Standards
This international standard gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this International standard apply when POCT is carried out in hospital , clinic and by a healthcare organization providing ambulatory care. This International standard can be applied to transcutaneous measurements ,the analysis of expired air, and in vivo monitoring of physiological parameters. Patient self-testing in a home or community setting is excluded, but elements of this International standard can be applicable.
This document specifies general terms and definitions relating to conformity assessment (including the accreditation of conformity assessment bodies) and to the use of conformity assessment to facilitate trade.
The general principles of conformity assessment and a description of the functional approach to conformity assessment are provided in Annex A.
Conformity assessment interacts with other fields such as management systems, metrology, standardization and statistics. The boundaries of conformity assessment are not defined in this document.
ISO/IEC 17000:2004 specifies general terms and definitions relating to conformity assessment, including the accreditation of conformity assessment bodies, and to the use of conformity assessment to facilitate trade. A description of the functional approach to conformity assessment is included as a further aid to understanding among users of conformity assessment, conformity assessment bodies and their accreditation bodies, in both voluntary and regulatory environments.
ISO/IEC 17000:2004 does not set out to provide a vocabulary for all of the concepts that may need to be used in describing particular conformity assessment activities. Terms and definitions are given only where the concept defined would not be understandable from the general language use of the term or where an existing standard definition is not applicable.
This document specifies requirements for safe practices in the medical laboratory (herein after referred to as “the laboratory”).
This International Standard specifies requirements for safe practices in the medical laboratory.
The object of this part of IEC 60107 is to define parameters and to provide a guideline for measurement on D2 - MAC/ packet equipment under uniform and repetitive conditions. The D2 - MAC/ packed process is specified in EBU in SPB 489.