SAFETY NEWS
Providing the latest product safety knowledge and techniques monthly.
2013年6月 (第224期)
一、符合UL60950-1資訊類產品,UL對於產品於生產線上的耐壓Hi-Pot test要求與做UL60950-1認證測試的耐壓要求不同,針對生產線上的耐壓要求說明如下:
生產線上的耐壓要求需要依據UL 的Generic Inspection Instructions的Part AC - Responsibilities and Requirements for Manufacturer進行,評估方式說明如下:
1. 產品是Class I,量測點是Primary to Earth,不用做Primary to Secondary,量測的電壓如下
2. 產品是Class II,量測點是Primary to Secondary,量測的電壓如下
二、車用充電產品申請美國UL 2089認證對於輸入正極尖端要求說明:
UL 2089對於輸入的正極有尺寸要求,須確認是否為平面,且直徑要大於3.57mm,若用圓弧面的造型,會因接觸面積太小,無法符合標準要求的結構。請見以下範例:
實際說明比較圖
以上要求標準節錄如下:
三、2013的 6月30日起,醫療產品進入美國市場須依 FDA 要求,提出符合ES60601-1 的文件
ES60601-1 對應到IEC60601-1 3rd Edition,主要邀其說明如下:
1. 新設計產品都需要符合 ES60601-1 第三版
2. 目前存在於市場的產品,若要繼續販售,就需要符合ES60601-1 第三版
3. ES60601-1要求製造商所需要做好風險評估管理,對應的品質系統及設計程序都需符合要求
以上要求詳見FDA公告網址如下:
Safety News 資料庫
- April 2025
- March 2025
- February 2025
- January 2025
- December 2024
- November 2024
- October 2024
- September 2024
- August 2024
- July 2024
- June 2024
- May 2024
- April 2024
- March 2024
- February 2024
- January 2024
- December 2023
- November 2023
- October 2023
- September 2023
- August 2023
- July 2023
- June 2023
- May 2023
- April 2023
- March 2023
- February 2023
- January 2023
- December 2022
- November 2022
- October 2022
- September 2022
- August 2022
- July 2022
- June 2022
- May 2022
- April 2022
- March 2022
- February 2022
- January 2022
- December 2021
- November 2021
- October 2021
- September 2021
- August 2021
- July 2021
- June 2021
- May 2021
- April 2021
- March 2021
- February 2021
- January 2021
- December 2020
- November 2020
- October 2020
- September 2020
- August 2020
- July 2020
- June 2020
- May 2020
- April 2020
- March 2020
- February 2020
- January 2020
- December 2019
- November 2019
- October 2019
- September 2019
- August 2019
- July 2019
- June 2019
- May 2019
- April 2019
- March 2019
- February 2019
- January 2019
- December 2018
- November 2018
- October 2018
- September 2018
- August 2018
- July 2018
- June 2018
- May 2018
- April 2018
- March 2018
- February 2018
- January 2018
- December 2017
- November 2017
- October 2017
- September 2017
- August 2017
- July 2017
- June 2017
- May 2017
- April 2017
- March 2017
- February 2017
- January 2017
- December 2016
- November 2016
- October 2016
- September 2016
- August 2016
- July 2016
- June 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- September 2015
- August 2015
- July 2015
- June 2015
- May 2015
- April 2015
- March 2015
- February 2015
- January 2015
- December 2014
- November 2014
- October 2014
- September 2014
- August 2014
- July 2014
- June 2014
- May 2014
- April 2014
- March 2014
- February 2014
- January 2014
- December 2013
- November 2013
- October 2013
- September 2013
- August 2013
- July 2013
- June 2013
- May 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
- April 2011
- March 2011
- February 2011
- January 2011
- December 2010
- November 2010
- October 2010
- September 2010
- August 2010
- July 2010
- June 2010
- May 2010
- April 2010
- March 2010
- February 2010
- January 2010
▸ 若需要他期安規月刊,請與我們聯絡,亦可使用標籤檢索查詢您感興趣的內容