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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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ISO 80601-2-67:2014
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Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment |
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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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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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CFR 45(PTS1-199) : OCT 2017
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PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE |
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DIN EN 60601-1-6 : 2016
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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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VDE 0750-1-2 : 2016
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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 (IEC 60601-1-2:2014) |
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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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DIN EN 62366 : 2016
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
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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 8835-7:2011
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Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
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ISO 10083:2006
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Oxygen concentrator supply systems for use with medical gas pipeline systems |
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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 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices |
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DIN EN ISO 7010 E : 2012
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GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 6:2014) |
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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 8185:2007
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Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
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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 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 14971:2007
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Medical devices Application of risk management to medical devices |
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ISO 7000:2014
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Graphical symbols for use on equipment Registered symbols |
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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 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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VDE 0750-1 : 2013
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MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
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VDE 0750-1-11 : 2016
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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 (IEC 60601-1-11:2015) |
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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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DIN EN ISO 4135:2002-03
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Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001 |
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DIN EN 60601-1-11 : 2016
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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 (IEC 60601-1-11:2015) |
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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 |