VDE 0750-1-3 : 2014
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008 + A1:2013) |
DIN EN ISO 8836 E : 2015
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SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014) |
IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV
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Information technology equipment - Safety - Part 1: General requirements |
IEC 60038:2009
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IEC standard voltages |
ISO 8836:2014
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Suction catheters for use in the respiratory tract |
ISO 7010:2011
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Graphical symbols Safety colours and safety signs Registered safety signs |
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 80601-2-13:2011
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Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
DIN EN 61672-1:2014-07
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ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013) |
DIN EN ISO 23328-2 E : 2009
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BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS |
EN 15986:2011
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Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
EN 13718-1:2014
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Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
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 |
DIN EN ISO 9360-2 E : 2009
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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 |
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 |
DIN EN 60601-1-3 : 2014
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008 + A1:2013) |
DIN EN ISO 5367 E : 2015
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
DIN EN 60601-2-2 : 2010
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES |
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 |
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) |
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) |
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 |
VDE 0750-2-2 : 2010
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES |
DIN EN 62366 : 2016
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
IEC 60721-3-7:1995+AMD1:1996 CSV
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Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use |
ISO 5356-1:2015
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Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
DIN EN ISO 9360-1 E : 2009
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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 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 |
DIN EN ISO 23328-1 E : 2008
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BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 1: SALT TEST METHOD TO ASSESS FILTRATION PERFORMANCE |
VDE 0750-101 : 2016
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MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
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 |
IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices |
DIN EN 60721-3-7:1995-09
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CLASSIFICATION OF ENVIRONMENTAL CONDITIONS - PART 3: CLASSIFICATION OF GROUPS OF ENVIRONMENTAL PARAMETERS AND THEIR SEVERITIES - SECTION 7: PORTABLE AND NON-STATIONARY USE |
ISO 32:1977
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Gas cylinders for medical use — Marking for identification of content |
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) |
ISO 5367:2014
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Anaesthetic and respiratory equipment — Breathing sets and connectors |
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 |
VDE 0750-241 : 2016
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
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 |
IEC 62304:2006+AMD1:2015 CSV
|
Medical device software - Software life cycle processes |
ISO 14159:2002
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Safety of machinery — Hygiene requirements for the design of machinery |
ISO 23328-2:2002
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Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
IEC TR 60878:2015
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Graphical symbols for electrical equipment in medical practice |
ASTM F 2761 : 2009 : R2013
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Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
DIN EN ISO 80601-2-55 : 2012
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2011) |
IEC 60601-1-3:2008+AMD1:2013 CSV
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Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
ISO 80369-1:2010
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Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
ISO 80601-2-55:2011
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Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
ISO 17510:2015
|
Medical devices — Sleep apnoea breathing therapy — Masks and application accessories |
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 |
DIN EN 62304 : 2016
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MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
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 |
EN 1789:2007+A2:2014
|
Medical vehicles and their equipment - Road ambulances |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
ISO 7000:2014
|
Graphical symbols for use on equipment Registered symbols |
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 |
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 |
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 11195:1995
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Gas mixers for medical use Stand-alone gas mixers |
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) |
VDE 0750-1-11 : 2016
|
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) |
VDE 0750-2-55 : 2012
|
MEDIZINISCHE ELEKTRISCHE GERAETE - TEIL 2-55: BESONDERE FESTLEGUNGEN FUER DIE SICHERHEIT EINSCHLIESSLICH DER WESENTLICHEN LEISTUNGSMERKMALE VON UEBERWACHUNGSGERAETEN FUER ATEMGASE (ISO 80601-2-55:2011) |
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 |
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) |
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 |
DIN EN ISO 4135:2002-03
|
Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001 |
DIN EN 60601-1-11 : 2016
|
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) |
ISO 7396-1:2016
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Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |