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DS DS 2450 |
Infection control in the health care sector - Requirements for the management system |
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DS DS 2450 E |
Infection control in the health care sector - Requirements for the management system |
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DS DS 2451- 1 |
Infection control in the health care sector - Part 1:Requirements for procedures in general medical practice |
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DS DS 2451- 10 |
Infection control in the health care sector - Part 10: Requirements for cleaning |
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DS DS 2451- 11 |
Infection control in the health care sector - Part 11: Requirements for treatment of food including transport and serving |
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DS DS 2451- 12 |
Infection control in the health care sector - Part 12: Requirements for procedures in dental clinics |
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DS DS 2451- 12/RET.1 |
Infection control in the health care sector - Part 12: Requirements for procedures in dental clinics |
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DS DS 2451- 2 |
Infection control in the health care sector - Part 2: Requirements for hand washing practice for the prevention of nosocomial infections |
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DS DS 2451- 2/RET.1 |
Infection control in the health care sector - Part 2: Requirements for hand washing practice for the prevention of nosocomial infections |
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DS DS 2451- 3 |
Infection control in the health care sector - Part 3: Requirements for use of intravascular catheters |
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DS DS 2451- 4 |
Infection control in the health care sector - Part 4: Requirements for surveillance and investigation of outbreaks performed by a Department of Clinical Microbiology |
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DS DS 2451- 5 |
Infection control in the health care sector - Part 5: Requirements for prevention of surgical site infections |
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DS DS 2451- 5/RET.1 |
Infection control in the health care sector - Part 5: Requirements for prevention of surgical site infections |
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DS DS 2451- 6 |
Infection control in the health care sector - Part 6: Requirements for infection prophylaxis in use of urine incontinence devices for single use |
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DS DS 2451- 6/RET.1 |
Infection control in the health care sector - Part 6: Requirements for infection prophylaxis in use of urine incontinence devices for single use |
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DS DS 2451- 7 |
Infection control in the health care sector - Part 7: Requirements for catheters left as drainage in the urinary tract |
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DS DS 2451- 8 |
Infection control in the health care sector - Part 8: Requirements for laundering and handling of textiles for multiple use |
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DS DS 2451- 9 |
Infection control in the health care sector - Part 9: Requirements for purchasing and maintenance of technical and medical equipment |
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DS DS 3028 |
General accessibility |
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DS DS/CEN/CR 13217 |
Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale |
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DS DS/CEN/CR 13825 |
Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings" |
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DS DS/CEN/CR 13903 |
General guidance on the equipment used for inhaled nitric oxide therapy |
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DS DS/CEN/CR 14060 |
Medical device traceability |
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DS DS/CEN/CR 14230 |
Global medical device nomenclature for the purpose of regulatory data exchange |
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DS DS/CEN/TR 12401 |
Dentistry - Guidance on the classification of dental devices and accessories |
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DS DS/CEN/TR 15133 |
Nomenclature Collective terms and codes for groups of medical devices |
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DS DS/CEN/TS 14507- 1 |
Inhalational nitric oxide systems - Part 1: Delivery systems |
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DS DS/CEN/TS 14507- 2 |
Inhalational nitric oxide systems - Part 2: Supply systems |
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DS DS/CEN/TS 15224 |
Health services Quality management systems Guide for the use of EN ISO 9001:2000 |
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DS DS/CWA 45546- 1 |
Guidelines to standardisers of Collective Transport Systems - Needs of older people and persons with disabilities - Part 1: Basic Guidelines |
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DS DS/EN 1040 |
Chemical disinfectants and antiseptics - Basic bactericidal activity - Test method and requirements (phase 1) |
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DS DS/EN 1041 |
Information supplied by the manufacturer with medical devices |
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DS DS/EN 1060- 1 |
Non-invasive sphygmomanometers - Part 1: General requirements |
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DS DS/EN 1060- 1/A1 |
Non-invasive sphygmomanometers - Part 1: General requirements- (AMENDS DS/EN 1060-1) |
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DS DS/EN 1060- 2 |
Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers |
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DS DS/EN 1060- 2/AC |
Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers |
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DS DS/EN 1060- 3 |
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
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DS DS/EN 1060- 4 |
Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
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DS DS/EN 1174- 1 |
Sterilization of medical devices - Estimation of the population of micro- organisms on product - Part 1: Requirements |
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DS DS/EN 1174- 2 |
Sterilization of medical devices - Estimation of the population of micro organisms on product - Part 2: Guidance |
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DS DS/EN 1174- 3 |
Sterilization of medical devices - Estimation of the population of micro- organisms on product - Part 3: Guide to the methods for validation of microbiological techniques |
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DS DS/EN 12006- 1 |
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes |
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DS DS/EN 12006- 2 |
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits |
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DS DS/EN 12006- 3 |
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices |
|
DS DS/EN 12010 |
Non-active surgical implants - Joint replacement implants - Particular requirements |
|
DS DS/EN 12011 |
Instrumentation to be used in association with non-active surgical implants - General requirements |
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DS DS/EN 12022 |
Blood gas exchangers |
|
DS DS/EN 12180 |
Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants |
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DS DS/EN 12181 |
Oropharyngeal airways |
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DS DS/EN 12182 |
Technical aids for disabled persons - General requirements and test methods |
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DS DS/EN 12183 |
Manually propelled wheelchairs - Requirements and test methods |
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DS DS/EN 12184 |
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
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DS DS/EN 12218 |
Rail systems for supporting medical equipment |
|
DS DS/EN 12218/A1 |
Rail systems for supporting medical equipment-(AMENDS DS/EN 12218) |
|
DS DS/EN 12286 |
In vitro diagnostic medical devices - Measurements of quantities in samples of biological origin - Presentation of reference measurement procedures |
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DS DS/EN 12286/A1 |
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures-(AMENDS DS/EN 12286) |
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DS DS/EN 12287 |
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials |
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DS DS/EN 12342 |
Breathing tubes intended for use with anaesthetic apparatus and ventilators |
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DS DS/EN 12353 |
Chemical disinfectants and antiseptics - Preservation of microbial strains used for the determination of bactericidal and fungicidal activity |
|
DS DS/EN 12376 |
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
|
DS DS/EN 12439 |
Sterile rectal catheters for single use |
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DS DS/EN 12442- 1 |
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk |
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DS DS/EN 12442- 2 |
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Control on sourcing, collection and handling |
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DS DS/EN 12442- 3 |
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and other transmissible agents |
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DS DS/EN 12470- 1 |
Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device |
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DS DS/EN 12470- 2 |
Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers |
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DS DS/EN 12470- 3 |
Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
|
DS DS/EN 12470- 4 |
Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement |
|
DS DS/EN 12470- 5 |
Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) |
|
DS DS/EN 12523 |
External limb prostheses and external orthoses - Requirements and test methods |
|
DS DS/EN 12530 |
Castors and wheels - Castors and wheels for manually propelled institutional applications |
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DS DS/EN 12531 |
Castors and wheels - Hospital bed castors |
|
DS DS/EN 12563 |
Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants |
|
DS DS/EN 12564 |
Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants |
|
DS DS/EN 12598 |
Oxygen monitors for patient breathing mixtures - Particular requirements |
|
DS DS/EN 1275 |
Chemical disinfectants and antiseptics - Basic fungicidal activity - Test method and requirements (Phase 1) |
|
DS DS/EN 12791 |
Chemical disinfectants and antiseptics Surgical hand disinfection Test method and requirement (phase 2/step 2) |
|
DS DS/EN 1280- 1 |
Agent specific filling systems for anaesthetic vaporizers - Part 1: Rectangular keyed filling systems |
|
DS DS/EN 1280- 1/A1 |
Agent specific filling systems for anaesthetic vaporizers - Part 1: Rectangular keyed filling systems-(AMENDS DS/EN 1280-1) |
|
DS DS/EN 1281- 2 |
Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors |
|
DS DS/EN 1282- 2 |
Tracheostomy tubes - Part 2: Paediatric tubes |
|
DS DS/EN 1283 |
Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits |
|
DS DS/EN 13014 |
Connections for gas sampling tubes to anaesthetic and respiratory equipment |
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DS DS/EN 13014/AC |
Connections for gas sampling tubes to anaesthetic and respiratory equipment |
|
DS DS/EN 13060 |
Small steam sterilizers |
|
DS DS/EN 13220 |
Flow-metering devices for connection to terminal units of medical gas pipeline systems |
|
DS DS/EN 13221 |
High-pressure flexible connections for use with medical gases |
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DS DS/EN 13328- 1 |
Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance |
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DS DS/EN 13328- 2 |
Breathing system filters for anaesthetic and respiratory use - Part 2: Non- filtration aspects |
|
DS DS/EN 13328- 2/A1 |
Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects-(AMENDS DS/EN 13328-2) |
|
DS DS/EN 13348 |
Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum-Amendment 1: 04/28/2005; |
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DS DS/EN 13503- 3 |
Ophthalmic implants - Intraoccular lenses - Part 3: Mechanical properties and test methods |
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DS DS/EN 13503- 5 |
Optics and optical instruments - Intraocular lenses - Part 5: Biocompability |
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DS DS/EN 13503- 6 |
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability |
|
DS DS/EN 13503- 7 |
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations |
|
DS DS/EN 13503- 8 |
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements |
|
DS DS/EN 13532 |
General requirements for in vitro diagnostic medical devices for self- testing |
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DS DS/EN 13544- 1 |
Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
|
DS DS/EN 13544- 1/A1 |
Respiratory therapy equipment - Part 1: Nebulizing systems and their components-(AMENDS DS/EN 13544-1) |
|
DS DS/EN 13544- 2 |
Respiratory therapy equipment - Part 2: Tubing and connectors |
|
DS DS/EN 13544- 3 |
Respiratory therapy equipment - Part 3: Air entrainment devices |
|
DS DS/EN 13612 |
Performance evaluation of in vitro diagnostic medical devices |
|
DS DS/EN 13612/AC |
Performance evaluation of in vitro diagnostic medical devices |
|
DS DS/EN 13624 |
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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DS DS/EN 13640 |
Stability testing of in vitro diagnostic reagents |
|
DS DS/EN 13641 |
Elimination or reduction of risk of infection related to in vitro diagnostic medical devices |
|
DS DS/EN 13718- 1 |
Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care |
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DS DS/EN 13718- 2 |
Air, water and difficult terrain ambulances - Part 2: Operational and technical requirements for the continuity of patient care |
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DS DS/EN 13726- 1 |
Test methods for primary wound dressings - Part 1: Aspects of absorbency |
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DS DS/EN 13726- 2 |
Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings |
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DS DS/EN 13726- 3 |
Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness |
|
DS DS/EN 13726- 4 |
Non-active medical devices - Test methods for primary wound dressings - Part 4: Comformability |
|
DS DS/EN 13726- 6 |
Non-active medical devices -Test methods for primary wound dressing - Part 6: Odour control |
|
DS DS/EN 13727 |
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) |
|
DS DS/EN 13795- 1 |
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 |
|
DS DS/EN 13826 |
Peak expiratory flow meters |
|
DS DS/EN 13867 |
Concentrates for haemodialysis and related therapies |
|
DS DS/EN 13868 |
Catheters - Test methods for kinking of single lumen catheters and medical tubing |
|
DS DS/EN 13975 |
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
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DS DS/EN 13976- 1 |
Rescue systems - Transportation of incubators - Part 1: Interface conditions |
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DS DS/EN 13976- 2 |
Rescue systems - Transportation of incubators - Part 2: System requirements |
|
DS DS/EN 13976- 2/AC |
Rescue systems - Transportation of incubators - Part 2: System requirements |
|
DS DS/EN 14079 |
Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
|
DS DS/EN 14136 |
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
|
DS DS/EN 14139 |
Ophthalmic optics - Specifications for ready-to-wear spectacles |
|
DS DS/EN 14180 |
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
|
DS DS/EN 1422 |
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
|
DS DS/EN 1422/AC |
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
|
DS DS/EN 14254 |
In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
|
DS DS/EN 14299 |
Non-active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents |
|
DS DS/EN 14348 |
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) |
|
DS DS/EN 14820 |
Single-use containers for venous blood specimen collection |
|
DS DS/EN 1499 |
Chemical disinfectants and antiseptics - Hygienic handwash - Test method and requirements (phase 2/step 2) |
|
DS DS/EN 1500 |
Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2) |
|
DS DS/EN 1615 |
Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing |
|
DS DS/EN 1616 |
Sterile urethral catheters for single use |
|
DS DS/EN 1616/A1 |
Sterile urethral catheters for single use-(AMENDS DS/EN 1616) |
|
DS DS/EN 1617 |
Sterile drainage catheters and accessory devices for single use |
|
DS DS/EN 1618 |
Catheters other than intravascular catheters - Test methods for common properties |
|
DS DS/EN 1639 |
Dentistry - Medical devices for dentistry - Instruments |
|
DS DS/EN 1640 |
Dentistry - Medical devices for dentistry - Equipment |
|
DS DS/EN 1641 |
Dentistry - Medical devices for dentistry - Materials |
|
DS DS/EN 1642 |
Dentistry - Medical devices for dentistry - Dental implants |
|
DS DS/EN 1644- 1 |
Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture of compresses |
|
DS DS/EN 1644- 2 |
Test methods for nonwoven compresses for medical use - Part 2: Finished compresses |
|
DS DS/EN 1658 |
Requirements for marking of in vitro diagnostic instruments |
|
DS DS/EN 1707 |
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
|
DS DS/EN 1733 |
Suction catheters for use in the respiratory tract |
|
DS DS/EN 1782 |
Tracheal tubes and connectors |
|
DS DS/EN 1789 |
Medical vehicles and their equipment - Road ambulances |
|
DS DS/EN 1789/A1 |
Medical vehicles and their equipment - Road ambulances- (AMENDS DS/EN 1789) |
|
DS DS/EN 1820 |
Anaesthetic reservoir bags |
|
DS DS/EN 1865 |
Specifications for stretchers and other patient handling equipment used in road ambulances |
|
DS DS/EN 1970 |
Adjustable beds for disabled persons - Requirements and test methods-Amendment 1: 05/02/2005 |
|
DS DS/EN 1985 |
Walking aids - General requirements and test methods |
|
DS DS/EN 20594- 1 |
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements |
|
DS DS/EN 20594- 1/A1 |
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements-(AMENDS DS/EN 20594- 1) |
|
DS DS/EN 21563 |
Dentistry - Alginate dental impression material |
|
DS DS/EN 21942- 1 |
Dental vocabulary - Part 1: General and clinical terms |
|
DS DS/EN 21942- 2 |
Dental vocabulary - Part 2: Dental materials |
|
DS DS/EN 21942- 3 |
Dental vocabulary - Part 3: Dental instruments |
|
DS DS/EN 21942- 4 |
Dental vocabulary - Part 4: Dental equipment |
|
DS DS/EN 23964 |
Dental handpieces - Coupling dimensions |
|
DS DS/EN 26871 |
Dental base metal casting alloys |
|
DS DS/EN 26871/AC1 |
Dental base metal casting alloys |
|
DS DS/EN 26874 |
Dentistry - Resin-based pit and fissure sealants |
|
DS DS/EN 27740 |
Instruments for surgery - Scalpels with detachable blades - Fitting dimensions |
|
DS DS/EN 27740/A1 |
Instruments for surgery, scalpels with detachable blades, fitting dimensions-(AMENDS DS/EN 27740) |
|
DS DS/EN 27787- 1 |
Dental rotary instruments - Cutters - Part 1: Steel laboratory cutters |
|
DS DS/EN 27787- 1/RET.1 |
Dental rotary instruments - Cutters - Part 1: Steel laboratory cutters |
|
DS DS/EN 27787- 3 |
Dental rotary instruments - Cutters - Part 3: Carbide laboratory cutters for milling machines |
|
DS DS/EN 28362- 2 |
Injection containers for injectables and accessories - Part 2: Closures for injection vials |
|
DS DS/EN 285 |
Sterilization - Steam sterilizers - Large sterilizers |
|
DS DS/EN 285/RET.1 |
Sterilization - Steam sterilizers - Large sterilizers |
|
DS DS/EN 29168 |
Dental handpieces - Hose connectors |
|
DS DS/EN 29333 |
Dentistry - Dental brazing materials |
|
DS DS/EN 29917 |
Dental water-based cements |
|
DS DS/EN 30993- 6 |
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation |
|
DS DS/EN 375 |
Information supplied by the manufacturer with in vitro diagnostic reagents for professional use |
|
DS DS/EN 376 |
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing |
|
DS DS/EN 45502- 1 |
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer |
|
DS DS/EN 45502-2- 1 |
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers) |
|
DS DS/EN 455- 1 |
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
|
DS DS/EN 455- 2 |
Medical gloves for single use - Part 2: Requirements and testing for physical properties |
|
DS DS/EN 455- 3 |
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
|
DS DS/EN 46001 |
Quality systems - Medical devices - Particular requirements for the application of DS/EN ISO 9001 |
|
DS DS/EN 46002 |
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 |
|
DS DS/EN 46003 |
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003 |
|
DS DS/EN 475 |
Medical devices - Electrically-generated alarm signals |
|
DS DS/EN 50061 + A1 + CORR. |
Safety of implantable cardiac pacemakers |
|
DS DS/EN 50103 |
Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry |
|
DS DS/EN 550 |
Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization |
|
DS DS/EN 552 |
Sterilization of medical devices - Validation and routine control of sterilization by irradiation |
|
DS DS/EN 552/A1 |
Sterilization of medical devices - Validation and routine control of sterilization by irradiation-(AMENDS DS/EN 552) |
|
DS DS/EN 552/A2 |
Sterilization of medical devices - Validation and routine control of sterilization by irradiation-(AMENDS DS/EN 552) |
|
DS DS/EN 554 |
Sterilization of medical devices - Validation and routine control of sterilization by moist heat |
|
DS DS/EN 556- 1 |
Sterilization of medical devices - Requirements for medical devices to be designated "Sterile" - Part 1: Requirements for terminally sterilized medical devices |
|
DS DS/EN 556- 2 |
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices |
|
DS DS/EN 591 |
Instructions for use for in vitro diagnostic instruments for professional use |
|
DS DS/EN 592 |
Instructions for use for in vitro diagnostic instruments for self- testing |
|
DS DS/EN 60118- 13 |
Hearing aids - Part 13: Electromagnetic compatibility (EMC) |
|
DS DS/EN 60335-2- 87 |
Household and similar electrical appliances - Safety - Part 2-87: Particular requirements for electric animal-stunning equipment |
|
DS DS/EN 60336 |
Medical electrical equipment X-ray tube assemblies for medical diagnosis Characteristics of focal spots |
|
DS DS/EN 60406 |
Cassettes for medical X-ray diagnosis - Radiographic cassettes and mammographic cassettes |
|
DS DS/EN 60522 |
Determination of the permanent filtration of X-ray tube assemblies |
|
DS DS/EN 60526 |
High-voltage cable plug and socket connections for medical X-ray equipment |
|
DS DS/EN 60580 |
Medical electrical equipment - Dose area product meters |
|
DS DS/EN 60601- 1+A1,2,12,13+CORR. |
Medical electrical equipment - Part 1: General requirements for safety |
|
DS DS/EN 60601-1- 1 |
Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
|
DS DS/EN 60601-1- 2 |
Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests |
|
DS DS/EN 60601-1- 3 |
Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral Standard: General requirements for radiation protection in diagnostic X-ray equipment |
|
DS DS/EN 60601-1- 4 |
Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral Standard: Programmable electronical medical systems |
|
DS DS/EN 60601-1- 4/A1 |
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems-(AMENDS DS/EN 60601-1-4) |
|
DS DS/EN 60601-1- 6 |
Medical electrical equipment Part 1-6: General requirements for safety Collateral standard: Usability |
|
DS DS/EN 60601-1- 8 |
Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
|
DS DS/EN 60601-2- 1 |
Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV |
|
DS DS/EN 60601-2- 1/A1 |
Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV-(AMENDS DS/EN 60601-2- 1) |
|
DS DS/EN 60601-2- 10 |
Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators |
|
DS DS/EN 60601-2- 10/A1 |
Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators-(AMENDS DS/EN 60601-2-10) |
|
DS DS/EN 60601-2- 16 |
Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment |
|
DS DS/EN 60601-2- 16/CORR. |
Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment |
|
DS DS/EN 60601-2- 17 |
Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment |
|
DS DS/EN 60601-2- 18 |
Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment |
|
DS DS/EN 60601-2- 18/A1 |
Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment-(AMENDS DS/EN 60601-2-18) |
|
DS DS/EN 60601-2- 2 |
Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment |
|
DS DS/EN 60601-2- 20 |
Medical electrical equipment - Part 2: Particular requirements for the safety of transport incubators |
|
DS DS/EN 60601-2- 22 |
Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment |
|
DS DS/EN 60601-2- 23 |
Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partical pressure monitoring equipment |
|
DS DS/EN 60601-2- 24 |
Medical electrical equipment - Part 2: Particular requirements for the safety of infusion pumps and controllers |
|
DS DS/EN 60601-2- 25 |
Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs |
|
DS DS/EN 60601-2- 25/A1 |
Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs-(AMENDS DS/EN 60601-2-25) |
|
DS DS/EN 60601-2- 26 |
Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs |
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DS DS/EN 60601-2- 27 |
Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment |
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DS DS/EN 60601-2- 28 |
Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis |
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DS DS/EN 60601-2- 29 |
Medical electrical equipment - Part 2-29: Particular requirements for the safety of radiotherapy simulators |
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DS DS/EN 60601-2- 3 |
Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment |
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DS DS/EN 60601-2- 3/A1 |
Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment-(AMENDS DS/EN 60601-2-3) |
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DS DS/EN 60601-2- 30 |
Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
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DS DS/EN 60601-2- 31 |
Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source |
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DS DS/EN 60601-2- 31/A1 |
Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source-(AMENDS DS/EN 60601-2-31) |
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DS DS/EN 60601-2- 32 |
Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment |
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DS DS/EN 60601-2- 33 |
Medical electrical equipment - Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis |
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DS DS/EN 60601-2- 33 |
Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis |
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DS DS/EN 60601-2- 34 |
Medical electrical equipment - Part 2-34: Particular requirements for safety, including essential performance, of invasive blood pressure monitoring equipment |
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DS DS/EN 60601-2- 35 |
Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use |
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DS DS/EN 60601-2- 37 |
Medical electrical equipment - Part 2- 37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment-Amendment 1:4/15/2005 |
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DS DS/EN 60601-2- 38 |
Medical electrical equipment - Particular requirements for the safety of electrically operated hospital beds |
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DS DS/EN 60601-2- 38/A1 |
Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds-(AMENDS DS/EN 60601-2-38) |
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DS DS/EN 60601-2- 39+CORR. |
Medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment |
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DS DS/EN 60601-2- 4 |
Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators |
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DS DS/EN 60601-2- 40 |
Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment |
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DS DS/EN 60601-2- 41 |
Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis |
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DS DS/EN 60601-2- 43 |
Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures |
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DS DS/EN 60601-2- 44 |
Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography |
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DS DS/EN 60601-2- 44/A1 |
Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography-(AMENDS DS/EN 60601-2- 44) |
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DS DS/EN 60601-2- 45 |
Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices |
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DS DS/EN 60601-2- 46 |
Medical electrical equipment - Part 2: Particular requirements for the safety of operating tables |
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DS DS/EN 60601-2- 47 |
Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems |
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DS DS/EN 60601-2- 49 |
Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment |
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DS DS/EN 60601-2- 5 |
Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment |
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DS DS/EN 60601-2- 50 |
Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment |
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DS DS/EN 60601-2- 51 |
Medical electrical equipment - Part 2-51: Particular requirements for the safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
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DS DS/EN 60601-2- 7 |
Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators |
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DS DS/EN 60601-2- 9+CORR. |
Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors |
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DS DS/EN 60601-3- 1 |
Medical electrical equipment - Part 3-1: Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment |
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DS DS/EN 60627 |
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
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DS DS/EN 60627/CORR. |
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
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DS DS/EN 60731/A1 |
Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy-(AMENDS DS/EN 60731) |
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DS DS/EN 60806 |
Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis |
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DS DS/EN 60976 |
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
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DS DS/EN 60976/A1 |
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics-(AMENDS DS/EN 60976) |
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DS DS/EN 61010-2- 041 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-041: Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes |
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DS DS/EN 61010-2- 041/CORR. |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-041: Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes |
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DS DS/EN 61010-2- 043 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-043: Particular requirements for dry heat sterilizers using either hot air or hot inert gas for the treatment of medical materials, and for laboratory proce |
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DS DS/EN 61010-2- 045 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields |
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DS DS/EN 61010-2- 101 |
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
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DS DS/EN 61206 |
Ultrasonics - Continuous-wave Doppler systems - Test procedures |
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DS DS/EN 61217 |
Radiotherapy equipment - Coordinates, movements and scales- Amendment 1:08/20/2001 |
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DS DS/EN 61223-3- 1 |
Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems |
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DS DS/EN 61223-3- 2 |
Evaluation and routine testing in medical departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
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DS DS/EN 61223-3- 3 |
Evaluation and routine testing in medical imaging departments - Part 3-3: Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA) |
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DS DS/EN 61223-3- 4 |
Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment |
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DS DS/EN 61262- 7 |
Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function |
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DS DS/EN 61331- 1 |
Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials |
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DS DS/EN 61331- 2 |
Protective devices against diagnostic medical X-radiation - Part 2: Protective glass plates |
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DS DS/EN 61331- 3 |
Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads |
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DS DS/EN 61674 |
Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in x-ray diagnosis imaging |
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DS DS/EN 61674/A1 |
Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging-(AMENDS DS/EN 61674) |
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DS DS/EN 61675- 1 |
Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission tomographs |
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DS DS/EN 61675- 2 |
Radionuclide imaging devices - Characteristics and test conditions - Part 2: Single photon emission computer tomographs |
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DS DS/EN 61675- 3 |
Radionuclide imaging devices - Characteristics and test conditions - Part 3: Gamma camera based wholebody imaging systems |
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DS DS/EN 61676 |
Medical electrical equipment - Dosimetric instuments used for non- invasive measurement of X-ray tube voltage in diagnostic radiology |
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DS DS/EN 61685 |
Ultrasonics - Flow measurement systems - Flow test object |
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DS DS/EN 61828 |
Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields |
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DS DS/EN 61846 |
Ultrasonics - Pressure pulse lithotripters - Characteristics of fields |
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DS DS/EN 61847 |
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics |
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DS DS/EN 62083 |
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
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DS DS/EN 62220- 1 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
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DS DS/EN 62274 |
Medical electrical equipment Safety of radiotherapy record and verify systems |
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DS DS/EN 724 |
Guidance on the application of EN 29001 and 46001 and of EN 29002 and EN 46002 for non-active medical devices |
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DS DS/EN 737- 1 |
Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum |
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DS DS/EN 737- 2 |
Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - Basic requirements |
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DS DS/EN 737- 2/A1 |
Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - Basic requirements-(AMENDS DS/EN 737-2) |
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DS DS/EN 737- 3 |
Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum |
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DS DS/EN 737- 3/A1 |
Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum-(AMENDS DS/EN 737-3) |
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DS DS/EN 737- 4 |
Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems |
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DS DS/EN 738- 1 |
Pressure regulators for use with medical gases. Part 1: Pressure regulators and pressure regulators with flow metering devices |
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DS DS/EN 738- 1/A1 |
Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices-(AMENDS DS/EN 738- 1) |
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DS DS/EN 738- 2 |
Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators |
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DS DS/EN 738- 3 |
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves |
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DS DS/EN 738- 3/A1 |
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves-(AMENDS DS/EN 738-3) |
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DS DS/EN 738- 4 |
Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment |
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DS DS/EN 738- 4/A1 |
Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment-(AMENDS DS/EN 738- 4) |
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DS DS/EN 739 |
Low-pressure hose assemblies for use with medical gases |
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DS DS/EN 739/A1 |
Low-pressure hose assemblies for use with medical gases- (AMENDS DS/EN 739) |
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DS DS/EN 793 |
Particular requirements for safety of medical supply units |
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DS DS/EN 794- 1 |
Lung ventilators - Part 1: Particular requirements for critical care ventilators |
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DS DS/EN 794- 1/A1 |
Lung ventilators - Part 1: Particular requirements for critical care ventilators-(AMENDS DS/EN 794-1) |
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DS DS/EN 794- 3 |
Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators-Amendment 1: 07/08/2005 |
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DS DS/EN 829 |
In-vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements, tests |
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DS DS/EN 864 |
Medical electrical equipment - Capnometers for use with humans - Particular requirements |
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DS DS/EN 866- 1 |
Biological systems for testing sterilizers and sterilization processes - Part 1: General requirements |
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DS DS/EN 866- 2 |
Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers |
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DS DS/EN 866- 3 |
Biological systems for testing sterilizers and sterilization processes - Part 3: Particular systems for use in moist heat sterilizers |
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DS DS/EN 866- 4 |
Biological systems for testing sterilizers and sterilization processes - Part 4: Particular systems for use in irradiation sterilizers |
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DS DS/EN 866- 5 |
Biological systems for testing sterilizers and sterilization processes - Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizers |
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DS DS/EN 866- 6 |
Biological systems for testing sterilizers and sterilization processes - Part 6: Particular systems for use in dry heat sterilizers |
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DS DS/EN 866- 7 |
Biological systems for testing sterilizers and sterilization processes - Part 7: Particular requirements for self-contained biological indicator systems for use in moist heat sterilizers |
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DS DS/EN 866- 8 |
Biological systems for testing sterilizers and sterilization processes - Part 8: Particular requirements for self-contained biological indicator systems for use in ethylene oxide sterilizers |
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DS DS/EN 867- 1 |
Non-biolological systems for use in sterilizers - Part 1: General requirements |
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DS DS/EN 867- 2 |
Non-biological systems for use sterilizers - Part 2: Process indicators (Class A) |
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DS DS/EN 867- 3 |
Non-biological systems for use in sterilizers - Part 3: Specification for Class B indicators for use in the Bowie and Dick test |
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DS DS/EN 867- 4 |
Non-biological systems for use in sterilizers - Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration |
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DS DS/EN 867- 5 |
Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S |
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DS DS/EN 868- 1 |
Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods |
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DS DS/EN 868- 10 |
Packaging materials and systems for medical devices which are to be sterilized - Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methods |
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DS DS/EN 868- 2 |
Packaging materials and systems for medical devices which are to be sterilized - Part 2: Sterilization wrap - Requirements and test methods |
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DS DS/EN 868- 3 |
Packaging materials and systems for medical devices which are to be sterilized - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test met |
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DS DS/EN 868- 4 |
Packaging materials and systems for medical devices which are to be sterilized - Part 4: Paper bags - Requirements and test methods |
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DS DS/EN 868- 5 |
Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods |
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DS DS/EN 868- 5/AC |
Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods |
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DS DS/EN 868- 6 |
Packaging materials and systems for medical devices which are to be sterilized - Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods |
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DS DS/EN 868- 7 |
Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods |
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DS DS/EN 868- 8 |
Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and tests methods |
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DS DS/EN 868- 9 |
Packaging materials and systems for medical devices which are to be sterilized - Part 9: Uncoated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methods |
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DS DS/EN 928 |
In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices |
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DS DS/EN 980 |
Graphical symbols for use in the labelling of medical devices |
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DS DS/EN ISO 10079- 1 |
Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements |
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DS DS/EN ISO 10079- 2 |
Medical suction equipment - Part 2: Manually powered suction equipment |
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DS DS/EN ISO 10079- 3 |
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source |
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DS DS/EN ISO 10139- 1 |
Dentistry Soft lining materials for removable dentures Part 1: Materials for short-term use |
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DS DS/EN ISO 10139- 2 |
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use |
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DS DS/EN ISO 10271 |
Dental metallic materials - Corrosion test methods |