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ÖNORM EN 14254:2004-09
Действует
In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
ÖNORM EN 13612:2002-08
Действует
Performance evaluation of in vitro diagnostic medical devices
ÖNORM EN 13612/AC:2003-09
Действует
Performance evaluation of in vitro diagnostic medical devices (Corrigendum of English version)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009) (consolidated version)
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2013)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
Laboratory glassware - Desiccators (ISO 13130:2011)
Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)
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