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  2. Clinical and Laboratory Standards Institute - Wikipedia

    en.wikipedia.org/wiki/Clinical_and_Laboratory...

    The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.

  3. Clinical Laboratory Improvement Amendments - Wikipedia

    en.wikipedia.org/wiki/Clinical_Laboratory...

    The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.

  4. ISO 15189 - Wikipedia

    en.wikipedia.org/wiki/ISO_15189

    ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization 's Technical Committee 212 (ISO/TC 212).

  5. LOINC - Wikipedia

    en.wikipedia.org/wiki/LOINC

    LOINC is one of the standards used in U.S. Federal Government systems for the electronic exchange of clinical health information. In 1999, it was identified by the HL7 Standards Development Organization as a preferred code set for laboratory test names in transactions between health care facilities, laboratories, laboratory testing devices, and ...

  6. Validation and verification (medical devices) - Wikipedia

    en.wikipedia.org/wiki/Validation_and...

    To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.

  7. International Federation of Clinical Chemistry and Laboratory ...

    en.wikipedia.org/wiki/International_Federation...

    The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a global professional association that promotes the fields of clinical chemistry and laboratory medicine. [1] It was established in Paris in 1952 as the International Association of Clinical Biochemists to organize the various national societies of these fields ...

  8. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    The Agency utilizes data obtained from laboratory inspections and audits to oversee the use of pesticides and industrial chemicals. [33] 40 CFR Part 160, Good Laboratory Practice Standards pertains specifically to the Good Laboratory Practice (GLP) standards for pesticide chemicals. It establishes the requirements for conducting studies and ...

  9. Good clinical laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Clinical_Laboratory...

    WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2; Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.