Ophthalmic implants — Irrigating solutions for ophthalmic surgery
眼科植入物 - 眼科手术的灌洗解决方案
发布日期:
2015-08-07
ISO 16671:2015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。
ISO 16671:2015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。
ISO 16671:2015 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.
ISO 16671:2015 applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.