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This document establishes requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions. It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (…

IEC 60335-2-34:2024 EXV contains both the international standard and its extended version (EXV). This extended version of the official IEC Standard is available in English only and provides the user with a comprehensive content of the Standard. IEC 60335-2-34:2024 EXV includes the content of the references made to IEC 60335-1:2020. IEC 60335-2-34:2024 deals with the safety of sealed (hermetic…

This pack contains IEC 60335-2-34:2024 EXV and IEC 60355-2-34:2024 CMV. IEC 60335-2-34:2024 deals with the safety of sealed (hermetic and semi-hermetic type) motor-compressors, their protection and control systems, if any, which are intended for use in equipment for household and similar purposes and which conform with the standards applicable to such equipment. It applies to motor-compressors…

IEC 60335-2-34:2024 CMV contains both the official standard and its commented version. The commented version provides you with a quick and easy way to compare all the changes between IEC 60335-2-34:2024 edition 7.0 and the previous IEC 60335-2-34:2021 edition 6.0. Furthermore, comments from IEC SC 61C experts are provided to explain the reasons of the most relevant changes, or to clarify any part…

IEC 60335-2-34:2024 deals with the safety of sealed (hermetic and semi-hermetic type) motor-compressors, their protection and control systems, if any, which are intended for use in equipment for household and similar purposes and which conform with the standards applicable to such equipment. It applies to motor-compressors tested separately, under the most severe conditions that can be expected…

This document gives the general requirements for interpretation and reporting of multiplex molecular tests which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs). It provides information for both qualitative…

This document specifies dynamic dummies used as replacements for participants in vibration tests of vehicle seats in laboratory. This document is applicable to seats installed in earth-moving machinery, agricultural wheeled tractors, and industrial trucks. This document specifies technical requirements, acceptance criteria, and a validation test for dynamic dummies representing the human body in…

This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, RNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of RNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in…

This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment, preparation for CTC staining, and documentation of venous whole blood specimens intended for staining of CTCs during the pre-examination phase before an examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests…

This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, DNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of DNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in…