F

failsafe

Guest
#1
Hello Everyone,
I am new to working with medical equipment regulations. That being said, I am helping with UL-60601, ISO13485, and ISO 14971 certification at my company. The eventual goal is to obtain our CE mark. We are currently FDA listed and FCC class A certified.

My question is regarding electrical safety testing for medical equipment. Specifically, what exactly are the required tests and what products on the market will help me fulfill those requirements.

First let me give you a brief overview of our product.

  • The product we produce is mains powered with a non-detachable power cord. Currently we power our equipment off of 240V AC.
    The majority of the electronics and power equipment (isolation transformer, fuses, circuit breakers, relays etc..) are located in a large painted metal box that is mounted to the wall. The lid of the metal box is locked and only accessible by qualified maintenance personnel.
  • The product never actually touches the patient. It is pretty much a patient lift. The only connection to the patient is a rope and harness.
  • We install our products at medical facilities and we make it mandatory that we service them once a year.

I am looking to comply with UL60601-1 electrical safety testing requirements for every product we produce. Heres a list of question regarding that:


  1. Is there a list of all of the types of electrical testing that needs to be done?
    example: Insulation testing, ground bond, etc...
    I have looked at UL-60601-1, but find it a bit confusing and overwhelming.
    A simple of list of required test and acceptable limits would be great.
  2. Any recommendations on which products to purchase in order to comply to those test?
    I have looked at: Fluke 175 Electrical Safety Tester, Fluke ESA612 Electrical Safety Analyzer, Rigel 266 Plus, Rigel SafeTest Manufacturing, and the LKG 601 Electrical Safety Analyzer. Also, I have looked at numerous Hi-Pot testers.

    The problem is that prices are all over the place, except cheap. I don't want to purchase something I don't need or won't guarantee compliance.
  3. From what I can gather some electrical safety testers just measure leakage current and resistance where others also provide for insulation testing. Is it better to purchase a traditional Hi-Pot for insulation testing and purchase a "passive" electrical safety tester to do the other tests. Note: An example of a "passive" tester ,in my mind, would be the Fluke 175 Electrical Safety Analyzer. Or is it better to buy an all in one unit like the Rigel 266 Plus?

    Also, it seems that ground bond testing is specific to medical equipment. This, I was told, would make the "Rigel SafeTest Manufacturing" a poor choice choice because it did not meet that requirement. What should I look for to make sure I purchase the equipment that satisfies the ground bond test?
  4. We service our equipment once a year. Do we need to (or should we) perform electrical safety testing on our installed equipment? If so, (I am guessing the answer is yes) should I look for equipment that is UL60601 certified or should I look for IEC 62353 rated equipment?

Thank you to anyone and everyone that took the time to read my long post. I greatly appreciate it. I look forward to hearing from the experts.
 

SteveK

Quite Involved in Discussions
#3
Maybe the starting point is to get the device tested and certified by an independent test house to 60601-1. They should then issue a clause by clause test report – applicable or n/a as the case maybe. This should include what test instruments were used in each case – well in an ideal world. Obviously not a cheap approach (there being nothing to stop you self testing of course) but considering the complexity of the standard, especially the 3rd edition (and possibly your device) it may be prudent. I have prepared such a report by myself, but it is for a fairly simple non-patient contact 12V device. Most of the clauses I have indicated are n/a. I have not submitted this to our NB yet, so whether I have got it right or not (being no electronics expert) I will find out shortly (having EMC testing conducted – which is applicable for this device – by an external test lab. - at a price!). As per applicable tests you should conduct e.g. for product release or servicing (once certified to the standard) then I think that would be up to you (as in the examples you indicate).

I don’t know if this helps any – but nobody else has chipped in thus far!

Steve
 
F

failsafe

Guest
#5
Thanks Steve,
We are planning to get certified to 60601-1, but we are first getting IOS13485 and ISO14971 certified. I was hoping to purchase the testing equipment before 60601. That way I can include the testing procedures in our "Final Acceptance Inspection" procedure, and our "Service and Installation" procedure.

Also, I have some idea of what tests are required but not the full picture.

  • We are definitely going to need to do insulation testing due to the product being main powered with basic installation.


  • We are definitely going to need to do leakage current and touch current due to the product using a metal enclosure.
Other tests I am not too sure about though.

Its hard to determine the best equipment to purchase because every salesperson tells me their product is the best.

  • Anyone using a HI-Pot, leakage current detector, and/or Electrical Safety Analyzer?

  • Do you like your equipment? Any recommendations?

Also, what is the requirements regarding electrical testing of medical equipment after it is sold and installed.
 

Pads38

Quite Involved in Discussions
#6
It might be worth working out whether you are trying to do "Type Approval" testing or whether you are looking at routine and production tests.

The standard IEC 62353 is good guidance for Recurrent Testing and Test after repair. Rigel produce a small booklet called "A Practical Guide to IEC 62353" which is worth a look.

We use Rigel testers for all the leakage current tests and earth bond tests. The one we use (277 IIRC) allows both manual tests (helps to precisely control each test) and programmed semi-auto (good for production). I think Fluke do similar testers.

I would suggest that measurements of earth bond and leakage currents are required on every unit, at time of manufacture, and at every service. (As suggested by 62353). Hi-pot tests are more part of the Type Approval (although we do an abbreviated test on all units when first manufactured.)
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#7
Hello Everyone,
I am new to working with medical equipment regulations. That being said, I am helping with UL-60601, ISO13485, and ISO 14971 certification at my company. The eventual goal is to obtain our CE mark. We are currently FDA listed and FCC class A certified.

My question is regarding electrical safety testing for medical equipment. Specifically, what exactly are the required tests and what products on the market will help me fulfill those requirements.

First let me give you a brief overview of our product.

  • The product we produce is mains powered with a non-detachable power cord. Currently we power our equipment off of 240V AC.
    The majority of the electronics and power equipment (isolation transformer, fuses, circuit breakers, relays etc..) are located in a large painted metal box that is mounted to the wall. The lid of the metal box is locked and only accessible by qualified maintenance personnel.
  • The product never actually touches the patient. It is pretty much a patient lift. The only connection to the patient is a rope and harness.
  • We install our products at medical facilities and we make it mandatory that we service them once a year.

I am looking to comply with UL60601-1 electrical safety testing requirements for every product we produce. Heres a list of question regarding that:


  1. Is there a list of all of the types of electrical testing that needs to be done?
    example: Insulation testing, ground bond, etc...
    I have looked at UL-60601-1, but find it a bit confusing and overwhelming.
    A simple of list of required test and acceptable limits would be great.
  2. Any recommendations on which products to purchase in order to comply to those test?
    I have looked at: Fluke 175 Electrical Safety Tester, Fluke ESA612 Electrical Safety Analyzer, Rigel 266 Plus, Rigel SafeTest Manufacturing, and the LKG 601 Electrical Safety Analyzer. Also, I have looked at numerous Hi-Pot testers.

    The problem is that prices are all over the place, except cheap. I don't want to purchase something I don't need or won't guarantee compliance.
  3. From what I can gather some electrical safety testers just measure leakage current and resistance where others also provide for insulation testing. Is it better to purchase a traditional Hi-Pot for insulation testing and purchase a "passive" electrical safety tester to do the other tests. Note: An example of a "passive" tester ,in my mind, would be the Fluke 175 Electrical Safety Analyzer. Or is it better to buy an all in one unit like the Rigel 266 Plus?

    Also, it seems that ground bond testing is specific to medical equipment. This, I was told, would make the "Rigel SafeTest Manufacturing" a poor choice choice because it did not meet that requirement. What should I look for to make sure I purchase the equipment that satisfies the ground bond test?
  4. We service our equipment once a year. Do we need to (or should we) perform electrical safety testing on our installed equipment? If so, (I am guessing the answer is yes) should I look for equipment that is UL60601 certified or should I look for IEC 62353 rated equipment?

Thank you to anyone and everyone that took the time to read my long post. I greatly appreciate it. I look forward to hearing from the experts.
If you seek testing, I recommend seeking a laboratory accredited to ISO/IEC 17025:2005 with IEC 60101-1 (and the other product specific standards) in the technical scope. Then you can be more confident regarding the results.

One additional note for that, pay attention to any specific exclusions that may be in the scope. An example may be IEC 60101-1 3rd edition except Section 10 (radiation).
 
F

failsafe

Guest
#8
I just wanted to let you guys know that I appreciate all the advice.
I will look into your suggestions.
Thanks again.
 
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