ISO 10993

What is the ISO 10993 series?

ISO 10993 is a family of standards addressing the biological evaluation of medical devices. Its central document, ISO 10993-1, explains how biological safety should be evaluated within a risk management process. Other parts address subjects such as chemical characterization, toxicological risk assessment and particular biological effects.

The series is relevant when a device, its materials or substances released from it can contact a patient or user directly or indirectly. Manufacturers should determine which parts apply to their device instead of treating every document in the series as mandatory.

What is the current edition of ISO 10993-1?

As of July 2026, the current edition is ISO 10993-1:2025. It replaced the 2018 edition and more closely aligns biological evaluation with ISO 14971 risk management.

Because individual parts of the ISO 10993 series are revised independently, manufacturers should verify the current edition of every applicable part and the edition recognized or accepted by each target regulator.

Does every medical device require the same biocompatibility tests?

No. ISO 10993 does not establish one universal testing checklist. The evaluation strategy depends on factors including the device’s materials, manufacturing processes, nature and duration of body contact, available chemical and toxicological information, and prior evidence for comparable materials or devices.

Testing should address unresolved biological risks. Existing evidence may support some endpoints, while new laboratory studies may be necessary for others. The FDA also describes this risk-based approach in its official ISO 10993-1 guidance.

What is the difference between biological evaluation and biocompatibility testing?

Biological evaluation is the broader process of reviewing evidence, identifying biological hazards and deciding whether remaining risks are acceptable. Biocompatibility testing is one possible source of evidence within that process.

A biological evaluation may also use material characterization, literature, supplier information, clinical history and toxicological assessment. A test report alone is therefore not a complete biological evaluation.

How does ISO 10993 support market access?

Biological safety evidence may support submissions in the United States, the European Union and other regulated markets. The required evidence still depends on the device and jurisdiction. For edition-specific developments, see Pure Global’s ISO 10993-1:2025 update.