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环氧乙烷灭菌参数释放

Parametric release for ethylene oxide sterilization

具有自动过程控制和环氧乙烷灭菌剂源的通用环氧乙烷灭菌器，用于医疗保健设施

General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities

医院蒸汽灭菌器

Hospital steam sterilizers

保健品灭菌 生物指标 第1部分：通用要求

Sterilization of health care products—Biological indicators—Part 1: General requirements

医疗器械灭菌微生物方法 第2部分：灭菌过程的定义、验证和维护中进行的无菌测试

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

医疗保健产品的灭菌 使用动物组织及其衍生物的一次性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的表征、开发、验证和常规控制的要求

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 医疗器械灭菌剂特性及灭菌过程开发、验证和常规控制的一般要求

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

保健品灭菌化学指示剂选择、使用和结果解释指南

Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results

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

牙科 牙髓吸收点

Dentistry — Endodontic absorbent points

医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验

Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing

医用消毒器.环氧乙烷消毒器.要求和试验方法

Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods

牙科.牙科医疗器材.人工植牙

Dentistry. Medical devices for dentistry. Dental implants

航空产品质量保证 杀菌过程中材料及硬件的兼容性测试

Space product assurance. Materials and hardware compatibility tests for sterilization processes

保健产品的灭菌.辐射.杀菌剂量的确定

Sterilization of health care products. Radiation. Establishing the sterilization dose

保健品灭菌 生物指标 一般要求

Sterilization of health care products. Biological indicators. General requirements

医疗保健产品灭菌.生物指示物.低温蒸汽和甲醛灭菌用生物指示剂

Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes

保健产品的灭菌.化学指示剂.一般要求

Sterilization of health care products. Chemical indicators. General requirements

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

医疗保健产品的灭菌.生物指示器.选择、使用和检验结果解释用指南

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

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

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

医疗美利体育官网首页网址消毒.低温蒸汽和甲醛.医疗美利体育官网首页网址消毒流程的开发,确认和常规控制要求

Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

牙科 牙髓吸点（英标）

Dentistry. Endodontic absorbent points (British Standard)

医用输液美利体育官网首页网址 与压力输液美利体育官网首页网址一起使用的一次性输液过滤器

Infusion equipment for medical use. Infusion filters for single use with pressure infusion equipment

健康护理产品灭菌——化学指示剂 第一部分：一般要求

Sterilization of health care products — Chemical indicators — Part 1: General requirements

消毒医疗器械 灭菌剂的特性描述及灭菌过程开发、验证和常规控制的一般要求

General requirements for the characterization of sterilizing agents for sterilizing medical devices and for the development, validation and routine control of sterilization processes

灭菌医疗器械 生物指示剂 选择、使用及结果解释指南

Guidelines for the selection, use and interpretation of biological indicators for sterilized medical devices

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（采用 ISO 17665-1:2006 第一版 2006-08-15

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15

医疗机构用环氧乙烷灭菌器

Ethylene oxide sterilizers for health care facilities

安装、通风及卫生设施中环氧乙烷灭菌器的安全使用

Safe use of ethylene oxide sterilizers in installation, ventilation and sanitation

牙科 牙髓吸收尖

Dentistry – Endodontic absorbent points

证明医疗器械模拟器在蒸汽灭菌期间适用性的测试方法 医疗器械模拟器测试；文本为德语和英语

Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing; Text in German and English

证明蒸汽消毒时医疗美利体育官网首页网址模拟器的适宜性的试验方法 -M医疗美利体育官网首页网址模拟器试验;德文和英文

Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing; Text in German and English

灭菌-药品蒸汽灭菌器-第1部分：词汇

Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Vocabulary; Text in German and English

灭菌 药品蒸汽灭菌器 第2部分：技术要求

Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English

灭菌 药品蒸汽灭菌器 第2部分：技术要求

Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English

灭菌-药品蒸汽灭菌器-第2部分：技术要求

Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English / Note: DIN 58950-2 (2011-01) remains valid alongside this standard until 2022-06-01.

消毒.药品蒸汽消毒器.第3部分:试验;德文和英文文本

Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English

消毒 药品蒸汽消毒器 第6部分：操作

Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation

消毒.药品蒸汽消毒器.第6部分:操作;德文和英文

Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation; Text in German and English

灭菌-药品蒸汽灭菌器-第7部分：服务和当地环境要求

Sterilization - Steam sterilizers for pharmaceutical products - Part 7: Requirements on services and local environment; Text in German and English / Note: DIN 58950-7 (2011-01) remains valid alongside this standard until 2023-05-31.

医用灭菌器 低温蒸汽和甲醛灭菌器 要求和试验（草案）

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验.德文版本EN 14180-2014

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014

医用灭菌器 环氧乙烷灭菌器 要求和试验方法（草案）

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

航天产品保证 灭菌过程的材料和硬件兼容性测试（草案）

Space product assurance - Materials and hardware compatibility tests for sterilization processes

航天产品保证 灭菌过程的材料和硬件兼容性测试；英文版 EN 16602-70-53:2015

Space product assurance - Materials and hardware compatibility tests for sterilization processes; English version EN 16602-70-53:2015

医用灭菌器-低温汽化过氧化氢灭菌器-要求和测试（草案）

Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing

保健品灭菌 辐射 第2部分：确定灭菌剂量 修正案 1（ISO 11137-2:2013/DAM 1:2021）

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - AMENDMENT 1 (ISO 11137-2:2013/DAM 1:2021); German and English version EN ISO 11137-2:2015/prA1:2021

电子美利体育官网首页网址用电位器 - 第 3 部分：分规范：旋转精密电位器 (IEC 40/2760/CD:2020)

Potentiometers for use in electronic equipment - Part 3: Sectional specification: Rotary precision potentiometers (IEC 40/2760/CD:2020); Text in German and English / Note: Date of issue 2021-01-29

保健品灭菌 生物指示剂 第8部分：生物指示剂缩短孵育时间的验证方法（草案）

Biological indicators for sterilization of health care products Part 8: Verification method for shortening the incubation time of biological indicators (draft)

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(ISO 11737-2-2009); 德文版本 EN 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); German version EN ISO 11737-2:2009

保健产品的处理 医疗器械制造商为医疗器械提供的信息（草案）

Disposal of Healthcare Products Information provided by medical device manufacturers for medical devices (draft)

基于细胞的保健产品的制造 加工过程中微生物风险的控制（ISO 18362:2016）

Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018

牙科 牙髓吸收点（ISO 7551:2023）

Dentistry - Endodontic absorbent points (ISO 7551:2023)

牙科 - 牙髓吸收点（ISO 7551:2023）

Dentistry - Endodontic absorbent points (ISO 7551:2023); German version EN ISO 7551:2023

保健品的灭菌.湿热.第2部分:ISO 17665.1标准ISO/TS17665-2:2009)的应用指南,德文版本CEN ISO/TS17665-2:2009

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009); German version CEN ISO/TS 17665-2:2009

人体血液及血液成分袋式塑料容器 第1部分：传统型血袋

Plastics collapsible containers for human blood and blood components—Part 1: Conventional containers

一次性使用输血器 第2部分：压力输血美利体育官网首页网址用

Transfusion sets for single use—Part 2: With pressure infusion apparatus use

医疗保健产品灭菌 生物指示物 第2部分：环氧乙烷灭菌用生物指示物

Biological indicators for sterilization of health care products Part 2: Biological indicators for ethylene oxide sterilization

医疗保健产品灭菌 生物指示物 第8部分：缩短生物指示物培养时间的确认方法

Biological indicators for sterilization of healthcare products Part 8: Validation methods for shortening the incubation time of biological indicators

医疗保健产品灭菌 化学指示物 第1部分：通则

Chemical indicators for sterilization of health care products Part 1: General

医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求

Sterilization of health care products.General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices

一次性使用灭菌橡胶外科手套

Single-use sterile rubber surgical gloves

牙科 牙髓吸收点

Dentistry — Endodontic absorbent points

Esterilización. Esterilización por calor seco. Conceptos generales.

Sterilization. Dry heat sterilizers. General concepts.

医疗产品灭菌 辐射 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. Radiation. Part 1 - Requirements for development, validation and routine control of sterilization process for medical devices.

医疗器械灭菌 微生物方法 第2部分：在灭菌过程的定义、验证和维护中进行的无菌试验 （ISO 11737-2:2019 等同采用）

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

医疗保健产品的消毒. 环氧乙烷. 医疗器械消毒方法的制定, 确认和常规控制要求

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

保健产品的灭菌 辐射 第1部分:医疗器械灭菌过程的开发、验证和常规控制的要求

Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

保健品灭菌.生物指示剂.第7部分:结果的选择、使用和解释指南

Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results

卫生保健产品的灭菌.生物指示剂.第8部分：生物指示剂缩短培养时间的验证方法

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator

保健产品的灭菌.化学指示剂.第1部分:一般要求

Sterilization of health care products - Chemical indicators - Part 1: General requirements

医疗器械的灭菌 - 微生物方法 - 第2部分:灭菌过程的定义 验证和维护中进行的无菌美利体育登录入口官网

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

非活动外科植入物——通用要求

Non-active surgical implants — General requirements

保健产品的灭菌.辐射.第1部分:医疗器件消毒过程的制定、确认、和常规控制的要求

Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

宇宙产品质质量保证：材料与美利体育官网首页网址兼容性测试 适用于灭菌过程

Space product assurance - Materials and hardware compatibility tests for sterilization processes

医疗卫生产品灭菌 生物指示物 第7部分：结果选择、使用和解释指南（ISO 11138-7:2019）

Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)

牙科 根管吸收桩 (ISO 7551:2023)

Dentistry - Endodontic absorbent points (ISO 7551:2023)

医疗器械的灭菌 微生物学方法 第2部分：灭菌过程定义、验证和维持过程中的无菌测试（ISO 11737-2:2009 IDT）

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, IDT)

牙科 牙髓吸收尖

Dentistry - Endodontic absorbent points

医用灭菌器 低温蒸汽和甲醛灭菌器 要求和测试

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

医用灭菌器 低温蒸汽和甲醛灭菌器 要求和测试

Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing

医疗用途的灭菌器 乙ylene oxide灭菌器 要求和试验方法

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

空间产品保证 灭菌过程的材料和硬件兼容性测试

Space product assurance - Materials and hardware compatibility tests for sterilization processes

医疗产品灭菌 生物指示剂 第1部分：通用要求（ISO 11138-1:2017）

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)

医疗产品灭菌 生物指示剂 第4部分：干热灭菌过程的生物指示剂（ISO 11138-4:2017）

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)

医疗器械灭菌产品 灭菌剂的特性、灭菌过程开发、验证和常规控制的一般要求（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)

医疗产品灭菌 低温蒸汽和甲醛 灭菌过程开发、验证及常规控制的要求（ISO 25424:2018）

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

牙科 根管吸湿点（ISO 7551:2023）

Dentistry - Endodontic absorbent points (ISO 7551:2023)

无菌医疗器械环氧乙烷灭菌过程管理规范

Ethylene oxide sterilization process practice of sterile medical device

航天产品保证 灭菌过程的材料和硬件兼容性测试

Space product assurance - Materials and hardware compatibility tests for sterilization processes (Endorsed by AENOR in March of 2015.)

蒸汽灭菌器 大型灭菌器

Steam Sterilizer Large Sterilizer

保健品灭菌 生物指示剂 第7部分：结果选择、使用和解释指南

Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)

医疗保健产品灭菌 灭菌剂表征的一般要求以及医疗器械灭菌过程的开发、验证和常规控制（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)

信息技术 光纤通道 第116部分：10 Gigabit (10GFC) 修改件1

Dentistry - Endodontic absorbent points (ISO 7551:2023)

牙科 牙髓吸收尖

Dentistry - Endodontic absorbent points

医用低温蒸汽甲醛灭菌器卫生要求

Hygiene requirements for medical low-temperature steam formaldehyde sterilizers

医用低温蒸汽甲醛灭菌器

Medical low temperature steam formaldehyde sterilizer