Hello,
I'm very pleased to join you on this unique forum and would like to start of with a thread that hopefully can help me and others distinguishing between APPLIED PARTS, ACCESSIBLE PARTS, ENCLOSURE and other parts of ME EQUIPMENT in accordance with 60601-1. The standard definition is as follows:
* APPLIED PART
part of ME EQUIPMENT that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function
The 60601-1 standard provides a good deal of information and detail on the matter in example images and subclause 3.8 but leaves out some basic definitions. So, to the question:
Let’s consider medical equipment operated by the patient in home settings, digital pill organizer, IR thermometer or a medical alarm clock. All of the items can be said to have a battery and a mains connected charger. Would following parts of the equipment, which are all touched during NORMAL USE be considered APPLIED PARTS according to 60601-1?
1. Power cord and plug.
2. External power supply.
3. On-off button.
4. Settings buttons.
5. Parts of enclosure that are held during normal use.
6. Parts of the transport bag in which the device is transported.
My general judgement is that while the listed parts can be argued to fall under definition of APPLIED PART, the standard is primarily describing applied parts as parts that are in constant contact with the patient or are touched in order to perform a clinical function. This is especially clear in subclause 3.8. My gut feeling is to argue that neither part on the list is APPLIED PART, especially if Risk Management shows that the parts are not a cause of potential harm.
Best Regards,
MW
I'm very pleased to join you on this unique forum and would like to start of with a thread that hopefully can help me and others distinguishing between APPLIED PARTS, ACCESSIBLE PARTS, ENCLOSURE and other parts of ME EQUIPMENT in accordance with 60601-1. The standard definition is as follows:
* APPLIED PART
part of ME EQUIPMENT that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function
The 60601-1 standard provides a good deal of information and detail on the matter in example images and subclause 3.8 but leaves out some basic definitions. So, to the question:
Let’s consider medical equipment operated by the patient in home settings, digital pill organizer, IR thermometer or a medical alarm clock. All of the items can be said to have a battery and a mains connected charger. Would following parts of the equipment, which are all touched during NORMAL USE be considered APPLIED PARTS according to 60601-1?
1. Power cord and plug.
2. External power supply.
3. On-off button.
4. Settings buttons.
5. Parts of enclosure that are held during normal use.
6. Parts of the transport bag in which the device is transported.
My general judgement is that while the listed parts can be argued to fall under definition of APPLIED PART, the standard is primarily describing applied parts as parts that are in constant contact with the patient or are touched in order to perform a clinical function. This is especially clear in subclause 3.8. My gut feeling is to argue that neither part on the list is APPLIED PART, especially if Risk Management shows that the parts are not a cause of potential harm.
Best Regards,
MW