ISO 7207-1:2007
Implants for surgery — Components for partial and total knee joint prostheses — Part 1: Classification, definitions and designation of dimensions
Implants for surgery — Components for partial and total knee joint prostheses — Part 1: Classification, definitions and designation of dimensions
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 14
- Дата публикации:
- 15 января 2007 г.
- Издание:
- ISO IS 7207 edition 3 version 1
- ICS:
- 11.040.40
ISO 7207-1:2007 classifies femoral, tibial and patellar components for knee joint prostheses in which the bearing surfaces of one or more compartments of the knee are replaced. It also gives definitions of components and the designation of dimensions.
Abstract
Overview
ISO 7207-1:2007 - Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions provides a standardized framework for describing components used in knee joint replacements. The standard classifies femoral, tibial and patellar components for uni-, bi- and tri‑compartmental replacements, defines component types and modularity, and prescribes how key dimensions and symbols are designated for design, documentation and communication.
Key topics and requirements
- Classification of prostheses
- Uni‑compartmental, bi‑compartmental and tri‑compartmental knee joint prostheses
- Stability/constraint levels: unconstrained, semi‑constrained and constrained (including hinged and rotating‑hinged designs)
- Bearing concepts: mobile‑bearing and fixed‑bearing
- Fixation approaches: cemented, uncemented, porous coated, and hybrid
- Definitions of components
- Clear terms for femoral, tibial and patellar components, plus subcomponents (tibial tray, tibial insert, patellar tray/insert)
- Component types: monobloc vs modular, intramedullary stems, augmentation elements, rotating/floating platforms
- Designation of dimensions and symbols
- Standardized dimension symbols (e.g., femoral depth, femoral width, tibial depth, tibial width, tibial insert thickness, stem diameters/lengths)
- Use of illustrative Figures (1–7) to indicate where dimensions apply and to support consistent measurement and documentation
- Normative references
Practical applications and who uses this standard
- Medical device manufacturers: for consistent design specifications, drawings, product labeling and interoperability of modular components.
- Design engineers and CAD teams: to apply standardized dimensioning and component nomenclature during product development.
- Orthopaedic surgeons and hospitals: to understand component types, select appropriate implants (uni/bi/tri‑compartmental, mobile vs fixed), and interpret implant documentation.
- Regulatory bodies and procurement: to evaluate conformity, compare products, and specify procurement criteria.
- Standards committees and testing labs: to harmonize terminology and link dimensional designations to performance and safety standards.
Related standards
- ISO 7207-2 (Part 2) - Articulating surfaces made of metal, ceramic and plastics materials
- ISO 21534 - Non‑active surgical implants - Joint replacement implants - Particular requirements
- ISO 21536 - Non‑active surgical implants - Specific requirements for knee‑joint replacement implants
ISO 7207-1:2007 supports clear communication across the knee implant supply chain by standardizing classification, definitions and dimension designation for knee joint prostheses.
Технические детали
- Технический комитет
- ISO/TC 150/SC 4 - Bone and joint replacements
- SKU
- ISO 7207-1:2007
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