ISO 10993-1 “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process” is the foundational standard for medical device biocompatibility evaluation. BS EN ISO 10993-1:2020 is the European adoption published by the British Standards Institution (BSI), corresponding to the international standard ISO 10993-1:2018.
About the standard
The standard requires biological evaluation within a risk management framework: first determine the biological endpoints to be evaluated according to the nature of body contact (surface, externally communicating, implant) and duration of contact (limited, prolonged, long-term), then decide whether testing is needed based on material information, chemical characterisation and existing data. It is the common basis for biocompatibility evaluation under the EU MDR, the US FDA and China’s NMPA; the corresponding Chinese national standard is GB/T 16886.1. If ISO publishes an updated edition, please refer to the ISO website.
Applicable products and users
- All medical devices in direct or indirect contact with the body of patients or users
- Manufacturers who need to write biological evaluation plans and reports
Main contents
- The risk-based biological evaluation process
- Evaluation endpoints determined by nature and duration of contact
- The role of chemical characterisation and existing data in the evaluation
- Requirements for biological evaluation plans and reports
Where to obtain the official standard
This standard is a copyrighted publication of the International Organization for Standardization (ISO) and related standards bodies. Please purchase or consult the official text through the following official channels:
- ISO Store: ISO 10993-1
- BSI Knowledge (British Standards Institution): BS EN ISO 10993-1
- Corresponding Chinese national standard GB/T 16886.1 (China national standards full-text public system)
Related articles
- FDA: The Complete Compliance Path for Biocompatibility Submissions for Medical Devices
- EU Medical Device CE Certification (MDR/IVDR) Services
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