Clinical laboratory testing and in vitro diagnostic test systems — In vitro diagnostic medical devic...
ISO/TR 18112:2006 summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use.
Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use.
Current labelling regulations and regulatory guidance from Canada, the European Union, Japan…
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: Genera...
specifies requirements for immunity and emissions regarding electromagnetic compatibility (EMC) for electrical equipment, operating from a supply or battery of less than 1 000 V a.c. or 1 500 V d.c. or from the circuit being measured, intended for professional, industrial-process, industrial-manufacturing and educational use, including equipment and computing devices The contents of the…
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Part...
specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment.
The contents of the corrigendum of September 2007 have been included
in this copy.
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-1: Part...
specifies more detailed test configurations, operational conditions and performance criteria for equipment with test and measurement circuits (both internal and/or external to the equipment) that are not EMC protected for operational and/or functional reasons, as specified by the manufacturer.
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-2: Part...
this part of IEC 61326 specifies more detailed test configurations, operational conditions and performance criteria for equipment which is used for testing, measuring or monitoring of protective measures in low-voltage distribution systems, and powered by battery and/or from the circuit measured, and portable
The contents of the corrigendum of November 2007 have been included in this copy.
1 Scope
1.1 General
This Standard specifies requirements for materials and methods for the manufacture, transportation, and installation of architectural, structural, and specialty precast concrete products. Note: This Standard should be specified for precast concrete elements used in segmental construction.
1.2 Shop drawings
This Standard specifies the requirements, in addition to…
Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity ...
IEC 61000-4-5:2005 relates to the immunity requirements, test methods, and range of recommended test levels for equipment to unidirectional surges caused by overvoltages from switching and lightning transients. Several test levels are defined which relate to different environment and installation conditions. These requirements are developed for and are applicable to electrical and electronic…
Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteri...
This International Standard applies to test procedures which, for the determination of characteristics of systems or components of medical diagnostic X-ray equipment, require well-defined radiation conditions.
Except for mammography, this standard does not apply to conditions where discontinuities in radiation absorption of elements are deliberately used to modify properties of the radiation…
