ISO 18192-1:2011/Amd 1:2018

Overview

ISO 18192-1:2011/Amd 1:2018 is an important international standard developed by the International Organization for Standardization (ISO) relating to implants for surgery, specifically addressing the wear testing of total intervertebral spinal disc prostheses. This amendment to the original 2011 standard focuses on specifying precise loading and displacement parameters as well as the environmental conditions necessary for standardized and reliable wear testing of spinal disc implants. By ensuring consistent testing protocols, this standard plays a critical role in enhancing the safety, durability, and performance evaluation of spinal disc prostheses used worldwide.

Key Topics

• Wear testing parameters
  Detailed guidelines on loading forces and displacement conditions that simulate the physical stresses prosthetic spinal discs undergo in vivo.

• Motion control system requirements
  The amendment specifies the necessity for motion control systems to generate angular movements with stringent accuracy - ±0.5° at motion limits and ±2% of cycle time for phasing - which is crucial for replicating physiological spinal motion during wear tests.

• Environmental conditions for testing
  Defines the conditions, such as temperature and medium, under which the wear tests must be conducted to ensure reproducibility and relevance to clinical environments.

• Multi-station test systems
  Addresses the performance validation of test systems when multiple samples are tested simultaneously, emphasizing consistency across all stations.

Applications

• Medical device manufacturers
  Provides critical guidelines for manufacturers of total intervertebral spinal disc prostheses to design, test, and validate the wear characteristics of their implants, ensuring compliance with international requirements.

• Regulatory agencies
  Assists regulatory bodies in evaluating pre-market submissions and post-market surveillance data related to spinal disc implant durability and safety.

• Research and development
  Supports R&D teams in developing new spinal disc prostheses with improved materials and designs by providing a standardized framework for wear testing.

• Quality assurance laboratories
  Serves as a reference for clinical testing facilities and material testing laboratories to conduct wear tests that meet global standards, ensuring product reliability.

Related Standards

• ISO 18192 series
  The full ISO 18192 series covers multiple parts related to the wear of total intervertebral spinal disc prostheses, where Part 1 lays the foundation by defining the loading and displacement parameters.

• ISO 14630
  General principles on the testing of medical devices can complement the testing procedures outlined in ISO 18192-1.

• ISO 10993 series
  Addresses biological evaluation of medical devices, which is pertinent to the biocompatibility assessment of spinal disc prostheses alongside mechanical wear testing.

• ISO/IEC Directives, Part 1 and 2
  Governs the development and editorial rules of ISO standards ensuring coherence and consistency across related documentation.

Keywords: ISO 18192-1, spinal disc prostheses, wear testing, loading parameters, displacement parameters, motion control system, implants for surgery, environmental conditions, spinal implant durability, medical device standards, intervertebral disc replacement.