Standard No.:	YY/T 0474-2004
English Name:	Poly(L-lactide) resins and fabricated forms for surgical implants -
Chinese Name:	外科植人物用聚 L-丙交酯树脂及制品体外降解试验
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:	4500 words
Price(USD):	130.00
Delivery:	via email in 1~3 business day

本标准描述了聚L-丙交酯在体外降解试验条件下化学或机械性能变化的测定方法。本标准的目的在于比较和(或)评价材料或加工条件。本标准适用于生产外科植入物的各种形态的聚L-丙交酯。包括：a)块材；b)加工材；c)最终产品(经包装和灭菌的植入物)。本标准中所规定的试验方法用于测定聚L-丙交酯体外降解速度和材料性能的变化。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。