非肠道用和制药设备用弹性部件 第二部分鉴别和特性.docx

非肠道用和制药设备用弹性部件 第二部分: 鉴别和特性 鉴别和特性 部分翻译如下： ISO 88712 ：2020 Elastomeric partsfor parenterals devices for pharmaceutical use — 非肠道用和制药设备用弹性部件— Part 2: 第二部分: Identification and characterization 鉴别和特性 Contents 内容 Foreword  and for 前言Introduction 介绍 Scope 范围 Normative references 标准参考文献 Terms and definitions 术语和定义 4Tests 测试 General 一般要求 Hardness 硬度 Density 密度 Ash 灼烧残渣 Infrared spectrum 红外光谱 Material 材料 Coating 覆膜 Compression set 压缩形变 Swelling 膨胀 Development of a fingerprint by gaschromatography 气相色谱法的指纹开发 Detection of volatile substances by gaschromatography 气相色谱法检测挥发性物质 Determination of residual moisture 残余水分的测定 Determination of fingerprint by thermogravimetricanalysis (TGA) 热重分析指纹图谱测定法 Determination of extractables inaqueous autoclavates 高压水溶液中可提取物的测定 Preparation of samples for testing 测试样品的准备 Treatment before testing 测试前的处理 Number of samples needed for the tests 测试所需的样品数量 Reagents and materials 试剂和材料 Annex A (informative) Identification ofelastomeric material by pyrolysis IR 附录 A（资料性）用热解红外光谱法鉴定弹性体材料Annex B (informative) Determination ofcompression set 附录 B （资料性）压缩永久形变的测定 Annex C (informative) Swelling behaviour inoils 附录 C （资料性）在油中的膨胀行为 Annex D (informative) Development of a fingerprintby gas chromatography 附录 D （资料性）气相色谱法指纹的开发 Annex E (informative) Analysis of volatilecomponents by headspace gas chromatography 附录 E（资料性）通过顶空气相色谱法分析挥发性成分Annex F (informative) Determination ofresidual moisture 附录 F（资料性）残余水分的测定 Annex G (informative) Determination of afingerprint by thermal gravimetry (TG) 附录 G（资料性）用热重分析法 (TG) 测定指纹图谱 Annex H (informative) Determination of theelastomer identity and verification of the presence of a coating by surfaceinfrared spectroscopy [attenuated total reflection (ATR)] 附录 H （资料性）通过表面红外光谱确定弹性体特性并验证覆膜的存在 [衰减全反射（ ATR ）] Bibliography 参考文献 Introduction 介绍 The elastomeric parts specified in the ISO 8871series are produced from rubber. However, rubber is not a unique entity, sincethe composition of rubber materials can vary considerably. The base