ГОСТ Р ИСО 18113-3-2015 Медицинские изделия для диагностики in vitro. Информация, предоставляемая изготовителем (маркировка). Часть 3. Инструменты для диагностики in vitro для профессионального применения

[1]

ISO 18113-2, Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use

[2]

ISO/IEC Directives, Part 2, Rules for the structure and drafting of International Standards

[3]

EN 591:2001, Instructions for use for in vitro diagnostic instruments for professional use

[4]

Directive 98/79/EC of the European Parliament and the Council of 27 October 1998 on in vitro diagnostic medical devices, Official Journal of the European Union L331, December 7, 1998

[5]

Global Harmonization Task Force (GHTF), Labelling for Medical Devices, Final Document GHTF/SG1/N43:2005, June 3, 2005

УДК 61:006.354

ОКС 11.100.10

Ключевые слова: изделия медицинские, диагностика in vitro, реагенты, маркировка