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Reference Title of Standard Price Buy One Now Add One To Basket
EN 285:1996 Sterilization - Steam sterilizers - Large sterilizers $183.00
EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

$118.00
EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing$123.00
EN 455-1:2000 Medical gloves for single use - Part 1 : Requirements and testing for absence of holes $38.00
EN 455-2:2000 Medical gloves for single use - Part 2 : Requirements and testing for physiological properties $98.00
EN 455-3:2000 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation $158.00
EN 475:1995 Medical devices. Electrically generated alarm signals $70.00
EN 540:1993 Clinical investigation of medical devices for humans $66.00
EN 550:1994 Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization $98.00
EN 552:2005 Sterilization of medical devices - Validation and routine control of sterilization by irradiation
$194.00
EN 554:1994 Sterilization of medical devices - Validation and routine control of sterilization by moist heat $98.00
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices $97.00
EN 556-2:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices $97.00
EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use $97.00
EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing $97.00
EN 737-1:1998 Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum $98.00
EN 737-2:1998 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - Basic requirements

Amendment 1 to EN 737-2:1999
$130.00
EN 737-3:2000 Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum $247.00
EN 737-4:1998 Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems $70.00
EN 738-1:1997 Pressure regulators for use with medical gases - Part 1: pressure regulators and pressure regulators with flow metering devices $98.00
EN 738-2:1998 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators $130.00
EN 738-3:1998 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves $130.00
EN 738-4:1998 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment $70.00
EN 739:1998 Low pressure hose assemblies for use with medical gases $98.00
EN 740:1998 Anaesthetic workstations and their modules - Particular requirements $198.00
EN 793:1997 Particular requirements for safety of medical supply units $98.00
EN 794-1:1997 Lung ventilators - Part 1 : particular requirements for critical care ventilators $126.00
EN 794-2:1997 Lung ventilators - Part 2 : particular requirements for home care use $98.00
EN 794-3:1998 Medical electrical equipment - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators $98.00
EN 864:1996 Medical electrical equipment : Capnometers for use with humans. Particular requirements $98.00
EN 865:1997 Pulse oximeters - Particular requirements $98.00
EN 867-2:1997 Non-biological systems for use in sterilizers - Part 2 : process indicators (class A) $70.00
EN 867-3:1997 Non-biological systems for use in sterilizers - Part 3 : specification for class B indicators for use in the Bowie and Dick test $70.00
EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized - Part 1 : general requirements and test methods $95.00
EN 980:2003 Graphical symbols for use in the labeling of medical devices $118.00
EN 1041:1998 Information supplied by the manufacturer with medical devices $98.00
EN 1060-1:1995 Non-invasive sphygmomanometers - Part 1 : general requirement $98.00
EN 1060-2:1995 Non-invasive sphygmomanometers - Part 2 : supplementary requirements for mechanical sphygmomanometers $98.00
EN 1060-3:1997 Non-invasive sphygmomanometers - Part 3 : supplementary requirements for electromechanical blood pressure measuring systems $70.00
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers $194.00
EN 1089-3:1997 Transportable gas cylinders - Cylinder identification - Part 3 : color coding $70.00
EN 1280-1:1997 Agent specific filling systems for anaesthetic vaporizers - Part 1 : rectangular keyed filling systems $98.00
EN 1281-1:1995 Anaesthetic and respiratory equipment - Conical connectors - Part 1 : cones and sockets

Amendment 1 to EN 1281-1:1998
$98.00
EN 1281-2:1995 Anaesthetic and respiratory equipment - Conical connectors - Part 2 : screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified) $70.00
EN 1282-1:1996 Anaesthetic and respiratory equipment - Tracheotomy tubes - Part 1 : tubes for use in adults $98.00
EN 1282-2:2005 Tracheotomy tubes - Part 2 : pediatric tubes (ISO 5366-3:2001, modified) $118.00
EN 1422:1997 Sterilisers for medical purposes - ethylene oxide sterilisers - requirements and test methods $130.00
EN 1441:1997 Medical devices - risk analysis $66.00
EN 1618:1997 Catheters other than intravascular catheters - test methods for common properties $70.00
EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments $118.00
EN 1640:2004 Dentistry - Medical devices for dentistry - Equipment $118.00
EN 1641:2004 Dentistry - Medical devices for dentistry - Materials $118.00
EN 1642:2004 Dentistry - Medical devices for dentistry - Dental implants $118.00
EN 1707:1996 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings $98.00
EN 1782:1998 Tracheal tubes and connectors $98.00
EN 1789:1999 Medical vehicles and their equipment - Road ambulances EN 1789:1999/A1:2003 $194.00
EN 1819:1997 Laryngoscopes for tracheal intubation - particular requirements $66.00
EN 1820:2005 Anaesthetic reservoir bags (ISO 5362:2000, modified) $97.00
EN 1865:1999 Specifications for stretchers and other patient handling equipment used in road ambulances $130.00
EN 1970:2000 Adjustable beds for disabled persons - Requirements and test methods EN 1970:2000/A1:2005 $194.00
EN 1985:1998 Walking aids - General requirements and test methods $70.00
EN/ ISO 4074:2002 Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002) $235.00
EN/ ISO 4135:2001 Anaesthesiology - Vocabulary (ISO 4135:2001) $256.00
EN/ ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004) $170.00
EN/ ISO 5366-1:2004 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) $170.00
EN/ ISO 5840:2005 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) $192.00
EN/ ISO 7376:2003 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2003) $170.00
EN/ ISO 7439:2002 Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002) $118.00
EN/ ISO 7886-3:2005 Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) $170.00
EN/ ISO 8185:1997 Humidifiers for medical use - General requirements for humidification systems $158.00
EN/ ISO 8359:1996 Oxygen concentrators for medical use - Safety requirements $130.00
EN/ ISO 8835-4:2004 Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)EN ISO 8835-4:2004/AC:2006 $170.00
EN/ ISO 8835-5:2004 Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)EN ISO 8835-5:2004/AC:2006 $170.00
EN/ ISO 9360-1:2000 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) $170.00
EN/ ISO 9360-2:2002 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) $118.00
EN/ ISO 9703-3:1998 Anaesthesia and respiratory care alarm signals - Part 3: Guidance on application of alarms (ISO 9703-3:1998) $70.00
EN/ ISO 9713:2004 Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002) $118.00
EN/ ISO 9919:2005 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) $256.00
EN/ ISO 10079-1:1999 Medical suction equipment - Part 1 : electrically powered suction equipment - Safety requirements (ISO 10079-1:1991, including technical corrigendum 1:1992 and technical corrigendum 2:1993)

Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)
$158.00
EN/ ISO 10079-2:1999 Medical suction equipment - Part 2 : manually powered suction equipment - (ISO 10079-2:1992)

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)
$141.00
EN/ ISO 10079-3:1999 Medical suction equipment - Part 3 : suction equipment powered from vacuum or pressure source (ISO 10079-3:1992)

Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)
$141.00
EN/ ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) $128.00
EN/ ISO 10535:1998 Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:1998) $158.00
EN/ ISO 10555-1:1996 Sterile, single-use intravascular catheters - Part 1 : general requirements (ISO 10555-1:1995)

Amendment 1 to EN/ISO 10555-1:2000
$98.00
EN/ ISO 10651-2:2004 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) $222.00
EN/ ISO 10651-4:2004 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) $170.00
EN/ ISO 10651-6:2004 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) $194.00
EN/ ISO 10993-1:1997 Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997) $70.00
EN/ ISO 10993-3:2003 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) $170.00
EN/ ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) $222.00
EN/ ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) $98.00
EN/ ISO 10993-7:1995 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995) $222.00
EN/ ISO 10993-9:1999 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) $98.00
EN/ ISO 10993-10:1995 Biological evaluation of medical devices - Part 10 : tests for irritation and sensitization (ISO 10993-10:1995) $130.00
EN/ ISO 10993-11:1995 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:1993) $118.00
EN/ ISO 10993-12:1996 Biological evaluation of medical devices - Part 12 : sample preparation and reference materials (ISO 10993-12:1996) $98.00
EN/ ISO 10993-13:1998 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) $70.00
EN/ ISO 10993-14:2001 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) $170.00
EN/ ISO 10993-15:2000 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) $170.00
EN/ ISO 10993-16:1997 Biological evaluation of medical devices - Part 16: toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) $70.00
EN/ ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) $194.00
EN/ ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) $194.00
EN/ ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005) $194.00
EN/ ISO 11196:1997 Anaesthetic gas monitors (ISO 11196:1995 including technical corrigendum 1:1997) $198.00
EN/ ISO 11197:2004 Medical supply units (ISO 11197:2004) $221.00
EN/ISO 11737-1:2006 Sterilization of medical devices - Microbiological Methods- PART 1: Determination of the population of micro-organisms on products $222.00
EN/ ISO 11990:2003 Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003) $118.00
EN 12006-1:1998 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes $198.00
EN 12006-2:1998 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits $70.00
EN 12006-3:1998 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices $70.00
EN 12010:1998 Non active surgical implants - Joint replacement implants - Particular requirements $70.00
EN 12011:1998 Instrumentation to be used in association with non-active surgical implants - General requirements $70.00
EN 12182:1999 Technical aids for disabled persons - General requirements and test methods $158.00
EN 12183:1999 Manually propelled wheelchairs - Requirements and test methods $98.00
EN 12184:1999 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods $130.00
EN 12218:1998 Rail systems for supporting medical equipment $98.00
EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media EN 12322:1999/A1:2001 $97.00
EN 12342:1998 Breathing tubes intended for use with anaesthetic apparatus and ventilators $70.00
EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk $170.00
EN 12442-2:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling $170.00
EN 12442-3:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents $170.00
EN 12470-1:2000 Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device $70.00
EN 12470-2:2000 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers $118.00
EN 12470-3:2000 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device $70.00
EN 12470-4:2000 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement $170.00
EN 12470-5:2003 Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) $170.00
EN 12523:1999 External limb prostheses and external orthoses - Requirements and test methods $198.00
EN 12563:1998 Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants $70.00
EN 12564:1998 Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants $70.00
EN 12598:1999 Oxygen monitors for patient breathing mixtures - Particular requirements $98.00
EN/ ISO 12870:1998 Ophthalmic optics - Spectacle frames - General requirements and test methods $98.00
EN 13014:2000 Connections for gas sampling tubes to anaesthetic and respiratory equipment $118.00
EN 13060:2004 Small steam sterilizers $235.00
EN 13220:1998 Flow-metering devices for connection to terminal units of medical gas pipeline systems $118.00
EN 13221:2000 High-pressure flexible connections for use with medical gases $170.00
EN 13228-1:2001 Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance $118.00
EN 13228-2:2002 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects $97.00
EN/ ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)EN 13328-2:2002/A1:2003 $170.00
EN 13503-8:2000 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:1999, modified) $97.00
EN 13544-1:2001 Respiratory therapy equipment - Part 1: Nebulizing systems and their components EN 13544-1:2001/A1:2004 $235.00
EN 13544-2:2002 Respiratory therapy equipment - Part 2: Tubing and connectors $118.00
EN 13544-3:2001 Respiratory therapy equipment - Part 3: Air entrainment devices $118.00
EN 13624:2003 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) $194.00
EN 13718-1:2002 Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care $170.00
EN 13718-2:2002 Air, water and difficult terrain ambulances - Part 2: Operational and technical requirements for the continuity of patient care $170.00
EN 13726-1:2002 Test methods for primary wound dressings - Part 1: Aspects of absorbency $177.00
EN 13726-2:2002 Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings $159.00
EN 13727:2003 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) $194.00
EN 13795-1:2002 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 $118.00
EN 13795-2:2004 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods $97.00
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements $235.00
EN 13826:2003 Peak expiratory flow meters $170.00
EN 13867:2002 Concentrates for haemodialysis and related therapies $118.00
EN 13976-1:2003 Rescue systems - Transportation of incubators - Part 1: Interface conditions $97.00
EN 13976-2:2003 Rescue systems - Transportation of incubators - Part 2: System requirements $118.00
EN 14079:2003 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze $118.00
EN/ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) $170.00
EN/ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) $118.00
EN/ ISO 14160:1998 Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants $98.00
EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing $235.00
EN 14299:2004 Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents $194.00
EN 14348:2005 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) $194.00
EN 14408:2005 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005) $97.00
EN/ ISO 14534:1997 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements $70.00
EN/ ISO 14602:1998 Non-active surgical implants - Implants for Osteosynthesis - Particular requirements $70.00
EN/ ISO 14630:1997 Non-active surgical implants - General requirements $98.00
EN 14683:2005 Surgical masks - Requirements and test methods $118.00
EN/ ISO 14889:2003 Ophthalmic optics - spectacle lenses - fundamental requirements for uncut finished lenses (ISO 14889:2003) $118.00
EN/ ISO 14937:2000 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 14937:2000) $235.00
EN/ ISO 14971:2000 Medical devices - Application of risk management to medical devices (ISO 14971:2000)EN ISO 14971:2000/A1:2003 $97.00
EN/ ISO 15001:2004 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003) $222.00
EN/ ISO 15004:1997 Ophthalmic instruments - Fundamental requirements and test methods (ISO 15004:1997) $98.00
EN/ ISO 15225:2000 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)EN ISO 15225:2000/A1:2004 $118.00
EN/ ISO 15747:2005 Plastics containers for intravenous injection (ISO 15747:2003) $240.00
EN/ ISO 17510-1:2002 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices (ISO 17510-1:2002) $240.00
EN/ ISO 17510-2:2003 Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2003) $118.00
EN/ ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) $170.00
EN/ ISO 18777:2005 Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005) $194.00
EN/ ISO 18778:2005 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) $194.00
EN/ ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005) $194.00
EN 20594-1:1993 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1 : General requirements (ISO 594-1:1986)

Amendment 1 to EN 20594-1:1994
$70.00
EN/ ISO 21647:2004 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)EN ISO 21647:2004/AC:2006 $235.00
EN/ ISO 22612:2005 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005) $118.00
EN 27740:1997 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

Amendment 1 to EN 27740:1998
$59.00
EN 30993-3:1993 Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992) $38.00
EN 30993-4:1997 Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood (ISO 10993-4:1992) $98.00
EN 30993-5 Biological evaluation of medical devices - Part 5 : tests for cytotoxicity - in vitro methods (ISO 10993-5:1992) $70.00
EN 30993-6:1994 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994) $118.00
EN 30993-7


Same as
Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals
(ISO 10993-7:1995)
Call For Quote    
EN 30993-11

Same as
Biological evaluation of medical devices - Part 11: tests for systemic toxicity
(ISO 10993-11:1993)
Call For Quote    
EN 46001:1996 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 $90.00
EN 46002:1996 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 $98.00
EN 46003:1999 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003 $70.00
EN 50103:1996 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 $98.00
EN 60118-13:1997 Hearing aids - Part 13: Electromagnetic compatibility (EMC) $105.00
EN 60522:1999 Determination of the permanent filtration of X-ray tube asemblies $89.00
EN 60580:2000 Medical Electrical equipment - Dose area product meters $181.00
EN 60601-1:1990 Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988

Amendment 3 to EN 60601-1:1997
$317.00
EN 60601-1-1:2001 Medical electrical equipment. Part 1-1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems

Amendment 1 to EN 60601-1-1:2000
$181.00
EN
60601-1-2:2001
Medical electrical equipment - Part 1-2: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 601-1-2: 2001
$239.00
EN 60601-1-3:1995 Medical electrical equipment. Part 1: General requirements for safety - 3: Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment. IEC 601-1-3:1994 $158.00
EN 60601-1-4:1997 Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems - IEC 60601-1-4:1996 $159.00
EN 60601-2-1:1998 Medical electrical equipment - Part 2-1L Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV $130.00
EN 60601-2-2:2001 Medical electrical equipment. Part 2: Particular requirements for the safety of high frequency surgical equipment - IEC 601-2-2:1991 $126.00
EN 60601-2-3:1993 Medical electrical equipment. Part 2: Particular requirements for the safety of short-wave therapy equipment - IEC 601-2-3:1991 $98.00
EN 60601-2-4:2003 Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators $219.00
EN 60601-2-5:2003 Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment $158.00
EN 60601-2-7:1998 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)

Amendment A1:1997 to EN 60601-2-8:1997
(IEC 60601-2-8:1987 /A1:1997)
$130.00
EN 60601-2-8:1997 Madical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10kV ro 1MV (IEC 60601-2-8:1987)
Amendment A1:1997 to EN 60601-2-8:1997
(IEC 60601-2-8:1987/A1:1997)
$205.00
EN 60601-2-9:1997 Medical electrical equipment --
Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors (IEC 60601-2-9:1996)
$90.00
EN 60601-2-10:2000 Medical Electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators (IEC 60601-2-10:1987)
Amendment A1:2001 to EN 60601-2-10:2000
(IEC60601-2-10:1987/A1:2001)
$158.00
EN 60601-2-11:1998 Medical electrical equipment --
Part 2: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997)
$166.00
EN 60601-2-16:1998 Medical electrical equipment --
Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration an haemofiltration equipment (IEC 60601-2-16: 1998)

Amendment 1 to EN 60601-2-16:2001
$130.00
EN 60601-2-17:1996 Medical electrical equipment. Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment
IEC 601-2-17:1989

Amendment 1 to EN 60601-2-17:1996
$120.00
EN 60601-2-17:2004 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004) $181.00
EN 60601-2-18:1997 Medical electrical equipment --
Part 2: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996)
$120.00
EN 60601-2-19:1997 Medical electrical equipment --
Part 2: Particular requirements for the safety of baby incubators (IEC 60601-2-19:1990)


Amendment A1:1996 to EN 60601-2-19:1996
(IEC 60601-2-19:1990/A1:1996)
$120.00
EN 60601-2-20:1997 Medical electrical equipment --
Part 2: Particular requirements for the safety of transport incubators (IEC 60601-2-20:1990 + A1:1996)
$166.00
EN 60601-2-21:1997 Medical electrical equipment -- Part 2: Particular requirements for the safety of infant radiant warmers (IEC 601-2-21:1994)

Amendment A1:1996 to EN 60601-2-21:1994
(IEC 60601-2-21:1994/A1:1996)
$90.00
EN 60601-2-22:1996 Medical electrical equipment . Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment. IEC 601-2-22:1995 $120.00
EN 60601-2-23:2000 Medical electrical equipment --
Part 2: Particular requirements for the safety of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:1993)
$158.00
EN 60601-2-24:1998 Medical electrical equipment --
Part 2: Particular requirements for the safety of infusion pumps and controllers (IEC 60601-2-24:1998)
$120.00
EN 60601-2-25:1996 Medical electrical equipment. Part 2: Particular requirements for the safety of electrocardiographs. IEC 601-2-25:1993 $222.00
EN 60601-2-26:2003 Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs (IEC 60601-2-26:2002) $158.00
EN 60601-2-27:1995 Medical electrical equipment. Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment - IEC 601-2-27:1994 $130.00
EN 60601-2-28:1993 Medical electrical equipment. Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis. IEC 601-2-28:1993 $98.00
EN 60601-2-29:1999 Medical electrical equipment --
Part 2: Particular requirements for the safety of radiotherapy simulators (IEC 60601-2-29:1993)


Amendment A1:1996 to EN 60601-2-29:1995 (IEC60601-2-29:1993/A1:1996)
$145.00
EN 60601-2-30:2000 Medical electrical equipment. Part 2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment . IEC 601-2-30:1995 $120.00
EN 60601-2-31:1995 Medical electrical equipment. Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source. IEC 601-2-31:1994 $120.00
EN 60601-2-32:1995 Medical electrical equipment. Part 2: Particular requirements for the safety of associated equipment of X-ray equipment - IEC 601-2-32:1994 $90.00
EN 60601-2-33:1996 Medical electrical equipment. Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. IEC 601-2-33:1995 $239.00
EN 60601-2-34:1995 Medical electrical equipment. Part 2: Particular requirements for the safety of direct blood-pressure monitoring equipment - IEC 601-2-34:1994 $158.00
EN 60601-2-35:1997 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)
$25.00
EN 60601-2-36:1997 Medical electrical equipment --
Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)
$90.00
EN 60601-2-37:2001 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2001)
Amendment A1:2005 to EN 60601-2-37:2001
(IEC 60601-2-37:2001/A1:2004)
$219.00
EN 60601-2-38:1997 Medical electrical equipment --
Part 2-38: Particular requirements for the safety of electrically operated hospital beds (IEC 60601-2-38:1996)
$120.00
EN 60601-2-39:1999 Medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment (IEC 60601-2-39:1999) $105.00
EN 60601-2-40:1998 Medical electrical equipment --
Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (IEC 60601-2-40:1998)
$90.00
EN 60601-2-41:2000 Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis $181.00
EN 60601-2-43:2000 Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures $143.00
EN 60601-2-44:2001 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography (IEC 60601-2-44:2001)
Amendment A1:2003 to EN 60601-2-44:2001
(IEC 60601-2-44:2001/A1:2002)
$181.00
EN 60601-2-45:2001 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) $181.00
EN 60601-2-46:1998 Medical electrical equipment - Part 2-46: Particular requirements for the safety of operation tables $105.00
EN 60601-2-47:2001 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems $205.00
EN 60601-2-49:2001 Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction parient monitoring equipment $205.00
EN 60601-2-50:2002 Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant photoherapy equipment $158.00
EN 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for the safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (IEC 60601-2-51:2003) $239.00
EN 60627:2001 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids $158.00
EN 60645-1:2001 Electroacoustics - Audiological equipment - Part1: Pure-tone audiometers $181.00
EN 60645-2:1997 Audiometers. Part 2: Equipment for speech audiometry. IEC 645-2:1993 $98.00
EN 60645-3:1995 Audiometers. Part 3 : auditory test signals of short duration for audiometric and neuro-otological purposes - IEC 645-3:1994 $98.00
EN 60645-4:1995 Audiometers. Part 4 : equipment for extended high-frequency audiometry.
IEC 645-4:1994
$70.00
EN 61217:1996 Radiotherapy equipment - Coordinates, movements and scales
(IEC 61217:1996)
Amendment A1:2001 to EN 61217:1996
(IEC 61217:1996/A1:2000)
$219.00
EN 61223-3-1:1999 Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging Performance of X-ray equipment for radiographic and radioscopic systems
(IEC 61223-3-1:1999)
$219.00
EN 61223-3-4:2000 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
(IEC 61223-3-4:2000)
$181.00
EN 61676:2002 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
(IEC 61676:2002)
$181.00
EN 62083:2001 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
(IEC 62083:2000)
$181.00
EN 62220-1:2004 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency $158.00