Regulatory Open Forum

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.  

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

Hello Dawn,

I would recommend inquiring with the testing laboratory who completed your EMC/EMD testing as they would be most knowledgeable.  Members of IECEE / IEC are typically those participating, unfortunately I do not know of a central list somewhere of which countries or national authorities are participating in CB Scheme.  Again, your testing laboratory should be able to help with any country deviations where you are planning to market the finished device.

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

Original Message:
Sent: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

The CB Scheme certificate is something you always want to take advantage of.  It streamlines the process of product registration.  I know working with CSA, we would tell them what countries we wanted coverage for and they would ensure the CB Scheme covered all those countries (provided the country on the list is part of the CB Scheme).

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
------------------------------

Original Message:
Sent: 10-Feb-2021 05:06
From: Richard Vincins
Subject: CB Scheme - which countries is this required for

Hello Dawn,

I would recommend inquiring with the testing laboratory who completed your EMC/EMD testing as they would be most knowledgeable.  Members of IECEE / IEC are typically those participating, unfortunately I do not know of a central list somewhere of which countries or national authorities are participating in CB Scheme.  Again, your testing laboratory should be able to help with any country deviations where you are planning to market the finished device.

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

Original Message:
Sent: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

Hi Al,

When you say ,'It streamlines the process of product registration', is CB certification , a requirement of registration for any of the countries ?

Regards,

Rashmi

------------------------------
Rashmi
------------------------------

Original Message:
Sent: 11-Feb-2021 09:29
From: Al Van Houdt
Subject: CB Scheme - which countries is this required for

The CB Scheme certificate is something you always want to take advantage of.  It streamlines the process of product registration.  I know working with CSA, we would tell them what countries we wanted coverage for and they would ensure the CB Scheme covered all those countries (provided the country on the list is part of the CB Scheme).

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 10-Feb-2021 05:06
From: Richard Vincins
Subject: CB Scheme - which countries is this required for

Hello Dawn,

I would recommend inquiring with the testing laboratory who completed your EMC/EMD testing as they would be most knowledgeable.  Members of IECEE / IEC are typically those participating, unfortunately I do not know of a central list somewhere of which countries or national authorities are participating in CB Scheme.  Again, your testing laboratory should be able to help with any country deviations where you are planning to market the finished device.

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

Original Message:
Sent: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

Hello,
Russia and Belarus are included in the list of countries included in CB scheme. Hoever Russia requires all the testing to be redone in our national local labs. Local labs will ask manufacturer's reports, but they always ask EMC reports and (if applicable) test reports covering some other standards.There is limited number of labs dealing with medical equipment in Russia, and they might not be accustomed working with CB scheme reports. They are not that well advanced as labs working with other types of elictric equipment.) So it would make no sense for my region to spend extra effort for obtaining this additional reports, though we are on the list.
Oksana

------------------------------
Oksana Kolosova
Moscow
------------------------------

Original Message:
Sent: 13-Feb-2021 01:17
From: Rashmi Pillay
Subject: CB Scheme - which countries is this required for

Hi Al,

When you say ,'It streamlines the process of product registration', is CB certification , a requirement of registration for any of the countries ?

Regards,

Rashmi

------------------------------
Rashmi

Original Message:
Sent: 11-Feb-2021 09:29
From: Al Van Houdt
Subject: CB Scheme - which countries is this required for

The CB Scheme certificate is something you always want to take advantage of.  It streamlines the process of product registration.  I know working with CSA, we would tell them what countries we wanted coverage for and they would ensure the CB Scheme covered all those countries (provided the country on the list is part of the CB Scheme).

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 10-Feb-2021 05:06
From: Richard Vincins
Subject: CB Scheme - which countries is this required for

Hello Dawn,

I would recommend inquiring with the testing laboratory who completed your EMC/EMD testing as they would be most knowledgeable.  Members of IECEE / IEC are typically those participating, unfortunately I do not know of a central list somewhere of which countries or national authorities are participating in CB Scheme.  Again, your testing laboratory should be able to help with any country deviations where you are planning to market the finished device.

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

Original Message:
Sent: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

Thank you everyone - this is all very useful information.

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

Original Message:
Sent: 15-Feb-2021 14:12
From: Oksana Kolosova
Subject: CB Scheme - which countries is this required for

Hello,
Russia and Belarus are included in the list of countries included in CB scheme. Hoever Russia requires all the testing to be redone in our national local labs. Local labs will ask manufacturer's reports, but they always ask EMC reports and (if applicable) test reports covering some other standards.There is limited number of labs dealing with medical equipment in Russia, and they might not be accustomed working with CB scheme reports. They are not that well advanced as labs working with other types of elictric equipment.) So it would make no sense for my region to spend extra effort for obtaining this additional reports, though we are on the list.
Oksana

------------------------------
Oksana Kolosova
Moscow

Original Message:
Sent: 13-Feb-2021 01:17
From: Rashmi Pillay
Subject: CB Scheme - which countries is this required for

Hi Al,

When you say ,'It streamlines the process of product registration', is CB certification , a requirement of registration for any of the countries ?

Regards,

Rashmi

------------------------------
Rashmi

Original Message:
Sent: 11-Feb-2021 09:29
From: Al Van Houdt
Subject: CB Scheme - which countries is this required for

The CB Scheme certificate is something you always want to take advantage of.  It streamlines the process of product registration.  I know working with CSA, we would tell them what countries we wanted coverage for and they would ensure the CB Scheme covered all those countries (provided the country on the list is part of the CB Scheme).

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 10-Feb-2021 05:06
From: Richard Vincins
Subject: CB Scheme - which countries is this required for

Hello Dawn,

I would recommend inquiring with the testing laboratory who completed your EMC/EMD testing as they would be most knowledgeable.  Members of IECEE / IEC are typically those participating, unfortunately I do not know of a central list somewhere of which countries or national authorities are participating in CB Scheme.  Again, your testing laboratory should be able to help with any country deviations where you are planning to market the finished device.

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

Original Message:
Sent: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

CB Scheme is voluntary.  It is not a requirement of Product Registration anywhere.  Having said that, when you provide proof of safety testing and you give them a CSA test report, don't be surprised if they ask you how have you have covered the national deviations to say IEC 60601-1?

With a CB scheme report that covers that specific country, there are no more questions.  The test report is accepted.


------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
------------------------------

Original Message:
Sent: 13-Feb-2021 01:17
From: Rashmi Pillay
Subject: CB Scheme - which countries is this required for

Hi Al,

When you say ,'It streamlines the process of product registration', is CB certification , a requirement of registration for any of the countries ?

Regards,

Rashmi

------------------------------
Rashmi

Original Message:
Sent: 11-Feb-2021 09:29
From: Al Van Houdt
Subject: CB Scheme - which countries is this required for

The CB Scheme certificate is something you always want to take advantage of.  It streamlines the process of product registration.  I know working with CSA, we would tell them what countries we wanted coverage for and they would ensure the CB Scheme covered all those countries (provided the country on the list is part of the CB Scheme).

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 10-Feb-2021 05:06
From: Richard Vincins
Subject: CB Scheme - which countries is this required for

Hello Dawn,

I would recommend inquiring with the testing laboratory who completed your EMC/EMD testing as they would be most knowledgeable.  Members of IECEE / IEC are typically those participating, unfortunately I do not know of a central list somewhere of which countries or national authorities are participating in CB Scheme.  Again, your testing laboratory should be able to help with any country deviations where you are planning to market the finished device.

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

Original Message:
Sent: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

CB Scheme does cover EMC testing but I have never seen anyone ever use it and I have never seen a test lab use it.  Even as a product reviewer I have not seen test reports from EMC labs that have ever been CB Scheme reports. 
CB Scheme covers IEC 60601-1, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12, in a way covers but not in the certificate IEC 62304 & 62366 & soon to be 62366-1.  For 62366-1 it will happen when the new version of IEC 60601-1 & 60601-1-6 are added into the Risk Management File Portion of the Test Report Forms or Procedures issued by the Risk Management Group of ETF-3 (a part of the CB Scheme) which I am a member of - we will start working on this process hopefully soon but the new versions of 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12 only came out in July - Sept '20 so will take a while before we get this all done.  Also, the CB scheme covers the Particular standards IEC 60601-2-XX and IEC/ISO 80601-2-XX.  The list of countries that are included in the CB scheme are on the IECEE website but I would not include Pakistan & Nigeria as they are not included in the voting members list.  You need to test in one country lab say UL in the US (I'm not recommending any lab just a for instance case) and pass all the testing get a CB scheme test report and certificate from that lab.  You would also ask them to get a CB scheme test report with national deviations for all countries you are interested in, if national deviations applies for that country.  Some countries have national deviations some don't.  In the medical field, it doesn't make sense in most cases to send your product to another countries test lab to get another safety mark like it does for computer equipment.  If you look at power supplies for computers you will see a lot of safety certification marks because they get certifications for ITE (computer equipment).  But if you look at medical device certifications you will rarely see more than one certification mark.  The main reason is most medical devices have to go through a regulatory approval process for one or more countries or has a regulatory body it has to deal with at some point in it's life cycle so it doesn't make sense to get additional safety certification marks.

Hope this helps clarify the CB scheme some.


------------------------------
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: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

All stories are right that CB is voluntary and that it is not widely used for EMC. Here at Philips we do use CB for EMC reporting in cooperation with CSA as our CBTL and NCB. I'm not saying its an easy regulatory pathway, but now we've gone through the process of getting high quality CB reports for EMC (and basic safety), we've been able to get our products to some markets quicker than we were used to because e.g. one of the most critical countries has accepted our reports without requiring additional in-country or oversea witness testing. It did require us to involve the local key-markets early in the process and diligently take the national differences into account and list them in the CB reports. This did include the 'mandatory' non-written national differences.
Carefully check the IECEE website for countries and standards within the CB scope, since not al countries listed to accept CB will accept CB for the medical standards. In order to be succesful, you really need a close cooperation with your CBTL.

------------------------------
Rob Kleihorst
System Designer / EMC Lead
Best
Netherlands
------------------------------

Original Message:
Sent: 14-Feb-2021 15:14
From: Leonard Eisner
Subject: CB Scheme - which countries is this required for

CB Scheme does cover EMC testing but I have never seen anyone ever use it and I have never seen a test lab use it.  Even as a product reviewer I have not seen test reports from EMC labs that have ever been CB Scheme reports.
CB Scheme covers IEC 60601-1, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12, in a way covers but not in the certificate IEC 62304 & 62366 & soon to be 62366-1.  For 62366-1 it will happen when the new version of IEC 60601-1 & 60601-1-6 are added into the Risk Management File Portion of the Test Report Forms or Procedures issued by the Risk Management Group of ETF-3 (a part of the CB Scheme) which I am a member of - we will start working on this process hopefully soon but the new versions of 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12 only came out in July - Sept '20 so will take a while before we get this all done.  Also, the CB scheme covers the Particular standards IEC 60601-2-XX and IEC/ISO 80601-2-XX.  The list of countries that are included in the CB scheme are on the IECEE website but I would not include Pakistan & Nigeria as they are not included in the voting members list.  You need to test in one country lab say UL in the US (I'm not recommending any lab just a for instance case) and pass all the testing get a CB scheme test report and certificate from that lab.  You would also ask them to get a CB scheme test report with national deviations for all countries you are interested in, if national deviations applies for that country.  Some countries have national deviations some don't.  In the medical field, it doesn't make sense in most cases to send your product to another countries test lab to get another safety mark like it does for computer equipment.  If you look at power supplies for computers you will see a lot of safety certification marks because they get certifications for ITE (computer equipment).  But if you look at medical device certifications you will rarely see more than one certification mark.  The main reason is most medical devices have to go through a regulatory approval process for one or more countries or has a regulatory body it has to deal with at some point in it's life cycle so it doesn't make sense to get additional safety certification marks.

Hope this helps clarify the CB scheme some.


------------------------------
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: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

Rob - I just checked the IECEE CB scheme website for IEC 60601-1-2, ed. 4.1 (standard issued Sept 1, 2020) for the Test Report Form but it has not been issued yet.  I was wondering if you have heard of any EMC CB scheme test labs that are able to meet all the EM Disturbance Tests of this newest version of the standard as there are the new RFDID tests which many EMC test labs that don't have the equipment to conduct the tests that I am aware of.  In the US there are some test labs that are aware of these tests as the FDA has insisted on a super set of AIM 7351731 RFID tests compared to what is in IEC 60601-1-2, ed. 4.1.  We are hoping with the FDA accepting this standard as a Recognized Consensus Standard in their db since the end of Dec 2020 they back off on the full list of AIM 7351731 RFID tests.


------------------------------
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: 17-Feb-2021 02:47
From: Rob Kleihorst
Subject: CB Scheme - which countries is this required for

All stories are right that CB is voluntary and that it is not widely used for EMC. Here at Philips we do use CB for EMC reporting in cooperation with CSA as our CBTL and NCB. I'm not saying its an easy regulatory pathway, but now we've gone through the process of getting high quality CB reports for EMC (and basic safety), we've been able to get our products to some markets quicker than we were used to because e.g. one of the most critical countries has accepted our reports without requiring additional in-country or oversea witness testing. It did require us to involve the local key-markets early in the process and diligently take the national differences into account and list them in the CB reports. This did include the 'mandatory' non-written national differences.
Carefully check the IECEE website for countries and standards within the CB scope, since not al countries listed to accept CB will accept CB for the medical standards. In order to be succesful, you really need a close cooperation with your CBTL.

------------------------------
Rob Kleihorst
System Designer / EMC Lead
Best
Netherlands

Original Message:
Sent: 14-Feb-2021 15:14
From: Leonard Eisner
Subject: CB Scheme - which countries is this required for

CB Scheme does cover EMC testing but I have never seen anyone ever use it and I have never seen a test lab use it.  Even as a product reviewer I have not seen test reports from EMC labs that have ever been CB Scheme reports.
CB Scheme covers IEC 60601-1, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12, in a way covers but not in the certificate IEC 62304 & 62366 & soon to be 62366-1.  For 62366-1 it will happen when the new version of IEC 60601-1 & 60601-1-6 are added into the Risk Management File Portion of the Test Report Forms or Procedures issued by the Risk Management Group of ETF-3 (a part of the CB Scheme) which I am a member of - we will start working on this process hopefully soon but the new versions of 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12 only came out in July - Sept '20 so will take a while before we get this all done.  Also, the CB scheme covers the Particular standards IEC 60601-2-XX and IEC/ISO 80601-2-XX.  The list of countries that are included in the CB scheme are on the IECEE website but I would not include Pakistan & Nigeria as they are not included in the voting members list.  You need to test in one country lab say UL in the US (I'm not recommending any lab just a for instance case) and pass all the testing get a CB scheme test report and certificate from that lab.  You would also ask them to get a CB scheme test report with national deviations for all countries you are interested in, if national deviations applies for that country.  Some countries have national deviations some don't.  In the medical field, it doesn't make sense in most cases to send your product to another countries test lab to get another safety mark like it does for computer equipment.  If you look at power supplies for computers you will see a lot of safety certification marks because they get certifications for ITE (computer equipment).  But if you look at medical device certifications you will rarely see more than one certification mark.  The main reason is most medical devices have to go through a regulatory approval process for one or more countries or has a regulatory body it has to deal with at some point in it's life cycle so it doesn't make sense to get additional safety certification marks.

Hope this helps clarify the CB scheme some.


------------------------------
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: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

Hi Leo,

there is indeed no TRF yet for the 4.1 edition of the IEC 60601-1-2. The CSA CBTL-Bayern is at this moment capable of performing the -4-39 tests mandated by edition 4.1 of the IEC 60601-1-2. Our lab in Eindhoven has received all equipment and is currently including it in their SOP's and certification. Internally we have started the EMC risk management and are in the process of ordering the equipment for our EMC risk control tests. Note that, just like with table 9 of the standard, it is the responsibility of the manufacturer to analyse the intended use environment and the to be expected disturbers in their EMC risk management and based on that define the frequencies, levels and modulations to be included in the compliance test in the range 9kHz to 13.56MHz, not limited to table11. That makes the whole selection of amplifiers and coils for testing a technical challenge. Some developments are still going on at the test equipment supplier regarding the impedance matching of the magnetic field test coils.

------------------------------
Rob Kleihorst
System Designer / EMC Lead
Best
Netherlands
------------------------------

Original Message:
Sent: 18-Feb-2021 00:48
From: Leonard Eisner
Subject: CB Scheme - which countries is this required for

Rob - I just checked the IECEE CB scheme website for IEC 60601-1-2, ed. 4.1 (standard issued Sept 1, 2020) for the Test Report Form but it has not been issued yet.  I was wondering if you have heard of any EMC CB scheme test labs that are able to meet all the EM Disturbance Tests of this newest version of the standard as there are the new RFDID tests which many EMC test labs that don't have the equipment to conduct the tests that I am aware of.  In the US there are some test labs that are aware of these tests as the FDA has insisted on a super set of AIM 7351731 RFID tests compared to what is in IEC 60601-1-2, ed. 4.1.  We are hoping with the FDA accepting this standard as a Recognized Consensus Standard in their db since the end of Dec 2020 they back off on the full list of AIM 7351731 RFID tests.


------------------------------
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: 17-Feb-2021 02:47
From: Rob Kleihorst
Subject: CB Scheme - which countries is this required for

All stories are right that CB is voluntary and that it is not widely used for EMC. Here at Philips we do use CB for EMC reporting in cooperation with CSA as our CBTL and NCB. I'm not saying its an easy regulatory pathway, but now we've gone through the process of getting high quality CB reports for EMC (and basic safety), we've been able to get our products to some markets quicker than we were used to because e.g. one of the most critical countries has accepted our reports without requiring additional in-country or oversea witness testing. It did require us to involve the local key-markets early in the process and diligently take the national differences into account and list them in the CB reports. This did include the 'mandatory' non-written national differences.
Carefully check the IECEE website for countries and standards within the CB scope, since not al countries listed to accept CB will accept CB for the medical standards. In order to be succesful, you really need a close cooperation with your CBTL.

------------------------------
Rob Kleihorst
System Designer / EMC Lead
Best
Netherlands

Original Message:
Sent: 14-Feb-2021 15:14
From: Leonard Eisner
Subject: CB Scheme - which countries is this required for

CB Scheme does cover EMC testing but I have never seen anyone ever use it and I have never seen a test lab use it.  Even as a product reviewer I have not seen test reports from EMC labs that have ever been CB Scheme reports.
CB Scheme covers IEC 60601-1, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12, in a way covers but not in the certificate IEC 62304 & 62366 & soon to be 62366-1.  For 62366-1 it will happen when the new version of IEC 60601-1 & 60601-1-6 are added into the Risk Management File Portion of the Test Report Forms or Procedures issued by the Risk Management Group of ETF-3 (a part of the CB Scheme) which I am a member of - we will start working on this process hopefully soon but the new versions of 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12 only came out in July - Sept '20 so will take a while before we get this all done.  Also, the CB scheme covers the Particular standards IEC 60601-2-XX and IEC/ISO 80601-2-XX.  The list of countries that are included in the CB scheme are on the IECEE website but I would not include Pakistan & Nigeria as they are not included in the voting members list.  You need to test in one country lab say UL in the US (I'm not recommending any lab just a for instance case) and pass all the testing get a CB scheme test report and certificate from that lab.  You would also ask them to get a CB scheme test report with national deviations for all countries you are interested in, if national deviations applies for that country.  Some countries have national deviations some don't.  In the medical field, it doesn't make sense in most cases to send your product to another countries test lab to get another safety mark like it does for computer equipment.  If you look at power supplies for computers you will see a lot of safety certification marks because they get certifications for ITE (computer equipment).  But if you look at medical device certifications you will rarely see more than one certification mark.  The main reason is most medical devices have to go through a regulatory approval process for one or more countries or has a regulatory body it has to deal with at some point in it's life cycle so it doesn't make sense to get additional safety certification marks.

Hope this helps clarify the CB scheme some.


------------------------------
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: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

Rob,

I assume you know about the FDA wanting more than just the IEC 60601-1, ed. 4.1 for RFID in many cases.  They are the ones that placed a lot of the requirements into this version of the standard.  The AIM 7351731 standard that is referenced in the IEC 60601-1, 4.1 ed is also an FDA Recognized Consensus Standard and in many cases they require more frequencies / magnetic field strengths tested than what is required by IEC 60601-1, 4.1 ed.  I'm not clear if the FDA will accept IEC 60601-1, 4.1 ed. without doing ht additional AIM tests they used to push on manufacturers.  The AIM standard is also referenced in the draft EMC guidance that came out around Nov.

------------------------------
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: 18-Feb-2021 02:44
From: Rob Kleihorst
Subject: CB Scheme - which countries is this required for

Hi Leo,

there is indeed no TRF yet for the 4.1 edition of the IEC 60601-1-2. The CSA CBTL-Bayern is at this moment capable of performing the -4-39 tests mandated by edition 4.1 of the IEC 60601-1-2. Our lab in Eindhoven has received all equipment and is currently including it in their SOP's and certification. Internally we have started the EMC risk management and are in the process of ordering the equipment for our EMC risk control tests. Note that, just like with table 9 of the standard, it is the responsibility of the manufacturer to analyse the intended use environment and the to be expected disturbers in their EMC risk management and based on that define the frequencies, levels and modulations to be included in the compliance test in the range 9kHz to 13.56MHz, not limited to table11. That makes the whole selection of amplifiers and coils for testing a technical challenge. Some developments are still going on at the test equipment supplier regarding the impedance matching of the magnetic field test coils.

------------------------------
Rob Kleihorst
System Designer / EMC Lead
Best
Netherlands

Original Message:
Sent: 18-Feb-2021 00:48
From: Leonard Eisner
Subject: CB Scheme - which countries is this required for

Rob - I just checked the IECEE CB scheme website for IEC 60601-1-2, ed. 4.1 (standard issued Sept 1, 2020) for the Test Report Form but it has not been issued yet.  I was wondering if you have heard of any EMC CB scheme test labs that are able to meet all the EM Disturbance Tests of this newest version of the standard as there are the new RFDID tests which many EMC test labs that don't have the equipment to conduct the tests that I am aware of.  In the US there are some test labs that are aware of these tests as the FDA has insisted on a super set of AIM 7351731 RFID tests compared to what is in IEC 60601-1-2, ed. 4.1.  We are hoping with the FDA accepting this standard as a Recognized Consensus Standard in their db since the end of Dec 2020 they back off on the full list of AIM 7351731 RFID tests.


------------------------------
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: 17-Feb-2021 02:47
From: Rob Kleihorst
Subject: CB Scheme - which countries is this required for

All stories are right that CB is voluntary and that it is not widely used for EMC. Here at Philips we do use CB for EMC reporting in cooperation with CSA as our CBTL and NCB. I'm not saying its an easy regulatory pathway, but now we've gone through the process of getting high quality CB reports for EMC (and basic safety), we've been able to get our products to some markets quicker than we were used to because e.g. one of the most critical countries has accepted our reports without requiring additional in-country or oversea witness testing. It did require us to involve the local key-markets early in the process and diligently take the national differences into account and list them in the CB reports. This did include the 'mandatory' non-written national differences.
Carefully check the IECEE website for countries and standards within the CB scope, since not al countries listed to accept CB will accept CB for the medical standards. In order to be succesful, you really need a close cooperation with your CBTL.

------------------------------
Rob Kleihorst
System Designer / EMC Lead
Best
Netherlands

Original Message:
Sent: 14-Feb-2021 15:14
From: Leonard Eisner
Subject: CB Scheme - which countries is this required for

CB Scheme does cover EMC testing but I have never seen anyone ever use it and I have never seen a test lab use it.  Even as a product reviewer I have not seen test reports from EMC labs that have ever been CB Scheme reports.
CB Scheme covers IEC 60601-1, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12, in a way covers but not in the certificate IEC 62304 & 62366 & soon to be 62366-1.  For 62366-1 it will happen when the new version of IEC 60601-1 & 60601-1-6 are added into the Risk Management File Portion of the Test Report Forms or Procedures issued by the Risk Management Group of ETF-3 (a part of the CB Scheme) which I am a member of - we will start working on this process hopefully soon but the new versions of 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12 only came out in July - Sept '20 so will take a while before we get this all done.  Also, the CB scheme covers the Particular standards IEC 60601-2-XX and IEC/ISO 80601-2-XX.  The list of countries that are included in the CB scheme are on the IECEE website but I would not include Pakistan & Nigeria as they are not included in the voting members list.  You need to test in one country lab say UL in the US (I'm not recommending any lab just a for instance case) and pass all the testing get a CB scheme test report and certificate from that lab.  You would also ask them to get a CB scheme test report with national deviations for all countries you are interested in, if national deviations applies for that country.  Some countries have national deviations some don't.  In the medical field, it doesn't make sense in most cases to send your product to another countries test lab to get another safety mark like it does for computer equipment.  If you look at power supplies for computers you will see a lot of safety certification marks because they get certifications for ITE (computer equipment).  But if you look at medical device certifications you will rarely see more than one certification mark.  The main reason is most medical devices have to go through a regulatory approval process for one or more countries or has a regulatory body it has to deal with at some point in it's life cycle so it doesn't make sense to get additional safety certification marks.

Hope this helps clarify the CB scheme some.


------------------------------
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: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------

Hi Leo,

yes I'm fully aware of the FDA putting the AIM standard on their list of recognized standards and pushing medical device manufacturers to add AIM standard test reports in their submission, despite the fact that risk-wise it was already addressed via the mandatory risk management responsiblity put on manufacturers in the 4.0 edition of IEC 60601-1-2. The actual problem is/was that manufacturers and testing laboratories simply used table 9 in their testing while not explicitly doing the EMC risk analysis and adding frequencies, modulations and immunity test levels adjusted to their EMC RMF. Table 9 does not  include the RFID frequencies since the -4-39 was not ready at the time the 60601-1-2:2014 was published. This has now been resolved by adding clause 8.11 explicit in the 4.1 edition of 60601-1-2 in the frequency range 9kHz to 13.56MHz for magnetic sensitve components at less than 15cm behind the EUT enclosure surface. It's still up to the manufacturer to do its EMC Risk Management and analyze what and where magnetic sensitive components are, what other risk frequencies like for wireless power charging there are and include in the test plan what surface of the EUT requires testing against clause 8.11.

So my guess is that FDA will accept doing the RFID testing per 60601-1-2 clause 8.11 provided the manufacturer had done their risk analysis diligently and based upon that included appropriate tests in the EMC test plan. The current discussions around the AIM standard with FDA are mainly for the smaller sized medical devices that did not include immunity testing against near magnetic fields in their EMC testing.

------------------------------
Rob Kleihorst
System Designer / EMC Lead
Best
Netherlands
------------------------------

Original Message:
Sent: 19-Feb-2021 03:41
From: Leonard Eisner
Subject: CB Scheme - which countries is this required for

Rob,

I assume you know about the FDA wanting more than just the IEC 60601-1, ed. 4.1 for RFID in many cases.  They are the ones that placed a lot of the requirements into this version of the standard.  The AIM 7351731 standard that is referenced in the IEC 60601-1, 4.1 ed is also an FDA Recognized Consensus Standard and in many cases they require more frequencies / magnetic field strengths tested than what is required by IEC 60601-1, 4.1 ed.  I'm not clear if the FDA will accept IEC 60601-1, 4.1 ed. without doing ht additional AIM tests they used to push on manufacturers.  The AIM standard is also referenced in the draft EMC guidance that came out around Nov.

------------------------------
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: 18-Feb-2021 02:44
From: Rob Kleihorst
Subject: CB Scheme - which countries is this required for

Hi Leo,

there is indeed no TRF yet for the 4.1 edition of the IEC 60601-1-2. The CSA CBTL-Bayern is at this moment capable of performing the -4-39 tests mandated by edition 4.1 of the IEC 60601-1-2. Our lab in Eindhoven has received all equipment and is currently including it in their SOP's and certification. Internally we have started the EMC risk management and are in the process of ordering the equipment for our EMC risk control tests. Note that, just like with table 9 of the standard, it is the responsibility of the manufacturer to analyse the intended use environment and the to be expected disturbers in their EMC risk management and based on that define the frequencies, levels and modulations to be included in the compliance test in the range 9kHz to 13.56MHz, not limited to table11. That makes the whole selection of amplifiers and coils for testing a technical challenge. Some developments are still going on at the test equipment supplier regarding the impedance matching of the magnetic field test coils.

------------------------------
Rob Kleihorst
System Designer / EMC Lead
Best
Netherlands

Original Message:
Sent: 18-Feb-2021 00:48
From: Leonard Eisner
Subject: CB Scheme - which countries is this required for

Rob - I just checked the IECEE CB scheme website for IEC 60601-1-2, ed. 4.1 (standard issued Sept 1, 2020) for the Test Report Form but it has not been issued yet.  I was wondering if you have heard of any EMC CB scheme test labs that are able to meet all the EM Disturbance Tests of this newest version of the standard as there are the new RFDID tests which many EMC test labs that don't have the equipment to conduct the tests that I am aware of.  In the US there are some test labs that are aware of these tests as the FDA has insisted on a super set of AIM 7351731 RFID tests compared to what is in IEC 60601-1-2, ed. 4.1.  We are hoping with the FDA accepting this standard as a Recognized Consensus Standard in their db since the end of Dec 2020 they back off on the full list of AIM 7351731 RFID tests.


------------------------------
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: 17-Feb-2021 02:47
From: Rob Kleihorst
Subject: CB Scheme - which countries is this required for

All stories are right that CB is voluntary and that it is not widely used for EMC. Here at Philips we do use CB for EMC reporting in cooperation with CSA as our CBTL and NCB. I'm not saying its an easy regulatory pathway, but now we've gone through the process of getting high quality CB reports for EMC (and basic safety), we've been able to get our products to some markets quicker than we were used to because e.g. one of the most critical countries has accepted our reports without requiring additional in-country or oversea witness testing. It did require us to involve the local key-markets early in the process and diligently take the national differences into account and list them in the CB reports. This did include the 'mandatory' non-written national differences.
Carefully check the IECEE website for countries and standards within the CB scope, since not al countries listed to accept CB will accept CB for the medical standards. In order to be succesful, you really need a close cooperation with your CBTL.

------------------------------
Rob Kleihorst
System Designer / EMC Lead
Best
Netherlands

Original Message:
Sent: 14-Feb-2021 15:14
From: Leonard Eisner
Subject: CB Scheme - which countries is this required for

CB Scheme does cover EMC testing but I have never seen anyone ever use it and I have never seen a test lab use it.  Even as a product reviewer I have not seen test reports from EMC labs that have ever been CB Scheme reports.
CB Scheme covers IEC 60601-1, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12, in a way covers but not in the certificate IEC 62304 & 62366 & soon to be 62366-1.  For 62366-1 it will happen when the new version of IEC 60601-1 & 60601-1-6 are added into the Risk Management File Portion of the Test Report Forms or Procedures issued by the Risk Management Group of ETF-3 (a part of the CB Scheme) which I am a member of - we will start working on this process hopefully soon but the new versions of 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12 only came out in July - Sept '20 so will take a while before we get this all done.  Also, the CB scheme covers the Particular standards IEC 60601-2-XX and IEC/ISO 80601-2-XX.  The list of countries that are included in the CB scheme are on the IECEE website but I would not include Pakistan & Nigeria as they are not included in the voting members list.  You need to test in one country lab say UL in the US (I'm not recommending any lab just a for instance case) and pass all the testing get a CB scheme test report and certificate from that lab.  You would also ask them to get a CB scheme test report with national deviations for all countries you are interested in, if national deviations applies for that country.  Some countries have national deviations some don't.  In the medical field, it doesn't make sense in most cases to send your product to another countries test lab to get another safety mark like it does for computer equipment.  If you look at power supplies for computers you will see a lot of safety certification marks because they get certifications for ITE (computer equipment).  But if you look at medical device certifications you will rarely see more than one certification mark.  The main reason is most medical devices have to go through a regulatory approval process for one or more countries or has a regulatory body it has to deal with at some point in it's life cycle so it doesn't make sense to get additional safety certification marks.

Hope this helps clarify the CB scheme some.


------------------------------
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: 09-Feb-2021 10:59
From: Dawn Vidgen
Subject: CB Scheme - which countries is this required for

Hi All,

So my company currently has a medical device on the market - we have completed both EMC and FCC testing for this device, which is sufficient for the markets we are currently selling into i.e. US and EU.  However, the question has been posed to us with regards to the CB scheme.  I know each country has their own requirements, but which countries is it an advantage to have the CB certification in place and which countries are happy to accept our current testing.

Any advice or pointing me into the correct direction would be appreciated.

Kindest regards,
Dawn

------------------------------
Dawn Vidgen
Cambridge
United Kingdom
------------------------------