Каталог стандартов

+7 (495) 223-46-76 +7 (812) 309-78-59
inform@normdocs.ru
Корзина
ON
1 2 3 4
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
ONR CEN/TS 17390-3:2020-05
Действует
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining (CEN/TS 17390-3:2020)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
ONR CEN/TS 17390-1:2020-05
Действует
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA (CEN/TS 17390-1:2020)
ONR CEN/TS 17390-2:2020-05
Действует
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA (CEN/TS 17390-2:2020)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
1 2 3 4