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ÖNORM EN 1970:2005-07
Действует
Adjustable beds for disabled persons - Requirements and test methods (consolidated version)
ÖNORM EN 866-4:2000-03
Действует
Biological systems for testing sterilizers and sterilization processes - Part 4: Particular systems for use in irradiation sterilizers
Dentistry - Ceramic denture teeth (ISO 4824:1996/AM1:2000) (Amendment)
ÖNORM EN 21560:1991-12
Действует
Dentistry - Dental mercury
ÖNORM EN 16844:2018-10
Действует
Aesthetic medicine services - Non-surgical medical treatments
Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2008/Cor 1:2009) (Corrigendum of English version)
Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006 + A1:2012) (english version)
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
ÖNORM EN 475:1995-06
Действует
Medical devices - Electrically generated alarm signals
ÖNORM EN 15986:2011-04
Действует
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (consolidated version)
OVE EN 60601-1-2:2016-06
Действует
Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014) (english version)
OVE EN 80601-2-35:2017-12
Действует
Medical electrical equipment -- Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (IEC 80601-2-35:2009 + COR1:2012 + COR2:2015 + A1:2016) (english version)
OVE EN 60601-2-62:2016-05
Действует
Medical electrical equipment -- Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment (IEC 60601-2-62:2013) (english version)
Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Amendment) (english version)
Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Corrigendum) (english version)
OVE EN 60601-1-10:2016-05
Действует
Medical electrical equipment -- Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007 + A1:2013) (english version)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
ÖNORM ENV 737-6:2003-09
Действует
Medical gas pipeline systems - Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum
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