ISO 4871:1996
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Acoustics — Declaration and verification of noise emission values of machinery and equipment |
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 |
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 |
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 |
IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
CSA C22.2 No. 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 |
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 |
ISO 5356-1:2015
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Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
ISO 10651-4:2002
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Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators |
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 |
NFPA 53 : 2016
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MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES |
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 |
ISO 5356-2:2012
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Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 32:1977
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Gas cylinders for medical use — Marking for identification of content |
CSA Z17510.2 : 2009
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SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
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 |
ISO 5359:2014
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Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases |
ISO 10651-3:1997
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Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators |
ISO 8185:2007
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Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
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 |
CSA C22.2 No. 60529 : 2016
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DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) |
ISO 23328-2:2002
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Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV
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Degrees of protection provided by enclosures (IP Code) |
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 |
CSA Z5359 : 2016
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS |
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 |
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 |
ISO/TS 11135-2:2008
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Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO 4135:2001
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Anaesthetic and respiratory equipment Vocabulary |
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 |
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 |
CSA C22.2 No. 60601.1 : 2014
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MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
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 |
IEC 60601-1-1:2000
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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 |
CSA Z8185 : 2008(R2013)
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RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
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 |
CSA C22.2 No. 60601.1.2 : 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 |
ISO 17510-2:2007
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Sleep apnoea breathing therapy Part 2: Masks and application accessories |
CAN/CSA-Z23328-2-03 (R2018)
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Breathing System Filters for Anaesthetic and Respiratory Use - Part 2: Non-Filtration Aspects (Adopted ISO 23328-2:2002, first edition, 2002-10-15) |