Standard No.:	YY/T 0640-2008
English Name:	Non-active surgical implants—General requirements
Chinese Name:	无源外科植入物通用要求
Chinese Classification:	C45    Extracorporeal circulation, artificial organ and prosthesis device
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Issued by:	China Food and Drug Administration
Issued on:	2008-04-25
Implemented on:	2009-6-1
Status:	superseded
Superseded by:	YY/T 0640-2016 Non-active surgical implants-General requirements
Superseded on:	2017-6-1
Language:	English
File Format:	PDF
Word Count:	6500 words
Price(USD):	190.0
Delivery:	via email in 1~3 business day

本标准规定了无源外科植入物的通用要求。
本标准不适用于齿科植入物、齿科修复材料、经牙髓牙根植入固定物和眼内水晶体。
关于安全方面，本标准规定了对预期性能、设计属性、材料、设计评估、制造、灭菌、包装和制造商提供信息的要求，以及验证符合这些要求的试验。其他试验在二级和三级标准中给出。