93/42/EEC 协调标准
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标准代号 |
标准英文名称 |
标准中文名称 |
被替代的标准 |
对应的国内标准 |
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EN 285:2006 |
Sterilization - Steam sterilizers - Large
sterilizers |
消毒 蒸气消毒 大型消毒设备 |
EN 285:1996 |
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EN 375:2001 |
Information supplied by the manufacturer
with in vitro diagnostic reagents for professional use |
由生产商提供的专业用活体外诊断试剂的信息 |
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EN 376:2002 |
Information supplied by the manufacturer
with in vitro diagnostic reagents for self-testing |
生产者在实验室中用自检测诊断试剂提供信息 |
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EN 455-1:2000 |
Medical gloves for single use - Part 1:
Requirements and testing for freedom from holes |
医疗专用手套.防洞要求和试验 |
EN 455-1:1993 |
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EN 455-2:2000 |
Medical gloves for single use - Part 2:
Requirements and testing for physical properties (including Technical
Corrigendum 1:1996) |
医疗专用手套.物理性能要求和试验 |
EN 455-2:1995 |
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EN 455-3:2006 |
Medical gloves for single use - Part 3:
Requirements and testing for biological evaluation |
医疗专用手套.生物评价的要求和试验 |
EN 455-3:1999 |
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EN 556-1:2001 |
Sterilization of medical devices -
Requirements for medical devices to be designated "STERILE" - Part
1: Requirements for terminally sterilized medical devices |
医疗设备的灭菌.拟被认定为无菌的医疗设备的要求.对最终灭菌设备的要求 |
EN 556:1994 + A1:1998 |
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EN 556-2:2003 |
Sterilization of medical devices -
Requirements for medical devices to be designated "STERILE" - Part
2: Requirements for aseptically processed medical devices |
医疗器械的消毒 标明为“消过毒”的医疗器械的要求 第2部分：消毒处理的医疗器械的要求 |
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EN 591:2001 |
Instructions for use for in vitro
diagnostic instruments for professional use |
专用试管诊断仪的使用说明 |
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EN 592:2002 |
Instructions for use for in vitro
diagnostic instruments for self-testing |
实验室条件下自测试诊断仪的使用说明 |
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EN 737-1:1998 |
Medical gas pipeline systems - Part 1:
Terminal units for compressed medical gases and vacuum |
医疗气体管道系统.压缩医疗气体用终端设备和真空终端设备 |
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EN 737-4:1998 |
Medical gas pipeline systems - Part 4:
Terminal units for anaesthetic gas scavenging systems |
医疗气体管道系统.麻醉气体净化系统的终端设备 |
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EN 738-4:1998 |
Pressure regulators for use with medical
gases - Part 4: Low-pressure regulators intended for incorporation into
medical equipment |
医用气体用压力调节器.医疗设备用低压压力调节器 |
Note 3 |
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EN 739:1998 |
Low-pressure hose assemblies for use with
medical gases |
医疗气体设备用低压软管组件 |
Note 3 |
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EN 740:1998 |
Anaesthetic workstations and their
modules - Particular requirements |
麻醉工作站及其工作舱特殊要求 |
Note 3 |
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EN
794-1:1997 |
Lung ventilators - Part 1: Particular
requirements for critical care ventilators |
肺呼吸器.临危看护呼吸器的特殊要求 |
Note 3 |
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EN 794-3:1998 |
Lung ventilators - Part 3: Particular
requirements for emergency and transport ventilators |
肺呼吸器.紧急情况和移动通风器的特殊要求 |
Note 3 |
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EN 980:2003 |
Graphical symbols for use in the
labelling of medical devices |
医疗器械标签用图形符号 |
EN 980:1996 |
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EN 1041:1998 |
Information supplied by the manufacturer
with medical devices |
医疗产品生产者提供的信息 |
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EN 1060-1:1995 |
Non-invasive sphygmomanometers - Part 1:
General requirements |
非侵入式血压计.第1部分:一般要求.修改件A1 |
Note 3 |
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EN 1060-2:1995 |
Non-invasive sphygmomanometers - Part 2:
Supplementary requirements for mechanical sphygmomanometers |
非侵入式血压表.第2部分:机械血压表的补充要求 |
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EN 1060-3:1997 |
Non-invasive sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure measuring
systems |
非侵入式血压表.第3部分:电机血压表的补充要求 |
Note 3 |
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EN 1060-4:2004 |
Non-invasive sphygmomanometers - Part 4:
Test procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers |
非介入式血压计.第4部分:自动非介入式血压计整体系统精确度测定的试验过程 |
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EN 1089-3:2004 |
Transportable gas cylinders - Gas
cylinder identification (excluding LPG) - Part 3: Colour coding |
可移动式气瓶.气瓶标识(不包括LPG).第3部分:色码 |
EN 1089-3:1997 |
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EN 1280-1:1997 |
Agent specific filling systems for
anaesthetic vaporizers - Part 1: Rectangular keyed filling systems |
麻醉气化装置制剂特殊添充系统.拒形键控填充系统 |
Note 3 |
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EN 1281-2:1995 |
Anaesthetic and respiratory equipment -
Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO
5356-2:1987 modified) |
麻醉和呼吸设备圆锥形接头第2部分：螺纹承重连接头 |
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EN 1282-2:2005 |
Tracheostomy tubes - Part 2: Paediatric
tubes (ISO 5366-3:2001, modified) |
气体切开插管.第2部分:儿科婴幼儿用管 |
EN 1282-2:1997 |
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EN 1422:1997 |
Sterilizers for medical purposes -
Ethylene oxide sterilizers - Requirements and test methods |
医用灭菌器.环氧乙烷灭菌器.要求和检验方法 |
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EN 1618:1997 |
Catheters other than intravascular
catheters - Test methods for common properties= |
管内导管除外的其它导管.通用性能的测试法 |
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EN 1639:2004 |
Dentistry - Medical devices for dentistry
- Instruments |
牙科学.牙科用医疗装置.器械 |
EN 1639:1996 |
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EN 1640:2004 |
Dentistry - Medical devices for dentistry
- Equipment |
牙科学.牙科用医疗装置.设备 |
EN 1640:1996 |
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EN 1641:2004 |
Dentistry - Medical devices for dentistry
- Materials |
牙科学.牙科用医疗装置.材料 |
EN 1641:1996 |
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EN 1642:2004 |
Dentistry - Medical devices for dentistry
- Dental implants |
牙科学.牙科用医疗装置.牙科植入物 |
EN 1642:1996 |
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EN 1707:1996 |
Conical fittings with a 6 % (Luer) taper
for syringes, needles and certain other medical equipment - Lock fittings |
注射器、针头和其它特定医疗器械用有6%(路厄)锥度的圆锥形配件.锁定配件 |
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EN 1782:1998 |
Tracheal tubes and connectors |
气管和连接件 |
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EN 1820:2005 |
Anaesthetic reservoir bags (ISO 5362:2000,
modified) |
麻醉贮袋 |
EN 1820:1997 |
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EN 1865:1999 |
Specifications for stretchers and other
patient handling equipment used in road ambulances |
救护车里的担架和其他病人运送设备规范 |
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EN 1970:2000 |
Adjustable beds for disabled persons -
Requirements and test methods |
残疾人用可调整的床.要求和试验方法 |
Note 3 |
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EN 1985:1998 |
Walking aids - General requirements and
test methods |
助步器.一般要求和试验方法 |
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EN ISO 4074:2002 |
Natural latex rubber condoms -
Requirements and test methods (ISO 4074:2002) |
天然胶乳橡胶避孕套--技术要求和试验方法 |
EN 600:1996 |
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EN ISO 4135:2001 |
Anaesthetic and respiratory equipment -
Vocabulary (ISO 4135:2001) |
麻醉和呼吸设备.词汇 |
EN ISO 4135:1996 |
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EN ISO
5356-1:2004 |
Anaesthetic and respiratory equipment -
Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004) |
麻醉和呼吸设备.锥形接头.第1部分:锥体和锥套 |
EN 1281-1:1997 |
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EN ISO
5366-1:2004 |
Anaesthetic and respiratory equipment -
Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO
5366-1:2000) |
麻醉和呼吸设备 气管造口插管 第1部分:成人用插管和接头 |
EN 1282-1:1996 |
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EN ISO
5840:2005 |
Cardiovascular implants - Cardiac valve
prostheses (ISO 5840:2005) |
心血管植入物.心脏瓣膜修复术 |
EN 12006-1:1999 |
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EN ISO 7197:2006 |
Neurosurgical implants - Sterile,
single-use hydrocephalus shunts and components (ISO 7197:2006) |
神经外科植入物一次性使用无菌脑积水分流管和组件 |
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EN ISO
7376:2003 |
Anaesthetic and respiratory equipment -
Laryngoscopes for tracheal intubation (ISO 7376:2003) |
麻醉和呼吸设备.气管插管术用喉镜 |
EN 1819:1997 |
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EN ISO
7396-1:2007 |
Medical gas pipeline systems - Part 1:
Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007) |
医用气体管道系统第1部分：医用压缩气体和真空用管道系统 |
EN 737-3:1998 |
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EN ISO
7396-2:2007 |
Medical gas pipeline systems - Part 2:
Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) |
医用气体管道系统第2部分：麻醉气体净化处理系统 |
EN 737-2:1998 |
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EN ISO 7439:2002 |
Copper-bearing intra-uterine
contraceptive devices - Requirements, tests (ISO 7439:2002) |
含铜的宫内节育避孕器具.要求、试验 |
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EN ISO
7886-3:2005 |
Sterile hypodermic syringes for single
use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO
7886-3:2005) |
一次性使用无菌皮下注射器 |