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