The ISO 10993-1: 2018 is the standard for biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body. It also includes:
- General biocompatibility testing considerations, including test article preparation
- Specific considerations for the following testing: cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and degradation assessments
- Chemical assessment recommendations 8 and considerations for labeling devices
- Device Master Files (MAFs) for Biocompatibility Evaluations, which includes information that goes in MAF
This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system to assess biological evaluation of primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medical device, because of their direct product contact. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry.
A certificate to ISO 10993-1 must include Risk Management. The risk assessment should also consider the proposed clinical use of the device, including the anatomical location, duration of exposure, and intended use population. For example, for pediatric patients with a limited life expectancy, the tolerance for risk associated with a permanently implanted medical device may be higher than the tolerance for risk from the same device in an otherwise healthy pediatric population. The potential exposure duration should also consider which material components of the device have direct or indirect contact with tissue, and whether exposure would be a one-time exposure, a constant exposure over time, or an intermittent exposure over time that could have a cumulative effect
Biological evaluation of medical devices is performed to determine the acceptability of any potential adverse biological response resulting from contact of the component materials of the device with the body. The device materials should not, either directly (e.g., via surface-bound chemicals or physical properties) or through the release of their material constituents:
- produce adverse local or systemic effects;
- be carcinogenic; or
- produce adverse reproductive and/or developmental effects, unless it can be determined that the benefits of the use of that material outweigh the risks associated with an adverse biological response.
Therefore, evaluation of any new device intended for human use requires information from a systematic analysis to ensure that the benefits provided by the device in its final finished form will outweigh any potential risks produced by device materials over the intended duration and use of the device in or on the exposed tissues.