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Conformance testing. Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation.
Lung compliance. Lung compliance, or pulmonary compliance, is a measure of the lung 's ability to stretch and expand (distensibility of elastic tissue). In clinical practice it is separated into two different measurements, static compliance and dynamic compliance. Static lung compliance is the change in volume for any given applied pressure. [1]
IEC 60601. IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission. First published in 1977 and regularly updated and restructured, as of 2011 it consists of a general standard, about 10 collateral standards, and about 80 ...
The Principles of Good Laboratory Practice (GLP) are guidelines for managing non-clinical health and environmental studies effectively. [1] They cover how studies are planned, conducted, recorded, and reported. These principles define roles and responsibilities within test facilities, set standards for facilities and equipment, emphasize the ...
Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:
ssued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration. CoC
Compliance (physiology) Compliance is the ability of a hollow organ (vessel) to distend and increase volume with increasing transmural pressure or the tendency of a hollow organ to resist recoil toward its original dimensions on application of a distending or compressing force. It is the reciprocal of "elastance", hence elastance is a measure ...
IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices. It has been adopted as national standards and ...
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