11.080.01 消毒和灭菌综合 标准查询与下载
共找到 873 条与 消毒和灭菌综合 相关的标准，共 59 页
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This document does not specify requirements for restricted access barrier systems (RABS). This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions. This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application. This document does not define biosafety containment requirements.
Aseptic processing of health care products — Part 6: Isolator systems
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- 11.080.01
- CCS
- 发布
- 2021-04-13
- 实施
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/FDIS 17664-1:2021)
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- 11.080.01
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- 发布
- 2021-04-01
- 实施
- 2021-04-01
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/DAM 1:2021)
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- 11.080.01
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- 发布
- 2021-04-00
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YY/T 0567本部分规定了医疗产品无菌加工中对除菌过滤方面的要求。本部分还为过滤器使用者提供了有关除菌过滤过程的建立、确认和常规操作的指南，用于医疗产品无菌加工。 本部分不适用于病毒的去除。除菌过滤不适用于含有效成分粒子大于过滤孔径的液体(如：全细胞菌苗)。
Aseptic processing of health care products - Part 2: filtration
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- 11.080.01
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- C47
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
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- 11.080.01
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- 发布
- 2021-03-03
- 实施
- 2021-03-03
Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
- ICS
- 11.080.01
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- 发布
- 2021-02-26
- 实施
- 2021-02-26
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation. This document excludes processing of: 1) critical and semi-critical medical devices; 2) medical devices intended to be sterilized; 3) textile medical devices used in patient draping systems or surgical clothing; 4) medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
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- 11.080.01
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- 发布
- 2021-02-25
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- 0000-00-00
包括次氯酸消毒剂的术语定义、原料要求、技术要求、标签标志和使用说明书、检验方法、用途及注意事项、包装贮存及运输和检验规则。
Hypochlorous acid disinfectant
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- 11.080.01
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- C268
- 发布
- 2021-02-23
- 实施
- 2021-03-04
Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
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- 11.080.01
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- 发布
- 2021-02-04
- 实施
- 2021-02-04
Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
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- 11.080.01
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- 发布
- 2021-01-26
- 实施
- 2021-01-26
Sterilization of health care products -- Biological indicators -- Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)
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- 11.080.01
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- 发布
- 2021-01-14
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- 2021-01-14
Accessibility and usability of the built environment - Functional requirements
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- 11.080.01
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- 发布
- 2021-01-13
- 实施
- 2021-03-10
本文件规定了抗菌性能检测相关的术语和定义、要求、试验方法、试验菌种（微生物）的选择和抗菌（微生物）性能的表征等相关内容。
General principles and requirements for antimicrobial testing
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- 11.080.01
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- C266
- 发布
- 2021-01-12
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- 2021-08-11
1.规定了消证字乳膏中8种抗真菌化学物质的高效液相色谱-串联质谱法的原理、试剂和材料、仪器和设备、分析步骤、结果表述、精密度、检出限和定量限。 2.适用于消证字乳膏中8种抗真菌化学物质咪康唑、益康唑、酮康唑、灰黄霉素、联苯苄唑、萘替芬、克霉唑、特比萘芬的定性定量测定。 3.当称样量为0.5 g，定容体积为50 mL时，灰黄霉素检出限为140μg/kg，定量限为400 μg/kg；克霉唑、酮康唑、特比萘芬、益康唑检出限为70μg/kg，定量限为200μg/kg；联苯苄唑、咪康唑、萘替芬检出限为30μg/kg，定量限为100μg/kg。
Determination of 8 Antifungal Components in Disinfectant Cream by Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry
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- 11.080.01
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- M734
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- 2021-01-10
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- 2021-03-08
Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
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- 11.080.01
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- C47
- 发布
- 2021-01-00
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Air cleanliness in the manufacture of medical devices
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- 11.080.01
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- 发布
- 2021-00-00
- 实施
- 2021-12-01
本文件从质量管理体系、安全和环境保护、灭菌过程控制和监视、变更和不合格控制以及重新灭菌等方面，对环氧乙烷灭菌生产过程控制提出了明确要求和指导，用于指导自行灭菌的医疗器械制造商和分包灭菌商，以规范环氧乙烷灭菌过程的管理。本规范文件中除适用范围、规范性引用文件、术语和定义及参考文献部分外，其它部分的主要内容概括如下： 1) 质量管理体系部分：从质量管理体系、文件要求、管理职责、人员和设备以及采购等方面规定了企业（制造商和分包灭菌商）提出要求和提供指导； 2) 安全和环境保护部分：从消防安全、人员安全、工艺安全和环境保护方面提出要求和指导； 3) 灭菌过程和监视部分：对企业灭菌过程中产品的接收和贮存、灭菌过程、灭菌后贮存、灭菌放行以及发货/转运过程等活动提出要求和指导； 4) 变更和不合格控制：对企业灭菌过程中变更和不合格控制进行了要求； 5) 对涉及到重新灭菌的过程提出要求。 通过如以上的几个部分的要求和指导，使得本标准规范文件是对GB18279.1和GB/T18279.2执行实施的形成了良好的补充。同时，使得环氧乙烷灭菌日常过程控制更具有可执行性和操作性，从而保障自行灭菌的医疗器械制造商和分包灭菌商灭菌过程控制的有效性和安全性。
Ethylene oxide sterilization process practice of sterile medical device
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- 11.080.01
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- C358
- 发布
- 2020-12-31
- 实施
- 2020-12-31
Sterilization of health care products — Chemical indicators —Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
- ICS
- 11.080.01
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- 发布
- 2020-12-30
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Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
- ICS
- 11.080.01
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- 发布
- 2020-12-30
- 实施
Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
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- 发布
- 2020-12-30
- 实施
