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In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
Description
In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples1 Scope This document specifies requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures and no fit for purpose certified reference materials or international conventional calibrators. In this case, the harmonisation protocol defines the highest level of metrological traceability for the stated measurand.
BS EN 285 has been revised to reference the relationship between the standard and Directive 93/42/EEC on medical devices
Updating of references and their associated requirements with regards to EN 81-20:2014
and Retention of the extinguishant-air mixture within the enclosure for a specified period after the completion of the discharge
BS 946 helps to assist factors or parameters which are required to express the yarn structure and properties are called yarn designation
BS EN 14449
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To ensure durability and quality in the construction of modern infrastructure
PD CLC IEC/TR 62453-51-150 is to be used in conjunction with IEC TR 62453-41
BS EN 2234 on electrical cables is useful for:
testers and users of electrotechnical products
ISO 5628 sets an approach to help you measure the bending stiffness and describes it in a consistent way
Manufacturers of gear-based products such as pumps
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