Residual Hydrogen Peroxide Determination

We assess hydrogen peroxide residues remaining on medical devices following H2O2 sterilisation processes to assess biocompatibility and patient safety.

Our Accreditations

Applicable Standards

BS EN ISO 22441:2022 – Sterilisation of health care products. Requirements for the development, validation and routine control of a low-temperature hydrogen peroxide sterilization process for medical devices. Directs that appropriate limits for sterilisation process residuals should be established using 10933-17.

BS EN ISO 109931-1:2020 - Biological evaluation of medical devices. Guidelines for the assessment of biological hazards and general principles governing the biological evaluation of medical devices within a risk assessment framework.

BS EN ISO 10993-17:2023 – Toxicological risk assessment of medical device constituents. Provides a process and requirements for the toxicological risk assessment of medical device constituents, as applied to chemical characterisation information derived in line with BS EN ISO 10993-18.

BS EN ISO 10993-18:2020+A1:2023 – Chemical characterisation of medical device materials within a risk management process. Provides a framework for the identification and quantification of the constituents of a medical device, allowing for the identification of biological hazards. This includes residues from chemical substances introduced during sterilisation.

Residual Hydrogen Peroxide Testing

We quantify extractable hydrogen peroxide residues present on or in medical devices having undergone H₂O₂ sterilisation and to assess if those residues represent a toxicological risk.

As outlined in ISO 22441 section 5.4.5. The limits for process residuals on/in healthcare product materials shall be based on a health-based risk assessment conducted in accordance with ISO 10993-17

ISO 10993-17 and 18 provide guidelines for test sample selection and treatment, extraction approach, construction of an appropriate toxicological risk assessment, derivation of exposure limits and the classification of process residues determined to represent a toxicological risk or else fall below harmful levels.