Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements

Peter Selvey

Staff member
Super Moderator
#11
Agree, my mistake, I did not read 8.6.9 carefully.

Even so, I would still recommend just labelling as Class I device to avoid confusion, even if there is no use of the earth terminal for protective function.

As mentioned before, if Class I, then Clause 8.6.9 is not applicable.

Apart from this, is there any reason (compliance or technical) not to label as Class I?
 
Elsmar Forum Sponsor

mehrnaz

Starting to get Involved
#13
Agree, my mistake, I did not read 8.6.9 carefully.

Even so, I would still recommend just labelling as Class I device to avoid confusion, even if there is no use of the earth terminal for protective function.

As mentioned before, if Class I, then Clause 8.6.9 is not applicable.

Apart from this, is there any reason (compliance or technical) not to label as Class I?
Hi
I am working on a a device which is connected to mains supply by a 12 v d.c Adapter. it is labelled as class I but there is no protective earth in the device. it is just used in the adapter. this device has also an insulated enclosure.
I would be pleased if you could help me to know is it correct to classify that as class I ? because adapter is separable and it can be replaced by a class II adapter by the operator....
 

Peter Selvey

Staff member
Super Moderator
#14
Class I/Class II is really only intended only for the item that connects to the mains supply. So if your device runs of 12Vdc from an adaptor, it does not connect to the mains and hence Class I/II is irrelevant.

At the moment I haven't checked the 3rd edition for the detailed references, but the 2nd edition had a table that clearly showed that Class II marking was not required if the adaptor is separable. This is because the appropriate marking is expected to be on the adaptor, not the 12V device (which makes sense if you think about it).
 

mehrnaz

Starting to get Involved
#15
Class I/Class II is really only intended only for the item that connects to the mains supply. So if your device runs of 12Vdc from an adaptor, it does not connect to the mains and hence Class I/II is irrelevant.

At the moment I haven't checked the 3rd edition for the detailed references, but the 2nd edition had a table that clearly showed that Class II marking was not required if the adaptor is separable. This is because the appropriate marking is expected to be on the adaptor, not the 12V device (which makes sense if you think about it).
Actually in third edition, clause 6.2 Protection against electric shock, equipment are classified as I , II or internally powered. INTERNALLY POWERED ME EQUIPMENT having a means of connection to a SUPPLY MAINS shall comply with the requirements for CLASS I ME EQUIPMENT or CLASS II ME EQUIPMENT while so connected, and with the requirements for INTERNALLY POWERED ME EQUIPMENT while not so connected.

As the adapter is separable, and the enclosure of the device is insulated, I suppose it shall be classified as class II while connecting to Mains supply by a means, which is adapter here, because maybe the operator uses an adapter that is class II that there is not any connection to protective earth.
Besides I have problem with clause 8.6 requirements of protective earthing and Impedance and current-carrying capability. Because there is just functional connection to adapter, which is not a fixed part of equipment and it cant be checked for requirements of protective earthing in the mentioned device.
is it technically correct?
 

Peter Selvey

Staff member
Super Moderator
#16
To be honest this is another area where the standard is a little bit fuddled (mixed up). Just for simplicity I'll refer to the the two parts of the system as the "adaptor" and "unit", where the unit gets a 12V supply from the adaptor.

To reconfirm, the origin of Class I, Class II is for mains supply (i.e. 100Vac, 230Vac, 415V etc). In the normal course of events, the adaptor would be seen as a completely separate device, full tested to meet standards. This means the unit does not need to worry about mains related issues at all. Historically the unit would have been designated Class III. This classification actually existed in the 1977 edition of IEC 60601-1 (which I am sadly old enough to have actually seen ...).

The 1988 edition got worried about the adaptor not having enough insulation or too much leakage for the medical environment, and as such the definition of Class III was ripped out. In effect, the standard applied to the system of the "adaptor + unit" as a single device. However, in principle, all mains related requirements (including Class II marking) were only required for the adaptor, not the unit.

The 2005 edition relaxed this somewhat as for many situations, non-medical adaptors are fine, or can be handled as a system under Clause 16.

But they did not re-introduce Class III. So, currently Clause 6.2 reads as if the unit is Class II.

As with the 1988 edition, if you search through the standard for all the references to Class II, you will find they are all mains supply related and hence not applicable to the unit. As such, the classification has no practical impact, and only serves as a point of confusion.

One common mistake is to mark the Class II "box in a box symbol" on the unit, even though it has no mains parts. In the 1988 edition the exclusion was hidden in "Table II", which meant it was easily overlooked, hence it was a very popular mistake. In the 2005 edition, the exclusion is less hidden in the title of the clause - 7.2.6 - "Connection to the supply mains", where "supply mains" is a defined term which essentially means the wall supply; but again easy to overlook if you miss the title or definition, and especially with the history of mistakes coming from the 1988 edition.

In fact, it should be noted that several items like supply voltage, current or power, dc symbol are not required to be marked on the unit, nor is the power input test applicable to the unit. These are all only required for equipment which connects to a mains supply.
 
Last edited:

mehrnaz

Starting to get Involved
#17
To be honest this is another area where the standard is a little bit fuddled (mixed up). Just for simplicity I'll refer to the the two parts of the system as the "adaptor" and "unit", where the unit gets a 12V supply from the adaptor.

To reconfirm, the origin of Class I, Class II is for mains supply (i.e. 100Vac, 230Vac, 415V etc). In the normal course of events, the adaptor would be seen as a completely separate device, full tested to meet standards. This means the unit does not need to worry about mains related issues at all. Historically the unit would have been designated Class III. This classification actually existed in the 1977 edition of IEC 60601-1 (which I am sadly old enough to have actually seen ...).

The 1988 edition got worried about the adaptor not having enough insulation or too much leakage for the medical environment, and as such the definition of Class III was ripped out. In effect, the standard applied to the system of the "adaptor + unit" as a single device. However, in principle, all mains related requirements (including Class II marking) were only required for the adaptor, not the unit.

The 2005 edition relaxed this somewhat as for many situations, non-medical adaptors are fine, or can be handled as a system under Clause 16.

But they did not re-introduce Class III. So, currently Clause 6.2 reads as if the unit is Class II.

As with the 1988 edition, if you search through the standard for all the references to Class II, you will find they are all mains supply related and hence not applicable to the unit. As such, the classification has no practical impact, and only serves as a point of confusion.

One common mistake is to mark the Class II "box in a box symbol" on the unit, even though it has no mains parts. In the 1988 edition the exclusion was hidden in "Table II", which meant it was easily overlooked, hence it was a very popular mistake. In the 2005 edition, the exclusion is less hidden in the title of the clause - 7.2.6 - "Connection to the supply mains", where "supply mains" is a defined term which essentially means the wall supply; but again easy to overlook if you miss the title or definition, and especially with the history of mistakes coming from the 1988 edition.

In fact, it should be noted that several items like supply voltage, current or power, dc symbol are not required to be marked on the unit, nor is the power input test applicable to the unit. These are all only required for equipment which connects to a mains supply.
I really want to thank you for your help and clarification.
so by the fact you mentioned, in sub clause 4.10.1, which it is stated that ME equipment shall be suitable for connection to a supply mains or specified power supply or an internal power source. the unit shall be assumed in which category? (It has rechargeable internal battery and also connection to mains supply by adapter)
another confusing point for me is that: as this device is an emergency ventilator, it also has a vehicular cable for connection to An external 12 V d.c battery (from an ambulance, helicopter...) as an option. is there any point to be considered by this type of connection?
because there is no any specific protection between vehicular battery and the unit...
 
Last edited:

Peter Selvey

Staff member
Super Moderator
#18
For 4.10 (power input test), let's say the adaptor is rated Input: 100-240Vac 1A, output 12Vdc 3A. Then the "unit" is also marked with 12V 1.5A, and is intended to get power only from the adaptor or internal battery.

The point of 4.10 is to check that the "mains supply" ratings are OK. There are three possibilities:
1) test the adaptor with the unit, and check that the input does not exceed 1.1A (1A + 10%)
2) test the adaptor with a dummy 3A load and check that the input does not exceed 1.1A (1A + 10%)
3) use the adaptor's certificate and skip the test (as the certificate will have tests with a dummy load of 3A)

Option (1) is often done, but in reality it is a bit meaningless. The "unit" often changes a lot (adding new features, options, change battery charging parameters etc.), which implies the test needs to be repeated with every little design change. There is usually a big margin so options 2 or 3 make more sense logistically.

The key point though is that the unit marking of 12V 1.5A is irrelevant to Clause 4.10. It does not need to be marked, and even if it is marked, it does not need to be tested. It's more of an internal specification for the designer to consider, not something the user needs to care about.

Now ... if you are connecting 12V supply from an ambulance or helicopter, ignore everything I just said :)

That type of 12V is considered a "mains supply", hence the 12Vdc 1.5A marking becomes the formal "ratings", the idea being that the user need to know so they can check if it is compatible with the "mains supply". Also, the issue of Class I, Class II could come into play. I don't have a lot of experience for that situation, but i would guess that in practice only Class II is an option, as the reliability of any "earth" would be unknown in an ambulance/helicopter. This is different to a building supply, where the wall earth conductor is seen to have a "reliable" protective function.
 
Thread starter Similar threads Forum Replies Date
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
Edward Reesor EU Authorized Representative for a Class I Medical Device CE Marking (Conformité Européene) / CB Scheme 11
W Direct to customer export of medical device (class I: prescription lenses + frame) US Food and Drug Administration (FDA) 2
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 4
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S How to register class IIA medical device accessories EU Medical Device Regulations 1
U Medical device trial budget - 2 hospitals for Class IIa medical device in Sweden Other Medical Device and Orthopedic Related Topics 2
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
M Notified Body audits -Class Ia medical device product EU Medical Device Regulations 4
N Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485? EU Medical Device Regulations 18
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
R Countries that accept 510k approvals - Class II nonsterile medical device Other Medical Device Regulations World-Wide 2
B Class III Medical Device Accelerated conditions Other Medical Device Related Standards 1
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
N CE Mark for Class 1 medical device CE Marking (Conformité Européene) / CB Scheme 11
D Class II medical device - When should a complaint be closed? Customer Complaints 6
D Software as an accessory to a Class I medical device EU Medical Device Regulations 4
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
N Can we take a part from 510k cleared medical device and use it in class I device? Other US Medical Device Regulations 3
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Selling a class II Medical Device in Canada in Pharmacies Elsmar Xenforo Forum Software Instructions and Help 10
S Acrylic in Class II b Active Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3
K Inventory Control - Class II (IIb for CE) medical device ISO 13485:2016 - Medical Device Quality Management Systems 6
S Software Release Note - Class A stand alone software medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 19
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M How is Class I Medical Device Compliance Enforced? EU Medical Device Regulations 7
K Calibration of Dose Area Product (DAP) Meter in our Class IIb X-Ray Medical Device General Measurement Device and Calibration Topics 1
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 4
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N Per the FDA regulations can a medical device be class I despite that it is sterile? Other Medical Device Related Standards 4
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom