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DIN EN 60601-2-12 : 2007
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
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DIN EN ISO 10651-2:2011-06
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LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
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ISO 4871:1996
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Acoustics — Declaration and verification of noise emission values of machinery and 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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DIN EN 60601-1-1 : 2002
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
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DIN EN ISO 17510-2:2009-07
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SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
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ISO 10651-2:2004
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Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
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DIN EN ISO 10651-4:2009-08
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Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
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DIN EN ISO 10651-6:2011-06
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LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
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ISO 10651-6:2004
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Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
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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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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 ISO 17664:2016-06 (Draft)
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PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
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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 10651-4:2002
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Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
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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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NFPA 53 : 2016
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MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
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DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
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VDE 0750-1-6 : 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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DIN EN ISO 3744:2011-02
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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 (ISO 3744:2010)
|
|
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 5356-2:2012
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Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
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ISO 32:1977
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Gas cylinders for medical use — Marking for identification of content
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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 5359:2014
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Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
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ISO 10651-3:1997
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Lung ventilators for medical use Part 3: Particular requirements for emergency and transport 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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DIN EN ISO 17665-1:2006-11
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Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
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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 23328-2:2002
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Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
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DIN EN ISO 5356-1:2015-06
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO 5356-1:2015)
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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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DIN EN ISO 11135-1:2007-08
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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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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DIN EN ISO 5356-2:2013-03
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 2: SCREW-THREADED WEIGHT-BEARING CONNECTORS (ISO 5356-2:2012)
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|
VDE 0750-1-1 : 2002
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MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY; 1 COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
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|
ISO 9170-1:2017
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Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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|
VDE 0750-1-4 : 2001
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY; COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
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|
ISO 4135:2001
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Anaesthetic and respiratory equipment Vocabulary
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|
IEC 60601-2-12:2001
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Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
|
|
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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DIN 45681:2005-03
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ACOUSTICS - DETERMINATION OF TONAL COMPONENTS OF NOISE AND DETERMINATION OF A TONE ADJUSTMENT FOR THE ASSESSMENT OF NOISE IMMISSIONS
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VDE 0750-1 : 2013
|
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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IEC 60601-1-1:2000
|
Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
|
|
IEC 60601-1-4:1996+AMD1:1999 CSV
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Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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|
VDE 0750-2-12 : 2012
|
MEDIZINISCHE ELEKTRISCHE GERAETE - TEIL 2-12: BESONDERE FESTLEGUNGEN FUER DIE SICHERHEIT EINSCHLIESSLICH DER WESENTLICHEN LEISTUNGSMERKMALE VON BEATMUNGSGERAETEN FUER DIE INTENSIVPFLEGE (ISO/IEC 80601-2-12:2011 + COR.: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
|
|
ISO 17510-2:2007
|
Sleep apnoea breathing therapy Part 2: Masks and application accessories
|
|
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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