美利体育登录入口官网

医疗设施无菌处理准备指南

A Guide to Preparing for Sterile Processing in Healthcare Facilities

蒸汽灭菌与医疗卫生设施中灭菌保证

Steam Sterilization and Sterility Assurance in Healthcare Facilities

技术信息报告 ANSI/AAMI/ISO TIR11139:2006 保健品灭菌—词汇

Technical Information Report ANSI/AAMI/ISO TIR11139:2006 Sterilization of health care products— Vocabulary

一次性使用无菌针灸针

Sterile acupuncture needles for single use

外科橡胶手套的标准规范

Standard Specification for Rubber Surgical Gloves

医疗装置再使用的消毒处理的有效性的标准测试方法

Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices

医疗装置再使用的消毒处理的有效性的标准试验方法

Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices

骨科植入物和器具的养护与处理的标准实施规程

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

生物技术.轴密封的性能标准

Biotechnology - Performance criteria for shaft seals

医疗器械的消毒 微生物学法 灭菌过程的定义、有效性和维护中进行的无菌试验

Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process

化学和制药行业无菌应用的不锈钢部件 清管系统用弯头

Stainless steel components for aseptic applications in the chemical and the pharmaceutical industries - Elbows for pigging systems

生物技术.美利体育官网首页网址.消毒性能的试验程序指南

Biotechnology - Equipment - Guidance on testing procedures for sterilizability; German version EN 12297:1998

医疗器械灭菌 指定为“STERILE”的医疗器械的要求 第2部分：无菌处理医疗器械的要求

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 / Note: To be replaced by DIN EN 556-2 (2023-02).

医疗器械灭菌 指定为“STERILE”的医疗器械的要求 第2部分：无菌处理医疗器械的要求

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...

用于标记医疗器械的图形符号

Graphic symbols for labeling medical devices

医疗器械的质量管理和相应的一般方面

Quality management and corresponding general aspects for medical devices

血管内导管 无菌和一次性导管 第1部分：一般要求

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013 + Amd 1:2017); German version EN ISO 10555-1:2013 + A1:2017 / Note: To be replaced by DIN EN ISO 10555-1 (2022-12).

保健品灭菌 辐射

Sterilization of Health Care Products — Radiation

医用输血器具.第3部分:一次性采血器(ISO 1135-3-2016);德文版本EN ISO 1135-3-2017

Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016); German version EN ISO 1135-3:2017

保健品灭菌-微生物学方法-第1部分：产品上微生物种群的测定（ISO 11737-1:2018）

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)

眼科植入物 人工晶体 第8部分：基本要求（草案）

Ophthalmic Implants and Intraocular Lenses Part 8: Basic Requirements (Draft)

眼科植入物.人工晶体.第8部分:基本要求(ISO 11979-8-2006 + Amd.1-2011);德文版本EN ISO 11979-8-2009 + A1-2011

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2009 + A1:2011

保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发,验证及常规控制的一般要求 (ISO 14937-2009); 德文版本 EN ISO 14937-2009

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009

保健品灭菌 湿热 第1部分：医疗器械灭菌过程的开发、验证和常规控制要求

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006 / Note: To be replaced b...

医用输液美利体育官网首页网址 第4部分：一次性使用输液器，重力输液（ISO 8536-4:2019）

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

医疗器械的消毒.标明为"消过毒"的医疗器械的要求.第1部分:定期消毒的医疗器械的要求.合并勘误表2006年9月［代替:CEN EN 556］

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

兽医用生物医药.无菌细菌控制方法

Medicine remedies biological for veterinary use. Method of bacteriological control of sterility

香水和化妆品 微生物学 无菌性测定方法

Perfumery and cosmetics. Microbiology. Method of determination of sterility

医疗器械灭菌.微生物法.第2部分.用于验证消毒程序的无菌试验

Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process

医疗产品的灭菌 微生物学方法 第2部分：在定义、验证和维持灭菌过程时进行的无菌测试

Sterilization of health care products. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process

医疗器械产品的灭菌 灭菌的验证和常规控制要求 湿热工业灭菌 使用、验证和控制

Sterilization of healthcare products. Requirements for validation and routine control. Industrial heat sterilization. Use, validation, and control.

一次性合成乳胶手套 第一部分 用于医疗检查 无菌或非无菌

Synthetic latex gloves for single use. Part 1 - For medical examination, sterile or not.

一次性合成乳胶手套 第2部分 手术用 无菌

Synthetic latex gloves for single use. Part 2 - For surgery, sterile.

医疗器械灭菌.微生物学方法.第2部分:灭菌过程的定义、有效性和维护中进行的无菌试验

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

眼科植入物.眼内透镜.第8部分:基本要求

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements

一次性使用无菌皮下注射器.第1部分:手推注射器

Sterile hypodermic syringes for single use - Part 1: Syringes for manual use

一次性使用无菌皮下注射器 第1部分：手动使用注射器

Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

保健品的消毒.词汇

Sterilization of health care products - Vocabulary

医疗器械产品灭菌 微生物方法 第1部分：产品上微生物种群测定 (ISO 11737-1:2018)

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)

医疗保健产品的灭菌 微生物学方法 第2部分：定义、验证和监控灭菌过程所采用的无菌性试验（ISO 11737-2:2019）

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

保健产品的灭菌.乙撑氧.第1部分:医疗美利体育官网首页网址灭菌过程开发、确认和常规控制的要求

Sterilization of health care products - Ethylene oxide - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.

商品化试剂盒美利体育登录入口官网方法 孔雀石绿 方法一

Commercial kit detection method malachite green method one

健康护理纺织品 可重复使用的帷帘（非无菌）

Health care textiles - Reusable drapes (non sterile)

医疗器械灭菌 被指定为“无菌”的医疗器械的要求 第2部分：无菌处理医疗器械的要求

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

医疗器械灭菌 微生物学方法 第2部分：灭菌过程的定义、验证和维护中进行的无菌测试（ISO 11737-2:2009）

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

药品生产用转移规程 要求与试验方法（ISO 22413:2010）

Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)

一次性使用的无菌皮下注射器 第1部分：手动使用注射器（ISO 7886-1:2016）

Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2016)

医疗器械灭菌 指定为“STERILE”的医疗器械的要求 第1部分：最终灭菌医疗器械的要求

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

压缩空气纯度 第2部分: 食品和制药行业特定应用的典型纯度等级

Compressed air purity Part 2: Typical purity grades for specific applications in the food and pharmaceutical industries

医用脱脂棉

Medical purified cotton

一次性使用无菌胰岛素注射器

Disposable sterile insulin syringe

标示“无菌”医疗器械的要求 第l部分：最终灭菌医疗器械的要求

Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices

一次性使用宫内节育器放置器通用要求

General requirements of disposable inserter for intrauterine devices