What is ISO 10993-1 about?
ISO 10993 discusses the biological evaluation of medical devices. ISO 10993-1 outlines a framework for planning and conducting biological evaluations of medical devices within a risk management process.
ISO 10993 specifies the general principles governing the biological evaluation of medical devices within a risk management process, general categorization of medical devices based on the nature and duration of their contact with the body, the evaluation of existing relevant data from all sources, the identification of gaps in the available data set based on risk analysis, the identification of additional data sets necessary to analyze the biological safety of the medical device, and the assessment of the biological safety of the medical device.
Who is ISO 10993-1 for?
ISO 10993-1 on biological evaluation of medical devices (risk management) is useful for:
- Medical device manufacturers
- Test laboratories
- Regulatory authorities
- Notified bodies
Why should you use ISO 10993-1?
A biological evaluation needs to be done before any medical device can interact with the human body. ISO 10993-1 on the biological evaluation of medical devices helps users to plan and conduct such biological evaluations.
ISO 10993-1 guidelines help you with the collection and evaluation of all types of data that are relevant to biological safety. ISO 10993-1 gives guidelines for the assessment of biological hazards arising from risks, such as changes to the medical device over time, as a part of the overall biological safety assessment and breakage of a medical device or medical device component which exposes body tissue to new or novel materials. This leads you to more reliable and cost-effective evaluations.
What’s changed since the last update?
BS EN ISO 10993-1:2020 supersedes ISO 10993-1:2009, which has been withdrawn. BS EN ISO 10993-1:2020 has some technical changes with respect to ISO 10993-1:2009. These include:
- Revised annex A “endpoints to be addressed in a biological risk assessment” with new columns for “physical and/or chemical information” and “material mediated pyrogenicity” as well as columns for “chronic toxicity,” “carcinogenicity,” “reproductive/developmental toxicity,” and “degradation” which now indicates “endpoints” to be considered with “E” (instead of “tests” to be conducted with an “X”)
- Replaced annex B “guidance on the risk management process” with “guidance on the conduct of biological evaluation within a risk management process” (formerly ISO TR 15499)
- Additional information on the evaluation of “non-contacting medical devices” and new information on the evaluation of “transitory-contacting medical devices”
- Additional information on the evaluation of nanomaterials, and absorbable materials
- Additional reference to ISO 18562 (all parts) for “biocompatibility evaluation of breathing gas pathways in healthcare applications”