The component acceptance process is covered in Clause 4.8. Although it would be ideal to source components which are already approve/evaluated to 60601-1 it is not always possible. The purpose in selecting pre-approved components is to minimize your risk of a non-conformity when evaluating the end product to 60601-1. It could also reduce cost as the test lab may not need to "dig into" the component to check compliance with the applicable clauses of 60601. If you are unable to source a component which is not already approved to 60601-1 then I suggest you perform some pre-testing, specifically dielectric strength and leakage current, to give you a better idea of the risks you are taking.
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Wade Munsch
Regulatory Affairs Manager
Biotex, Inc.
Houston TX
United States
Website:
www.biotexmedical.com------------------------------
Original Message:
Sent: 25-Mar-2022 05:17
From: Martin Eberl
Subject: Application of IEC 60601-1 and IEC 60601-1-2 standards on sensors provided by vendors
As a manufacturer of a medical device, I have to test sensors from supplier's according to IEC 60601-1 or 60601-1-2. The review of supplier's technical specification indicates that other standards has been applied, which are mainly focused on the EMC test and do not cover all requirements. I'm looking for relevant regulation / standards for the application of Ultra-Wideband (UWB) Radar or Thermal Imaging Camera (IR-cam) in clinical environment.
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Martin
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