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可重复使用医疗器械清洁和灭菌过程验证与确认的基本概念

Basic Concepts in Validation and Qualification of Cleaning and Sterilization Processes for Reusable Medical Devices

保健品灭菌微生物学方法 第1部分：产品微生物种群的测定

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

医疗美利体育官网首页网址灭菌 微生物学方法 第3部分：生物负荷数据评估与解释指导

Microbiological methods for sterilization of medical devices Part 3: Guidance for the evaluation and interpretation of bioburden data

保健品无菌加工 第2部分：除菌过滤

Aseptic processing of health care products—Part 2: Sterilizing filtration

给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid sterilants

采用微生物方法 (模拟使用试验) 测定可重复使用医疗器械清洁过程有效性的标准试验方法

Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)

床上用品、室内装饰品和其他家用物品的填充物和填充物的清洁度 - 第2部分：羽毛和/或羽绒填充物和填充物规范

Cleanliness offillings and stuffings for bedding, upholstery and other domestic articles — Part 2 : Specification for feather and / or down fillings and stuffings

航天产品保证. 飞行硬件和洁净室的微生物检验

Space product assurance. Microbiological examination of flight hardware and cleanrooms

航天产品保证. 飞行硬件的气相负荷量减少

Space product assurance. Vapour Phase Bioburden Reduction for Flight Hardware

航天产品保证. 飞行硬件的干热微生物减少

Space product assurance. Dry Heat Bioburden Reduction for Flight Hardware

医疗器械灭菌 湿热灭菌的验证和常规控制

Sterilization ofmedical devices — Validation and routine control ofsterilization by moist heat

非肠道注射用药物和制药装置用弹性盖.生物学要求和试验方法

Elastomeric parts for parenterals and for devices for pharmaceutical use - Biological requirements and test methods

空间产品保证 飞行硬件和洁净室的微生物检查（草案）

Space product assurance - Microbiological examination of flight hardware and cleanrooms

航天产品保证 飞行硬件的干热生物负载减少

Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware; English version EN 16602-70-57:2015

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 11137-1-2015

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, including Amd 1:2013); German version EN ISO 11137-1:2015

医疗美利体育官网首页网址的消毒.微生物法.第1部分:产品上微生物群落的测定(ISO 11737-1-2006)(包括勘误表AC-2009).英文版本DIN EN ISO 11737-1-2009-09

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) (includes Corrigendum AC:2009); English version of DIN EN ISO 11737-1:2009-09

保健品灭菌 微生物方法 第1部分：产品上微生物种群的测定（ISO 11737-1:2018 + Amd 1:2021）；德文版 EN ISO 11737-1:2018 + A1:2021

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021); German version EN ISO 11737-1:2018 + A1:2021

医疗保健产品的无菌加工 第2部分：过滤（草案）

Sterile Processing of Healthcare Products Part 2: Filtration (Draft)

天然乳胶男用避孕套.要求和试验方法(ISO 4074-2015).德文版本EN ISO 4074-2015

Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015); German version EN ISO 4074:2015

医疗器械灭菌.微生物法.第1部分.产品上微生物数量的估计

Sterilization of medical devices. Microbiological methods. Part 1. Estimation of population of microorganisms on products

保健产品消毒.使用动物组织以及衍生产品的一次性医用器具用液体消毒剂.消毒程序特性描述,开发确认以及常规控制的要求

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

医疗保健产品灭菌.生物指示物.选择,使用及检验结果判断指南

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

保健产品的灭菌.辐射.第2部分:杀菌剂量的确定

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose

一次性食品接触手套的NSF协议

Disposable Food Contact Gloves

医疗器械灭菌 产品微生物数量估算 第2部分：指导

Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance

医疗器械灭菌 湿热灭菌的验证和常规控制

Sterilization of medical devices - Validation androutine control of sterilization by moist heat

注射用和药用器械用弹性部件 第4部分：生物学要求和测试方法（ISO 8871-4:2006）

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)