11.080.10 消毒设备 标准查询与下载
共找到 403 条与 消毒设备 相关的标准，共 27 页
BS EN 17180. Sterilizers for medical purposes. Low temperature vapourized hydrogen peroxide sterilizers. Requirements and testing
- ICS
- 11.080.10
- CCS
- 发布
- 2023-02-23
- 实施
- 2023-02-23
本文件规定了紫外线消毒牙刷架的工作条件、要求、试验方法、检验规则、标志、包装、运输和贮存。
Toothbrush rack with ultraviolet disinfection
- ICS
- 11.080.10
- CCS
- C354
- 发布
- 2022-11-02
- 实施
- 2022-11-02
ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs. The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).
Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
- ICS
- 11.080.10
- CCS
- 发布
- 2022-05-12
- 实施
本文件规定了工业用环氧乙烷灭菌器的术语和定义、分类与标记、基本要求、技术要求、试验方法、检验规则、标志、使用说明书和包装、运输、贮存、报废处理、质量承诺。 本文件适用于最高工作压力低于100 kPa、采用环氧乙烷液化气体灭菌的工业用环氧乙烷灭菌器(以下简称灭菌器)。该灭菌器容积＞1 m3，适用于医疗器械工业生产中灭菌。 本文件不适用于灭菌器容积≤1 m3，用于临床医疗器械灭菌的环氧乙烷灭菌器。 注： 若无特别说明，本标准中所指的压力均为相对压力。 本文件的内容包括使灭菌器工作于大气压之上或大气压之下的最低性能和结构等要求： ——确保灭菌过程能够用来对灭菌物品进行灭菌； ——进行灭菌过程的实施和监测所必须的设备与控制装置。 本文件对环氧乙烷灭菌的包装材料未做出规定，有关要求参见 GB 19633。 本文件对灭菌材料未做出规定，对灭菌材料的有关要求参见标准 YY/T 1267—2015。 本文件对灭菌确认和常规控制未做出规定，有关要求参见 GB 18279.1， GB 18279.2。 本文件不讨论医疗器械内环氧乙烷残留量问题。 注： 国家标准和行业标准中对某些医疗器械产品规定了其环氧乙烷残留量应予以采用。
Industrial ethvlene oxide sterilizer
- ICS
- 11.080.10
- CCS
- C358
- 发布
- 2022-03-28
- 实施
- 2022-04-08
6 技术要求 6.1 一般要求 6.1.1 外观 6.1.1.1 外形应端正，表面应平整光洁、色泽均匀。外表面不应有涂层起泡、龟裂、锈蚀、边角锋棱和明显划痕。 6.1.1.2 外表面附着使用说明的各种文字、符号、图形标志应标记清晰、准确、牢固。 6.1.1.3 各控制装置应操作灵活、可靠，无阻滞。各紧固件应连接牢固，无松动现象。 6.1.2 适用体积不能小于30m3。 6.1.3 等离子体空气消毒机向室内传输的空气中不应有任何化学物质。 6.2 等离子体发生量 等离子体发生器所产生的等离子体密度应不低于1.0×1018m-3。 6.3 消毒效果 6.3.1 在进行消毒效果试验时，应确定消毒效果是由等离子体发生器所产生的等离子体作为唯一消毒因子。 6.3.2 消毒时间 单次消毒作用时间应≤1h。 6.3.3 模拟现场消毒试验 用等离子体空气消毒机进行模拟现场消毒试验，在20℃~25℃，相对湿度50%~70%条件以及说明书规定的适用空间下，开机作用至说明书规定的时间,对白色葡萄球菌(8032)的杀灭率应≥99.9%。 6.3.4 现场消毒试验 现场自然条件下，用等离子体空气消毒机进行现场消毒试验，在说明书规定的适用空间内，开机作用至说明书规定的时间,对空气中自然菌的消亡率应≥90%，且消毒后空气中残留菌数应达到GB 15982要求。 6.4 电气安全性能 6.4.1 电气安全性能应符合GB 4706.45的规定。 6.4.2 电磁兼容性应符合GB 17625.1的规定。 6.5 有害物质释放量 等离子体空气消毒机有害物质释放量应满足GB4706.45第32章、GB21551.3第4章规定的要求。 6.6 循环风量 循环风量应大于适用体积的8倍。 6.7 噪声 等离子体空气消毒机工作时应平稳、无振动，循环风量标称值对应的声功率噪声，人机共存时应≤60dB(A)，人不在时≤65dB(A)。
Plasma air disinfecting machine
- ICS
- 11.080.10
- CCS
- C358
- 发布
- 2022-03-16
- 实施
- 2022-06-30
What is ISO 15883-5 about? ISO 15883-5 is one of a series of documents for Washer-disinfectors that specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices. The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical, and veterinary practice. Note: ISO 15883-5 does not apply to the activities to be performed by the manufacturers of reusable medical devices. Who is ISO 15883-5 for?
Washer-disinfectors - Performance requirements and test method criteria for demonstrating cleaning efficacy
- ICS
- 11.080.10
- CCS
- 发布
- 2022-02-28
- 实施
- 2022-02-28
Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
- ICS
- 11.080.10
- CCS
- 发布
- 2021-12-28
- 实施
Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
- ICS
- 11.080.10
- CCS
- 发布
- 2021-12-28
- 实施
GBZ 159 工作场所空气中有害物质监测的采样标准 GB/T 191 包装储运图示标志 GBZ/T 300.48 工作场所空气有毒物质测定 第48部分:臭氧和过氧化氢 GB/T 700 碳素结构钢 GB/T 1173 铸造铝合金 GB/T 1220 不锈钢棒 GB/T 2060-1989 黄铜带 GB 4793.1 测量、控制和实验室用电气设备的安全要求 第1部分：通用要求 GB 4793.4 测量、控制和实验室用电气设备的安全要求 第4部分：用于处理医用材料的灭菌器和清洗消毒器的特殊要求 GB/T 14710 医用电气环境要求及试验方法 GB/T 18268.1 测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求 GB 18281.1 医疗保健产品灭菌 生物指示物 第1部分:通则 GB/T 19104 过氧乙酸溶液 GB 19192-2003 隐形眼镜护理液卫生要求 YY/T 0466.1 医疗器械 用于医疗器械标签、标记和提供信息的符号 消毒技术规范 2002版
General technical criteria of peroxyacetic acid low temperature sterilizer
- ICS
- 11.080.10
- CCS
- C276
- 发布
- 2021-12-14
- 实施
- 2021-12-14
This document specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this document are selec
Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015+A1:2021
- ICS
- 11.080.10
- CCS
- 发布
- 2021-12-00
- 实施
What is BS EN 285- Large steam sterilizers about? BS EN 285 details best practices for ensuring safe and low-cost sterilization method. BS EN 285 specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. BS EN 285 applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.
Sterilization. Steam sterilizers. Large sterilizers
- ICS
- 11.080.10
- CCS
- 发布
- 2021-11-30
- 实施
- 2021-11-30
Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for laboratory equipment for mixing and stirring
- ICS
- 11.080.10
- CCS
- 发布
- 2021-11-04
- 实施
- 2021-11-04
This part of ISO 15883 specifies recommended procedures and the choice of test methods to be used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of re-usable medical devices and other items used in medical,
Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021); German version EN ISO 15883-5:2021
- ICS
- 11.080.10
- CCS
- 发布
- 2021-11-00
- 实施
Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for laboratory atomic spectrometers with thermal atomization and ionization
- ICS
- 11.080.10
- CCS
- N20
- 发布
- 2021-10-31
- 实施
- 2021-10-31
Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)
- ICS
- 11.080.10
- CCS
- 发布
- 2021-10-29
- 实施
- 2021-10-29
Sterilization – Steam sterilizers – Large sterilizers
- ICS
- 11.080.10
- CCS
- 发布
- 2021-10-13
- 实施
- 2021-10-13
Sterilization - Steam sterilizers - Large sterilizers
- ICS
- 11.080.10
- CCS
- 发布
- 2021-10-00
- 实施
Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)
- ICS
- 11.080.10
- CCS
- 发布
- 2021-10-00
- 实施
- 2021-10-01
