新版居家醫療器材, 防水, 防塵設計注意事項
親愛的客戶,
目前居家醫療用醫療器材最新版法規
IEC 60601-1-11:2015/AMD1:2020/ EN 60601-1-11:2015/A1:2021已經出版,其中關於IP測試後,
產品符合性要求有所更改, 比IEC 60601-1-11:2015/ EN 60601-1-11:2015版更加嚴格, 其要求如下:
一、不能影響 Basic safety or essential performance;
二、不能影響沿面距離;
三、塵, 水不能接觸到帶電導體 (live part), 包含電池;
已經申請過IEC 60601-1-11:2015/ EN 60601-1-11:2015 standard的產品, 廠商必需重新檢視當初申請認證時, 其IP測試結果,
是否能通過新版法規要求, 如果不能, 其防水防塵設計需要重新考慮. 標準原文如下:
Subclause 8.3.1 – Ingress of water or particulate matter into ME EQUIPMENT
Add, after the existing last paragraph, the following new paragraphs:
Care should be taken to ensure that liquid does not accumulate or that it drains away such that
it does not:
– interfere with BASIC SAFETY or ESSENTIAL PERFORMANCE;
– deposit on insulation parts where it could lead to tracking along the creepage distances; or
– reach live parts, including INTERNAL ELECTRICAL POWER SOURCES, or windings not designed
to operate when wet.
There are particular standards that exempt certain types of ME EQUIPMENT from these
requirements.
*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
2023-07-11