Каталог стандартов

+7 (495) 223-46-76 +7 (812) 309-78-59
inform@normdocs.ru
Корзина
ON
О компании Стандарты Контакты Заказать стандарт
1 2 3 4
ÖNORM EN 12376:1999-06
Действует
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ÖNORM EN ISO 14155-1:2009-12
Действует
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
ÖNORM EN ISO 14155-2:2009-12
Действует
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
ÖNORM EN 928:1996-01
Действует
In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
ÖNORM EN ISO 10993-8:2000-12
Действует
Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)
ONR CEN/TS 16826-3:2018-10
Действует
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA (CEN/TS 16826-3:2018)
ONR CEN/TS 17305:2019-08
Действует
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (CEN/TS 17305:2019)
ÖNORM EN ISO 7405:2019-03
Действует
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, corrected version 2018-12)
ÖNORM EN ISO 13132:2011-10
Действует
Laboratory glassware - Petri dishes (ISO 13132:2011)
ÖNORM EN ISO 15189:2014-12
Действует
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
ÖNORM EN ISO 16256:2013-04
Действует
Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)
ÖNORM EN ISO 15197:2015-12
Действует
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
ÖNORM EN ISO 15194:2009-09
Действует
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
ÖNORM EN ISO 29701:2010-12
Действует
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)
ÖNORM EN 12322:1999-09
Действует
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
ÖNORM EN 12322/A1:2002-04
Действует
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media (Amendment)
ÖNORM EN 13641:2002-07
Действует
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
ÖNORM EN 14136:2004-07
Действует
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
ÖNORM EN 13532:2002-08
Действует
General requirements for in vitro diagnostic medical devices for self-testing
ÖNORM EN 13975:2003-11
Действует
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
1 2 3 4