Laboratory Test Request

Project Description

Medical Device laboratory needed for ASTM and ISO product safety testing for evaluation of medical devices including toxicology, packaging and microbiology testing:

ASTM D7661-10, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms for compliance with latex and polyisoprene condoms.

ISO 10993-5 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity

ISO 10993-10 Biological Evaluation of Medical Devices-Part 10: Tests for irritation and skin sensitization

ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for systemic toxicity

United States Pharmacopeia, National Formulary General Chapter <88>: Biological Reactivity Tests, In Vivo

USP <51> Antimicrobial Effectiveness Testing

USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

ISTA 3A: Packaged-Products for Parcel Delivery System Shipment 70 Kg (150 lb) or Less Shelf-life testing

Project Information

Number:17-00128

Industry:Medical Devices

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