MDD Vertical Harmonized Standards
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EN 794-3

Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators more

EN 1282-2

Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) more

EN 1782

Tracheal tubes and connectors more

EN 1820

Anaesthetic reservoir bags (ISO 5362:2000, modified) more

EN ISO 4135

Anaesthetic and respiratory equipment - Vocabulary more

EN ISO 5356-1

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets more

EN ISO 5356-2

Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors more

EN ISO 5360

Anaesthetic vaporizers - Agent-specific filling systems more

EN ISO 5366-1

Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults more

EN ISO 7376

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation more

EN ISO 8185

Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems more

EN ISO 8835-2

Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems more

EN ISO 8835-3

Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems more

EN ISO 8835-4

Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices more

EN ISO 8835-5

Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators more

EN ISO 9360-1

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 more

EN ISO 9360-2

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 more

EN ISO 10651-2

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients more

EN ISO 10651-4

Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators more

EN ISO 10651-6

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices more

EN 12342

Breathing tubes intended for use with anaesthetic apparatus and ventilators more

EN 13544-1

Respiratory therapy equipment - Part 1: Nebulizing systems and their components more

EN 13544-2

Respiratory therapy equipment - Part 2: Tubing and connectors more

EN 13544-3

Respiratory therapy equipment - Part 3: Air entrainment devices more

EN ISO 14408

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information more

EN ISO 15001

Anaesthetic and respiratory equipment - Compatibility with oxygen more

EN ISO 17510-1

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment more

EN ISO 17510-2

Sleep apnoea breathing therapy - Part 2: Masks and application accessories more

EN ISO 18778

Respiratory equipment - Infant monitors - Particular requirements more

EN ISO 23328-1

Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance more

EN ISO 23328-2

Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects more

EN ISO 23747

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans more

EN ISO 26782

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans more

EN 1618

Catheters other than intravascular catheters - Test methods for common properties more

EN ISO 5840

Cardiovascular implants - Cardiac valve prostheses more

EN 12006-2

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits more

EN ISO 25539-1

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses more

EN ISO 25539-2

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents more

EN 1060-3

Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems more

EN 1060-4

Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers more

EN ISO 81060-1

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type more

EN 1639

Dentistry - Medical devices for dentistry - Instruments more

EN 1640

Dentistry - Medical devices for dentistry - Equipment more

EN 1641

Dentistry - Medical devices for dentistry - Materials more

EN 1642

Dentistry - Medical devices for dentistry - Dental implants more

EN ISO 14607

Non-active surgical implants - Mammary implants - Particular requirements more

EN 13867

Concentrates for haemodialysis and related therapies more

EN 1789

Medical vehicles and their equipment - Road ambulances more

EN 1865-3

Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher more

EN 1865-5

Patient handling equipment used in road ambulances - Part 5: Stretcher support more

EN 1985

Walking aids - General requirements and test methods more

EN ISO 10079-1

Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999) more

EN ISO 10079-2

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999) more

EN ISO 10079-3

Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) more

EN ISO 10535

Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) more

EN ISO 11197

Medical supply units more

EN 12183

Manual wheelchairs - Requirements and test methods more

EN 12184

Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods more

EN 13060

Small steam sterilizers more

EN 13976-1

Rescue systems - Transportation of incubators - Part 1: Interface conditions more

EN 13976-2

Rescue systems - Transportation of incubators - Part 2: System requirements more

EN ISO 15883-1

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests more

EN ISO 15883-2

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. more

EN ISO 15883-3

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers more

EN ISO 15883-4

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes more

EN ISO 16201

Technical aids for disabled persons - Environmental control systems for daily living more

EN ISO 19054

Rail systems for supporting medical equipment more

EN ISO 21649

Needle-free injectors for medical use - Requirements and test methods more

EN ISO 11810-1

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 more

EN ISO 11810-2

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 more

EN 455-1

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes more

EN 455-3

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation more

EN 455-4

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination more

EN ISO 3826-3

Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features more

EN ISO 7886-3

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization more

EN ISO 4074

Natural latex rubber condoms - Requirements and test methods more

EN ISO 7886-4

Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature more

EN ISO 10555-1

Sterile, single-use intravascular catheters - Part 1: General requirements more

EN 12470-1

Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device more

EN 12470-2

Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers more

EN 12470-3

Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device more

EN 12470-4

Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement more

EN 12470-5

Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) more

EN 14079

Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze more

EN 14683

Surgical masks - Requirements and test methods more

EN ISO 15747

Plastic containers for intravenous injections more

EN ISO 21171

Medical gloves - Determination of removable surface powder more

EN ISO 22610

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 more

EN ISO 22612

Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration more

EN ISO 7197

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components more

EN ISO 9713

Neurosurgical implants - Self-closing intracranial aneurysm clips more

EN ISO 11979-8

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements more

EN ISO 12870

Ophthalmic optics - Spectacle frames - Requirements and test methods more

EN 14139

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003) more

EN ISO 14889

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses more

EN ISO 15004-1

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments more

EN ISO 15798

Ophthalmic implants - Ophthalmic viscosurgical devices more

EN ISO 21987

Ophthalmic optics - Mounted spectacle lenses more

EN ISO 10328

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006) more

EN ISO 14602

Non-active surgical implants - Implants for osteosynthesis - Particular requirements more

EN ISO 21534

Non-active surgical implants - Joint replacement implants - Particular requirements more

EN ISO 21536

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants more

EN ISO 22523

External limb prostheses and external orthoses - Requirements and test methods more

EN ISO 22675

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods more

EN 60118-13

Electroacoustics - Hearing aids -- Part 13: Electromagnetic compatibility (EMC) more

EN 60645-1

Electroacoustics - Audiological equipment -- Part 1: Pure-tone audiometers more

EN 60645-2

Audiometers -- Part 2: Equipment for speech audiometry more

EN 60645-3

Electroacoustics - Audiometric equipment -- Part 3: Test signals of short duration more

EN 60645-4

Audiometers -- Part 4: Equipment for extended high-frequency audiometry more

EN 60522

Determination of the permanent filtration of X-ray tube assemblies more

EN 60627

Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids more

EN 61217

Radiotherapy equipment - Coordinates, movements and scales more

EN 13726-1

Test methods for primary wound dressings - Part 1: Aspects of absorbency more

EN 13726-2

Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings more