Standard No.:	YY/T 0661-2017/XG1-2025
English Name:	Standard specification for semi—Crystalline poly(lactide) polymer and copolymer resin for surgical implants includes Amendment 1
Chinese Name:	《外科植入物 半结晶型聚丙交酯聚合物和共聚物树脂》含行业标准第1号修改单
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2025-08-26
Implemented on:	2026-8-26
Status:	to be valid
Superseding:	YY/T 0661-2017 Standard specification for semi-Crystalline poly ( lactide) polymer and copolymer resin for surgical implants
Target Language:	English
File Format:	PDF
Word Count:	10000 words
Translation Price(USD):	300.0
Delivery:	via email in 1~5 business day

本标准规定了外科植入物用原生半结晶型聚丙交酯基树脂的材料特性。
本标准适用于外科植入物用原生半结晶型聚（L-丙交酯）或聚（D-丙交酯）均聚物树脂，也适用于由L-丙交酯与其它生物可吸收单体共聚的半结晶型树脂。
本标准不适用于由这些材料制造的经包装灭菌的成品植入物。