• DIN EN ISO 21534:2009-08

    Current The latest, up-to-date edition.

    NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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    Table of Contents - (Show below) - (Hide below)

    Vorwort
    Einleitung
    1 Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Beabsichtigte Funktion
    5 Konstruktionsmerkmale
       5.1 Allgemeines
       5.2 Oberflächenbeschaffenheit von Implantaten
            aus Metall oder Keramik bei Artikulation mit
            ultrahochmolekularem Polyethylen (UHMWPE)
       5.3 Oberflächenbeschaffenheit von Teilimplantaten
            aus Metall und Keramik
       5.4 Oberflächen kugelkonvexer Implantate aus
            Metall oder Keramik bei Artikulation mit UHMWPE
       5.5 Oberflächen kugelförmiger Teilimplantate
            aus Metall und Keramik
       5.6 Oberflächen kugelkonkaver UHMWPE-Komponenten
    6 Werkstoffe
       6.1 Allgemeines
       6.2 Verschiedenartige Metalle oder Legierungen
    7 Designprüfung
       7.1 Allgemeines
       7.2 Präklinische Bewertung
            7.2.1 Allgemeines
            7.2.2 Messung der Oberflächenrauheit
            7.2.3 Messung der Rundheit
       7.3 Klinische Prüfung
       7.4 Überwachung nach Markteinführung
    8 Herstellung und Kontrolle
       8.1 Allgemeines
       8.2 Metallische Oberflächen
       8.3 Kunststoffoberflächen
       8.4 Keramikoberflächen
    9 Sterilisation
       9.1 Allgemeines
       9.2 Verfallsdatum
    10 Verpackung
    11 Bereitstellung von Informationen durch
       den Hersteller
       11.1 Allgemeines
       11.2 Beschriftung von nur an einer Körperseite
            anzuwendenden Implantaten
       11.3 Anweisungen zur Ausrichtung des Implantats
       11.4 Kennzeichnung zur Ausrichtung des Implantats
       11.5 Kennzeichnungsstelle am Implantat
       11.6 Einschränkungen der Anwendung
       11.7 Resterilisation von Keramiken aus
            Zirkoniumdioxid
       11.8 Beschriftung von Implantaten zur Anwendung
            mit oder ohne Knochenzement
    Anhang A (informativ) Aufstellung von Normen über
              Werkstoffe, die für die Herstellung von
              Implantaten als geeignet befunden wurden
    Anhang B (informativ) Aufstellung von Normen über
              Werkstoffe, die für artikulierende Flächen
              von Implantaten als geeignet oder ungeeignet
              befunden wurden
              B.1 Geeignete Werkstoffkombinationen
              B.2 Ungeeignete Werkstoffkombinationen für
                  miteinander artikulierende Oberflächen
    Anhang C (informativ) Aufstellung von Werkstoffen,
              die bei Implantaten für Metallkombinationen
              an Kontaktflächen ohne Gelenkfunktion als
              geeignet oder ungeeignet befunden wurden
              C.1 Geeignete Kombinationen ungleicher Metalle
                  an nicht miteinander artikulierenden
                  Kontaktflächen
              C.2 Für nicht miteinander artikulierende
                  Kontaktflächen ungeeignete
                  Metallkombinationen
    Literaturhinweise
    Anhang ZA (informativ) Zusammenhang zwischen
              dieser Europäischen Norm und den
              grundlegenden Anforderungen der EG-Richtlinie
              93/42/EWG

    Abstract - (Show below) - (Hide below)

    Describes particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes DIN EN 12010. (12/2007)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN EN ISO 21535:2009-08 NICHTAKTIVE CHIRURGISCHE IMPLANTATE - IMPLANTATE ZUM GELENKERSATZ - BESONDERE ANFORDERUNGEN AN IMPLANTATE FUER DEN HUEFTGELENKERSATZ (ISO 21535:2007 + AMD 1:2016)
    DIN EN ISO 21536:2014-07 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS (ISO 21536:2007 + AMD.1:2014)

    Standards Referencing This Book - (Show below) - (Hide below)

    BS 6324-3:1983 Terms relating to surgical implants Glossary of terms relating to materials
    BS 6324-2:1983 Terms relating to surgical implants Glossary of terms relating to mechanics
    ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
    NFS 94 167-4 : 1998 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 4: CHEMICAL CHARACTERIZATION - IDENTIFICATION OF TEXTILE MATERIALS (METHOD A) AND DETERMINATION OF EXTRACTABLE HEAVY METAL CONTENT (METHOD B)
    ISO 14242-1:2014 Implants for surgery Wear of total hip-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
    ISO 7206-8:1995 Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion
    ASTM F 1357 : 2014 : REDLINE Standard Specification for Articulating Total Wrist Implants
    BS 6324-5:1990 Terms relating to surgical implants Guidance on the usage of the terms \'valgus\' and \'varus\' in orthopaedic surgery
    ISO 7206-4:2010 Implants for surgery Partial and total hip joint prostheses Part 4: Determination of endurance properties and performance of stemmed femoral components
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ISO 14242-2:2016 Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
    ASTM F 370 : 1994 : R1999 Standard Specification for Proximal Femoral Endoprosthesis (Withdrawn 2005)
    NFS 94 167-2 : 2014 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 2: MECHANICAL CHARACTERIZATION - DETERMINATION OF DIRECT TENSILE STRENGTH AND ELONGATION (METHOD A), DETERMINATION OF INDIRECT TENSILE STRENGTH AND ELONGATION (METHOD B) AND RESIDUAL ELONGATION (METHOD C)
    ISO 7206-6:2013 Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
    ISO/TR 9326:1989 Implants for surgery Partial and total hip joint prostheses Guidance for laboratory evaluation of change of form of bearing surfaces
    ISO/TR 9325:1989 Implants for surgery Partial and total hip joint prostheses Recommendations for simulators for evaluation of hip joint prostheses
    ISO 14630:2012 Non-active surgical implants General requirements
    NFS 94 167-6 : 1998 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 6: CHARACTERIZATION OF DIMENSIONS
    ISO 9584:1993 Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants
    ISO 7207-2:2011 Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials
    DIN EN ISO 14155-1:2009-11 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
    BS 6324-1:1983 Terms relating to surgical implants Glossary of general medical terms
    ISO 9583:1993 Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    ASTM F 1223 : 2014 : REDLINE Standard Test Method for Determination of Total Knee Replacement Constraint
    NFS 94 167-3 : 1998 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 3: FATIGUE TEST - DETERMINATION OF RESISTANCE TO ABRASION (METHOD A) AND DETERMINATION OF RESISTANCE TO TORSION (METHOD B)
    ISO 14879-1:2000 Implants for surgery Total knee-joint prostheses Part 1: Determination of endurance properties of knee tibial trays
    ISO 7206-2:2011 Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
    ISO 8828:2014 Implants for surgery Guidance on care and handling of orthopaedic implants
    ISO 7207-1:2007 Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions
    NFS 94 167-5 : 1998 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 5: CHARACTERIZATION OF CLEANNESS - VERIFICATION OF EXTRACTABLE RESIDUES
    ISO 14243-3:2014 Implants for surgery Wear of total knee-joint prostheses Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
    ISO 7206-1:2008 Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions
    ISO 14243-1:2009 Implants for surgery Wear of total knee-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
    ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
    ISO 14243-2:2016 Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
    NFS 94 167-1 : 1998 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 1: GENERAL
    BS 6324-4:1983 Terms relating to surgical implants Glossary of orthopaedic surgical terms
    NFS 94 065 : 1998 MATERIALS FOR SURGICAL IMPLANTS - DETERMINATION OF ARSENIC, MERCURY, CADMIUM AND LEAD ON COATINGS BASED ON PHOSPHATE OF CALCIUM
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