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**電動輪椅 / 電動代步車 電性安全檢測服務** (** Electric wheelchair / electric scooter safety testing service **)
 
 
發佈日期:2017/06/19


財團法人精密機械研究發展中心

Precision Machinery Research & Development Center


台中市台中工業區
3727

No.27, 37th Road, Taichung Industrial Park, Taichung, Taiwan, R.O.C.  

04-23599009#566沈峻霆(Shen, Chun Ting)




 

TAF ISO 17025認證實驗室

Accredited by Taiwan Accreditation Foundation (TAF) for ISO 17025 certification laboratory


 

符合法規設計輔導:
Providing design counseling and testing assistance

 


衛福部 查驗登記 及 FDA 510k 諮詢協助

Consultation assistance for inspection registration for TFDA and 510k of FDA

 

歐盟驗證單位或TUV 體系AK證書申請

Verification application of TUV Accreditation or Notfied Body of EU



Compliance with regulatory advice:

ISO 7176-14 ANSI RESNA WC-2 SECTION 14設計評估、輔導與諮詢

ISO 7176-14 ANSI RESNA WC-2 SECTION 14 Design evaluation and counseling

ISO 7176-21 ANSI RESNA WC-2 SECTION 21電磁相容預測

ISO 7176-21 ANSI RESNA WC-2 SECTION 2 Electromagnetic compatibility pretest


符合ISO 7176-25 產品設計輔導

Complies with ISO 7176-25 product design


IEC 60601-1
電氣安全設計輔導與諮詢

Electrical Safety Design Counseling and Consultation for IEC 60601-1


 

Testing service

IEC 60601-1 EN 60601-1電性安全檢測

IEC 60601-1 EN 60601-1 Safety

IEC 60601-1-2 EN 60601-1-2電磁相容測試

IEC 60601-1-2 EN 60601-1-2 EMC


EN 12184 Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods


ISO 7176-14 ANSI RESNA WC-2 SECTION 14
電性安全及充電器檢測服務

ISO 7176-14 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods


ISO 7176-16
耐燃測試

ISO 7176-16 Wheelchairs -- Part 16: Resistance to ignition of postural support devices


ISO 7176-25
電池及充電器檢測服務

ISO 7176-25 Wheelchairs -- Part 25: Batteries and chargers for powered wheelchairs


IEC 60335-2-29
充電器檢測服務

IEC 60335-2-29 Household and similar electrical appliances - Safety - Part 2-29: Particular requirements for battery chargers

 

 

測試對策建議與協助修改:

Test recommendations and assistance to modify

ISO 7176-21 ANSI RESNA WC-2 SECTION 21


 

技術評估文件輔導:

Counseling of Technical Document:

IEC 60601-1 風險評估輔導

Risk Assessment of IEC 60601-1


ISO 14971
風險評估撰寫

Risk Assessment of ISO 14971


IEC 60601-1-4 IEC 62304 EN 62304
軟體確效輔導

Software validation and verification of IEC 62304 and FDA guidance


IEC 60601-1-6 EN 62366
可用性評估

Usability of IEC 60601-1-6 and EN 62366


 
 


聯絡資料:
財團法人精密機械研究發展中心
台中市台中工業區3727
聯絡人: 沈峻霆
電話:04-23599009 分機 566 / 0928952818
 e9406@mail.pmc.org.tw

 

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