Regulatory Open Forum

Hi everyone,
Can anyone advise if it's ok to use an external power supply in a Class 2 Medical device comply with IEC 60950-1 only or it should comply with 60601-1

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Hello Yasser,

I will let our resident expert Leo address specifically, but from my understanding IEC 60950-1 is for a completely different type of mains power supply configuration, i.e. like powering telecom systems or network hubs.  I am not sure it is applicable to medical devices and believe you should use IEC 60601-1, though I guess it depends on exactly what actually is your external power supply and your medical device (maybe a large x-ray device might be appropriate).

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 01-Jul-2020 08:00
From: YASSER ESTAFANOUS
Subject: POwer supply for Medical Supply

Hi everyone,
Can anyone advise if it's ok to use an external power supply in a Class 2 Medical device comply with IEC 60950-1 only or it should comply with 60601-1

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Hi Yasser,

Thx Richard, I will take it from here.  Thx for the plug Richard.....

The product being a medical regulatory class 2 device has nothing to do with what standard the power supply is certified to.  

The first thing you need to do is to know the classification of your product per IEC 60601-1, edition 3.1 per clause 6.

1. Is the device powered from an external power supply and is the external power supply grounded?  Is the ground passed into the device to the secondary (goes across the isolation of the mains to the secondary of the power supply)?  Then the device is Class I.
2. Is the device powered from an external power supply and is the external power supply not grounded. Then the device is Class II.
3. If the device is powered by batteries alone then it is classified as internally powered.
4. Are there any APPLIED PARTS.  The definition of APPLIED PART is "part of ME EQUIPMENT (the device) that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function" and the beginning part of the ME EQUIPMENT definition is important because of the energy transfer aspect "electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT...", which links to the APPLIED PART definition.
5. Once you know if you have any APPLIED PARTS define each one if they are B, BF or CF. You could have more than one APPLIED PART & they each could be classified different type APPLIED PART classifications.  Type B is pretty rare nowadays.  B is not floating, F means it is an isolated (floating) APPLIED PART, and C means intended for cardiac region (provides the highest degree of leakage current protection to the patient of all 3 APPLIED PART classifications).
6. The rest of the classifications of clause 6 don't have impact on the isolation requirements for your device so we won't get into those in this discussion.

The next step is to put an isolation diagram together based on the classification information above. There are a lot of variables involved and based on voltages of the insulation (isolation) and the type of insulation so gets I can't answer your question based on the info above and even if you gave me the exact info I wouldn't be able to answer in this forum as would be a 5 - 10+ hour task which you would have to hire me to conduct :).  There are a lot of rules to follow as well, within the standard.  The isolation diagram & what I call the table of requirements will show you the required spacing (Air-Clearance and Creepage) and Dielectric requirements for each area of the required isolation.  If you put the isolation diagram & table of requirements for your device upfront instead of waiting for the test lab to do this is always best. That way you can design the product the way that best fits your product design instead of finding out at the last minute you may need to redesign your product as you don't meet the requirements of the standard. 

So, to answer your question sometimes you can use an IEC 60950-1 power supply for an IEC 60601-1 product but only in some cases.  Typically when the power supply is outside the patient environment and the product (preferred) and there is sufficient isolation between the area outside the patient environment to inside the patient environment (typically in the APPLIED PART).  There are just too many variables to get into here.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 01-Jul-2020 08:00
From: YASSER ESTAFANOUS
Subject: POwer supply for Medical Supply

Hi everyone,
Can anyone advise if it's ok to use an external power supply in a Class 2 Medical device comply with IEC 60950-1 only or it should comply with 60601-1

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Thanks Leo, I knew you had a much better explanation !  My only experience with that standard as you said was working with very large device where the power source was in a completely different room than the device - not anywhere near the patient.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 03-Jul-2020 00:59
From: Leonard Eisner
Subject: POwer supply for Medical Supply

Hi Yasser,

Thx Richard, I will take it from here.  Thx for the plug Richard.....

The product being a medical regulatory class 2 device has nothing to do with what standard the power supply is certified to.

The first thing you need to do is to know the classification of your product per IEC 60601-1, edition 3.1 per clause 6.

1. Is the device powered from an external power supply and is the external power supply grounded?  Is the ground passed into the device to the secondary (goes across the isolation of the mains to the secondary of the power supply)?  Then the device is Class I.
2. Is the device powered from an external power supply and is the external power supply not grounded. Then the device is Class II.
3. If the device is powered by batteries alone then it is classified as internally powered.
4. Are there any APPLIED PARTS.  The definition of APPLIED PART is "part of ME EQUIPMENT (the device) that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function" and the beginning part of the ME EQUIPMENT definition is important because of the energy transfer aspect "electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT...", which links to the APPLIED PART definition.
5. Once you know if you have any APPLIED PARTS define each one if they are B, BF or CF. You could have more than one APPLIED PART & they each could be classified different type APPLIED PART classifications.  Type B is pretty rare nowadays.  B is not floating, F means it is an isolated (floating) APPLIED PART, and C means intended for cardiac region (provides the highest degree of leakage current protection to the patient of all 3 APPLIED PART classifications).
6. The rest of the classifications of clause 6 don't have impact on the isolation requirements for your device so we won't get into those in this discussion.

The next step is to put an isolation diagram together based on the classification information above. There are a lot of variables involved and based on voltages of the insulation (isolation) and the type of insulation so gets I can't answer your question based on the info above and even if you gave me the exact info I wouldn't be able to answer in this forum as would be a 5 - 10+ hour task which you would have to hire me to conduct :).  There are a lot of rules to follow as well, within the standard.  The isolation diagram & what I call the table of requirements will show you the required spacing (Air-Clearance and Creepage) and Dielectric requirements for each area of the required isolation.  If you put the isolation diagram & table of requirements for your device upfront instead of waiting for the test lab to do this is always best. That way you can design the product the way that best fits your product design instead of finding out at the last minute you may need to redesign your product as you don't meet the requirements of the standard.

So, to answer your question sometimes you can use an IEC 60950-1 power supply for an IEC 60601-1 product but only in some cases.  Typically when the power supply is outside the patient environment and the product (preferred) and there is sufficient isolation between the area outside the patient environment to inside the patient environment (typically in the APPLIED PART).  There are just too many variables to get into here.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 01-Jul-2020 08:00
From: YASSER ESTAFANOUS
Subject: POwer supply for Medical Supply

Hi everyone,
Can anyone advise if it's ok to use an external power supply in a Class 2 Medical device comply with IEC 60950-1 only or it should comply with 60601-1

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Thanks, A lot for your very detailed answer 
The Device is Portable Oxygen concentrator, of course, has a rechargeable battery, the External power supply is grounded

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Original Message:
Sent: 03-Jul-2020 00:59
From: Leonard Eisner
Subject: POwer supply for Medical Supply

Hi Yasser,

Thx Richard, I will take it from here.  Thx for the plug Richard.....

The product being a medical regulatory class 2 device has nothing to do with what standard the power supply is certified to.

The first thing you need to do is to know the classification of your product per IEC 60601-1, edition 3.1 per clause 6.

1. Is the device powered from an external power supply and is the external power supply grounded?  Is the ground passed into the device to the secondary (goes across the isolation of the mains to the secondary of the power supply)?  Then the device is Class I.
2. Is the device powered from an external power supply and is the external power supply not grounded. Then the device is Class II.
3. If the device is powered by batteries alone then it is classified as internally powered.
4. Are there any APPLIED PARTS.  The definition of APPLIED PART is "part of ME EQUIPMENT (the device) that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function" and the beginning part of the ME EQUIPMENT definition is important because of the energy transfer aspect "electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT...", which links to the APPLIED PART definition.
5. Once you know if you have any APPLIED PARTS define each one if they are B, BF or CF. You could have more than one APPLIED PART & they each could be classified different type APPLIED PART classifications.  Type B is pretty rare nowadays.  B is not floating, F means it is an isolated (floating) APPLIED PART, and C means intended for cardiac region (provides the highest degree of leakage current protection to the patient of all 3 APPLIED PART classifications).
6. The rest of the classifications of clause 6 don't have impact on the isolation requirements for your device so we won't get into those in this discussion.

The next step is to put an isolation diagram together based on the classification information above. There are a lot of variables involved and based on voltages of the insulation (isolation) and the type of insulation so gets I can't answer your question based on the info above and even if you gave me the exact info I wouldn't be able to answer in this forum as would be a 5 - 10+ hour task which you would have to hire me to conduct :).  There are a lot of rules to follow as well, within the standard.  The isolation diagram & what I call the table of requirements will show you the required spacing (Air-Clearance and Creepage) and Dielectric requirements for each area of the required isolation.  If you put the isolation diagram & table of requirements for your device upfront instead of waiting for the test lab to do this is always best. That way you can design the product the way that best fits your product design instead of finding out at the last minute you may need to redesign your product as you don't meet the requirements of the standard.

So, to answer your question sometimes you can use an IEC 60950-1 power supply for an IEC 60601-1 product but only in some cases.  Typically when the power supply is outside the patient environment and the product (preferred) and there is sufficient isolation between the area outside the patient environment to inside the patient environment (typically in the APPLIED PART).  There are just too many variables to get into here.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 01-Jul-2020 08:00
From: YASSER ESTAFANOUS
Subject: POwer supply for Medical Supply

Hi everyone,
Can anyone advise if it's ok to use an external power supply in a Class 2 Medical device comply with IEC 60950-1 only or it should comply with 60601-1

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Hi Yasser, 

With all the good advice already provided by experts, I would suggest to look at IEC 62368-1 since it will replace IEC 60950-1 by December 20, 2020 in EU and if I am right then in US at the same time too. 

So, if you are selecting a Class II power supply at this moment, it should be tested for IEC 62368-1.



------------------------------
Saqib Tanweer
Manager QA/RA
Toronto ON
Canada
------------------------------

Original Message:
Sent: 04-Jul-2020 10:04
From: YASSER ESTAFANOUS
Subject: POwer supply for Medical Supply

Thanks, A lot for your very detailed answer
The Device is Portable Oxygen concentrator, of course, has a rechargeable battery, the External power supply is grounded

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States

Original Message:
Sent: 03-Jul-2020 00:59
From: Leonard Eisner
Subject: POwer supply for Medical Supply

Hi Yasser,

Thx Richard, I will take it from here.  Thx for the plug Richard.....

The product being a medical regulatory class 2 device has nothing to do with what standard the power supply is certified to.

The first thing you need to do is to know the classification of your product per IEC 60601-1, edition 3.1 per clause 6.

1. Is the device powered from an external power supply and is the external power supply grounded?  Is the ground passed into the device to the secondary (goes across the isolation of the mains to the secondary of the power supply)?  Then the device is Class I.
2. Is the device powered from an external power supply and is the external power supply not grounded. Then the device is Class II.
3. If the device is powered by batteries alone then it is classified as internally powered.
4. Are there any APPLIED PARTS.  The definition of APPLIED PART is "part of ME EQUIPMENT (the device) that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function" and the beginning part of the ME EQUIPMENT definition is important because of the energy transfer aspect "electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT...", which links to the APPLIED PART definition.
5. Once you know if you have any APPLIED PARTS define each one if they are B, BF or CF. You could have more than one APPLIED PART & they each could be classified different type APPLIED PART classifications.  Type B is pretty rare nowadays.  B is not floating, F means it is an isolated (floating) APPLIED PART, and C means intended for cardiac region (provides the highest degree of leakage current protection to the patient of all 3 APPLIED PART classifications).
6. The rest of the classifications of clause 6 don't have impact on the isolation requirements for your device so we won't get into those in this discussion.

The next step is to put an isolation diagram together based on the classification information above. There are a lot of variables involved and based on voltages of the insulation (isolation) and the type of insulation so gets I can't answer your question based on the info above and even if you gave me the exact info I wouldn't be able to answer in this forum as would be a 5 - 10+ hour task which you would have to hire me to conduct :).  There are a lot of rules to follow as well, within the standard.  The isolation diagram & what I call the table of requirements will show you the required spacing (Air-Clearance and Creepage) and Dielectric requirements for each area of the required isolation.  If you put the isolation diagram & table of requirements for your device upfront instead of waiting for the test lab to do this is always best. That way you can design the product the way that best fits your product design instead of finding out at the last minute you may need to redesign your product as you don't meet the requirements of the standard.

So, to answer your question sometimes you can use an IEC 60950-1 power supply for an IEC 60601-1 product but only in some cases.  Typically when the power supply is outside the patient environment and the product (preferred) and there is sufficient isolation between the area outside the patient environment to inside the patient environment (typically in the APPLIED PART).  There are just too many variables to get into here.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 01-Jul-2020 08:00
From: YASSER ESTAFANOUS
Subject: POwer supply for Medical Supply

Hi everyone,
Can anyone advise if it's ok to use an external power supply in a Class 2 Medical device comply with IEC 60950-1 only or it should comply with 60601-1

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------

Depends on configuration of the system if an IEC 62368-1 power supply will be a good selection.  You need to know the isolation of the individual aspects of the system / device and that will determine if you need to use an IEC 60601-1 or an IEC 62368-1 or IEC 609501-1 power supply.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 07-Jul-2020 12:44
From: Saqib Tanweer
Subject: POwer supply for Medical Supply

Hi Yasser,

With all the good advice already provided by experts, I would suggest to look at IEC 62368-1 since it will replace IEC 60950-1 by December 20, 2020 in EU and if I am right then in US at the same time too.

So, if you are selecting a Class II power supply at this moment, it should be tested for IEC 62368-1.



------------------------------
Saqib Tanweer
Manager QA/RA
Toronto ON
Canada

Original Message:
Sent: 04-Jul-2020 10:04
From: YASSER ESTAFANOUS
Subject: POwer supply for Medical Supply

Thanks, A lot for your very detailed answer
The Device is Portable Oxygen concentrator, of course, has a rechargeable battery, the External power supply is grounded

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States

Original Message:
Sent: 03-Jul-2020 00:59
From: Leonard Eisner
Subject: POwer supply for Medical Supply

Hi Yasser,

Thx Richard, I will take it from here.  Thx for the plug Richard.....

The product being a medical regulatory class 2 device has nothing to do with what standard the power supply is certified to.

The first thing you need to do is to know the classification of your product per IEC 60601-1, edition 3.1 per clause 6.

1. Is the device powered from an external power supply and is the external power supply grounded?  Is the ground passed into the device to the secondary (goes across the isolation of the mains to the secondary of the power supply)?  Then the device is Class I.
2. Is the device powered from an external power supply and is the external power supply not grounded. Then the device is Class II.
3. If the device is powered by batteries alone then it is classified as internally powered.
4. Are there any APPLIED PARTS.  The definition of APPLIED PART is "part of ME EQUIPMENT (the device) that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function" and the beginning part of the ME EQUIPMENT definition is important because of the energy transfer aspect "electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT...", which links to the APPLIED PART definition.
5. Once you know if you have any APPLIED PARTS define each one if they are B, BF or CF. You could have more than one APPLIED PART & they each could be classified different type APPLIED PART classifications.  Type B is pretty rare nowadays.  B is not floating, F means it is an isolated (floating) APPLIED PART, and C means intended for cardiac region (provides the highest degree of leakage current protection to the patient of all 3 APPLIED PART classifications).
6. The rest of the classifications of clause 6 don't have impact on the isolation requirements for your device so we won't get into those in this discussion.

The next step is to put an isolation diagram together based on the classification information above. There are a lot of variables involved and based on voltages of the insulation (isolation) and the type of insulation so gets I can't answer your question based on the info above and even if you gave me the exact info I wouldn't be able to answer in this forum as would be a 5 - 10+ hour task which you would have to hire me to conduct :).  There are a lot of rules to follow as well, within the standard.  The isolation diagram & what I call the table of requirements will show you the required spacing (Air-Clearance and Creepage) and Dielectric requirements for each area of the required isolation.  If you put the isolation diagram & table of requirements for your device upfront instead of waiting for the test lab to do this is always best. That way you can design the product the way that best fits your product design instead of finding out at the last minute you may need to redesign your product as you don't meet the requirements of the standard.

So, to answer your question sometimes you can use an IEC 60950-1 power supply for an IEC 60601-1 product but only in some cases.  Typically when the power supply is outside the patient environment and the product (preferred) and there is sufficient isolation between the area outside the patient environment to inside the patient environment (typically in the APPLIED PART).  There are just too many variables to get into here.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 01-Jul-2020 08:00
From: YASSER ESTAFANOUS
Subject: POwer supply for Medical Supply

Hi everyone,
Can anyone advise if it's ok to use an external power supply in a Class 2 Medical device comply with IEC 60950-1 only or it should comply with 60601-1

------------------------------
YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
------------------------------