C47 公共医疗设备 标准查询与下载
共找到 1175 条与 公共医疗设备 相关的标准，共 79 页
Biological Indicators for Sterilization of Healthcare Products Part 5: Biological Indicators for Formaldehyde Sterilization by Low Temperature Steam
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- 11.080
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Chemical Indicators for Sterilization of Healthcare Products Part 1: General Rules
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- 11.080
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Ethylene oxide for sterilization of healthcare products Part 1: Requirements for the development, validation and routine control of sterilization processes for medical devices
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- 11.080
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Biological indicators for sterilization of healthcare products - Part 2: Biological indicators for ethylene oxide sterilization
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- 11.080
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Chemical Indicators for Sterilization of Healthcare Products Part 5: Class II Indicators for Class BD Air Exclusion Tests
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- 11.080
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Biological Indicators for Sterilization of Healthcare Products Part 4: Biological Indicators for Dry Heat Sterilization
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- 11.080
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Specifications for configuration and management of emergency medical decontamination facilities for hazardous chemicals emergencies
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- 11.160
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- 2023-12-12
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- 2024-01-12
本文件规定了压力蒸汽灭菌器（以下简称灭菌器）生物安全性能要求，并描述了相应的试验方法。本文件适用于以生物安全为目的的材料、器械、器皿、培养基以及废弃物等物品的灭菌，以防止通过气溶胶等方式传播的致病因子对人员、动植物或环境造成污染。本文件中规定的灭菌器通常用于有生物安全需求且生物安全防护水平达到二级及以上的实验室或其他场所。本文件未规定涉及使用风险范围的安全要求，未规定湿热灭菌的确认和常规控制的要求。本文件不适用于密闭性液体的灭菌。
Biosafety performance requirements for pressure steam sterilizers
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- 11.080.10
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- 发布
- 2023-09-05
- 实施
- 2026-09-15
本文件规定了一次性使用便携式输注泵-非电驱动（以下简称输注泵）的基本要求和相应的试验方法。本文件适用于神经、血管内或皮下应用的可持续（固定的或可调节）给液和/或自控给液的输注泵。本文件不适用于：GB 9706.224所涵盖的电动或电控输注泵；供单个患者使用的，用于输送YY/T 1768系列所涵盖的离散（丸剂）药液的装置；植入器械；肠给养泵；经皮给液装置；输液动力不是由装置本身提供或由患者主动干预获得动力的装置（例如，仅由重力作为动力的装置）。
Single use portable infusion pump non-electrically driven
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- 11.080.01
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- 2023-09-05
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- 2026-09-15
Cognitive function assessment room construction and management specifications
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- 11.040.01
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- 2023-04-12
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- 2023-10-01
本文件规定了对全部或部分来源于动物材料的一次性使用医疗器械进行灭菌的液体化学灭菌剂的特征，以及灭菌开发、确认、过程控制和监控的要求。本文件适用于液体化学灭菌过程中细菌和真菌污染的风险控制，与其它微生物相关的风险可使用其他方法进行评估。本文件不适用于：人体来源的材料；病毒和传染性海绵状脑病（TSE）灭活的确认；原生动物和寄生虫灭活或消除的确认；生产过程中降低生物负载的处理过程；灭菌过程对医疗器械使用适宜性的测试评估；医疗器械中灭菌剂残留水平的制定。
Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes
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- 11.080.01
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- 发布
- 2023-03-14
- 实施
- 2026-05-01
本文件规定了医疗器械环氧乙烷灭菌过程中新产品或变更的产品追加到已经确认的灭菌过程的要求，并为使用不同灭菌设备时评估灭菌过程等效性提供方法。本文件适用于经环氧乙烷灭菌处理、采用传统放行或参数放行的医疗器械。本文件适用的医疗器械环氧乙烷灭菌情况包括：a) 在已经确认的环氧乙烷灭菌过程中增加新产品；b) 评估已确认产品的变更；c) 已确认的过程转移到不同的场地或设备；d) 评估灭菌过程的等效性。
Product additions and process equivalence for ethylene oxide sterilization
- ICS
- 11.080.01
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- C47
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- 2023-03-14
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- 2024-05-01
First Aid Workstation Configuration Specifications
- ICS
- 11.160
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- C47
- 发布
- 2022-12-27
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- 2023-04-01
Continuous Glucose Monitoring System
- ICS
- 11.040.01
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- 发布
- 2022-12-26
- 实施
- 2023-05-01
本文件规定了医疗器械低温蒸汽甲醛灭菌过程的开发、确认和常规控制的要求。本文件适用于在负压条件下使用混合低温蒸汽甲醛作为灭菌因子的灭菌过程。本文件不适用于对海绵状脑病(如羊痒症、牛海绵状脑病和克雅症)病原体灭活过程的开发、确认和常规控制的要求。
Development, validation and routine control requirements for low-temperature steam formaldehyde medical device sterilization process for sterilization of healthcare products
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- 11.080.01
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- 2022-10-17
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- 2023-10-01
Technical Requirements for Inspection of Export Medical Devices Part 1: Ventilators
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- 11.040.10
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- 发布
- 2022-03-14
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- 2022-10-01
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes in
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021
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- 11.080.01
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- 发布
- 2021-11-00
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Medical electrical equipment - Part 2-21 : particular requirements for the basic safety and essential performance of infant radiant warmers
- ICS
- 11.040.60
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- C47
- 发布
- 2021-07-16
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- 2021-09-18
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
- ICS
- 11.080.01
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- 发布
- 2021-06-30
- 实施
- 2021-09-11
