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消毒过程的基本概念：验证、确认及资格评定

Basic Concepts in Sterilization Processes: Verification, Validation, and Qualification

微生物方法 产品生物负载数据的理解和使用

Microbiological methods—Understanding and use of product bioburden data

工业湿热灭菌原理，1ed

Principles of industrial moist heat sterilization, 1ed

环氧乙烷灭菌的微生物学方面

Microbiological aspects of ethylene oxide sterilization

保健品灭菌 辐射 使用修改方法 2 设定剂量的指南

Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2

最终灭菌保健品环境监测

Environmental monitoring for terminally sterilized healthcare products

医疗保健产品的辐射灭菌——单批生产的灭菌剂量的选择

Sterilization of health care products—Radiation sterilization—Selection of a sterilization dose for a single production batch

医疗产品灭菌 微生物学方法 生物负载测定和无菌性测试的指导

Guidance on bioburden determination and sterility testing of medical products using microbiological methods for sterilization

闪蒸灭菌：立即使用医疗器械的蒸汽灭菌

Flash Sterilization: Steam Sterilization of Immediate-Use Medical Devices

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 保健品灭菌—辐射—所选灭菌剂量的证实：方法VDmax SD

Technical Information Report Sterilization of health care products—Radiation— Substantiation of a selected sterilization dose: Method VDmax SD

保健用品的消毒．辐射法．医疗器械消毒程序的开发；验证和常规控制的要求

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

保健品灭菌-辐射第2部分：确定灭菌剂量

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

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

航天产品保证. 洁净室微生物控制

Space product assurance. Bioburden control of cleanrooms

医疗器械灭菌 环氧乙烷灭菌的验证和常规控制

Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization

保健品灭菌.微生物学方法.产品上微生物群落的测定

Sterilization of health care products. Microbiological methods. Determination of a population of microorganisms on products

保健品灭菌 微生物学方法 产品上微生物群落的测定

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

保健品灭菌 利用动物组织及其衍生物的一次性医疗器械液体化学灭菌剂 ... 的表征、开发、验证和常规控制要求

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 ...

保健产品灭菌 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 a Sterilization Process for Medical Devices

健康卫生产品 — 辐射灭菌 第2部分：确定灭菌剂量

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

保健品灭菌 微生物学

Sterilization of health care products — Microbiological

保健品灭菌 微生物方法 第2部分：灭菌过程的定义、验证和维持中进行的无菌试验

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

洗衣机消毒器 第一部分：一般要求、术语和定义及测试

Washer disinfectors Part 1: General requirements, terms and definitions and tests

医疗保健产品灭菌 辐射 选定灭菌剂量的证实：方法 VDmaxSD（ISO 13004:2022）

Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

植入性医疗器械 高分子材料 浸提液中有毒有害物质的测定 生物负载 薄膜过滤法

Determination of Toxic and Hazardous Substances in Implantable Medical Device Polymer Materials Extraction Bioburden Membrane Filtration Method

手术衣和手术单要求和测试方法第2部分：洁净空气服（草案）

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

空间产品保证 飞行硬件和洁净室的微生物检查；英文版 EN 16602-70-55:2015

Space product assurance - Microbiological examination of flight hardware and cleanrooms; English version EN 16602-70-55:2015

航天产品保证 飞行硬件和洁净室的微生物检查

Space product assurance - Microbiological examination of flight hardware and cleanrooms; English version EN 16602-70-55:2015

航天产品保证 飞行硬件的气相生物负载减少

Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware; English version EN 16602-70-56:2015

空间产品保证 洁净室的生物负载控制（草案）

Space product assurance - Bioburden control of cleanrooms

空间产品保证 洁净室的生物负载控制

Space product assurance - Bioburden control of cleanrooms; English version EN 16602-70-58:2015

空间可持续性 行星保护；英文版 EN 16604-20:2020

Space sustainability - Planetary protection; English version EN 16604-20:2020

太空可持续性 行星保护

Space sustainability - Planetary protection; English version EN 16604-20:2020

灭菌医疗器械产品的环氧乙烷灭菌要求 开发、验证和应用控制的要求 (ISO 11135:2014/DAM 1:2017)

Requirements for the development, validation and application of controls for ethylene oxide sterilization of sterilized medical device products (ISO 11135:2014/DAM 1:2017)

保健产品的灭菌 辐射 第2部分：杀菌剂量的确定（草案）

Sterilizing radiation for health care products Part 2: Determination of germicidal dose (draft)

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（草案）

Microbiological Methods for Disinfection of Medical Devices Part 1: Determination of Microbial Communities on Products (Draft)

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)

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（草案）

Microbiological methods for sterilization of medical devices Part 2: Definition, effectiveness and maintenance of sterility tests during sterilization processes (draft)

保健品灭菌 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测试（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)

保健品灭菌 辐射 所选灭菌剂量的证实：方法 VD（ISO 13004:2022）

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD (ISO 13004:2022); German and English version prEN ISO 13004:2023

保健品灭菌-辐射-选定灭菌剂量的证实：方法VD＜

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO 13004:2022); German and English version prEN ISO 13004:2023 / Note: Date of issue 2023-02-10*Intended as...

保健品灭菌-辐射-所选灭菌剂量的证实：方法VD<(Index)max><(hoch)SD> （ISO 13004:2022）；德文版 EN ISO 13004:2023

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO 13004:2022); German version EN ISO 13004:2023

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 (ISO 13408-2:2018); German version EN ISO 13408-2:2018

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

医疗产品灭菌 辐射 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求

Medical Device Sterilization - Radiation - Part 1: Requirements for the Development, Validation and Routine Control of Sterilization Processes for Medical Devices

医疗产品灭菌 辐射 第2部分：建立灭菌剂量

Medical Device Sterilization - Radiation - Part 2: Establishing the Sterilization Dose

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

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

包含动物源材料的一次性医用器具的消毒.通过液体消毒剂的确认和常规控制

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

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

医疗卫生产品的杀菌.医疗卫生设施湿热灭菌的确认与常规控制要求

Sterilization of health care products. Requirements for validation and routine control of moist heat sterilization in health care facilities

医疗保健产品的消毒. 医疗器械消毒方法的制定, 确认和常规控制及消毒剂特定的通用标准

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

医疗器械的灭菌. 低温蒸汽和甲醛医疗器械消毒方法的制定, 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

医疗器械灭菌.微生物学方法.第1部分:产品上微生物群落的测定

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products

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

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

保健产品的灭菌.辐射.选定灭菌剂量的验证:方法VDmaxSD

Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD

保健产品的无菌加工 - 第2部分:灭菌过滤

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

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

清洗消毒器. 第1部分: 一般要求, 术语, 定义和试验; 修改件1

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests; Amendment 1

化妆品.微生物学.浸渍或涂层湿巾和口罩的试验

Cosmetics — Microbiology — Testing of impregnated or coated wipes and masks

保健品的消毒.词汇

Sterilization of health care products - Vocabulary

保健产品的灭菌.辐射.选定的灭菌剂量的证实:VD<(Index)max><(hoch)SD>方法

Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD>

洁净室微生物污染控制

Space product assurance - Bioburden control of cleanrooms

空间可持续性 行星保护

Space sustainability - Planetary protection

医疗保健产品灭菌 辐射 选定灭菌剂量的依据 VDmaxSD方法 (ISO 13004:2022)

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

现场qPCR应用快速微生物美利体育登录入口官网与量化方法

Rapid microbial detection and quantification methods using on-site qPCR

医疗保健产品灭菌 辐射 选定灭菌剂量的证实：方法VDmaxSD

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose : method VDmaxSD

医疗保健产品灭菌 辐射 选定灭菌剂量的证实：方法VDmaxSD

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose : method VDmaxSD

纳米技术 词汇 第3部分：碳纳米物体

Nanotechnologies - Vocabulary - Part 3: Carbon nano-objects

航天产品保证 飞行硬件的气相生物负载降低

Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware

医疗器械灭菌 辐照灭菌的验证和常规控制

Sterilization of medical devices - Validation androutine control of sterilization by irradiation

医疗器械灭菌 被指定为“无菌”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

医疗保健产品灭菌 环氧乙烷 第2部分：ISO 11135-1应用指南

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1

医疗保健产品灭菌 辐射 第2部分：确定灭菌剂量(ISO 11137-2:2006 修正版2006-08-01)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

医疗器械灭菌 微生物学方法 第1部分：产品上微生物种群的测定（ISO 11737-1:2006）

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

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)

医疗器械的灭菌 辐射 选定灭菌剂量的证实：方法VDmaxSD（ISO 13004:2022）

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

医疗产品消毒 利用动物组织及其衍生物的一次性医用美利体育官网首页网址液体化学消毒剂 消毒 characterization、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...

航天产品保证 飞行硬件和洁净室的微生物检查

Space product assurance - Microbiological examination of flight hardware and cleanrooms (Endorsed by AENOR in November of 2015.)

航天产品保证 减少飞行硬件的气相生物负载

Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware (Endorsed by AENOR in November of 2015.)

航天产品保证 洁净室的生物负载控制

Space product assurance - Bioburden control of cleanrooms (Endorsed by AENOR in November of 2015.)

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

保健产品灭菌 微生物方法 第1部分：产品上微生物种群的测定

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

保健产品灭菌 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 (ISO 11737-2:2019)

保健品灭菌 辐射 选定灭菌剂量的证实：方法 VDmaxSD (ISO 13004:2022)

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

保健品灭菌 辐射 所选灭菌剂量的证实：方法VDmaxSD

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

全棉非织造布外科敷料性能要求.第1部分：敷料生产用非织造布

Performance requirements for pure cotton nonwoven surgical compresses.Part 1:Nonwovens used in the manufacture of surgical compresses

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

标示“无菌”医疗器械的要求 第2部分：无菌加工医疗器械的要求

Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices

医疗器械生物负载控制水平的分析方法

Analytical methods for bioburden control levels of medical devices