欧洲医疗标准目录.docVIP

欧洲医疗标准(EN medical standards) 编号 中文名称 英文名称 CR 13217-1998 用于常规数据交换的医疗设备的术语体系 基本原理 Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale CR 14060-2000 医疗设备示踪能力 Medical device traceability CR 14230-2001 用于常规数据交换目的的全球医疗设备术语（ISO/TS 20225:2001） Global medical device nomenclature for the purpose of regulatory data exchange (ISO/TS 20225:2001) EN 1041-1998 厂商提供的医疗设备信息 Information supplied by the manufacturer with medical devices EN 1174-1-1996 医疗器械的消毒 产品的微生物群数的估算 第1部分：要求 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements EN 1174-2-1996 医疗器械的消毒 产品的微生物总数的估算 第2部分：指南 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance EN 1174-3-1996 医疗器械的消毒 产品的微生物总数的估算 第3部分：微生物技术确认方法指南 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques EN 12218-1998+A1-2002 医疗设备用护栏系统 Rail systems for supporting medical equipment EN 12286-1998+A1-2000 体外诊断医疗器械　生物起源样品中数量的测量　标准测量程序表达 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures EN 12287-1999 体外诊断医疗器械　生物起源样品中数量的测量　标准物质描述 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials EN 12322-1999+A1-2001 体外诊断医疗器械　微生物学用培养基　培养基的性能标准 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media EN 12376-1999 体外诊断医疗器械　由制造商提供的有关生物学染色用体外诊断剂的信息 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology EN 12442-1-2000 医疗设备制造中使用的动物组织及其衍生物　第1部分：风险分析和管理 Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and manag