Medical Electrical Equipment / System Peripherals - IEC 60601-1-3

M

MIREGMGR

#11
I don't think this thread clarifies whose definition of "medical device" applies for that question.

The FDA's definition, from http://www.fda.gov/cdrh/devadvice/312.html, is in part:

"an instrument, apparatus, implement, machine (...) including a component part, or accessory which is:
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals (...)
It appears to me that your overall system will meet that definition. Thus (as I understand the definition) all of its component parts and accessories are medical devices when they're incorporated into that system.

Of course, the MDD definition would be different.
 
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M

MIREGMGR

#12
By the way, as a point of clarification, your original post asked about IEC 60601-1-3, which is "Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment", current edition = January 2008. It seems that all of the responses to date have assumed from your explanatory context that you actually are referring to IEC 60601-1 Third Edition.
 
F

freewind

#13
Hi MIREGMGR,

Sorry I made a mistake in my first post. I was referring to the 3rd edition of IEC 60601-1 and not the collateral standard. Thanks for pointing that out.

On the subject of collateral standards, say I have a medical electrical system. Would testing to the General requirements (IEC 60601-1) be sufficient of would the collateral IEC 60601-1-1 (Medical electrical equipment) be required?
 

Al Rosen

Staff member
Super Moderator
#14
Hi MIREGMGR,

Sorry I made a mistake in my first post. I was referring to the 3rd edition of IEC 60601-1 and not the collateral standard. Thanks for pointing that out.

On the subject of collateral standards, say I have a medical electrical system. Would testing to the General requirements (IEC 60601-1) be sufficient of would the collateral IEC 60601-1-1 (Medical electrical equipment) be required?
I think that if you have a system, then testing to IEC 60601-1 alone would not be sufficient.
iec60601-1-1 said:
1 Scope and object
*1.201 Scope
This standard applies to the safety of MEDICAL ELECTRICAL SYSTEMS, as defined in 2.201. It describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.



iec60601-1-1 said:
2.201
MEDICAL ELECTRICAL SYSTEM (hereinafter referred to as SYSTEM)
Combination of items of equipment, at least one of which must be MEDICAL ELECTRICAL EQUIPMENT and inter-connected by FUNCTIONAL CONNECTION or use of a MULTIPLE PORTABLE SOCKET-OUTLET
 
F

freewind

#15
I managed to find this in Annex A subclause 1.3 of the 60601-1 3rd edition:

The requirements from two of the collateral standards developed for the second edition of IEC 60601-1 have been incorporated into the body of this standard. They are:
– IEC 60601-1-1:2000,
[FONT=Arial,Italic][FONT=Arial,Italic]Medical electrical equipment – General requirements for safety – Collateral standard: Safety requirements for medical electrical systems

[/FONT]
[/FONT]
– IEC 60601-1-4:1996,
[FONT=Arial,Italic][FONT=Arial,Italic]Medical electrical equipment – Part 1: General requirements for safety – 4. Collateral standard: Programmable electrical medical systems [/FONT][/FONT]and its

Amendment 1 (1999)

So doesn't that mean 60601-1-1 is already included in the 3rd edition?


 

Marcelo

Inactive Registered Visitor
#17
Hello All

Sorry to have missed this post, but i think you all managed to get a good consensus.

Anyway, here are some of my thoughts.

The collateral standard IEC 60601-1-1 (aligned with the second edition of IEC 60601-1) was merged with the general standard in the third edition. It´s been revised and some points better clarified. In fact, the original questions are better answered by the third edition than by the old collateral standard. Please see in Annex A - Subclause 3.8 – APPLIED PART -, which has a lot of drawings and rationale to help understanding what is a equipment and what is a system.


1. Would a touch screen panel PC be considered a medical electrical equipment?
As Temujin told you before, the decision on what is an ME Equipment falls on the manufacturer. Under the third edition, there are at least three options when you have a ME equipment and a non-ME equipment. Note that they it doesn´t matter (in the case of non-ME equipment) if the equipment falls or not in the definition of medical electrical equipment).

a - the system is comprised of a ME equipment and a non-ME equipment (the monitor)

b - the system is comprised of two ME equipment (in this case the monitor is considered a ME equipment)

b- there´s no system, the whole is a ME equipment.

Every combination has it´s pros and cons and it´s respective requirements.

Please take a look at the example related to Figure A.7 in the third edition for more explanations.

In any case the basic principle apllies: PATIENTS should only be connected to APPLIED PARTS of ME EQUIPMENT complying with this standard (IEC 60601-1). Other equipment should comply with relevant IEC or ISO standards.

So the touch screen panel has to conply with IEC 60601-1 or with a standard applied to touch screen panels (IEC 60065, maybe?:), or even IEC 60950)

2. If a printer is connected to an ME equipment, what electrical safety standard should it comply with?
The same principles apply, but the printer would have to comply with IEC 60601-1 or IEC 60950 (this is the standard which applies to printers).

3. If a network router is used with an ME equipment, what electrical safety standard should it comply with?
The same principles apply, but the router would have to comply with IEC 60601-1 or IEC 60950 (this is the standard which applies to routers).
 
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