美国当地时间6月24日，FDA更新了认可标准清单，清单编号为062。特别提请注意以下几个与中国生产商相关的重要信息：
1.安规/性能测试通标更新版本
IEC TS 60601–4–2 Edition 1.0 2024–03 Medical electrical equipment— Part 4–2: Guidance and interpretation—Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. 电磁抗扰
2.五个安规/性能测试专标更新版本
- ISO 80601–2–74 Second edition 2021–07 Medical electrical equipment—Part 2–74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment. 呼吸湿化装置
- IEC 60601–2–57 Edition 2.0 2023–07 Medical Electrical Equipment—Part 2–57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use非激光光源诊断、治疗和医美设备
- IEC 60601–2–22 Edition 4.0 2019–11 Medical electrical equipment—Part 2–22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment 采用激光光源的诊断、治疗和医美设备
3.新增的专标
ISO 80601-2-85:2021 (Edition 1.0) Medical electrical equipment: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment脑组织血氧仪设备
还有一些关于灭菌和软件相关的标准更新/新增值得关注。