CAN/CSA-ISO 10993.6-97 (R2009)
Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation (Adopted ISO 10993-6:1994)
Risk management is a decision-making process helping organizations plan for the potential outcome of future events whose exact outcome is unknown. This guideline:
- Helps decision-makers effectively manage all types of risk issues -- including injury or damage to health, property, the environment or something else of value
- Describes a process for acquiring, analyzing, evaluating and communicating information needed to make these decisions
- Provides a description of the major components of the risk management decision process, and their relationship to each other, in a step-by-step process
This part of ISO 10993 specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level.
The test specimen is implanted into a site and tissue appropriate for evaluation of the biological safety of the material. The implant is not intended to be subjected to mechanical or functional loading. The local effects are evaluat ed by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical acceptability has been established.
The test methods for local effects after implantation are used to assess subchronic effects (short-term, up to 12 weeks), or chronic effects (long-term, longer than 12 weeks).