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DIN EN ISO 21534:2009-08

Current
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

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

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

DevelopmentNote
Supersedes DIN EN 12010. (12/2007)
DocumentType
Standard
Pages
22
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
ISO 21534:2007 Identical
EN ISO 21534:2009 Identical

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)

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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