Laboratory Test Request

Medical Device Toxicological Risk Assessment (TRA)

Project Description

Contract Research Organization needed to conduct medical device toxicological risk assessment (TRA) in accordance with ISO 10993-17:2002 and ISO/TS 21726:2019.

Could you please provide a formal quote and lead time of it?

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Please kindly note that the quote should apply the following.

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1) The sponsor has completed the chemical characterization test for a pool of lenses with different colors (tones) according to 10993-18: 2020. From the report, the following substances were detected and TRA for these substances needs to be conducted.

- Total 11 substances (Aluminum, boron, barium, calcium, potassium, magnesium, sodium, phosphorus, sulfur, silicon and chlorides) are detected.

- Only If possible, TRA for not identified compounds shall be performed.

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2) For product info, please refer to Product info and Instruction for use attached.

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If you have further questions, please let me know.

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Best regards,

Sanglok

Project Information

Number:21-01995

Industry:Medical Devices

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