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Reference Title of Standard Price Buy One Now Add One To Basket
EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use $98.00
EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing $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 $89.00
EN 591:2001 Instructions for use for in vitro diagnostic instruments for self-testing $89.00
EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing $89.00
EN 794-1:1997 Lung ventilators - Part 1: Particular requirements for critical care ventilators
EN 794-1:1997/A1:2000
$181.00
EN 980:2003 Graphical symbols for use in the labelling of madical devices $105.00
EN 1280-1:1997 Agent spcific filling systems for anaethetic vaporizers - Part1: Rectrangular keyed filling systems
EN1280-1:1997/A1:2000
$98.00
EN/ ISO 4135:2001 Anaethetic and respiratory equipment - Vocabulary (ISO 4135:2001) $239.00
EN 12286:1998 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures $98.00
EN 12287:1999 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials $98.00
EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media $70.00
EN/ ISO 13485:2003 Medical Devices - Quality management systems - Requirements for regulatory purpose (ISO 13485:2003) Call For Quote    
EN 13532:2002 General requirements for in vitro diagnostic medical devices $89.00
EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices $105.00
EN 13640:2002 Stability testing of in vitro diagnostic reagents $89.00
EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents $89.00
EN 13975:2003 Sampling procedures used for risk of infection related to in vitro diagnostic medical devices - Statistical aspects $105.00
EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans $105.00
EN 14820:2004 Single-use containers for human venous blood specimen collection $105.00
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 sterilization process for medical devices (ISO 14937:2000) $219.00
EN/ ISO 14971:2000 Medical Devices - Application of risk management ro medical devices (ISO 14971:2000)
EN ISO 14971:2000/A1:2003
$89.00
EN/ ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systens fir self-testing in managing diabetes melitus (ISO 15197:2003) $205.00
EN/ ISO 15225:2000 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) $158.00
EN/ ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological tracebility of values assigned to calibrators and control materials (ISO 17511:2003) $105.00
EN/ ISO 18153:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) $105.00