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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…

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…

ISO 18589-1:2005 specifies the general requirements to carry out radionuclides tests on soil sample, including sampling. ISO 18589-1:2005 is addressed to people responsible for determining the radioactivity present in soils for the purpose of radiation protection. This may concern soils from gardens and farmland, urban or industrial sites, as well as soil not affected by human activities. ISO…

For the purposes of ISO 9919:2005, the Scope given in IEC 60601-1:1988 (Clause 1) applies, except as follows. Amendment (add at the end of 1.1): ISO 9919:2005 specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe…

For the purposes of ISO 9919:2005, the Scope given in IEC 60601-1:1988 (Clause 1) applies, except as follows. Amendment (add at the end of 1.1): ISO 9919:2005 specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe…

ISO 15314:2004 describes three methods for the exposure of plastics in a marine environment. Method A covers exposures where specimens float on the surface, method B covers exposures where specimens are partially immersed and method C covers exposures where specimens are completely immersed. Although intended for marine (salt water) exposure, the methodology might be used with outdoor brackish…

ISO 340:2004 specifies a method for assessing, on a small scale, the reaction of a conveyor belt to an ignition flame source. It is applicable to conveyor belts having a textile carcass as well as steel cord conveyor belts.

ISO/TS 17892-9:2004 covers the determination of stress-strain relationships and effective stress paths for a cylindrical, water-saturated specimen of undisturbed, remoulded or reconstituted soil when subjected to an isotropic or an anisotropic stress under undrained or drained conditions and thereafter sheared under undrained or drained conditions within the scope of the geotechnical…

ISO 13347-3:2004 applies to industrial fans as defined in ISO 5801 and ISO 13349. It is limited to the determination of airborne sound emission for the specified set-ups. Vibration is not measured, nor is the sensitivity of airborne sound emission to vibration effects determined. The sizes of fan which can be tested in accordance with ISO 13347-3:2004 are limited only by the practical aspects of…

This National Standard of Canada is equivalent to International Standard IEC 61010-2-010:2003, second edition, 2003. 1 Scope and object This clause of Part 1 is applicable except as follows: 1.1.1 Equipment included in scope Replacement: Replace the text by the following: This part of IEC 61010 applies only to electrically powered laboratory equipment for the heating of materials, where the…