詎詮技科 資通、影音類產品申請醫療認證必需明確說明欲搭配的醫療終端產品
親愛的客戶您好,
主旨: 資通、影音類產品 (例: PCs、Monitors、Routers等) 申請醫療認證,
需要有更明確的intended of use, 說明欲搭配的終端醫療設備, 否則不能申請Medical IEC 60601-1 CB。
說明:
一、根據IECEE 2022.06.22 OD5002-F3 CTL Provisional Decision Sheet 2208 Decision, The scope of IEC 60601-1 is limited to MEE and MES. Typical OFF/ITE/AV_ICT Equipment does not meet the 60601-1 definition of MEE/MES and cannot be evaluated and certified to IEC 60601-1 under the CB scheme.
See IECEE OD-2055 (Operational Document on Medical Electrical Equipment in the CB Scheme according to the IEC 60601 and ISO/IEC 80601 Series of Standards) for specific rules associated with power supply and component/subassemblies certifications under the CB Scheme.
二、IEC認為PCs、 Monitors、 Routers等資通、影音類產品, 不符合IEC60601-1 Medical產品的定義, 不能申請IEC60601-1 CB, 目前僅是先出CTL Provisional Decision Sheet, 明年或許會發佈正式的CTL decision, 屆時, intended of use若無明確定義的資通、影音類產品 (例: general purpose medical use..等, 將不被接受), 也將無法申請IEC 60601-1 CB, 甚至更近一步影響NRTL Mark (UL 60601-1) 的申請.
建議作法:
生產PCs、 Monitors、 Routers等資通、影音類產品, 爾後需要明確於使用手冊Manual中定義intended of use, 例如將搭配終端內視鏡系統、X-ray…等醫療系統使用.
*上述部分認證說明或許不夠詳盡清楚，歡迎您直接諮詢聯絡本公司客服人員,謝謝
2023-07-17