ГОСТ Р ИСО 18153-2006 Изделия медицинские для диагностики in vitro. Измерение величин в биологических пробах. Метрологическая прослеживаемость значений каталитической концентрации ферментов, приписанных калибраторам и контрольным материалам

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EH 12286:1998

Изделия медицинские для диагностики .     
Измерение величин в пробах биологической природы.
Представление эталонных методик выполнения измерений

ЕН 12286:1998/А1:2000

Изделия медицинские для диагностики .     
Измерение величин в пробах биологической природы.      
Представление эталонных методик выполнения измерений

ЕН 12287:1999

Изделия медицинские для диагностики .     
Измерение величин в пробах биологической природы.     
Описание стандартных образцов

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ, 1998, No L 331

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