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Biocompatibility and Sterilisation

Biocompatibility — ISO 10993 series​

Japan has adopted the ISO 10993 series as recognised standards for biocompatibility evaluation. The framework follows the ISO 10993-1:2018 approach — a risk-based evaluation that considers:

  • Nature and duration of patient contact (surface contact, blood contact, tissue contact; limited / prolonged / permanent)
  • The biological endpoints relevant to the contact category
  • Whether the materials have a history of safe clinical use that can be used as supporting evidence

ISO 10993 standards recognised in Japan:

  • ISO 10993-1: Evaluation and testing within a risk management process
  • ISO 10993-2: Animal welfare requirements
  • ISO 10993-3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
  • ISO 10993-4: Selection of tests for interactions with blood
  • ISO 10993-5: Tests for in vitro cytotoxicity
  • ISO 10993-10: Tests for skin sensitisation
  • ISO 10993-12: Sample preparation and reference materials
  • And others

PMDA follows the ISO 10993-1 framework for determining which tests are required for a specific device. A biocompatibility evaluation rationale — explaining which endpoints were assessed, which tests were conducted, and the basis for concluding biocompatibility — must be included in the application dossier.

Sterilisation validation​

For sterile devices, sterilisation validation data is required in the application. Japan recognises the key ISO sterilisation standards:

  • ISO 11135 (EO sterilisation)
  • ISO 11137 series (radiation sterilisation)
  • ISO 17665-1 (steam sterilisation)
  • ISO 13485 requirements for sterilisation process controls

PMDA expects the validation to cover: sterility assurance level (SAL ≤10⁻⁶), method selection rationale, bioburden data, and ongoing monitoring requirements.

PMDA-specific expectations​

PMDA applies the ISO 10993-1:2018 framework but may have device-type-specific expectations articulated in PMDA guidance documents. For novel materials or complex contact scenarios, early PMDA consultation on the biocompatibility testing plan is advisable.