metal materials using electron beams as energy sources. This standard applies to the processing of medical devices manufactured using metal material powder bed electron beam melting technology. | YY/T 1909-2023: Additive manufacturing for medical applications - Requirements for control and validation of metal powder-bed electron beam fusion process
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ICS 11.040.30
CCSC30
Pharmaceutical Industry Standards of the People's Republic of China
Medical Additive Manufacturing Metal Powder Bed Electron Beam
Melting process control and validation requirements
Published on 2023-09-05
Implemented on 2024-09-15
Released by the State Drug Administration
Table of contents
PrefaceⅠ
Introduction II
1 Scope 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 General 2
5 Confirm 4
6 Routine monitoring and control 7
7 Process Release 8
8 Maintain process effectiveness8
Appendix A (informative) Equipment maintenance 9
Reference 10
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the China Institute for Food and Drug Control.
This document was drafted by. Tianjin Qingyan Zhisu Technology Co., Ltd., Xi'an Sailong Additive Technology Co., Ltd., Shanghai Medical Devices
Cosmetics Review and Verification Center, China Institute of Food and Drug Control, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
The main drafters of this document. Zhu Jilei, Zhao Dechen, Fan Zhijin, Wang Jinwu, Liu Xin, Xie Neng, He Ting, Jiang Xin, Han Qianqian, Mao Xin, Hao Yongqiang,
Kan Wenbin, Jin Yuanyuan, Zhao Pei, Deng Liang.
Introduction
Metal powder bed electron beam melting technology has the advantages of high energy utilization, pure materials, small stress deformation, and high forming efficiency. It is an ideal choice for metal
Important methods for additive manufacturing of medical devices.
Additive manufacturing medical devices ensure product quality through process control, which requires effective process validation and must meet the requirements of relevant regulations.
beg. This document aims at the risk points of each link of "man-machine-material-method-environment" in the metal powder bed electron beam melting process, and provides guidance on personnel, equipment,
Clear requirements have been put forward in terms of environment, raw materials, process, especially installation qualification, operation qualification and performance qualification.
This document is based on the current development status of this technology. Enterprises can modify this document based on the actual conditions of specific processes and products.
Applicable provisions shall apply.
Medical Additive Manufacturing Metal Powder Bed Electron Beam
Melting process control and validation requirements
1 Scope
This document specifies a standard for routine control and process validation of powder bed fusion additive manufacturing processes for metal materials using electron beams as energy sources.
General requirements.
This document applies to the processing of medical devices manufactured using powder bed electron beam melting technology for metallic materials.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 3836.1 Explosive atmosphere Part 1.General requirements for equipment
GB/T 3836.9 Explosive atmospheres Part 9.Equipment protected by casting type "m"
GB/T 3836.31 Explosive atmospheres Part 31.Equipment protected by dust ignition resistant enclosure "t"
GB/T 13277.1-2008 Compressed air Part 1.Pollutant purification level
GB 18871 Basic standards for ionizing radiation protection and radiation source safety
GB/T 35351 Additive Manufacturing Terminology
GB/T 42061 Medical device quality management system for regulatory requirements
GB 50169 Specifications for construction and acceptance of grounding devices in electrical installation installation projects
3 Terms and definitions
The terms and definitions defined in GB/T 35351, GB/T 42061 and the following apply to this document.
3.1
Confirmation
A documented procedure for obtaining, recording, and interpreting the results required to determine that a process will continue to produce product that meets predetermined specifications.
[Source. GB/T.19971-2015,2.55]
3.2
The process of obtaining and forming documented evidence to prove that equipment has been provided and installed according to specification requirements.
[Source. GB/T.19971-2015,2.22]
3.3
The process of obtaining and forming documented evidence to prove that installed equipment can operate within predetermined limits when used according to operating procedures.
[Source. GB/T.19971-2015,2.27]
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