YY/T 0661-2008 in English

本标准涵盖了由原料供应商提供的PEEK聚合物原料（粒料、粉料等）。本标准提供了当这些热塑性塑料制造用于人体的植入器械，诸如外科植入物、外科或牙科器械的部件时的要求和相关的试验方法。
本标准对应于ASTM F 1925-05《外科植入物用聚（L-乳酸）树脂的标准规范》。本标准与ASTM F 1925-05的一致性程度为修改采用，技术内容不变，主要差异如下：
——按照汉语习惯对一些编排格式进行了修改；
——将一些适用于美国标准的表述改为适用于我国标准的表述；
——将第2章“规范性引用文件”中已转化为国标的国际标准用转化的国标代替；
——将原文4.1中的编辑性错误进行修改；
——删除第9章“关键词”。

Scope

This standard applies to poly(L-lactic acid) resin (or abbreviated PLLA resin) for surgical implants. But it does not include D, L stereoisomers or DL copolymers in any ratio. This standard describes the properties of poly(L-lactic acid) resin and does not apply to packaged, sterilized, finished implants processed from this material. This standard uses the International System of Units (SI). This standard does not attempt to address all safety issues involved, even those relevant to its use. It is the responsibility of the user of this standard to establish appropriate safe operating practices and to clarify the applicability of regulatory limitations prior to application.