YY/T 1909-2023 Active Industry standards-Medicine

YY/T 1909-2023 Additive manufacturing for medical applications—Requirements for control and validation of metal powder-bed electron beam fusion process

Publish Date: 2023-09-05 Implement Date: 2024-09-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1909-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2023-09-05

Implement Date: 2024-09-15

Publisher: 国家药品监督管理局

Technical Committee: 中国食品药品检定研究院

Pages: 16 pages

Scope

本文件规定了以电子束作为能量源的金属材料粉末床熔融增材制造工艺常规控制和过程确认的一般要求。
本文件适用于采用金属材料粉末床电子束熔融技术制造的医疗器械加工过程。

Development Information

Drafting Units:

天津清研智束科技有限公司、西安赛隆增材技术股份有限公司、上海市医疗器械化妆品审评核查中心、中国食品药品检定研究院、上海交通大学医学院附属第九人民医院

Drafting Persons:

朱纪磊、赵德陈、范之劲、王金武、刘歆、谢能、何婷、姜歆、韩倩倩、毛歆、郝永强、阚文斌、金园园、赵培、邓亮

Word Count: 29 Thousand words Pages: 16 pages

Referenced Standards

GB/T 13277.1-2008 Compressed air—Part 1:Contaminants and purity classes GB 3836.1-2000 Electrical apparatus for explosive gas atmospheres—Part 1:General requirements GB 3836.1-2010 Explosive atmospheres—Part 1:Equipment—General requirements GB/T 3836.1-2021 Explosive atmospheres—Part 1:Equipment—General requirements GB 3836.9-1990 Electrical apparatus for explosive atmospheres Encapsulated electrical apparatus "m" GB 3836.9-2006 Electrical apparatus for explosive gas atmospheres—Part 9:Encapsulation "m" GB 3836.9-2014 Explosive atmospheres—Part 9:Equipment protection by type of protection “m” GB/T 3836.9-2021 Explosive atmospheres—Part 9:Equipment protection by encapsulation “m” GB/T 3836.31-2021 Explosive atmospheres—Part 31:Equipment dust ignition protection by enclosure “t” GB 18871-2002 Basic standards for protection against ionizing radiation and for the safety of radiation sources GB/T 35351-2017 Additive manufacturing—Terminology GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes GB 50169-2016 Code for construction and acceptance of grounding connection electric equipment installation engineering GB/T 35351-2025 Additive manufacturing—Terminology

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