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Spec:
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Title:
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EN 285
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Sterilization - Steam sterilizers - Large sterilizers
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EN 455-1
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Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
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EN 455-2
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Medical gloves for single use - Part 2: Requirements and testing for physical properties
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EN 455-3
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Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
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EN 455-4
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Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
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EN 556-1
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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
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EN 556-2
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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
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EN 794-1
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Lung ventilators - Part 1: Particular requirements for critical care ventilators
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EN 794-3
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Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
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EN 980
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Symbols for use in the labelling of medical devices
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EN 1041
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Information supplied by the manufacturer of medical devices
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EN 1060-1
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Non-invasive sphygmomanometers - Part 1: General requirements
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EN 1060-2
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Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
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EN 1060-3
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Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
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EN 1060-4
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Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers
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EN 1089-3
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Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding
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EN 1282-2
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Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
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EN 1422
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Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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EN 1618
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Catheters other than intravascular catheters - Test methods for common properties
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EN 1639
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Dentistry - Medical devices for dentistry - Instruments
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EN 1640
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Dentistry - Medical devices for dentistry - Equipment
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EN 1641
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Dentistry - Medical devices for dentistry - Materials
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EN 1642
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Dentistry - Medical devices for dentistry - Dental implants
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EN 1707
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Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings
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EN 1782
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Tracheal tubes and connectors
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EN 1789
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Medical vehicles and their equipment - Road ambulances
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EN 1820
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Anaesthetic reservoir bags (ISO 5362:2000, modified)
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EN 1985
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Walking aids - General requirements and test methods
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EN ISO 3826-2
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Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)
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EN ISO 3826-3
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Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)
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EN ISO 4074
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Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)
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EN ISO 4135
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Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)
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EN ISO 5356-1
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Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004)
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EN ISO 5356-2
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Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006)
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EN ISO 5359
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Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)
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EN ISO 5360
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Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)
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EN ISO 5366-1
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Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
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EN ISO 5840
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Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
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EN ISO 7197
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Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
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EN ISO 7376
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Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
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EN ISO 7396-1
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Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)
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EN ISO 7396-2
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Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
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EN ISO 7439
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Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)
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EN ISO 7886-3
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Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
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EN ISO 7886-4
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Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)
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EN ISO 8185
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Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
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EN ISO 8359
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Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
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EN ISO 8536-4
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Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)
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EN ISO 8835-2
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Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)
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EN ISO 8835-3
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Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)
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EN ISO 8835-4
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Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
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EN ISO 8835-5
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Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
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EN ISO 9170-1
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Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)
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EN ISO 9170-2
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Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)
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EN ISO 9360-1
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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 9360-1:2000)
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EN ISO 9360-2
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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 9360-2:2001)
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EN ISO 9713
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Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
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EN ISO 9919
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Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)
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EN ISO 10079-1
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Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)
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EN ISO 10079-2
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Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)
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EN ISO 10079-3
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Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)
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EN ISO 10328
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Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)
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EN ISO 10524-1
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Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
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EN ISO 10524-2
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Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
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EN ISO 10524-3
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Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)
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EN ISO 10524-4
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Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)
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EN ISO 10535
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Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)
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EN ISO 10555-1
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Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)
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EN ISO 10651-2
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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 10651-2:2004)
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EN ISO 10651-4
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Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
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EN ISO 10651-6
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Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
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EN ISO 10993-1
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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
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EN ISO 10993-4
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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
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EN ISO 10993-5
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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
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EN ISO 10993-6
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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
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EN ISO 10993-7
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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
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EN ISO 10993-9
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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
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EN ISO 10993-11
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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
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EN ISO 10993-12
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Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)
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EN ISO 10993-13
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Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
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EN ISO 10993-14
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Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
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EN ISO 10993-15
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Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
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EN ISO 10993-16
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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
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EN ISO 10993-17
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Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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EN ISO 10993-18
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Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
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EN ISO 11135-1
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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 11135-1:2007)
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EN ISO 11137-1
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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 11137-1:2006)
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EN ISO 11137-2
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)
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EN ISO 11138-2
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Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
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EN ISO 11138-3
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Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
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EN ISO 11140-3
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Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
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EN ISO 11197
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Medical supply units (ISO 11197:2004)
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EN ISO 11607-1
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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
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EN ISO 11607-2
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
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EN ISO 11737-1
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Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
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EN ISO 11737-2
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Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
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EN ISO 11810-1
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Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005)
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EN ISO 11810-2
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Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)
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EN ISO 11979-8
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Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)
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EN ISO 11990
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Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)
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EN 12006-2
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Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
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EN 12006-3
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Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
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EN 12182
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Technical aids for disabled persons - General requirements and test methods
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EN 12183
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Manual wheelchairs - Requirements and test methods
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EN 12184
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Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
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EN 12342
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Breathing tubes intended for use with anaesthetic apparatus and ventilators
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EN 12470-1
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Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
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EN 12470-2
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Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
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EN 12470-3
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Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
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EN 12470-4
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Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
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EN 12470-5
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Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)
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EN ISO 12870
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Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)
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EN 13060
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Small steam sterilizers
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EN ISO 13485
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
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EN 13544-1
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Respiratory therapy equipment - Part 1: Nebulizing systems and their components
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EN 13544-2
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Respiratory therapy equipment - Part 2: Tubing and connectors
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EN 13544-3
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Respiratory therapy equipment - Part 3: Air entrainment devices
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EN 13624
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Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)
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EN 13718-1
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Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
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EN 13726-1
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Test methods for primary wound dressings - Part 1: Aspects of absorbency
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EN 13726-2
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Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
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EN 13727
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Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)
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EN 13795-1
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Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
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EN 13795-2
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Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
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EN 13795-3
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Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
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EN 13824
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Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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EN 13867
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Concentrates for haemodialysis and related therapies
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EN 13976-1
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Rescue systems - Transportation of incubators - Part 1: Interface conditions
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EN 13976-2
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Rescue systems - Transportation of incubators - Part 2: System requirements
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EN 14079
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Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
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EN 14139
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Ophthalmic optics - Specifications for ready-to-wear spectacles
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EN ISO 14155-1
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Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
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EN ISO 14155-2
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Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
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EN ISO 14160
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Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998)
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EN 14180
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Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
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EN 14348
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Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
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EN ISO 14408
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Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)
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EN ISO 14534
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Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)
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EN 14561
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Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2
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EN 14562
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Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
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EN 14563
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Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)
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EN ISO 14607
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Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
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EN ISO 14630
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Non-active surgical implants - General requirements (ISO 14630:2008)
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EN 14683
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Surgical masks - Requirements and test methods
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EN ISO 14889
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Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)
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EN 14931
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Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
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EN ISO 14937
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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 (ISO 14937:2009)
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EN ISO 14971
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Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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EN ISO 15002
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Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
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EN ISO 15004-1
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Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)
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EN 15424
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Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
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EN 15546-1
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Small bore connectors for liquids and gases in healthcare applications - Part 1 - General Requirements
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EN ISO 15798
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Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)
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EN ISO 15883-1
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Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
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EN ISO 15883-2
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Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)
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EN ISO 15883-3
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Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
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EN ISO 15883-4
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Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
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EN ISO 16061
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Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)
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EN ISO 16201
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Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)
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EN ISO 17510-1
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Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
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EN ISO 17510-2
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Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
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EN ISO 17664
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Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
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EN ISO 17665-1
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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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EN ISO 18777
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Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
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EN ISO 18778
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Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
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EN ISO 18779
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Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
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EN ISO 19054
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Rail systems for supporting medical equipment (ISO 19054:2005)
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EN 20594-1
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Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
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EN ISO 21171
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Medical gloves - Determination of removable surface powder (ISO 21171:2006)
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EN ISO 21534
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Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
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EN ISO 21535
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Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
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EN ISO 21536
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Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
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EN ISO 21647
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Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)
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EN ISO 21649
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Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
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EN ISO 21969
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High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
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EN ISO 21987
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Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009)
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EN ISO 22442-1
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Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)
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EN ISO 22442-2
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Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)
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EN ISO 22442-3
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Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
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EN ISO 22523
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External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
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EN ISO 22610
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Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)
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EN ISO 22612
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Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)
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EN ISO 22675
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Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)
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EN ISO 23328-1
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Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)
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EN ISO 23328-2
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Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
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EN ISO 23747
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Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)
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EN ISO 25539-1
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Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
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EN ISO 25539-2
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Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
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EN ISO 26782
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Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)
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EN 27740
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Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
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EN 60118-13
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Electroacoustics - Hearing aids -- Part 13: Electromagnetic compatibility (EMC) IEC 60118-13:2004
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EN 60522
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Determination of the permanent filtration of X-ray tube assemblies IEC 60522:1999
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EN 60580
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Medical electrical equipment - Dose area product meters IEC 60580:2000
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EN 60601-1
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Medical electrical equipment -- Part 1: General requirements for safety IEC 60601-1:2005
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EN 60601-1-1
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Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-1:2000
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EN 60601-1-2
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Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 60601-1-2:2007 (Modified)
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EN 60601-1-3
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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
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EN 60601-1-4
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Medical electrical equipment -- Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems IEC 60601-1-4:1996
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EN 60601-1-6
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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
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EN 60601-1-8
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Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601-1-8:2006
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EN 60601-1-10
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Medical electrical equipment -- Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers IEC 60601-1-10:2007
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EN 60601-1-11
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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 60601-1-11:2010
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EN 60601-2-1
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Medical electrical equipment -- Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV IEC 60601-2-1:1998
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EN 60601-2-2
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Medical electrical equipment -- Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories IEC 60601-2-2:2009
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EN 60601-2-3
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Medical electrical equipment -- Part 2: Particular requirements for the safety of short-wave therapy equipment IEC 60601-2-3:1991
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EN 60601-2-4
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Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators IEC 60601-2-4:2002
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EN 60601-2-5
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Medical electrical equipment -- Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment IEC 60601-2-5:2000
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EN 60601-2-7
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Medical electrical equipment -- Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators IEC 60601-2-7:1998
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EN 60601-2-8
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Medical electrical equipment -- Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV IEC 60601-2-8:1987
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EN 60601-2-10
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Medical electrical equipment -- Part 2-10: Particular requirements for the safety of nerve and muscle stimulators IEC 60601-2-10:1987
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EN 60601-2-11
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Medical electrical equipment -- Part 2-11: Particular requirements for the safety of gamma beam therapy equipment IEC 60601-2-11:1997
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EN 60601-2-12
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Medical electrical equipment -- Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators IEC 60601-2-12:2001
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EN 60601-2-13
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Medical electrical equipment -- Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems IEC 60601-2-13:2003
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EN 60601-2-16
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Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment IEC 60601-2-16:1998
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EN 60601-2-17
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Medical electrical equipment -- Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment IEC 60601-2-17:2004
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EN 60601-2-18
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Medical electrical equipment -- Part 2: Particular requirements for the safety of endoscopic equipment IEC 60601-2-18:1996
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EN 60601-2-19
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Medical electrical equipment -- Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators IEC 60601-2-19:2009
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EN 60601-2-20
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Medical electrical equipment -- Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators IEC 60601-2-20:2009
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EN 60601-2-21
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Medical electrical equipment -- Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers IEC 60601-2-21:2009
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EN 60601-2-22
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Medical electrical equipment -- Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment IEC 60601-2-22:1995
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EN 60601-2-23
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Medical electrical equipment -- Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment IEC 60601-2-23:1999
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EN 60601-2-24
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Medical electrical equipment -- Part 2-24: Particular requirements for the safety of infusion pumps and controllers IEC 60601-2-24:1998
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EN 60601-2-25
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Medical electrical equipment -- Part 2-25: Particular requirements for the safety of electrocardiographs IEC 60601-2-25:1993
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EN 60601-2-26
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Medical electrical equipment -- Part 2-26: Particular requirements for the safety of electroencephalographs IEC 60601-2-26:2002
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EN 60601-2-27
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Medical electrical equipment -- Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment IEC 60601-2-27:2005
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EN 60601-2-28
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Medical electrical equipment -- Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis IEC 60601-2-28:2010
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EN 60601-2-29
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Medical electrical equipment -- Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators IEC 60601-2-29:2008
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EN 60601-2-30
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Medical electrical equipment -- Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment IEC 60601-2-30:1999
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EN 60601-2-31
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Medical electrical equipment -- Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source IEC 60601-2-31:1994
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EN 60601-2-32
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Medical electrical equipment -- Part 2: Particular requirements for the safety of associated equipment of X-ray equipment IEC 60601-2-32:1994
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EN 60601-2-33
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Medical electrical equipment -- Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis IEC 60601-2-33:2002
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EN 60601-2-34
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Medical electrical equipment -- Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment IEC 60601-2-34:2000
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EN 60601-2-35
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Medical electrical equipment -- Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use IEC 60601-2-35:1996
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EN 60601-2-36
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Medical electrical equipment -- Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy IEC 60601-2-36:1997
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EN 60601-2-37
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Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment IEC 60601-2-37:2007
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EN 60601-2-38
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Medical electrical equipment -- Part 2-38: Particular requirements for the safety of electrically operated hospital beds IEC 60601-2-38:1996
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EN 60601-2-39
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Medical electrical equipment -- Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment IEC 60601-2-39:2007
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EN 60601-2-40
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Medical electrical equipment -- Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment IEC 60601-2-40:1998
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EN 60601-2-41
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Medical electrical equipment -- Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis IEC 60601-2-41:2009
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EN 60601-2-43
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Medical electrical equipment -- Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures IEC 60601-2-43:2010
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EN 60601-2-44
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Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography IEC 60601-2-44:2009
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EN 60601-2-45
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Medical electrical equipment -- Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices IEC 60601-2-45:2001
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EN 60601-2-46
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Medical electrical equipment -- Part 2-46: Particular requirements for the safety of operating tables IEC 60601-2-46:1998
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EN 60601-2-47
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Medical electrical equipment -- Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems IEC 60601-2-47:2001
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EN 60601-2-49
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Medical electrical equipment -- Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment IEC 60601-2-49:2001
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EN 60601-2-50
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Medical electrical equipment -- Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment IEC 60601-2-50:2009
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EN 60601-2-51
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Medical electrical equipment -- Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs IEC 60601-2-51:2003
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EN 60601-2-54
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Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy IEC 60601-2-54:2009
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EN 60627
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Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids IEC 60627:2001
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EN 60645-1
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Electroacoustics - Audiological equipment -- Part 1: Pure-tone audiometers IEC 60645-1:2001
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EN 60645-2
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Audiometers -- Part 2: Equipment for speech audiometry IEC 60645-2:1993
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EN 60645-3
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Electroacoustics - Audiometric equipment -- Part 3: Test signals of short duration IEC 60645-3:2007
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EN 60645-4
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Audiometers -- Part 4: Equipment for extended high-frequency audiometry IEC 60645-4:1994
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EN 61217
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Radiotherapy equipment - Coordinates, movements and scales IEC 61217:1996
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EN 61676
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Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology IEC 61676:2002
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EN 62083
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Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems IEC 62083:2009
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EN 62220-1
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Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1: Determination of the detective quantum efficiency IEC 62220-1:2003
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EN 62220-1-2
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Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography IEC 62220-1-2:2007
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EN 62220-1-3
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Medical electrical equipment - Characteristics of digital X-ray imaging devices -- Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging IEC 62220-1-3:2008
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EN 62304
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Medical device software - Software life-cycle processes IEC 62304:2006
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EN 62366
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Medical devices - Application of usability engineering to medical devices IEC 62366:2007
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EN 80601-2-35
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Medical electrical equipment -- Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use IEC 80601-2-35:2009
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EN 80601-2-58
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Medical electrical equipment -- Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery IEC 80601-2-58:2008
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EN 80601-2-59
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Medical electrical equipment -- Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening IEC 80601-2-59:2008
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