IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV
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Information technology equipment - Safety - Part 1: General requirements
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IEC 60038:2009
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IEC standard voltages
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ISO 7010:2011
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Graphical symbols Safety colours and safety signs Registered safety signs
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EN ISO 14937:2009
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Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
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ISO 80601-2-13:2011
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Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
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ISO/TS 29041:2008
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Gas mixtures — Gravimetric preparation — Mastering correlations in composition
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EN 15986:2011
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Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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IEC 60068-2-27:2008
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Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
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EN 13718-1:2014
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Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
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MIL-STD-810 Revision G:2008
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ENVIRONMENTAL ENGINEERING CONSIDERATIONS AND LABORATORY TESTS
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IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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IEC 60601-1-6:2010+AMD1:2013 CSV
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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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IEC 60721-3-7:1995+AMD1:1996 CSV
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Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
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EN 60068-2-64:2008
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ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
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ISO 14937:2009
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Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
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EN 60601-1-6:2010/A1:2015
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
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IEC 60601-1-8:2006+AMD1:2012 CSV
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Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
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IEC 60068-2-64:2008
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Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
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IEC 60601-1-2:2014
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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ISO 6143:2001
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Gas analysis — Comparison methods for determining and checking the composition of calibration gas mixtures
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EN 60601-1-2:2015
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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EN 60068-2-27:2009
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Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
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EN 60601-1-12:2015
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Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
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ISO/TR 16142:2006
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Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
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ISO 14159:2002
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Safety of machinery — Hygiene requirements for the design of machinery
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ISO 23328-2:2002
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Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
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IEC TR 60878:2015
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Graphical symbols for electrical equipment in medical practice
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IEC 60529:1989+AMD1:1999+AMD2:2013 CSV
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Degrees of protection provided by enclosures (IP Code)
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ASTM F 2761 : 2009 : R2013
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Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
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ISO 6142:2001
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Gas analysis Preparation of calibration gas mixtures Gravimetric method
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IEC 60601-1-3:2008+AMD1:2013 CSV
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Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
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IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV
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Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
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NFPA 53M : 1990
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FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
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ISO 80000-1:2009
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Quantities and units — Part 1: General
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IEC TR 60721-4-7:2001+AMD1:2003 CSV
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Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use
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ISO 23328-1:2003
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Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
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ISO 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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EN 60529:1991/AC:2016-12
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DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
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ISO 7000:2014
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Graphical symbols for use on equipment Registered symbols
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ISO 15223-1:2016
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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IEC 60601-1-9:2007+AMD1:2013 CSV
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Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
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EN ISO 7010 : 2012 AMD 7 2017
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GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 7:2016)
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EN ISO 80601-2-13:2012
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Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
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ISO 17664:2017
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Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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EN 60601-1-11:2015
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Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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EN 60601-1-8:2007/A11:2017
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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)
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