Glossary Updates12 new terms added to the glossaries · October 2, 2026, 22:44 CEST
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Glossary · ISO and IEC standards for MedTech and pharma

ISO 10993-1

Also known as: EN ISO 10993-1, Biological evaluation of medical devices, Biocompatibility evaluation

ISO 10993-1 is the international standard that sets the framework for the biological evaluation of medical devices within a risk management process. It requires manufacturers to assess the device's materials and body contact and to decide which data, such as chemical characterization, existing data or biological tests, are needed to evaluate biological safety.

  • Standards
  • MDR

In one sentence

ISO 10993-1 frames the biological evaluation of medical devices within risk management: materials, body contact, existing data and targeted tests.

Example

A manufacturer of a urinary catheter writes a biological evaluation plan, uses chemical characterization and literature data for a known polymer, adds cytotoxicity, sensitization and irritation tests, and summarizes the findings in a biological evaluation report.

How it applies

  • Legal hook: The GSPR in Annex I MDR require manufacturers to consider the choice of materials, their toxicity and their biological compatibility with tissues, cells and body fluids.
  • Categorization: Devices are categorized by the nature of body contact and its duration. These categories point to the biological effects, called endpoints, that the evaluation has to address.
  • Risk-based, not a checklist: The standard asks for an evaluation within the ISO 14971 process. Existing data and chemical characterization (ISO 10993-18) can make animal tests unnecessary; tests are chosen to close gaps, not to fill a table.
  • Whole device: The final device is evaluated as supplied to the user, including processing effects such as residues from sterilization or manufacturing aids.
  • Other parts: The ISO 10993 series has many parts for specific tests and topics; ISO 10993-1 is the umbrella that decides which apply. Check the current edition before citing test categories.
  • Technical documentation: The biological evaluation plan and report belong in the technical documentation and must be updated when materials, suppliers or processes change.

Biological evaluation vs. biocompatibility testing

Biocompatibility testing is one input: individual laboratory tests on specific endpoints. Biological evaluation is the documented judgment that the device is biologically safe for its intended use, drawing on materials knowledge, chemical data, clinical experience and tests. A folder of passed test reports without an evaluation doesn't meet ISO 10993-1.

Compared with the USA

The FDA recognizes ISO 10993-1 and has issued guidance on its use in premarket submissions, with its own expectations on endpoints and test details. The same evaluation can serve both markets if these differences are addressed.

By knowledge.aitechdoc.world · Published September 25, 2026 · Last reviewed

Source: ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

Definitions follow the cited standards and specifications. Where a source is a copyrighted publication, such as an ISO, IEC or EN standard, the definition is a close paraphrase, not a verbatim quotation, so as not to infringe copyright. We recommend reading the original publication. The sections “How it applies” are editorial commentary by AI TechDoc Knowledge and are not part of any standard.

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