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Standard · Svensk standard SS-EN ISO 13356:2013 Kirurgiska implantat - Keramiska material - Yttriumoxid-stabiliserad tetragonal zirkoniumoxid (Y-TZP) (ISO 13356:2008) ISO 13356:2008 specifies the characteristics of, and corresponding test methods for, a biocompatible and biostable ceramic bone-substitute material based on yttria-stabilized tetragonal zirconia (y... Språk Publicerad 2013-04-23

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Standard · Svensk standard SS-EN 60601-1-8 A 1 Elektrisk utrustning för medicinskt bruk - Säkerhet - Del 1-8: Allmänna fordringar beträffande säkerhet och väsentliga prestanda - Tilläggsstandard... - Språk Publicerad 2013-04-15

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Standard · Svensk standard SS-EN 61157 A 1 Ultraljud - Deklaration av akustisk emission från medicinsk ultraljudsutrustning för diagnostiskt bruk - Språk Publicerad 2013-04-15

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Standard · Svensk standard SS-EN 62127-1 A 1 Ultraljud - Hydrofoner - Del 1: Mätning och karaktärisering av medicinska ultraljudsfält upp till 40 MHz - Språk Publicerad 2013-04-15

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Standard · Svensk standard SS-EN 61674 Elektrisk utrustning för medicinskt bruk - Dosmätare med jonkammare och/eller halvledardetektorer för användning inom röntgendiagnostik - Språk Publicerad 2013-04-15

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Standard · Svensk standard SS-EN ISO 19001:2013 In vitro diagnostik - Information som ska tillhandahållas av tillverkaren av in vitro-diagnostiska reagens för färgning av biologiska material (ISO... ISO 19001:2013 specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromog... Språk Publicerad 2013-03-28

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Standard · Svensk standard SS-EN ISO 5840-3:2013 Hjärt- och kärlimplantat - Proteser för hjärtklaffar - Del 3: Hjärtklaffssubstitut implanterade med kateterburen teknik (ISO 5840-3:2013) ISO 5840-3:2013 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification... Språk Publicerad 2013-03-25

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Standard · Svensk standard SS-EN 60601-2-22 Elektrisk utrustning för medicinskt bruk - Säkerhet och väsentliga prestanda - Del 2-22: Särskilda fordringar på laserutrustning för kirurgi, terap... - Språk Publicerad 2013-03-18

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Standard · Svensk standard SS-EN ISO 10524-3:2006/A1:2013 Tryckregulatorer för medicinska gaser - Del 3: Tryckregulatorer integrerande i gasflaskventiler - Tillägg 1: Filtrering och information att tillhan... - Språk Publicerad 2013-03-15

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Standard · Svensk standard SS-EN ISO 7396-1:2007/A3:2013 Medicinska gassystem - Del 1: Medicinska centralgasanläggningar - Terminologi avseende larmsystem (ISO 7396-1:2007/Amd 3:2013) - Språk Publicerad 2013-03-15

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Standard · ISO standard ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components -- Part 1: Conventional containers ISO 3826-1:2013 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle, a... Språk Publicerad 2013-05-24

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Standard · IEC standard IEC 60601-1-3 Amd 1 Amendement 1 - Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et les performances essentielles - Norme collat... - Språk Publicerad 2013-05-24

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Standard · IEC standard IEC 60601-2-33 Amd 1 Amendement 1 - Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appar... - Språk Publicerad 2013-05-24

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Standard · IEC standard IEC 60601-1-3 Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale... IEC 60601-1-3:2008+A1:2013 applies to X-ray equipment and to subassemblies of such equipment, where radiological images of a human patient are used for diagnosis, planning or guidance o... Språk Publicerad 2013-05-13

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Standard · IEC standard IEC 60601-2-33 Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à réson... IEC 60601-2-33:2010+A1:2013 establishes particular basic safety and essential performance requirements for magnetic resonance equipment to provide protection for the patient and the magnetic reson... Språk Publicerad 2013-05-13

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Standard · ISO standard ISO 81060-2:2013 Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type ISO 81060-2:2013 specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by ... Språk Publicerad 2013-05-06

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Standard · EUROPEISK ELSTANDARD DS-EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELEECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYST... Språk Publicerad 2013-04-22

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Standard · EUROPEISK ELSTANDARD DS-EN 60601-1/A11:2011 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELEECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYST... Språk Publicerad 2013-04-22

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Standard · ISO standard ISO 5841-3:2013 Implants for surgery -- Cardiac pacemakers -- Part 3: Low-profile connectors (IS-1) for implantable pacemakers ISO 5841-3:2013 specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pacemaker pulse generators. Essential dimensions and performance requirements related... Språk Publicerad 2013-04-19

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Standard · ISO standard ISO 8637:2010/Amd 1:2013 Revision to Figure 2 -- Main fitting dimensions of dialysis fluid inlet and outlet ports - Språk Publicerad 2013-04-08

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Standard · ISO standard ISO 5840-3:2013 Cardiovascular implants -- Cardiac valve prostheses -- Part 3: Heart valve substitutes implanted by transcatheter techniques ISO 5840-3:2013 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification... Språk Publicerad 2013-03-25

PDF · 1.789 SEK

Standard · ISO standard ISO 19001:2013 In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology ISO 19001:2013 specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromog... Språk Publicerad 2013-03-25

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Standard · ISO standard ISO 8600-1:2013 Endoscopes -- Medical endoscopes and endotherapy devices -- Part 1: General requirements ISO 8600-1:2013 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine. Språk Publicerad 2013-03-25

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Standard · ISO standard ISO 10524-3:2005/Amd 1:2013 Filtration and information to be supplied by the manufacturer - Språk Publicerad 2013-03-07

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Standard · ISO standard ISO 7396-1:2007/Amd 3:2013 Terminology relating to alarm systems - Språk Publicerad 2013-03-07

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Standard · ISO standard ISO 8536-4:2010/Amd 1:2013 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed - Språk Publicerad 2013-03-07

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Standard · IEC standard IEC 61689 Ultrasons - Systèmes de physiothérapie - Spécifications des champs et méthodes de mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz IEC 61689:2013 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous wave ultrasound in the frequency range ... Språk Publicerad 2013-03-07

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Standard · IEC standard IEC 60601-2-20 Cor 2 Corrigendum 2 - Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base et les performances essentielles des incu... - Språk Publicerad 2013-03-07

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Standard · IEC standard IEC 60601-2-21 Cor 1 Corrigendum 1 - Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base et les performances essentielles des incu... - Språk Publicerad 2013-03-07

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Standard · ISO standard ISO 5838-1:2013 Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements - Språk Publicerad 2013-02-22

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