FSP PMP400 Series Switching Power Supply Verification of Compliance

Brand: FSP

Product Type: Switching Power Supply

Compliance Details

This document verifies the compliance of FSP PMP400 series switching power supplies with various international standards, particularly concerning Electromagnetic Compatibility (EMC) and requirements for medical electrical equipment.

Issuing Body and Dates

Issuing Body: SGS

Verification Issue Date: July 20, 2023

Internal Document Reference (FSP): SFD16021180-R1 (Version 02)

Internal Document Issue Date (FSP): 2023/08/04

Applicant and Manufacturer Information

Applicant: FSP Group Inc.

Applicant Address: 2-3, East 3rd Street, Nanzih District, Kaohsiung City, 811 Taiwan

Manufacturer(s):

Manufacturer Addresses:

Product Identification

Product: Switching power supply

Brand Name/Trade Mark: PROTEK POWER; FSP

Model/Type:

Internal FSP Model Reference: PMP400 series, Medical, EMC Certificate

Applicable Standards

The product has been verified against the following standards:

StandardDetails/Notes
EN 60601-1-2: 2015 + A1: 2021(Including subclause 8.11 immunity to proximity magnetic fields, Test method refer to IEC 61000-4-39)
BS EN 60601-1-2: 2015 + A1: 2021(Including subclause 8.11 immunity to proximity magnetic fields, Test method refer to IEC 61000-4-39)
IEC 60601-1-2: 2014+AMD: 2020 (Edition 4.1)(Including subclause 8.11 immunity to proximity magnetic fields, Test method refer to IEC 61000-4-39)
EN 55011: 2016+A1: 2017+A11: 2020 (Group 1, Class B)
CISPR 11: 2015+A1: 2016+A2: 2019
EN 61000-3-2: 2014
IEC 61000-3-2: 2018+A1:2020
EN IEC 61000-3-2: 2019 + A1: 2021
BS EN IEC 61000-3-2: 2019 + A1: 2021
EN 61000-3-3: 2013
EN 61000-3-3: 2013+A1: 2019
BS EN 61000-3-3: 2013+A1: 2019
EN 61000-3-3: 2013 +A1: 2019 + A2: 2021
BS EN 61000-3-3: 2013 +A1: 2019 + A2: 2021
IEC 61000-3-3:2013+A1: 2017
EN 61000-3-3: 2013+A1: 2019+A1: 2019+A2: 2021
IEC 61000-4-2: 2008
IEC 61000-4-6: 2013 + C1: 2015
IEC 61000-4-3: 2020
IEC 61000-4-8: 2009
IEC 61000-4-4: 2012
IEC 61000-4-11: 2020 + C1: 2020 + C2: 2020
IEC 61000-4-5: 2014 + A1: 2017

Test Laboratory and Report

Test Laboratory: Compliance Certification Services Inc., Tainan Lab

Test Report Number: TMTN2306000877NE

Test Report Date: July 20, 2023

Conclusion

Based upon a review of the Test Report(s), the tested sample of the product mentioned above is deemed to comply with the requirements of the above standards.

Important Note

This verification is only valid for the product and configuration described and in conjunction with the test report as detailed above.

Authorised Signatory

Name: Jeter Wu

Title: Manager

Organization: Compliance Certification Services Inc.

Further Information

For detailed terms and conditions, please refer to the issuing body's website:

http://www.sgs.com.tw/Terms-and-Conditions

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PMP400-xx-S EMC 60601 ed3.2 cert. SFD16021180-R1-R02 Neevia Converter Pro v7.2.0.131 (http://neevia.com)

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