Spezielle Anforderungen an Gelenkimplantate - ISO 21534
Aktuelle Prüfverfahren
ISO 21534: Non-active surgical implants - Joint replacement implants - Particular requirements
ISO 4287: Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parameters
ISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of
endurance properties of stemmed femoral components
ISO 7206-8: Implants for surgery - Partial and total hip joint prostheses - Part 8: Methods of determining endurance performance of stemmed femoral components
ISO 14155-1: Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests
ISO 14242-2: Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurement
ISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
ISO 14630: Non-active surgical implants - General requirements
ISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
The standard provides particular requirements for joint replacement implants. Amongst others, test services evaluating the geometrical, fatigue and wear properties of joint replacement implants are provided by EndoLab®.
