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
Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
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
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygnomanometers
In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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
In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
Medical electrical equipment.Medical image display systems.Part 1: Evaluation methods
Use and handling of medical devices covered by the scope of ISO/TC 84 - Risk assessment on mucocutaneous blood exposure
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
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
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
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
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
Non-invasive sphgmomanometers-Part 2:Clinical investigation of automated measurement type
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