DIN EN ISO 21534:2009-08
Current
The latest, up-to-date edition.
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
Hardcopy , PDF
English
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) (includes Amendment :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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