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ISO 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
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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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ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
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ISO 15223-2:2010
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Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
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EN 556-1:2001/AC:2006
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STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED "STERILE" - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES |
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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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ISO 11135:2014
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Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
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ASTM F 2503 : 2013 : REDLINE
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Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
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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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ISO 15001:2010
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Anaesthetic and respiratory equipment Compatibility with oxygen |
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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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CFR 21(PTS800-1299) : 0
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FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
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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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ISO 10414-2:2011
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Petroleum and natural gas industries Field testing of drilling fluids Part 2: Oil-based fluids |
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ISO 15403-1:2006
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Natural gas Natural gas for use as a compressed fuel for vehicles Part 1: Designation of the quality |
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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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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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EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices |
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ISO 10524-3:2005
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Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves |
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ASTM F 2052 : 2015 : REDLINE
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Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
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ASTM F 2213 : 2017 : REDLINE
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Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
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ANSI Z79.16 : 1983
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CUFFED OROTRACHEAL AND NASOTRACHEAL TUBES FOR PROLONGED USE, |
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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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ISO/IEC Guide 21-1:2005
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Regional or national adoption of International Standards and other International Deliverables — Part 1: Adoption of International Standards |
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ISO 80369-7:2016
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Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications |
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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 6142-1:2015
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Gas analysis Preparation of calibration gas mixtures Part 1: Gravimetric method for Class I mixtures |
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ISO/TR 11991:1995
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Guidance on airway management during laser surgery of upper airway |
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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 7000:2014
|
Graphical symbols for use on equipment Registered symbols |
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ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
|
ISO 4135:2001
|
Anaesthetic and respiratory equipment Vocabulary |
|
ISO 10524-1:2006
|
Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices |
|
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 |
|
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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ASTM F 640 : 2012 : REDLINE
|
Standard Test Methods for Determining Radiopacity for Medical Use |
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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 |