C38 普通诊察器械 标准查询与下载
共找到 209 条与 普通诊察器械 相关的标准，共 14 页
Medical electrical equipment. Particular requirements for basic safety and essential performance of oxygen concentrator equipment
- ICS
- 11.040.10
- CCS
- C38
- 发布
- 2014-07-31
- 实施
- 2014-07-31
Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
- ICS
- 11.040.55;19.080
- CCS
- C38
- 发布
- 2013-09-01
- 实施
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2013
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-09
- 实施
- 2013-09-01
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-09
- 实施
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-07-19
- 实施
- 2013-07-19
本大纲适用于(台式和立式)水银血压计(以下简称血压计)和弹性式血压表(以下简称血压表)的型式评价。
Program of Pattern Evaluation of Sphygmomanometers
- ICS
- CCS
- C38
- 发布
- 2013-07-04
- 实施
- 2013-10-04
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygnomanometers
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2013-07
- 实施
In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-06-30
- 实施
- 2013-06-30
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
- ICS
- 11.040.55;11.100.10
- CCS
- C38
- 发布
- 2013-06-15
- 实施
- 2013-06-15
DIN EN ISO 16256:2013 临床实验室测试和体外诊断试验系统.检测体外抗菌剂抗传染病中酵母菌的活性的标准方法(ISO 16256-2012).德文版本EN ISO 16256-2012
Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012); German version EN ISO 16256:2012
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-04
- 实施
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-03-31
- 实施
- 2013-03-31
In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-03-31
- 实施
- 2013-03-31
Medical electrical equipment.Medical image display systems.Part 1: Evaluation methods
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2013-03-01
- 实施
Use and handling of medical devices covered by the scope of ISO/TC 84 - Risk assessment on mucocutaneous blood exposure
- ICS
- 11.040.01
- CCS
- C38
- 发布
- 2013-03
- 实施
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information suoplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to: a)IVD instruments or equipment, b)IVD reagents for professional use.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-01
- 实施
- 2013-01-01
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a)IVD devices for performance evaluation (e.g., for investigational use only), b)instrument marking, c)material safety data sheets.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-01
- 实施
- 2013-01-01
This part of ISO 18113 specifies requirements for infornation supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to a)instructions for instrument servicing or repair, b)IVD reagents, including calibrators and control materials for use in control of the reagent, c)IVD instruments for professional use.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-01
- 实施
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to a) IVD instruments or equipment, b) IVD reagents for self-testing.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-01
- 实施
- 2013-01-01
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to: a)instructions for instrument servicing or repair, b)IVD reagents, including calibrators and control materials for use in control of the reagent, c)IVD instruments for self-testing.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-01
- 实施
- 2013-01-01
Non-invasive sphgmomanometers-Part 2:Clinical investigation of automated measurement type
- ICS
- 11.040.10
- CCS
- C38
- 发布
- 2013
- 实施
- 2013-05-01
