BS EN ISO 16671:2015+A1:2017定义了与预期性能、设计属性、临床前和临床评估、灭菌、产品包装、产品标签和制造商提供的信息有关的安全要求。本国际标准适用于眼科手术期间使用的眼科冲洗液（OIS）。这些溶液不提供任何主要的免疫、药理或代谢功能。交叉引用:ISO 15223- 1:2012 ED2ISO 11607-1:2006（R10）Ed 1ISO 14630:2012ISO 22442-1:2015ISO 13408-1:2008/AMD 1:2013ISO 13408-1:2008ISO 10993-1:2009ISO 14971:2007ISO 10993-2:2006ISO 14155:2011EN 1041:2008+A1:2013AMI TIR 19:1998ISO 10993-6:2007ISO 10993-7:2008包含以下内容:修订，2018年1月

BS EN ISO 16671:2015+A1:2017 defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.This International Standard applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.Cross References:ISO 15223-1:2012 ED2ISO 11607-1:2006 (R10) Ed 1ISO 14630:2012ISO 22442-1:2015ISO 13408-1:2008/AMD 1:2013ISO 13408-1:2008ISO 10993-1:2009ISO 14971:2007ISO 10993-2:2006ISO 14155:2011EN 1041:2008+A1:2013AAMI TIR 19:1998ISO 10993-6:2007ISO 10993-7:2008Incorporates the following:Amendment, January 2018