Regulatory Open Forum

Greetings,

I'd like to do a quick gut check - my company is moving into the wireless medical device space and I've been tasked with determining whether or not we're on the right track regarding which regulations to follow, testing to complete, etc. The device itself will be wearable for a timeframe of 60 minutes or less. Here's what I've found, specifically regarding wireless devices (frequency range between 2400 MHz 0 2483.5 MHz), thus far for particular markets:

U.S.
47 CFR Part 15 (FCC) 

Testing to:
IEEE ANSI C63.10-2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices
IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

EU
Radio Equipment Directive (RED) 2014/53/EU

Testing to the following harmonized standards:
EN 300 328 V2.2.2 (2019-07) Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonised Standard for access to radio spectrum
EN 301 489-1 V2.2.3 (2019-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility 
IEC 62368-1:2018 Information and communication technology equipment – Part 1: Safety Requirements

Other
IEEE 802.11b/g/n/ac (covers 1 to 450 Mbps)
IEEE 802.15.2 Coexistence of Wireless Personal Area Networks with Other Unlicensed Frequency Bands Operating Wireless Devices

Note, we already have an electronic device that is CE Marked and we test to the 60601 series, IEC 62366, CISPR 11:2009/AMD1:2010, and CISPR 32:2015.

Regards, Tonia

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

I see you indicate the 60601 series already but a few notes is that the series has updated last summer.  So, best to update to the latest versions especially if transitioning to MDR even though no Harmonized Standards yet.

Likely will need to meet IEC 60601-1 General Electrical Medical Devices, ed. 3.2, 2020
IEC 60601-1-2, ed. 4.1:2020 EM DIsturbances which will impact this. - Are you testing to this most recent version as FDA is pushing this RFID requirement that will have an impact (AIM standard tests - using the newer IEC 60601-1-2 is a better option than the AIM standard as a stand-alone requirement which is referenced in the EMC Guidance)
IEC 60601-1-11, 2020 Home Use - Likely applies if a wearable device

Note, that IEC 62368-1 doesn't meet the same level of safety as IEC 60601-1 (I noticed you listed it for the RED for ICT - This is something it depends where in your system if this makes sense to meet the 60601 requirements or if needs to absolutely require to meet 60601-1 level requirements.)

------------------------------
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-Apr-2021 09:33
From: Tonia Bryant
Subject: Wireless Medical Device Regulations

Greetings,

I'd like to do a quick gut check - my company is moving into the wireless medical device space and I've been tasked with determining whether or not we're on the right track regarding which regulations to follow, testing to complete, etc. The device itself will be wearable for a timeframe of 60 minutes or less. Here's what I've found, specifically regarding wireless devices (frequency range between 2400 MHz 0 2483.5 MHz), thus far for particular markets:

U.S.
47 CFR Part 15 (FCC)

Testing to:
IEEE ANSI C63.10-2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices
IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

EU
Radio Equipment Directive (RED) 2014/53/EU

Testing to the following harmonized standards:
EN 300 328 V2.2.2 (2019-07) Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonised Standard for access to radio spectrum
EN 301 489-1 V2.2.3 (2019-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility
IEC 62368-1:2018 Information and communication technology equipment – Part 1: Safety Requirements

Other
IEEE 802.11b/g/n/ac (covers 1 to 450 Mbps)
IEEE 802.15.2 Coexistence of Wireless Personal Area Networks with Other Unlicensed Frequency Bands Operating Wireless Devices

Note, we already have an electronic device that is CE Marked and we test to the 60601 series, IEC 62366, CISPR 11:2009/AMD1:2010, and CISPR 32:2015.

Regards, Tonia

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

There's also a nice compilation of references on the FDA web page "Wireless Medical Devices".
https://www.fda.gov/medical-devices/digital-health-center-excellence/wireless-medical-devices
​

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 10-Apr-2021 03:12
From: Leonard Eisner
Subject: Wireless Medical Device Regulations

I see you indicate the 60601 series already but a few notes is that the series has updated last summer.  So, best to update to the latest versions especially if transitioning to MDR even though no Harmonized Standards yet.

Likely will need to meet IEC 60601-1 General Electrical Medical Devices, ed. 3.2, 2020
IEC 60601-1-2, ed. 4.1:2020 EM DIsturbances which will impact this. - Are you testing to this most recent version as FDA is pushing this RFID requirement that will have an impact (AIM standard tests - using the newer IEC 60601-1-2 is a better option than the AIM standard as a stand-alone requirement which is referenced in the EMC Guidance)
IEC 60601-1-11, 2020 Home Use - Likely applies if a wearable device

Note, that IEC 62368-1 doesn't meet the same level of safety as IEC 60601-1 (I noticed you listed it for the RED for ICT - This is something it depends where in your system if this makes sense to meet the 60601 requirements or if needs to absolutely require to meet 60601-1 level requirements.)

------------------------------
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-Apr-2021 09:33
From: Tonia Bryant
Subject: Wireless Medical Device Regulations

Greetings,

I'd like to do a quick gut check - my company is moving into the wireless medical device space and I've been tasked with determining whether or not we're on the right track regarding which regulations to follow, testing to complete, etc. The device itself will be wearable for a timeframe of 60 minutes or less. Here's what I've found, specifically regarding wireless devices (frequency range between 2400 MHz 0 2483.5 MHz), thus far for particular markets:

U.S.
47 CFR Part 15 (FCC)

Testing to:
IEEE ANSI C63.10-2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices
IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

EU
Radio Equipment Directive (RED) 2014/53/EU

Testing to the following harmonized standards:
EN 300 328 V2.2.2 (2019-07) Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonised Standard for access to radio spectrum
EN 301 489-1 V2.2.3 (2019-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility
IEC 62368-1:2018 Information and communication technology equipment – Part 1: Safety Requirements

Other
IEEE 802.11b/g/n/ac (covers 1 to 450 Mbps)
IEEE 802.15.2 Coexistence of Wireless Personal Area Networks with Other Unlicensed Frequency Bands Operating Wireless Devices

Note, we already have an electronic device that is CE Marked and we test to the 60601 series, IEC 62366, CISPR 11:2009/AMD1:2010, and CISPR 32:2015.

Regards, Tonia

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

Thanks, Leo.

We're definitely aware that the 60601 series has been updated and we'll test to the most recent versions.

Regarding IEC 60601-1, it doesn't fully meet the requirements for wireless, which is why we'll also need to utilize IEC 62368-1.

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

Original Message:
Sent: 10-Apr-2021 03:12
From: Leonard Eisner
Subject: Wireless Medical Device Regulations

I see you indicate the 60601 series already but a few notes is that the series has updated last summer.  So, best to update to the latest versions especially if transitioning to MDR even though no Harmonized Standards yet.

Likely will need to meet IEC 60601-1 General Electrical Medical Devices, ed. 3.2, 2020
IEC 60601-1-2, ed. 4.1:2020 EM DIsturbances which will impact this. - Are you testing to this most recent version as FDA is pushing this RFID requirement that will have an impact (AIM standard tests - using the newer IEC 60601-1-2 is a better option than the AIM standard as a stand-alone requirement which is referenced in the EMC Guidance)
IEC 60601-1-11, 2020 Home Use - Likely applies if a wearable device

Note, that IEC 62368-1 doesn't meet the same level of safety as IEC 60601-1 (I noticed you listed it for the RED for ICT - This is something it depends where in your system if this makes sense to meet the 60601 requirements or if needs to absolutely require to meet 60601-1 level requirements.)

------------------------------
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-Apr-2021 09:33
From: Tonia Bryant
Subject: Wireless Medical Device Regulations

Greetings,

I'd like to do a quick gut check - my company is moving into the wireless medical device space and I've been tasked with determining whether or not we're on the right track regarding which regulations to follow, testing to complete, etc. The device itself will be wearable for a timeframe of 60 minutes or less. Here's what I've found, specifically regarding wireless devices (frequency range between 2400 MHz 0 2483.5 MHz), thus far for particular markets:

U.S.
47 CFR Part 15 (FCC)

Testing to:
IEEE ANSI C63.10-2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices
IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

EU
Radio Equipment Directive (RED) 2014/53/EU

Testing to the following harmonized standards:
EN 300 328 V2.2.2 (2019-07) Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonised Standard for access to radio spectrum
EN 301 489-1 V2.2.3 (2019-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility
IEC 62368-1:2018 Information and communication technology equipment – Part 1: Safety Requirements

Other
IEEE 802.11b/g/n/ac (covers 1 to 450 Mbps)
IEEE 802.15.2 Coexistence of Wireless Personal Area Networks with Other Unlicensed Frequency Bands Operating Wireless Devices

Note, we already have an electronic device that is CE Marked and we test to the 60601 series, IEC 62366, CISPR 11:2009/AMD1:2010, and CISPR 32:2015.

Regards, Tonia

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

Tonia,

The problem with IEC 62368-1 is that it doesn't isolate to the same levels as IEC 60950-1 so you need to be careful if you are using a switch-mode power for any of your isolation in your system.  Also, IEC 62368-1 doesn't address wireless in the sense of EM issues.  That is covered well by post #5 and by Anne's post as well.​​

------------------------------
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: 12-Apr-2021 10:11
From: Tonia Bryant
Subject: Wireless Medical Device Regulations

Thanks, Leo.

We're definitely aware that the 60601 series has been updated and we'll test to the most recent versions.

Regarding IEC 60601-1, it doesn't fully meet the requirements for wireless, which is why we'll also need to utilize IEC 62368-1.

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States

Original Message:
Sent: 10-Apr-2021 03:12
From: Leonard Eisner
Subject: Wireless Medical Device Regulations

I see you indicate the 60601 series already but a few notes is that the series has updated last summer.  So, best to update to the latest versions especially if transitioning to MDR even though no Harmonized Standards yet.

Likely will need to meet IEC 60601-1 General Electrical Medical Devices, ed. 3.2, 2020
IEC 60601-1-2, ed. 4.1:2020 EM DIsturbances which will impact this. - Are you testing to this most recent version as FDA is pushing this RFID requirement that will have an impact (AIM standard tests - using the newer IEC 60601-1-2 is a better option than the AIM standard as a stand-alone requirement which is referenced in the EMC Guidance)
IEC 60601-1-11, 2020 Home Use - Likely applies if a wearable device

Note, that IEC 62368-1 doesn't meet the same level of safety as IEC 60601-1 (I noticed you listed it for the RED for ICT - This is something it depends where in your system if this makes sense to meet the 60601 requirements or if needs to absolutely require to meet 60601-1 level requirements.)

------------------------------
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-Apr-2021 09:33
From: Tonia Bryant
Subject: Wireless Medical Device Regulations

Greetings,

I'd like to do a quick gut check - my company is moving into the wireless medical device space and I've been tasked with determining whether or not we're on the right track regarding which regulations to follow, testing to complete, etc. The device itself will be wearable for a timeframe of 60 minutes or less. Here's what I've found, specifically regarding wireless devices (frequency range between 2400 MHz 0 2483.5 MHz), thus far for particular markets:

U.S.
47 CFR Part 15 (FCC)

Testing to:
IEEE ANSI C63.10-2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices
IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

EU
Radio Equipment Directive (RED) 2014/53/EU

Testing to the following harmonized standards:
EN 300 328 V2.2.2 (2019-07) Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonised Standard for access to radio spectrum
EN 301 489-1 V2.2.3 (2019-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility
IEC 62368-1:2018 Information and communication technology equipment – Part 1: Safety Requirements

Other
IEEE 802.11b/g/n/ac (covers 1 to 450 Mbps)
IEEE 802.15.2 Coexistence of Wireless Personal Area Networks with Other Unlicensed Frequency Bands Operating Wireless Devices

Note, we already have an electronic device that is CE Marked and we test to the 60601 series, IEC 62366, CISPR 11:2009/AMD1:2010, and CISPR 32:2015.

Regards, Tonia

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

This message was posted by a user wishing to remain anonymous

For 60601, keep in mind, it is not just the series. It is picking the right collateral and particular standards, and then, picking the right edition since different regions accept different regions, and they are not always backwards compatible.

And when doing the 60601 testing, make sure they have defined the essential performance, prepared a risk management plan, and a test plan, before the testing takes place. 

There's also the labeling which is very important.

The FDA's Radiofrequency Guidance and recently published EMC guidance cover a lot of the areas where test labs and the standards don't get into, but which the FDA expects.

As well check out the webinar Leo Eisner did with Rob Packard on the recent changes. Leo posts on here a lot. https://www.youtube.com/watch?v=W8LPfXi2qNk



Original Message:
Sent: 09-Apr-2021 09:33
From: Tonia Bryant
Subject: Wireless Medical Device Regulations

Greetings,

I'd like to do a quick gut check - my company is moving into the wireless medical device space and I've been tasked with determining whether or not we're on the right track regarding which regulations to follow, testing to complete, etc. The device itself will be wearable for a timeframe of 60 minutes or less. Here's what I've found, specifically regarding wireless devices (frequency range between 2400 MHz 0 2483.5 MHz), thus far for particular markets:

U.S.
47 CFR Part 15 (FCC)

Testing to:
IEEE ANSI C63.10-2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices
IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

EU
Radio Equipment Directive (RED) 2014/53/EU

Testing to the following harmonized standards:
EN 300 328 V2.2.2 (2019-07) Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonised Standard for access to radio spectrum
EN 301 489-1 V2.2.3 (2019-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility
IEC 62368-1:2018 Information and communication technology equipment – Part 1: Safety Requirements

Other
IEEE 802.11b/g/n/ac (covers 1 to 450 Mbps)
IEEE 802.15.2 Coexistence of Wireless Personal Area Networks with Other Unlicensed Frequency Bands Operating Wireless Devices

Note, we already have an electronic device that is CE Marked and we test to the 60601 series, IEC 62366, CISPR 11:2009/AMD1:2010, and CISPR 32:2015.

Regards, Tonia

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

Hello,
You are definitely on the right track for FCC however you should also review the "other" parts that maybe applicable to your device.  Below is my go to list and note, most of my devices are implantable and I assume your device is not implantable so you could most like do away with SAR testing.  

• Spectrum use:
  • Part 15 – Radio Frequency Devices (Unlicensed)
  • Part 95 – Personal Radio Services - Subpart I - Medical Device Radio Communications Service (Licensed by Rule)
  • Part 22 – Public Mobile Services, Subpart H – Cellular Radio Telephone Service (Licensed)
  • Part 24 – Personal Communications Services, Subpart E – Broadband PCS (Licensed)
  • Part 27– Miscellaneous Wireless Communications Services, Subpart C (Licensed)
• SAR
  • Part 1.1310 - Radiofrequency Radiation Exposure Limits
  • Part 2.1091 - Radiofrequency Radiation Exposure Evaluation: Mobile devices
  • Part 2.1093 - Radiofrequency Radiation Exposure Evaluation: Portable devices
• Labeling:
  • Part 2.925 - Identification of Equipment (Implanted Medical Device)
  • Part 2.926- FCC Identifier
  • Part 15.19 – Labeling Requirements (Implanted Medical Device)
  • Part 95.2593- Labeling Requirements
• KDB publications:
  • KDB 726920 D01 Confidentiality Request Procedures
  • KDB 178919 D01 Permissive Change Policy
  • KDB 784748 D01 Labelling Part 15 18 Guidelines
  • KDB 784748 D02 e labelling
  • KDB 784748 D03 Labelling Quick Guide
  • KDB 996369 D01 Module Certification Guide
  • KDB 388624 D02 Pre-Approval Guidance List
  • KDB 447498 D01 General RF Exposure Guidance
  • KDB 865664 D01 SAR Measurement 100 MHz to 6 GHz
  • KDB 865664 D02 RF Exposure Reporting
  • KDB 249227 D01 802.11 Wi-Fi SAR
  • KDB 941225 D01 3G SAR Procedures
  • KDB 896810 D01 Supplier's Declaration of Conformity Guidance
  • KDB 896810 D02 Supplier's Declaration of Conformity Frequently Asked Questions

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Regulatory Affairs Specialist]
[NAMSA]
[Bailey [Colorado]
[USA]
------------------------------

Original Message:
Sent: 09-Apr-2021 09:33
From: Tonia Bryant
Subject: Wireless Medical Device Regulations

Greetings,

I'd like to do a quick gut check - my company is moving into the wireless medical device space and I've been tasked with determining whether or not we're on the right track regarding which regulations to follow, testing to complete, etc. The device itself will be wearable for a timeframe of 60 minutes or less. Here's what I've found, specifically regarding wireless devices (frequency range between 2400 MHz 0 2483.5 MHz), thus far for particular markets:

U.S.
47 CFR Part 15 (FCC)

Testing to:
IEEE ANSI C63.10-2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices
IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

EU
Radio Equipment Directive (RED) 2014/53/EU

Testing to the following harmonized standards:
EN 300 328 V2.2.2 (2019-07) Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonised Standard for access to radio spectrum
EN 301 489-1 V2.2.3 (2019-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility
IEC 62368-1:2018 Information and communication technology equipment – Part 1: Safety Requirements

Other
IEEE 802.11b/g/n/ac (covers 1 to 450 Mbps)
IEEE 802.15.2 Coexistence of Wireless Personal Area Networks with Other Unlicensed Frequency Bands Operating Wireless Devices

Note, we already have an electronic device that is CE Marked and we test to the 60601 series, IEC 62366, CISPR 11:2009/AMD1:2010, and CISPR 32:2015.

Regards, Tonia

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

This message was posted by a user wishing to remain anonymous

What does SAR stand for?
Original Message:
Sent: 22-Apr-2021 08:52
From: Monica Montanez
Subject: Wireless Medical Device Regulations

Hello,
You are definitely on the right track for FCC however you should also review the "other" parts that maybe applicable to your device.  Below is my go to list and note, most of my devices are implantable and I assume your device is not implantable so you could most like do away with SAR testing.

• Spectrum use:
  • Part 15 – Radio Frequency Devices (Unlicensed)
  • Part 95 – Personal Radio Services - Subpart I - Medical Device Radio Communications Service (Licensed by Rule)
  • Part 22 – Public Mobile Services, Subpart H – Cellular Radio Telephone Service (Licensed)
  • Part 24 – Personal Communications Services, Subpart E – Broadband PCS (Licensed)
  • Part 27– Miscellaneous Wireless Communications Services, Subpart C (Licensed)
• SAR
  • Part 1.1310 - Radiofrequency Radiation Exposure Limits
  • Part 2.1091 - Radiofrequency Radiation Exposure Evaluation: Mobile devices
  • Part 2.1093 - Radiofrequency Radiation Exposure Evaluation: Portable devices
• Labeling:
  • Part 2.925 - Identification of Equipment (Implanted Medical Device)
  • Part 2.926- FCC Identifier
  • Part 15.19 – Labeling Requirements (Implanted Medical Device)
  • Part 95.2593- Labeling Requirements
• KDB publications:
  • KDB 726920 D01 Confidentiality Request Procedures
  • KDB 178919 D01 Permissive Change Policy
  • KDB 784748 D01 Labelling Part 15 18 Guidelines
  • KDB 784748 D02 e labelling
  • KDB 784748 D03 Labelling Quick Guide
  • KDB 996369 D01 Module Certification Guide
  • KDB 388624 D02 Pre-Approval Guidance List
  • KDB 447498 D01 General RF Exposure Guidance
  • KDB 865664 D01 SAR Measurement 100 MHz to 6 GHz
  • KDB 865664 D02 RF Exposure Reporting
  • KDB 249227 D01 802.11 Wi-Fi SAR
  • KDB 941225 D01 3G SAR Procedures
  • KDB 896810 D01 Supplier's Declaration of Conformity Guidance
  • KDB 896810 D02 Supplier's Declaration of Conformity Frequently Asked Questions

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Regulatory Affairs Specialist]
[NAMSA]
[Bailey [Colorado]
[USA]

Original Message:
Sent: 09-Apr-2021 09:33
From: Tonia Bryant
Subject: Wireless Medical Device Regulations

Greetings,

I'd like to do a quick gut check - my company is moving into the wireless medical device space and I've been tasked with determining whether or not we're on the right track regarding which regulations to follow, testing to complete, etc. The device itself will be wearable for a timeframe of 60 minutes or less. Here's what I've found, specifically regarding wireless devices (frequency range between 2400 MHz 0 2483.5 MHz), thus far for particular markets:

U.S.
47 CFR Part 15 (FCC)

Testing to:
IEEE ANSI C63.10-2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices
IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

EU
Radio Equipment Directive (RED) 2014/53/EU

Testing to the following harmonized standards:
EN 300 328 V2.2.2 (2019-07) Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonised Standard for access to radio spectrum
EN 301 489-1 V2.2.3 (2019-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility
IEC 62368-1:2018 Information and communication technology equipment – Part 1: Safety Requirements

Other
IEEE 802.11b/g/n/ac (covers 1 to 450 Mbps)
IEEE 802.15.2 Coexistence of Wireless Personal Area Networks with Other Unlicensed Frequency Bands Operating Wireless Devices

Note, we already have an electronic device that is CE Marked and we test to the 60601 series, IEC 62366, CISPR 11:2009/AMD1:2010, and CISPR 32:2015.

Regards, Tonia

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

SAR: Specific Absorption Rate

Also note: for FDA Guidance document you will use this testing to respond to the guidance appropriately.  For example, Description of Performance of Wireless Functions and Specifications. What type of radio is in use?  What type of medical data is transferred between the device and Server? I don't know enough to provide to much information however you will need to provide a transmitter description to FDA.  Then provide a risk based approach to verification and validation  (Quality of Service) and the section for Wireless Coexistence you will need to review AAMI TIR69 for risk category and evaluate for coexistance according to ANSI C63.27, Annex A, Tier 3 requirements.  Depending on the environment the device will be used in: home/clinical or both.  
Security of Data will be based on how Cybersecurity protections were designed into your device.  Next you will need to provide software testing to address data integrity, data security and data latency and finally this is where the EMC testing is presented  and a summary of the RF Compliance testing

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Regulatory Affairs Specialist]
[NAMSA]
[Bailey [Colorado]
[USA]
------------------------------

Original Message:
Sent: 22-Apr-2021 09:27
From: Anonymous Member
Subject: Wireless Medical Device Regulations

This message was posted by a user wishing to remain anonymous

What does SAR stand for?
Original Message:
Sent: 22-Apr-2021 08:52
From: Monica Montanez
Subject: Wireless Medical Device Regulations

Hello,
You are definitely on the right track for FCC however you should also review the "other" parts that maybe applicable to your device.  Below is my go to list and note, most of my devices are implantable and I assume your device is not implantable so you could most like do away with SAR testing.

• Spectrum use:
  • Part 15 – Radio Frequency Devices (Unlicensed)
  • Part 95 – Personal Radio Services - Subpart I - Medical Device Radio Communications Service (Licensed by Rule)
  • Part 22 – Public Mobile Services, Subpart H – Cellular Radio Telephone Service (Licensed)
  • Part 24 – Personal Communications Services, Subpart E – Broadband PCS (Licensed)
  • Part 27– Miscellaneous Wireless Communications Services, Subpart C (Licensed)
• SAR
  • Part 1.1310 - Radiofrequency Radiation Exposure Limits
  • Part 2.1091 - Radiofrequency Radiation Exposure Evaluation: Mobile devices
  • Part 2.1093 - Radiofrequency Radiation Exposure Evaluation: Portable devices
• Labeling:
  • Part 2.925 - Identification of Equipment (Implanted Medical Device)
  • Part 2.926- FCC Identifier
  • Part 15.19 – Labeling Requirements (Implanted Medical Device)
  • Part 95.2593- Labeling Requirements
• KDB publications:
  • KDB 726920 D01 Confidentiality Request Procedures
  • KDB 178919 D01 Permissive Change Policy
  • KDB 784748 D01 Labelling Part 15 18 Guidelines
  • KDB 784748 D02 e labelling
  • KDB 784748 D03 Labelling Quick Guide
  • KDB 996369 D01 Module Certification Guide
  • KDB 388624 D02 Pre-Approval Guidance List
  • KDB 447498 D01 General RF Exposure Guidance
  • KDB 865664 D01 SAR Measurement 100 MHz to 6 GHz
  • KDB 865664 D02 RF Exposure Reporting
  • KDB 249227 D01 802.11 Wi-Fi SAR
  • KDB 941225 D01 3G SAR Procedures
  • KDB 896810 D01 Supplier's Declaration of Conformity Guidance
  • KDB 896810 D02 Supplier's Declaration of Conformity Frequently Asked Questions

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Regulatory Affairs Specialist]
[NAMSA]
[Bailey [Colorado]
[USA]

Original Message:
Sent: 09-Apr-2021 09:33
From: Tonia Bryant
Subject: Wireless Medical Device Regulations

Greetings,

I'd like to do a quick gut check - my company is moving into the wireless medical device space and I've been tasked with determining whether or not we're on the right track regarding which regulations to follow, testing to complete, etc. The device itself will be wearable for a timeframe of 60 minutes or less. Here's what I've found, specifically regarding wireless devices (frequency range between 2400 MHz 0 2483.5 MHz), thus far for particular markets:

U.S.
47 CFR Part 15 (FCC)

Testing to:
IEEE ANSI C63.10-2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices
IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

EU
Radio Equipment Directive (RED) 2014/53/EU

Testing to the following harmonized standards:
EN 300 328 V2.2.2 (2019-07) Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonised Standard for access to radio spectrum
EN 301 489-1 V2.2.3 (2019-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility
IEC 62368-1:2018 Information and communication technology equipment – Part 1: Safety Requirements

Other
IEEE 802.11b/g/n/ac (covers 1 to 450 Mbps)
IEEE 802.15.2 Coexistence of Wireless Personal Area Networks with Other Unlicensed Frequency Bands Operating Wireless Devices

Note, we already have an electronic device that is CE Marked and we test to the 60601 series, IEC 62366, CISPR 11:2009/AMD1:2010, and CISPR 32:2015.

Regards, Tonia

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

Hi Tanya

The EN 300 328 standard was updated, as was the EN 301-489.   You may want to take a look.  Most recent updates were in 2020.

So many standards in this area, it is crazy.   Electrical engineers will never lack for work writing standards.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 23-Apr-2021 10:12
From: Monica Montanez
Subject: Wireless Medical Device Regulations

SAR: Specific Absorption Rate

Also note: for FDA Guidance document you will use this testing to respond to the guidance appropriately.  For example, Description of Performance of Wireless Functions and Specifications. What type of radio is in use?  What type of medical data is transferred between the device and Server? I don't know enough to provide to much information however you will need to provide a transmitter description to FDA.  Then provide a risk based approach to verification and validation  (Quality of Service) and the section for Wireless Coexistence you will need to review AAMI TIR69 for risk category and evaluate for coexistance according to ANSI C63.27, Annex A, Tier 3 requirements.  Depending on the environment the device will be used in: home/clinical or both.
Security of Data will be based on how Cybersecurity protections were designed into your device.  Next you will need to provide software testing to address data integrity, data security and data latency and finally this is where the EMC testing is presented  and a summary of the RF Compliance testing

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Regulatory Affairs Specialist]
[NAMSA]
[Bailey [Colorado]
[USA]

Original Message:
Sent: 22-Apr-2021 09:27
From: Anonymous Member
Subject: Wireless Medical Device Regulations

This message was posted by a user wishing to remain anonymous

What does SAR stand for?
Original Message:
Sent: 22-Apr-2021 08:52
From: Monica Montanez
Subject: Wireless Medical Device Regulations

Hello,
You are definitely on the right track for FCC however you should also review the "other" parts that maybe applicable to your device.  Below is my go to list and note, most of my devices are implantable and I assume your device is not implantable so you could most like do away with SAR testing.

• Spectrum use:
  • Part 15 – Radio Frequency Devices (Unlicensed)
  • Part 95 – Personal Radio Services - Subpart I - Medical Device Radio Communications Service (Licensed by Rule)
  • Part 22 – Public Mobile Services, Subpart H – Cellular Radio Telephone Service (Licensed)
  • Part 24 – Personal Communications Services, Subpart E – Broadband PCS (Licensed)
  • Part 27– Miscellaneous Wireless Communications Services, Subpart C (Licensed)
• SAR
  • Part 1.1310 - Radiofrequency Radiation Exposure Limits
  • Part 2.1091 - Radiofrequency Radiation Exposure Evaluation: Mobile devices
  • Part 2.1093 - Radiofrequency Radiation Exposure Evaluation: Portable devices
• Labeling:
  • Part 2.925 - Identification of Equipment (Implanted Medical Device)
  • Part 2.926- FCC Identifier
  • Part 15.19 – Labeling Requirements (Implanted Medical Device)
  • Part 95.2593- Labeling Requirements
• KDB publications:
  • KDB 726920 D01 Confidentiality Request Procedures
  • KDB 178919 D01 Permissive Change Policy
  • KDB 784748 D01 Labelling Part 15 18 Guidelines
  • KDB 784748 D02 e labelling
  • KDB 784748 D03 Labelling Quick Guide
  • KDB 996369 D01 Module Certification Guide
  • KDB 388624 D02 Pre-Approval Guidance List
  • KDB 447498 D01 General RF Exposure Guidance
  • KDB 865664 D01 SAR Measurement 100 MHz to 6 GHz
  • KDB 865664 D02 RF Exposure Reporting
  • KDB 249227 D01 802.11 Wi-Fi SAR
  • KDB 941225 D01 3G SAR Procedures
  • KDB 896810 D01 Supplier's Declaration of Conformity Guidance
  • KDB 896810 D02 Supplier's Declaration of Conformity Frequently Asked Questions

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Regulatory Affairs Specialist]
[NAMSA]
[Bailey [Colorado]
[USA]

Original Message:
Sent: 09-Apr-2021 09:33
From: Tonia Bryant
Subject: Wireless Medical Device Regulations

Greetings,

I'd like to do a quick gut check - my company is moving into the wireless medical device space and I've been tasked with determining whether or not we're on the right track regarding which regulations to follow, testing to complete, etc. The device itself will be wearable for a timeframe of 60 minutes or less. Here's what I've found, specifically regarding wireless devices (frequency range between 2400 MHz 0 2483.5 MHz), thus far for particular markets:

U.S.
47 CFR Part 15 (FCC)

Testing to:
IEEE ANSI C63.10-2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices
IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

EU
Radio Equipment Directive (RED) 2014/53/EU

Testing to the following harmonized standards:
EN 300 328 V2.2.2 (2019-07) Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonised Standard for access to radio spectrum
EN 301 489-1 V2.2.3 (2019-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility
IEC 62368-1:2018 Information and communication technology equipment – Part 1: Safety Requirements

Other
IEEE 802.11b/g/n/ac (covers 1 to 450 Mbps)
IEEE 802.15.2 Coexistence of Wireless Personal Area Networks with Other Unlicensed Frequency Bands Operating Wireless Devices

Note, we already have an electronic device that is CE Marked and we test to the 60601 series, IEC 62366, CISPR 11:2009/AMD1:2010, and CISPR 32:2015.

Regards, Tonia

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------