ГОСТ Р 55992.1—2014
Библиография
[1] ГОСТ Р ЕН 13532—2010 Общие требования к медицинским изделиям т vitro для самотестирования
[2] ГОСТ Р ЕН 592—2010 Инструкция по применению инструментов для диагностики in vitro для самотестирова
ния
supplied
by the manufacturer
(3)
ISO 18113.1—2009 In vitro diagnostic medical devices — Information
(labelling)— Part 1: Terms, definitions and general requirements
И)
ISO 18113.2—2009 In vitro diagnostic medical devices — Information
(labelling)— Part 2: In vitro diagnostic reagents for professional use
supplied
by the manufacturer
(5)
ISO 18113.3—2009 In vitro diagnostic medical devices — Information supplied by the manufacturer
(labelling) — Pari 3: In vitro diagnostic instruments lor professional use
(6) CLSI L A4-A5. Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard — Fifth Edition,
vol. 27 Number CLSI. Wayne. PA, USA. 2007
(7) CLSI L A23-A.Assessmg the Quality of Immunoassay Systems. Radioimmunoassays, and Enzyme. Fluorescence, and
Luminescence Immunoassays; Approved Guideline. 13.10.2005
(8) CLSI L A 24-A. Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved
Guideline. 03.11.2006
(9) GHTF/SG1/N 071
Л
2012. Finaldocument/Definltion of the Terms Medical Device and In Vitro Diagnostic (IVD) Medical
Device. Study Group 1 of the Global Harmonization Task Force (revision of GHTF/SG1/N29;2005).
(10) EUROPEAN COMMISION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Health
technology and Cosmetics. MEDDEV 2.14.1 revision 2 January 2012. Guidelines on Medical Devices IVD Medical
DeviceBorderline andClassificationIssues. AGuidefor manufacturers and notifiedBodies.
http//ec.europa.eu/health/medical-devices.’documentsi’border1lne/lndex
_
en.htm
(11) Приказ Министерства здравоохранения и социального развития РФ от 22 марта 2006 года К» 185 «О массовом
обследовании новорожденных детей на наследственные заболевания».
(12) Массовый скрининг новорожденных на наследственные болезни обмена веществ. Клиническая лабораторная
диагностика. Национальное руководство. Главные редакторы В.В. Долгов. В.В. Меньшиков. Москва, Издате
льская группа «Геотар-Медиа». 2011. том 1, с. 844—859.
(13) Robert L.Sunheimer. Gregory A. Threatte. Marks. Lifshitz. Matthew R. Pmcus. Analysts; Principles of Instrumentation.
Molecular Luminescence Spectroscopy (Fluorometry). In Henry’s Clinical Diagnosis and Management by Laboratory
Methods. Twenty-First Edition. Richard A.McPherson, Mattew R.Pmcus (eds) Saunders Elsevier. London. 2007. p.
39—40.
(14) Yoshlhiro Ashlhara. Yasushi Kasahara, Robert M.Nakamura. Immunoassay and Immunochemistry. Fluorescent
Immunoassay. Time-resolved Fluoroimmunoassay. In Henry’s Clinical Diagnosis and Management by Laboratory
Methods. Twenty-First Edition. Richard A.McPherson. Mattew R.Pmcus (eds) Saunders Elsevier. London. 2007. p.
808—809.
14