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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

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

用于制药和生物制药制造的一次性系统的辐射验证和日常维护指南

Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing

环氧乙烷灭菌的微生物学方面[历史]

Microbiological aspects of ethylene oxide sterilization [HISTORICAL]

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

变更ISO 11135:2014版的更新摘要

Summary of changes to ISO 11135:2014

保健品灭菌 辐射 在指定的无菌保证水平下证实选定的灭菌剂量：方法 Vdmax SD-S

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S

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

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

医疗装置的消毒.贴有"已消毒"标签的产品要求

Sterilization of medical devices - Requirements for products labeled "STERILE"

保健品灭菌 辐射 第2部分：灭菌剂量的确定

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

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

保健品无菌加工 第5部分：就地灭菌

Aseptic processing of health care products — Part 5: Sterilization in place

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

保健产品的消毒.潮热.ISO 17665-1应用指南

Sterilization of health care products - Moist heat - Guidance on the application of ISO 17665-1

保健品的无菌加工.适当消毒

Aseptic processing of health care products. Sterilization in place

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

医疗保健产品灭菌.湿热.医疗器械灭菌过程技术革新、检验、日程控制的要求

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

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

麻醉和呼吸美利体育官网首页网址 超声门气道和连接器（采用ISO 11712:2023第二版 2023-11）

Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2023, second edition, 2023-11)

灭菌指示剂选择使用指南（第一版）

Guide to the selection and use of sterilization indicators (First Edition)

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; German and English version prEN 556-1:2023 / Note: Date of issue 2023-01-06*Intended as r...

保健品灭菌 辐射

Sterilization of Health Care Products — Radiation

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

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

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)

保健产品的灭菌.辐射.第2部分:杀菌剂量的确定(ISO 11137-2-2013).德文版本EN ISO 11137-2-2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015

牙科 - 牙科综合治疗台水线生物膜处理的测试方法（ISO 16954:2015）

Dentistry - Test methods for dental unit waterline biofilm treatment (ISO 16954:2015); German version EN ISO 16954:2015

保健品灭菌-生物指标-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)

医疗保健产品灭菌-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表-修正案1（ISO 11139:2018/DAM 1:2023）

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1 (ISO 11139:2018/DAM 1:2023); German and English version EN ISO 11139:2018/prA1:2023

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 修订1

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1 (ISO 11139:2018/DAM 1:2023); German and English version EN ISO 11139:2018/prA1:2023 / Note: Date of issue 2023-0...

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

保健品的无菌加工-第5部分：就地灭菌

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006); German version EN ISO 13408-5:2011

医疗保健产品的消毒.生物指示剂.选择、使用和检验结果解释指南(ISO 14161-2009); 德文版本 EN ISO 14161-2009

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009); German version EN ISO 14161:2009

保健品消毒 干热 医疗器材消毒步骤的制定,确认和常规控制要求（草案）

Formulation, confirmation and routine control requirements for disinfection of health care products and dry heat medical equipment (draft)

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

医疗器械的消毒. 干热. 医疗器械消毒方法的制定, 确认和常规控制要求

Sterilization of medical devices. Dry heat. Requirements for development, validation and routine control of a sterilization process for medical devices

保健产品的无菌加工.第5部分:现场消毒

Aseptic processing of health care products - Part 5: Sterilization in place

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

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)

保健产品灭菌 灭菌过程和相关美利体育官网首页网址标准中使用的术语词汇 修改件1：修改和附加术语和定义

Sterilization of healthcare products - Vocabulary of terms used in standards for sterilization processes and related equipment - Amendment 1: modified and additional terms and definitions

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

保健品灭菌-辐照-所选灭菌剂量的合理性：DVmaxD方法

Sterilization of health products - Irradiation - Justification of the chosen sterilizing dose: DVmaxD method

医疗保健产品灭菌 灭菌及相关美利体育官网首页网址及工艺标准中使用的术语词汇 修改1:修改和附加术语和定义

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1 : amended and additional terms and definitions

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

关于基于风险的方法的各个方面的指南 以确保最终灭菌的一次性医疗保健产品的无菌性 这些产品无法承受加工以达到最大10-6的无菌保证水平

Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6

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)

医疗产品灭菌 辐射 第2部分：确定灭菌剂量（ISO 11137-2:2013）

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

医疗产品灭菌 生物指示剂 第7部分：选择、使用和结果解释的指导（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)

医疗保健产品无菌加工 第1部分：通用要求

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

医疗保健产品无菌加工 第5部分：现场灭菌（ISO 13408-5:2006）

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

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 (ISO 11137-2:2013)

医疗保健产品的无菌加工.第5部分：在线灭菌

Aseptic processing of health care products.Part 5:Sterilization in place