首页 馆藏资源 舆情信息 标准服务 科研活动 关于我们
现行 ISO 15883-7:2016
到馆阅读
收藏跟踪
购买正版
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment 洗衣机消毒器 - 第7部分:采用化学消毒的非侵入性非关键耐热不可转换医疗设备和保健设备的洗衣机消毒器的要求和测试
发布日期: 2016-02-02
ISO 15883-7:2016规定了清洗消毒器(WD)的特殊要求,该清洗消毒器(WD)用于在单个操作周期内清洗和化学消毒可重复使用的物品,例如: a) 床架; b) 床头柜; c) 运输车; d) 容器; e) 手术台; f) 消毒容器; g) 手术用木屐; h) 轮椅,残疾人辅助设备。 ISO 15883-7:2016还规定了清洗消毒器及其部件和附件的清洁和消毒性能要求,这些部件和附件可能是实现所需性能所必需的。 在ISO 15883?2、ISO 15883?3、ISO I5883-4和ISO 15883?6范围内识别的设备不属于ISO 15883的本部分范围。 此外,还规定了型式试验、工程试验、验证(首次安装时的安装、运行和性能鉴定)、常规控制和监测所需的方法、仪器和说明,以及定期和必要维修后需要进行的再鉴定。 注:根据设备制造商的建议,与ISO 15883本部分相对应的WDs也可用于清洁和化学消毒其他不耐热和可重复使用的设备。 ISO 15883本部分规定的性能要求可能无法确保传染性海绵状脑病病原体(朊蛋白)的灭活或去除。
ISO 15883-7:2016 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following: a) bedframes; b) bedside tables; c) transport carts; d) containers; e) surgical tables; f) sterilization containers; g) surgical clogs; h) wheelchairs, aids for the disabled. ISO 15883-7:2016 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance. Devices identified within the scopes of ISO 15883?2, ISO 15883?3, ISO I5883-4, and ISO 15883?6 do not fall within the scope of this part of ISO 15883. In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs. NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer. The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.
分类信息
关联关系
研制信息
归口单位: ISO/TC 198
相似标准/计划/法规
现行
KS P ISO 15883-4
세척소독기 — 제4부: 비내열성 내시경용 화학 소독 세척소독기의 요구사항 및 시험
洗衣机消毒器 - 第4部分:使用化学消毒用于耐热内窥镜的洗衣机消毒器的要求和测试
2019-11-25
现行
ISO 15883-4-2018
Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
洗衣机消毒器 - 第4部分:使用化学消毒用于耐热内窥镜的洗衣机消毒器的要求和测试
2018-11-12
现行
GOST R ISO 15883-4-2012
Машины моюще-дезинфицирующие. Часть 4. Требования и методы испытаний аппаратов, использующих химическую дезинфекцию для термолабильных эндоскопов
洗衣机消毒器第4部分对不耐热内窥镜采用化学消毒的洗衣机消毒器的要求和试验
现行
KS P ISO 15883-3
세척소독기 — 제3부: 인체 유래 배출물 용기의 열소독 세척소독기의 요구사항 및 시험
洗衣机消毒器 - 第3部分:对人体废物容器采用热消毒的洗衣机消毒器的要求和测试
2019-11-25
现行
GOST R ISO 15883-3-2011
Машины моюще-дезинфицирующие. Часть 3. Требования и методы испытаний машин, использующих термическую дезинфекцию контейнеров для отходов жизнедеятельности человека
洗衣机消毒器第3部分对人体废物容器采用热消毒的洗衣机消毒器的要求和试验
现行
YY/T 0734.3-2018
清洗消毒器 第3部分:对人体废弃物容器进行湿热消毒的清洗消毒器 要求和试验
Washer-disinfector—Part 3:Washer-disinfectors employing thermal disinfection for human waste containers—Requirements and tests
2018-12-20
现行
ISO 15883-3-2024
Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
洗衣机消毒器 - 第3部分:对人体废物容器采用热消毒的洗衣机消毒器的要求和测试
2024-11-06
现行
YY/T 0734.1-2018
清洗消毒器 第1部分:通用要求和试验
Washer-disinfectors—Part 1:General requirements and tests
2018-11-07
现行
YY/T 0734.4-2016
清洗消毒器 第4部分:对非介入式等医疗器械进行湿热消毒的清洗消毒器 要求和试验
Washer-disinfectors—Part 4:Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive medical devices,etc.
2016-01-26
现行
ISO 15883-2-2024
Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
洗衣机消毒器 - 第2部分:对外科手术器械 麻醉设备 碗 菜肴 接收器 器具 玻璃器皿等采用热消毒的洗衣机消毒器的要求和测试
2024-11-06
现行
YY/T 0734.2-2018
清洗消毒器 第2部分:对外科和麻醉器械等进行湿热消毒的清洗消毒器 要求和试验
Washer-disinfectors—Part 2:Washer-disinfectors employing thermal disinfection for surgical instruments, anaestetic equipment,etc.—Requirements and tests
2018-12-20
现行
DIN EN ISO 15883-7
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
洗衣机消毒器第7部分:非侵入性非临界不耐热医疗器械和医疗设备用化学消毒洗衣机消毒器的要求和试验(ISO 15883-7-2016)
2016-10-01
现行
YY/T 0734.5-2020
清洗消毒器 第5部分:对不耐高温的非介入式医疗器械进行化学消毒的清洗消毒器要求和试验
Washer-disinfectors—Part 5:Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, noncritical thermolabile medical devices
2020-02-21
现行
UNE-EN ISO 15883-4-2009
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
洗涤消毒器第4部分:不耐热内窥镜用化学消毒洗涤消毒器的要求和试验(ISO 15883-4-2008)
2009-10-21
现行
KS P ISO 15883-1
세척소독기 — 제1부: 일반 요구사항, 용어 및 정의, 시험
洗衣机消毒器 - 第1部分:一般要求 术语和定义和测试
2019-11-25
现行
ISO 15883-1-2024
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
洗涤消毒机第1部分:一般要求、术语、定义和试验
2024-10-04
现行
GOST ISO 15883-1-2011
Машины моюще-дезинфицирующие. Часть 1. Общие требования, термины, определения и испытания
洗衣机消毒器一般要求 术语 定义和测试
2011-11-29
现行
UNE-EN ISO 15883-3-2009
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
洗涤消毒器.第3部分:人类废物容器用热消毒洗涤消毒器的要求和试验(ISO 15883-3-2006)
2009-10-21
现行
ISO 15883-6-2011
Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
洗衣机消毒器第6部分:非侵入性非关键医疗器械和医疗设备用热消毒洗衣机消毒器的要求和试验
2011-04-12
现行
AAMI ST15883-3-2012/(R)2023
Washer-disinfectors -Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006, MOD)
洗涤消毒器第3部分:人类废物容器用热消毒洗涤消毒器的要求和试验
2012-12-03