In vitro diagnostic test systems; Requirements for blood-glucose monitoring systems for self-testing in managine diabetwes mellitus
适用范围：This standard specifies requirements for blood glucose monitoring systems used by laypersons for the determination of the concentration of glucose in capillary blood for the management of diabetes mell...
Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - General requirements and definitions
适用范围：The standard applies to the testing of foodstuffs and isolates obtained from them for microbial contamination using the polymerase chain reaction (PCR) and relates to the general requirements for the i...
实施日期：2009-03-01
Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Part 1:Referenc...
适用范围： This part of ISO 20776 describes one reference method, broth microdilution, for determination of MICs. The MIC reflects the activity of the drug under the described test conditions, and can be interp...
实施日期：2006-11-15
Safety Requirements for Electrical Equipment for Measurement,Control,and Laboratory Use Part 2-101:Particular Requirements for in Vitro Diagnostic (IVD) Medical Equipment Regles De Securite Pour Appare...
发布日期：2002-01-01 实施日期：2002-01-01
Probenahmeverfahren fuer die Annahmepruefung von In-vitro-Diagnostika. Statistische Aspekte Sampling procedures used for acceptance testing of in vitro diagnostic medical devices-Statistical aspects Pr...
适用范围：This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body. Two different ...
实施日期：2003-03-28
In vitro diagnostic medical devices measurement of quantities in biological samples metrological traceability of values assigned to calibrators and control materials first edition
适用范围： 水标准规定厂对以建立或确认测量正确度为日的的校准品和控制物质赋值的计量学溯源性进{；确 认的方法。校准品和控制物质山制造商提供，作为体外诊断医疗器械的—·部分或与其—起使用， 由国际公认的参考测量系统或国...
实施日期：2003-08-15
Soil quality - Absorption availability of organic and inorganic pollutants from contaminated soil material
适用范围：This standard specifies a method of testing the bioaccessibility of substances in contaminated soil materialand materials that may be applied to the soil or introduced into it (see article 6 of the Bun...
Clinical laboratory medicine in vitro diagnostic medical devices validation of user quality control procedures by the manufacturer first edition
适用范围：This International Standard describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control proc...
实施日期：2004-07-15
In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus first edition
适用范围：This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the val...
实施日期：2003-05-01
Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 84: Microdilution; special requirements for testing of fungi against antifungal agents
适用范围：Together with DIN 58940-8, this document specifies the in vitro testing of the susceptibility of fungi to antifungal agents by broth dilution. The minimal inhibitory concentration (MIC) of fungi is det...
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