YY/T 0647-2021 Active Industry standards-Medicine

YY/T 0647-2021 Non-active surgical implants—Particular requirements of mammary implants

Publish Date: 2021-12-06 Implement Date: 2022-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0647-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2021-12-06

Implement Date: 2022-12-01

Publisher: 国家药品监督管理局

Technical Committee: 全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)

Pages: 38 pages

Scope

本文件规定了乳房植入物的专用要求。
本文件给出了预期性能、设计属性、材料、设计评价、制造、包装、灭菌和由制造商提供的信息等具体说明，同时考虑了植入物的安全性因素。

Development Information

Drafting Units:

中国食品药品检定研究院、河北省医疗器械与药品包装材料检验研究院、河南省医疗器械检验所、天津市医疗器械质量监督检验中心

Drafting Persons:

付步芳、王硕、王丽、刘东、李佳、王健、付海洋、陈明、刘若锦、徐玉茵、韩倩倩、李立宾、王春仁

Word Count: 75 Thousand words Pages: 38 pages

Replace the following standards

YY 0647-2008 Non-active surgical implants—Mammary implants—Particular requirements

Referenced Standards

YY/T 0640-2016 Non-active surgical implants—General requirements ISO 34-1:2015 ISO 37:2017 ISO 4287 ISO 7619-1 ISO 10993-1 ISO 10993-5 ISO 10993-18 ISO 11607-1 ISO 14155 ASTM D412-16 ASTM D624-00 ASTM D792-13 ASTM D2240-15