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需灭菌材料的兼容性

Compatibility of materials subject to sterilization

灭菌材料的兼容性

Compatibility of materials subject to sterilization

卫生保健产品灭菌辐射 第3部分：开发、验证和常规剂量测定方面的指南

Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine

含有活人体细胞的医疗产品 风险管理的应用和加工实践的要求

Medical products containing viable human cells.Application of risk management and requirements for processing practices

技术信息报告 保健产品灭菌 湿热 第2部分：ANSI/AAMI/ISO 17665-1 应用指南

Technical Information Report Sterilization of health care products – Moist Heat – Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1

医疗产品初级软包装的设计和评估标准指南

Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

医疗产品初级软包装设计与评估标准指南

Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

组织工程医疗产品（TEMP）的标准分类

Standard Classification for Tissue-Engineered Medical Products (TEMPs)

评估细胞外基质脱细胞过程的标准指南

Standard Guide for Evaluating Extracellular Matrix Decellularization Processes

医疗器械的灭菌 微生物的种类 第3部分：细菌内毒素测试

Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing

保健品的无菌加工 一般要求

Aseptic processing of health care products. General requirements

保健品灭菌 微生物学方法 细菌内毒素美利体育登录入口官网

Sterilization of health care products. Microbiological methods. Bacterial endotoxin testing

医疗保健产品灭菌 微生物学方法 第3部分：细菌内毒素美利体育登录入口官网

Sterilization of health care products – Microbiological methods – Part 3: Bacterial endotoxin testing

医疗器械 Ruskin 型咬骨钳

Medical instruments - Rongeur type Ruskin

医疗器械 Overholt-Gei?end?rfer 型止血钳

Medical instruments - Haemostatic forceps type Overholt-Gei?end?rfer

医疗器械 Dandy型动脉夹

Medical instruments - Haemostatic forceps type Dandy

医疗器械 毛式敷料钳 第1部分：直型

Medical instruments - Dressing forceps type Gross - Part 1: Straight

医疗器械 毛式敷料钳 第2部分：弯曲

Medical instruments - Dressing forceps type Gross - Part 2: Curved

医疗器械 Verbrugge 型持骨钳

Medical instruments - Bone holding forceps type Verbrugge

医疗器械 弗里尔型电梯

Medical instruments - Elevator type Freer

医疗器械 手术剪刀 平面弯曲 Tnnis 型

Medical instruments - Surgical scissors, curved on flat, type T?nnis

用作医疗器械的患者, 医护人员和医疗器械用覆盖巾, 手术服和清洁空气套装 生产商, 处理器和产品的一般要求, 试验方法, 性能要求和性能等级（草案）

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels

医疗保健产品灭菌. 辐射. 第1部分:医疗器械灭菌过程的设计, 确认和常规控制要求 (ISO 11137-1-2006+Amd 1-2013); 德文版本EN ISO 11137-1-2006+A1-2013

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd 1:2013); German version EN ISO 11137-1:2006 + A1:2013

保健品灭菌-灭菌及相关美利体育官网首页网址和工艺标准中使用的术语词汇

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018); German and English version EN ISO 11139:2018

医疗保健应用中呼吸气体通路的生物相容性评估 第4部分：冷凝物中可浸出物的测试（ISO 18562-4:2017）

Biocompatibility evaluation of breathing gas pathways in healthcare application - Part 4: Tests for leachables in condensate (ISO 18562-4:2017)

用于医疗保健应用中液体和气体的小口径连接器 第3部分：用于肠内应用的连接器（ISO 80369-3:2016 + Amd 1:2019）（包括修正案 A1:2022）

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016 + Amd 1:2019) (includes Amendment A1:2022)

医疗产品 评估医疗器械的生物效应 第16部分：降解产物和浸出物毒代动力学研究的概念

Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables

医疗服务 医疗器械的生物学评价 第33部分 遗传毒性评价试验指南 ISO 10993-3 的补充

Medical levices. Biological evaluation of medical devices. Part 33. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

医疗器械. ISO 14971应用指南

Medical devices. Guidance on the application of ISO 14971

产品开发和投入生产的系统 医疗美利体育官网首页网址 术语和定义

System of product development and launching into manufacture. Medical devices. Terms and definitions

医疗产品消毒 显微物体方法 第3部分：细菌内毒素测试

Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing

保健品灭菌.微生物学方法.第1部分:产品上微生物群落的测定

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

含活性人体细胞的医疗产品.风险管理的应用和生产实践要求

Medical products containing viable human cells - Application of risk management and requirements for processing practices

健康信息学. 医药产品的识别. 受管制医药产品信息的唯一识别和交换用ISO 11615数据元素和结构的实施指南

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information

医疗保健产品灭菌 微生物学方法 第3部分:细菌内毒素美利体育登录入口官网

Sterilization of health care products - Microbiological methods - Part 3 : Bacterial endotoxin testing

医疗保健产品灭菌 微生物学方法 第3部分:细菌内毒素美利体育登录入口官网

Sterilization of health care products - Microbiological methods - Part 3 : Bacterial endotoxin testing

健康信息学 电子处方要求

Health informatics - Requirements for electronic prescriptions (ISO 17523:2016) (Endorsed by AENOR in August of 2016.)

医疗保健应用中用于液体和气体的小口径连接器 第3部分：肠内应用连接器

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications

基于模型的医疗美利体育官网首页网址测试的系统开发

Systematische Entwicklung modellbasierter Pruefungen fuer Medizinprodukte

基于模型的医疗器械测试的系统开发

Systematical development for a model-based testing of medical devices

医疗器械维护和管理目录 基础知识

Catalogues in maintenance and management of medical devices - Fundamentals