Do all Class 1 Medical Devices (Electrical) have to comply with IEC60601-1?

C

curiousone

#1
Hi all-
I am a little confused, do all class 1 medical devices (electrical) have to comply with IEC60601-1? My understanding is that Class 1 do not as long as they are non-invasive and do not come in contact with the patient.
Also, do they need to have EMI testing done, or is this for Class 2 and higher?
I thank you in advance for your help.:thanx:
 
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P

PaulGr

#2
Re: IEC 60601-1 3rd Edition Certification - New Products Only?

I assume you are asking about European regulations (MDD)? Manufacturers must be able to show compliance with the MDD essential requirements for all medical devices including class 1. To show compliance, reference to harmonized standards is expected including 60601-1 and 60601-1-2.

Using these standards is not mandatory and you can document an alternative way to show compliance with the essential requirements. So the formal answer to your question is no. However, for both standards, I have not yet seen examples of alternative approaches...

Anyone else?

Paul
 

Peter Selvey

Staff member
Super Moderator
#3
As far as documenting compliance with standards, there is no difference for Class I, I*, IIa, IIb and III. For electrical medical equipment that contacts the patient (or exchanges energy), EN 60601-1, EN 60601-1-2 and all the other applicable harmonized standards should be used irrespective of the device classification.

The different classes only changes the amount of third party review by a notified body. For Class I, in general there is no review. For Class I* (which includes devices with measurement and/or sterile parts) and above, a certificate is required which acts as evidence of third party review.

Also note that while no standard is mandatory, the path for not using a standard still involves checking every individual clause and requirement, and providing an alternate solution if the device does not comply with that particular requirement. So it's impossible to ignore a standard altogether and practically the "alternate solution" is only used for rare individual clauses that have some special reason why compliance is difficult, not for whole standards.
 
C

curiousone

#4
Peter and Paul,
Thank you for your insight. I am not worried about the classification as I am about the requirement for testing. The device in question is a Class 1 device that does not come in contact with the patient, nor does it supply energy to the patient. The device itself has no contact with the patient. I was curious if IEC60601-1 applies to this device or would the Low Voltage Directive show compliance to the ER's? :bonk:
 
#5
60601-1 (and 60601-1-2) apply to all classes of electrical medical device.

However your device, with no applied parts and not suppling energy, will be exempt from many (but not all) of the clauses within the standard.

If you need to have a test lab involved you will need to go through the standard(s) beforehand to identify the clauses that do not apply; otherwise you will be paying them a lot of money to do non-relevant testing.
 
S

SteveK

#6
Pads is right on the issue with test houses, if the device is as indicated lots of clauses (probably 60+%) will be N/A and you could do the relevant testing yourself (apart from EMC) e.g. rub test (7.1.3). Lots of the clauses will be covered in other parts of a TF i.e. Risk Management File, IFU, Usability File as well as just being statements of fact e.g. address/item label present (7.2.2), symbol used (7.6.2), colour of indicator lights (7.8.1) etc. Oh, and do not mix up directives. A medical device is covered by the MDD, the LV Directive is for non-medical products.:2cents:
 
C

curiousone

#7
Pads and Steve,
Many thanks for the information. Here is a question for you; the device in question is used to heat water for moist heat therapy packs (like a hydrocollator). Would this still be considered a medical device then?
Regardless, we will need to purchase the Standard then? :notme:
 
S

SteveK

#8
Not really familiar with these water heaters/therapy pack combinations - but a quick Google certainly shows a Hydrocollator System that has been tested to UL 60601-1 by a medical device (ISO 13485) company. Does that make it a medical device? I am not 100% sure - you could just stick these therapy packs in a pan of hot water. Does that make a pan a medical device?

Steve
 
R

RA gal

#9
I would suggest starting with your intended use (from your own labeling/IFU). Then, refer to Article 1 of the MDD to determine if your product is a medical device. It is basically up to the manufacturer to decide. However, if you are indeed making a medical device, ALL devices, no matter their classification, are required to meet the Essential Requirements in Annex I, which includes electrical safety. There are also definitions in Annex IX which explain what constitutes an "active" device. Hope this helps!
 

Peter Selvey

Staff member
Super Moderator
#10
First the issue of whether it is a medical device: it depends on the intended purpose in the instructions for use and advertising. Is a pen a medical device if it is used to record diagnostic information? In general no, because the pen manufacturer does not state such a purpose, but it is possible if the manufacturer claimed the pen to be specially made for medical use. Same deal for the heater for therapeutic packs: it will depend on the IFU and advertising.

Next, I would disagree in principle with the application of EN 60601-1. If there is no contact or exchange of energy with the patient, EN 60601-1 does not apply. The definition of "medical electrical equipment" does not include such equipment, and the scope clause clearly says this.

There are many examples of electrical medical devices under the MDD where EN 60601-1 does not apply. For example, a printer for X-ray film, a sterilizer, endoscope washing device.

For these devices, there is no harmonized standard, however IEC 60950-1 (for IT equipment) or IEC 61010-1 (for laboratory equipment) are appropriate. For a heater it seems IEC 61010-1 might be appropriate.

It is common practice to use EN/IEC 60601-1 out of scope (e.g. by UL) and it might be convenient to do so. The market is confused about the correct standard. But keep in mind it is the wrong standard and may expose all parties to some liablity.
 
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