Suitability of ISO standards for medical device toxicity measurement

Girish K. Srivastava,

IOBA, Universidad de Valladolid, Valladolid, Spain


ISO standards are applied at global level for quality assurance of medical devices. More specifically, ISO 16672 is used for ophthalmic implants and ocular endotamponades, and ISO 10993 for biological evaluation of medical devices. Recently, several clinical cases of perfluorocarbon liquid (PFCL), which are used in vitreo-retinal surgery, are reported from Chile, Spain, Switzerland, Holland, France, Italy, the Middle East and South America which has raised the questions on suitability of ISO standards for cytotoxicity measurement of PFCL. The investigation showed that ISO recommended extract indirect and agarose overlay method failed to detect the cytotoxicity of CE-marked PFCL samples, however a new direct method had detected the cytotoxicity of same samples confirming that clinical cases were due to PFCL toxicity. Therefore, this is very crucial to consider specific device-type situation for cytotoxicity test during applying the ISO standards for quality assurance. The PFCL is non-soluble and highly volatile substance. Similarly, intraocular gases, PFCL and silicon oils are completely different products and they may need different ISO standards for their quality measurement. 

Article ID: O0401019 (Suppl 1)   RA  Preprint
Received: 08/06/2022 
Accepted: 08/07/2022
Published: 08/08/2022

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