How does IEC-60601-1 apply to a non-medical device in the patient vicinity?

#1
I am developing a system which is not a medical device. It is a data system for collection of vital signs from patient monitors in a hospital. It is not a medical device per the FDA's own definition (see MDDS rule).

As part of this new system, I want to put an off-the-shelf serial-to-ethernet converter at the patient bedside (such as the IOLAN SDS1 M Secure Device Server). This device will connect to the RS232 port on the patient monitor and transmit the RS232 data (encrypted, of course) across the network to my server.

I am confused about how 60601-1 applies to such a design. To save costs, I'd prefer to use a non-60601-compliant serial-to-ethernet converter. Could I just power it using a 60601-compliant power supply?

And the loaded question is: Would my system need to be tested for 60601-1 compliance in order to be sold to a hospital?
 
Elsmar Forum Sponsor

Peter Selvey

Staff member
Moderator
#2
Technically a non-601 power supply is OK as long as additional measures are taken to make sure the leakage meets the 601 limits inside the patient environment. In the standard they talk about extra earth bonding or isolation transformers to limit the leakage, but one of the simplest methods would be to select a double insulated power supply that already has low leakage (<0.1mA to the secondary in normal condition), and make sure it is powered directly from a wall socket, not from expander board (i.e. via the instructions for use, installation section).

From memory the standard for power supplies might have a 0.25mA leakage but most manufacturers will stay well below that, so it's possible to find one that is <0.1mA off the shelf.

You could also just source a 601 power supply anyway, which should be below the 0.1mA limit.

The system itself does not need to meet 601 standard. However make sure the power supply meets the relevant standards for a power supply. And if the power supply has an instructions for use, make sure to include that as part of the package you supply to the end user.

This is a quick summary/interpretation of Clause 16 in the 601 standard.
 
Thread starter Similar threads Forum Replies Date
shimonv IEC 60601-1-8 - When does an error message become an alarm signal? IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
MDD_QNA IEC 60601-1 Ed2 vs Ed3 - Does a product that conforms to Ed3 also fulfill Ed2? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-2-27: What does "linear within ±20% of the full scale output" mean? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
E What does "other APPLIED PARTS" mean in IEC 60601-1 ed 3.0 8.7.4.7 b) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R Does long-term body worn medical monitoring device need to meet IEC 60601-1-11? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S IEC 60601-1 3rd Gap analysis template TO BUY - Does anyone know where? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Will buyers (hospitals) require IEC 60601, even when FDA does not? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R Does the Banana connector deviate from the IEC 60601-2-25? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
C Does IEC 60601-2-49 apply to Thoracic Bioimpedance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Does a 12V DC device need EMC (IEC 60601-1-2) Testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A Does Canade recognize IEC 60601-2-22? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
S Does IEC 62304 require documenting unresolved anomalies for all safety classes? IEC 62304 - Medical Device Software Life Cycle Processes 4
M Does Calibration to ISO/IEC 17025 conform to Z540.3? ISO 17025 related Discussions 1
M Does ISO/IEC 17021 Accreditation work for 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
L Does IEC 61010-1 apply for Surgical Microscopes? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedures ISO 17025 related Discussions 4
T Does anybody know about EN45014? (Replaced by ISO/IEC 17050-1) Other Medical Device Related Standards 1
A Sampling - What does it mean by Sampling in ISO:IEC 17025 ISO 17025 related Discussions 1
R Does ISO/IEC 17025 supersede ANSI/NCSL Z540 ISO 17025 related Discussions 6
A Does anybody have an audit check list for ISO/IEC 17025 to replace ISO/IEC Guide 25 ISO 17025 related Discussions 14
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How long does it take to register a product with MHRA? UK Medical Device Regulations 3
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4

Similar threads

Top Bottom