|
标准代号 |
标准英文名称 |
标准中文名称 |
被替代的标准 |
对应国内标准 |
| EN 375: 2001 |
Information supplied by the manufacturer with in vitro diagnostic
reagents for professional use |
制造商提供的专业用实验室诊断试剂的信息 |
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|
| EN 376: 2002 |
Information supplied by the manufacturer with in vitro diagnostic
reagents for self-testing |
制造商提供的有关自我测试用的体外诊断试剂的信息 |
|
|
| EN 591: 2001 |
Instructions for use in vitro diagnostic instruments for
professional use |
专业用体外诊断仪器的使用说明 |
|
|
| EN 592: 2002 |
Instructions for use for in vitro diagnostic instruments
for self-testing |
自我测试用体外诊断仪器的使用说明书 |
|
|
| EN 928: 1995 |
In vitro diagnostic systems – Guidance on the application
of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for
in vitro diagnostic medical devices |
实验室用于淋巴诊断仪的EN 29001,EN 46001,EN 29002,EN 46002的应用导则 |
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| EN 980: 1996/ A2:2001 |
Graphical symbols for use in the labelling of medical devices
|
医疗器械标签用图形符号 |
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|
| EN 1658: 1996 |
Requirements for marking of in vitro diagnostic instruments
|
对体外诊断仪器作标记的要求 |
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| EN 12286: 1998/ A1:2000 |
In vitro diagnostic medical devices – Measurement of quantities
in samples of biological origin – Presentation of reference
measurement procedures |
体外诊断医疗设备.生物有机体试样数量测量.参考测量过程说明 |
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|
| EN 12287: 1999 |
In vitro diagnostic medical devices – Measurement of quantities
in samples of biological origin – Description of reference
materials |
体外诊断医疗设备.生物起始试样中的数量测量.标准物质的说明 |
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| EN 12322: 1999/ A1:2001 |
In vitro diagnostic medical devices – Culture media for
microbiology – Performance criteria for culture media |
体外诊断医疗装置.微生物培养基.培养基性能标准 |
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|
| EN 13532: 2002 |
General requirements for in vitro diagnostic medical devices
for self-testing |
自测试用的体外诊断医疗装置的一般要求 |
|
|
| EN 13612: 2002 |
Performance evaluation of in vitro diagnostic medical devices |
体外诊断医疗装置的性能评估 |
|
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| EN 13640: 2002 |
Stability testing of in vitro diagnostic medical devices |
体外诊断试剂的稳定性试验 |
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|
| EN 13641: 2002 |
Elimination or reduction of risk of infection related to
in vitro diagnostic reagents |
消除和降低与体外诊断试剂有关的感染的危险性 |
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|
| EN 13975:2003 |
Sampling procedures used for acceptance testing of in vitro
diagnostic medical devices - Statistical aspects |
体外诊断用医疗装置的验收试验用取样规程.统计特性 |
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|
| EN ISO 14971 |
Medical devices – Application of risk management to medical
devices (ISO 14971:2000) |
医疗器械.风险管理在医疗器械上的应用 |
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|
| EN ISO 18153:2003 |
In vitro diagnostic medical devices - Measurement of quantities
in biological samples - Metrological traceability of values
for catalytic concentration of enzymes assigned to calibrators
and control materials (ISO 18153:2003) |
体外诊疗装置.生物样品的定量测量.校准仪和控制系统指定酶的催化浓度的测量溯源性 |
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| EN 61010-2-101: 2002 |
Safety requirements for electrical equipment for measurement,
control, and laboratory use - Part 2-101: Particular requirements
for in vitro diagnostic (IVD) medical equipment |
测量、控制和实验室用电气设备的安全要求.实验室诊断(IVD)医疗设备的特殊要求 |
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