Standard No.:	YY/T 0473-2004
English Name:	Implants for surgery - Copolymers and blends based on polylactide -
Chinese Name:	外科植入物 聚交酯共聚物和共混物体外降解试验
Chinese Classification:	C30    Medical apparatus and devices in general
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:	SFDA
Issued on:	2004-3-23
Implemented on:	2005-1-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	5000 words
Price(USD):	150.00
Delivery:	via email in 1~3 business day

本标准适用于生产外科植入物用的聚交酯共聚物和(或)共混物的块材或加工材。本标准描述了在体外降解条件下测定这些共聚物和(或)共混物化学和(或)机械性能的变化。本标准中所规定的试验方法，用于在体外测定含有不同共聚单体(如乙交酯、三亚甲基碳酸酯、ε-内酯)的聚交酯基的共聚物和(或)共混物的降解速度和材料特性的变化。这些体外试验方法不能用来确切地预测材料在体内条件下的行为。本标准的目的是在于比较和(或)评价材料或加工条件。