Laboratory Test Request Details

Contraception Products Test Request


Request: 19-00397

Status: Closed


Title:

Condom Biological, Toxicity, Microbiology and Packaging Studies

Description:

Product Safety laboratory needed for ASTM and ISO testing of a liquid applying the following tests: 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


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Consumer Products,Personal and Intimate Products,Personal Care Products,Contraception Products,Hygiene, Personal Care, and  Toiletries,Medical Devices,Medical Disposables,Pharmaceutical - Over the Counter (OTC),Pharmaceuticals ,Public Health,

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