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Ophthalmic optics - Contact lenses - Determination of scattered light (ISO 12864:1997)
Radionuclide imaging devices - Characteristics and test conditions - Partie 1: Positron emission tomographs (IEC 61675-1:1998/A1:2008) (Amendment)
ÖNORM EN 724:1995-01
Действует
Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices
Ophthalmic optics - Format of digital data files for data transfer for profiling of spectacle lenses - Part 1: Two-dimensional tracers (ISO 11715-1:1998)
ÖNORM ENV 14027:2001-05
Действует
Method for the simulation of wear before the detection of nickel release from coated metal and combination spectacle frames
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
ÖNORM EN 13014/AC:2002-10
Действует
Connections for gas sampling tubes to anaesthetic and respiratory equipment (Corrigendum)
ÖNORM EN ISO 9340:1999-01
Действует
Optics and optical instruments - Contact lenses - Determination of strains for rigid contact lenses (ISO 9340:1996)
Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements and tests (ISO 595-2:1987)
Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (IEC 60601-1-6:2010) (english version)
Medical electrical equipment -- Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:2014) (english version)
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (IEC 60601-2-22:2007) (english version)
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2014) (english version)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) (english version)
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities (IEC 80001-1:2010) (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
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