Glossary Term
ISO 5834 (Implants for Surgery – Ultra-High-Molecular-Weight Polyethylene)
Definition
ISO 5834 is an international standard that defines the characteristics of ultra-high-molecular-weight polyethylene (UHMWPE) as a material used in surgical implants. It provides guidelines for manufacturing, material composition, mechanical properties, and testing to ensure its suitability for orthopedic and other medical applications.
Relevance to the MedTech Industry
ISO 5834 ensures that UHMWPE used in surgical implants meets stringent safety and performance standards. It provides manufacturers with a benchmark for material quality, supporting the development of reliable and durable implants for orthopedic and other surgical applications.
Additional Information & Related Terms
Key Sections of ISO 5834
ISO 5834-1: Requirements for Virgin Polymer
Specifies the properties of raw UHMWPE resin, including molecular weight, density, and purity.
ISO 5834-2: Requirements for Molding and Extrusion Materials
Provides guidelines for processed UHMWPE used in implant manufacturing, focusing on mechanical properties, wear resistance, and fatigue performance.
ISO 5834-3 to ISO 5834-5
Covers specific applications and advanced properties, including crosslinked UHMWPE and its wear resistance enhancements.
Examples of Applications
Orthopedic Implants: UHMWPE is commonly used for articulating surfaces in hip, knee, and shoulder replacements.
Spinal Implants: Provides wear-resistant components in intervertebral disc replacements.
Cranial Implants: Used in custom surgical implants requiring biocompatibility and durability.
Dental Implants: Utilized in specific applications where wear resistance and low friction are essential.