ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories
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ISO 25539-2:2012
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Cardiovascular implants Endovascular devices Part 2: Vascular stents
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ISO 4287:1997
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Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
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ISO 13779-4:2002
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Implants for surgery Hydroxyapatite Part 4: Determination of coating adhesion strength
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ISO 14577-4:2016
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Metallic materials Instrumented indentation test for hardness and materials parameters Part 4: Test method for metallic and non-metallic coatings
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2007/47/EC : 2007 COR 1 2015
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DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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ASTM F 1377 : 2013 : REDLINE
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Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
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ISO 13779-3:2008
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Implants for surgery Hydroxyapatite Part 3: Chemical analysis and characterization of crystallinity and phase purity
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ISO 14242-2:2016
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Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
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ISO 25539-1:2017
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Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
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ISO 14630:2012
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Non-active surgical implants — General requirements
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ISO 13779-2:2008
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Implants for surgery Hydroxyapatite Part 2: Coatings of hydroxyapatite
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ISO/TR 14283:2004
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Implants for surgery Fundamental principles
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NFS 94 072 : 1998
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MATERIALS FOR SURGICAL IMPLANTS - DETERMINATION OF TENSILE ADHERENCE OF PHOSPHOCALCIC COATINGS FOR BIOMEDICAL APPLICATIONS
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ISO 12417-1:2015
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Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
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ISO/TS 12417:2011
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Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
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ISO 25539-3:2011
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Cardiovascular implants Endovascular devices Part 3: Vena cava filters
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ISO 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice
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ISO 14243-2:2016
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Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
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ISO 13179-1:2014
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Implants for surgery Plasma-sprayed unalloyed titanium coatings on metallic surgical implants Part 1: General requirements
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ISO 9277:2010
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Determination of the specific surface area of solids by gas adsorption — BET method
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ASTM F 1926/F1926M : 2014 : REDLINE
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Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
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ASTM F 1854 : 2015 : REDLINE
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Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
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