Standards · Standard or regulation
ISO 10993-1
Biological evaluation of medical devices, Part 1: Evaluation and testing within a risk management process
In plain words
What it covers.
The starting point for showing that materials touching the body are biologically safe. The manufacturer classifies the device by type of body contact (surface, external communicating or implant) and duration, then plans an evaluation of possible effects such as cytotoxicity, sensitisation and irritation, using existing data first and tests only where needed.
Who uses it: Device designers, materials engineers and regulatory specialists.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Categorisation by nature of body contact
- Contact duration: limited, prolonged, long-term
- Biological endpoints to consider
- Chemical characterisation
- Use of existing data
- Biological evaluation plan and report
Key points
What engineers need to know.
- Contact duration bands: limited up to 24 hours, prolonged 24 hours to 30 days, long-term over 30 days.
- Cytotoxicity, sensitisation and irritation are considered for almost every device.
- Implants and blood-contacting devices need wider evaluation, such as haemocompatibility.
- Material or process changes can change biological safety and must be reassessed.
- Evaluation sits inside ISO 14971 risk management, not as a separate tick box.
- Animal testing should be reduced where other evidence is enough.
Devices
Devices it applies to.
Each device in the Medical City Device Lab, with its Device Library course on the Platform.
Medical City
Where you practise it.
- Design Studio verification and validation stage
- Device Mastery implants track