EN ISO 5367:2014
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Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
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ISO 80601-2-69:2014
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Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
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IEC 60601-2-19:2009+AMD1:2016 CSV
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Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
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ISO 3744:2010
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Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
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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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EN ISO 5356-1:2015
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Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
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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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EN ISO 80369-1:2010
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Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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ISO 5356-1:2015
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Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
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ISO 16142-1:2016
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Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
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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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ISO 80601-2-70:2015
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Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
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EN 60601-2-19:2009/A1:2016
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS (IEC 60601-2-19:2009/A1:2016)
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EN ISO 9360-2:2009
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Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)
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ISO 5367:2014
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Anaesthetic and respiratory equipment — Breathing sets and connectors
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ISO 80601-2-12:2011
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Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
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ISO 8185:2007
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Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
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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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EN 61672-1:2013
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Electroacoustics - Sound level meters - Part 1: Specifications
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IEC TR 60878:2015
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Graphical symbols for electrical equipment in medical practice
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ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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ISO 80369-1:2010
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Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
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EN ISO 9360-1:2009
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Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)
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ISO 9360-1:2000
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Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
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ISO 10780:1994
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Stationary source emissions — Measurement of velocity and volume flowrate of gas streams in ducts
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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ISO 4135:2001
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Anaesthetic and respiratory equipment Vocabulary
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ISO 9360-2:2001
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Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
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EN ISO 4135:2001
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
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ISO 10524-1:2006
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Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
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ISO 594-2:1998
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Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
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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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ISO 594-1:1986
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Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
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EN 13544-2:2002+A1:2009
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Respiratory therapy equipment - Part 2: Tubing and connectors
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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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PREN 3744 : 200P1
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AEROSPACE SERIES - STRAIGHT PINS, SPRING TYPE, LIGHT DUTY, IN CORROSION RESISTING SPRING STEEL, PASSIVATED
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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 ISO 10993-1:2009/AC:2010
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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ISO 27427:2013
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Anaesthetic and respiratory equipment — Nebulizing systems and components
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ISO 7396-1:2016
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Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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