ISO 14730:2014 眼科光学 隐形眼镜护理产品 测定有效期的杀菌防腐功效试验和指南

标准编号：ISO 14730:2014

中文名称：眼科光学 隐形眼镜护理产品 测定有效期的杀菌防腐功效试验和指南

英文名称：Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on determining discard date

发布日期：2014-10

标准范围

This International Standard specifies a procedure to be used in evaluating the antimicrobial preservativeactivity of all preserved multidose contact lens care products, and provides guidance on methods fordetermination of discard date as informative annexes.This test is applicable to products for up to a 28-day discard date.The test is not applicable to sterile products packaged in unit doses for single use or multidose containersdesigned with physical barriers to microbial contamination (e.g. aerosol containers).NOTE 1 Principles of the test can be used to extend discard dating beyond 28 d. See Annexes B, C, D and E.NOTE 2 Use of multiple or mixed microbial challenges and/or inclusion of contact lenses or other organicload can influence the apparent antimicrobial activity of a particular product. The evaluation of these variablestogether with testing against a larger panel of microorganisms and testing of samples from partially usedcontainers can be of value in developing a contact lens care product, but are excluded from the scope of thisInternational Standard.

标准预览图