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Enzyme multiplied immunoassay technique (EMIT) is a common method for qualitative and quantitative determination of therapeutic and recreational drugs and certain proteins in serum and urine. [1] It is an immunoassay in which a drug or metabolite in the sample competes with a drug/metabolite labelled with an enzyme, to bind to an antibody. The ...
National Accreditation Board for Testing and Calibration Laboratories (NABL) provides accreditation to Conformity Assessment Bodies (Laboratories) in India.NABL Schemes include Accreditation (Recognition) of Technical competence of testing, calibration, medical testing laboratories, Proficiency testing providers (PTP) & Reference Material Producers (RMP) for a specific scope following ISO/IEC ...
IEC 60168 Tests on indoor and outdoor post insulators of ceramic material or glass for systems with nominal voltages greater than 1000 V; IEC 60169 Radio frequency connectors; IEC 60172 Test procedure for the determination of the temperature index of enamelled and tape wrapped winding wires
The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
The RoHS 2 directive (2011/65/EU) contains allowance to add new materials and 4 materials are highlighted for this attention in the original version, the amendment 2015/863 adds four additional substances to Annex II of 2011/65/EU (3/4 of the new restrictions are recommended for investigation in the original directive, ref Para 10 of preamble).
Reagent testing is one of the processes used to identify substances contained within a pill, usually illicit substances. With the increased prevalence of drugs being available in their pure forms, the terms "drug checking" or "pill testing" [1] may also be used, although these terms usually refer to testing with a wider variety of techniques covered by drug checking.
The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance).The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1]