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 |
ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
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 |
EN 15986:2011
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Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
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 |
IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 5356-1:2015
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Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
ISO 10079-1:2015
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Medical suction equipment Part 1: Electrically powered suction equipment |
ISO 5367:2014
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Anaesthetic and respiratory equipment — Breathing sets and connectors |
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 |
EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices |
ISO 8185:2007
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Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
ISO 10079-2:2014
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Medical suction equipment Part 2: Manually powered suction equipment |
ISO 5366-1:2000
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Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults |
ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 5366-3:2001
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Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes |
ISO 10079-3:2014
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Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
ISO 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice |
ISO 5361:2016
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Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
ISO/TR 11991:1995
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Guidance on airway management during laser surgery of upper airway |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO 7000:2014
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Graphical symbols for use on equipment Registered symbols |
ISO 11607-1:2006
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Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
ISO 4135:2001
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Anaesthetic and respiratory equipment Vocabulary |
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 |
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 |
ASTM F 640 : 2012 : REDLINE
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Standard Test Methods for Determining Radiopacity for Medical Use |