Regulatory Open Forum

Hi all,

My question is: are all ECG devices automatically classified as CF applied part according to IEC 60601-1 and IEC 60601-2-25 or can they be BF, as well?
What confuses me a bit is the definition of "direct cardiac application" - is it related only to invasive intracardiac electrodes or electrodes in general?

Thanks in advance!

Hi all,

My question is: are all ECG devices automatically classified as CF applied part according to IEC 60601-1 and IEC 60601-2-25 or can they be BF, as well?
What confuses me a bit is the definition of "direct cardiac application" - is it related only to invasive intracardiac electrodes or electrodes in general?

Thanks in advance!

Hi all,

My question is: are all ECG devices automatically classified as CF applied part according to IEC 60601-1 and IEC 60601-2-25 or can they be BF, as well?
What confuses me a bit is the definition of "direct cardiac application" - is it related only to invasive intracardiac electrodes or electrodes in general?

Thanks in advance!

According to IEC 60601-1, the international standard for medical electrical equipment, ECG devices can be classified as either CF (Cardiac Floating) or BF (Body Floating) applied parts. The classification depends on the level of protection required for patient safety.

In general, CF applied parts are used for direct cardiac applications, which involve making electrical contact with the heart or invasive procedures within the cardiovascular system. This typically includes invasive intracardiac electrodes used during procedures such as cardiac catheterization. CF applied parts have more stringent requirements for insulation and leakage current limits to ensure patient safety.

On the other hand, BF applied parts are used for non-invasive applications where there is no direct contact with the heart or invasive procedures involved. This includes most standard ECG devices that use external electrodes placed on the skin surface to measure and record electrical activity of the heart. BF applied parts have less stringent requirements compared to CF applied parts.

Therefore, most ECG devices that use external electrodes placed on the skin would typically fall under the classification of BF applied part according to IEC 60601-1 and IEC 60601-2-25.

Hi all,

My question is: are all ECG devices automatically classified as CF applied part according to IEC 60601-1 and IEC 60601-2-25 or can they be BF, as well?
What confuses me a bit is the definition of "direct cardiac application" - is it related only to invasive intracardiac electrodes or electrodes in general?

Thanks in advance!

I believe the submitters original questions comes from 201.6.2 of IEC 60601-2-25 which modifies section 6.2 of IEC 60601-1 as follows:

Replacement of the last paragraph:
APPLIED PARTS shall be classified as TYPE CF APPLIED PARTS (see 7.2.10 and 8.3 of the general
standard). APPLIED PARTS shall be classified as DEFIBRILLATION-PROOF APPLIED PARTS (see
8.5.5 of the general standard).

To me this means that all applied parts related to the ECG function are required to be classified as Type CF applied parts since 60601-2-25 removes the classification of Type B and Type BF as options. 

According to IEC 60601-1, the international standard for medical electrical equipment, ECG devices can be classified as either CF (Cardiac Floating) or BF (Body Floating) applied parts. The classification depends on the level of protection required for patient safety.

In general, CF applied parts are used for direct cardiac applications, which involve making electrical contact with the heart or invasive procedures within the cardiovascular system. This typically includes invasive intracardiac electrodes used during procedures such as cardiac catheterization. CF applied parts have more stringent requirements for insulation and leakage current limits to ensure patient safety.

On the other hand, BF applied parts are used for non-invasive applications where there is no direct contact with the heart or invasive procedures involved. This includes most standard ECG devices that use external electrodes placed on the skin surface to measure and record electrical activity of the heart. BF applied parts have less stringent requirements compared to CF applied parts.

Therefore, most ECG devices that use external electrodes placed on the skin would typically fall under the classification of BF applied part according to IEC 60601-1 and IEC 60601-2-25.

Hi all,

My question is: are all ECG devices automatically classified as CF applied part according to IEC 60601-1 and IEC 60601-2-25 or can they be BF, as well?
What confuses me a bit is the definition of "direct cardiac application" - is it related only to invasive intracardiac electrodes or electrodes in general?

Thanks in advance!

Hi Wade and Rajeswari,

Thanks for the answers.

Basically the dilemma is can standard ECG devices be classified as CF applied parts according to 60601-2-25 but at the same time be not suitable for direct cardiac application (as the electrodes are not invasive) although 60601-1 says that CF applied parts are suitable for direct cardiac application?

Maybe the answer lies in the attached section of 60601-1 - am I interpreting it right or not?

I believe the submitters original questions comes from 201.6.2 of IEC 60601-2-25 which modifies section 6.2 of IEC 60601-1 as follows:

Replacement of the last paragraph:
APPLIED PARTS shall be classified as TYPE CF APPLIED PARTS (see 7.2.10 and 8.3 of the general
standard). APPLIED PARTS shall be classified as DEFIBRILLATION-PROOF APPLIED PARTS (see
8.5.5 of the general standard).

To me this means that all applied parts related to the ECG function are required to be classified as Type CF applied parts since 60601-2-25 removes the classification of Type B and Type BF as options. 

According to IEC 60601-1, the international standard for medical electrical equipment, ECG devices can be classified as either CF (Cardiac Floating) or BF (Body Floating) applied parts. The classification depends on the level of protection required for patient safety.

In general, CF applied parts are used for direct cardiac applications, which involve making electrical contact with the heart or invasive procedures within the cardiovascular system. This typically includes invasive intracardiac electrodes used during procedures such as cardiac catheterization. CF applied parts have more stringent requirements for insulation and leakage current limits to ensure patient safety.

On the other hand, BF applied parts are used for non-invasive applications where there is no direct contact with the heart or invasive procedures involved. This includes most standard ECG devices that use external electrodes placed on the skin surface to measure and record electrical activity of the heart. BF applied parts have less stringent requirements compared to CF applied parts.

Therefore, most ECG devices that use external electrodes placed on the skin would typically fall under the classification of BF applied part according to IEC 60601-1 and IEC 60601-2-25.

Hi all,

My question is: are all ECG devices automatically classified as CF applied part according to IEC 60601-1 and IEC 60601-2-25 or can they be BF, as well?
What confuses me a bit is the definition of "direct cardiac application" - is it related only to invasive intracardiac electrodes or electrodes in general?

Thanks in advance!