FAQ - Implementation of EN 60601-1:2006 related to MDD 93/42/EEC

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M

MIREGMGR

#3
The Guidance states


Question 3.3.2:
Are the mechanical requirements of the 3rd edition standard relevant for non-active products?
Answer 3.3.2:
Here we have to give a two-fold answer: the scope of EN 60601-1 states that this standard is applicable to MEDICAL ELECTRICAL EQUIPMENT. That means non-active products are not covered by EN 60601-1.

My copy of IEC 60601-1:2005 has (I think) the same text in its scope as EN 60601:2006, and its scope mentions only Equipment and Systems, but not accessories. Annex 1 doesn't include any discussion of scope and accessories either. However, the standard's Terminology and Definitions section includes "Accessory", indicating that that term appears at least twice in the standard's requirements. Presumably we are to refer to "IEC 60788:2004, m rm-83-06 modified" for a definitive discussion of how accessories are included within 60601-1's scope.

I'm intentionally not referring to the discussion of "accessories" in the MDD here, since it needs to be possible to understand IEC 60601-1 in an FDA context as well.

Is the standard's definition of "accessory", in its use of the term "part", intending to be narrowly applicable only to components that are design- and function-integrated with and specific to the system or equipment, are minor in physical extent and independent function compared to the system or equipment, and are not devices in their own right? If not, why is the word "part" used? If so, why does the explanation use "or" and include the first clause, i.e. "achieve the intended use"?

If not intending to be so narrowly applicable, does "accessory" include other medical devices that may be used with the equipment or system to achieve its intended use, but aren't specifically or solely intended for such use? In this case, so as to distinguish how the primary standards applicability should be analyzed, which of the two devices is the accessory, and which is the primary system?

Is a separate medical device that's "for use with equipment in order to achieve the intended use", but is non-active and is made and marketed independently by a third party, and is specific to that system or equipment only to the extent that it's an element of a product family that happens to be sized such that it's compatible with that system or equipment, an accessory?

An example of the latter would be a disposable, single-use contamination-prevention and sterile-field-establishing equipment cover, tailored to a size and shape that fits some other company's item of medical imaging equipment. In normal intended use, such equipment definitely cannot achieve its intended use in common intraoperative imaging use without the use of such an equipment cover, because mandatory clinical practice requires such a sterile barrier. Thus the equipment-cover product seems to perfectly fit the standard's definition of an accessory...but was that really the drafters' intent, given that it's hard to understand how to apply the standard if you aren't responsible for the system or equipment to which it presumably primarily applies, and don't have access to that system or equipment in an engineering context that would allow compliance evaluation?
 
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Marcelo

Inactive Registered Visitor
#4
Presumably we are to refer to "IEC 60788:2004, m rm-83-06 modified" for a definitive discussion of how accessories are included within 60601-1's scope.
IEC 60788 is just a compilation of defined terms used in the second edition of IEC 60601, so no, you won't find a definitive discussion there.

Is the standard's definition of "accessory", in its use of the term "part", intending to be narrowly applicable only to components that are design- and function-integrated with and specific to the system or equipment, are minor in physical extent and independent function compared to the system or equipment, and are not devices in their own right? If not, why is the word "part" used? If so, why does the explanation use "or" and include the first clause, i.e. "achieve the intended use"?
Part means..hum...part. Such as applied part?

Accesories are meant to be a lot of stuff, and can aldo de MEE on their own right. For example, anesthesia workstations have a lot of accesories which are MEE.

The "or" is to be read in the end of all options - it's a ISO/IEC draft rule.

If not intending to be so narrowly applicable, does "accessory" include other medical devices that may be used with the equipment or system to achieve its intended use, but aren't specifically or solely intended for such use? In this case, so as to distinguish how the primary standards applicability should be analyzed, which of the two devices is the accessory, and which is the primary system?
Example: it depends on who is applying the standard. Example: You manufacture a critical care lung ventilator (80601-2-12). An accessorie might be a gas monitor (which is a MEE under 80601-2-55). For you, the ventilator is the "device" while the gas monitor us the accessory.

Is a separate medical device that's "for use with equipment in order to achieve the intended use", but is non-active and is made and marketed independently by a third party, and is specific to that system or equipment only to the extent that it's an element of a product family that happens to be sized such that it's compatible with that system or equipment, an accessory?
It depends on what the sysem or equipment manufacturer says. Note that you cannot name tour device an accessory to a MEE. The MEE manufacturer needs to name your device an accessory.

Thus the equipment-cover product seems to perfectly fit the standard's definition of an accessory...but was that really the drafters' intent, given that it's hard to understand how to apply the standard if you aren't responsible for the system or equipment to which it presumably primarily applies, and don't have access to that system or equipment in an engineering context that would allow compliance evaluation?
The same rationale here. Note that, if the medical imaging equipment manufacturer would need to define which accessories to use with his equipment. This is the general idea behind the definition of accessory. Oh, and also, if the equipment manufacturer wanted to, he could say, for example, that your device cannot be used with his equipment. It does happena a lot (for example, if the equipment manufacturer also sells a device-accessory like yours).
 
M

MIREGMGR

#5
Is a separate medical device that's "for use with equipment in order to achieve the intended use", but is non-active and is made and marketed independently by a third party, and is specific to that system or equipment only to the extent that it's an element of a product family that happens to be sized such that it's compatible with that system or equipment, an accessory?
It depends on what the sysem or equipment manufacturer says. Note that you cannot name tour device an accessory to a MEE. The MEE manufacturer needs to name your device an accessory.
The same rationale here. Note that, if the medical imaging equipment manufacturer would need to define which accessories to use with his equipment. This is the general idea behind the definition of accessory.
This is a helpful extension to the definition. Where is this documented?

This also necessarily leads to another question. As an example, suppose we make a disposable equipment-cover device that will fit another maker's item of equipment, as in the prior scenario. Per your explanation above we don't consider our product to be an Accessory. However, not at our request and without our knowledge, the responsible manufacturer of that third-party equipment declares our device to be an Accessory to their equipment. What is our responsibility regarding conformance? Or can our product become an Accessory to another maker's equipment only if we agree? And if this is the case, where is this interpretation documented?
 

Marcelo

Inactive Registered Visitor
#6
This is a helpful extension to the definition. Where is this documented?
It's really not documented anywhere. It's a direct read of the standard:

NOTE 1 ME EQUIPMENT includes those ACCESSORIES as defined by the MANUFACTURER that are necessary to enable the NORMAL USE of the ME EQUIPMENT.

This also necessarily leads to another question. As an example, suppose we make a disposable equipment-cover device that will fit another maker's item of equipment, as in the prior scenario. Per your explanation above we don't consider our product to be an Accessory.
Sorry, maybe I wasnt very clear on this. What I was saying regarding accessories pertains to IEC 60601. If your device isn't a medical electrical equipment, the definitions of accessory and MEE of 60601 do not apply. You will register/ce mark/510king your device in it's own right

However, not at our request and without our knowledge, the responsible manufacturer of that third-party equipment declares our device to be an Accessory to their equipment. What is our responsibility regarding conformance?
You would not have in principle any responsibility related to device performance - the equipment manufacturer has the responsibility to make sure the device, with it's accessories, is safety and effective and whatever.


Or can our product become an Accessory to another maker's equipment only if we agree? And if this is the case, where is this interpretation documented?
This question is outside the IEC 60601 solutions. It depends on the reg system.

In the case of IEC 60601 testing and/or certification, if the equipment manufacturer defines any device as an accessory, the tester/certifier will usually only worry with the face that the equipment must be testet with all accesories, which includes the device in this example.

The correct procedure, IMHO, would that someone only uses your device as accessory if they have some type of agreement of undeerstanding with you. The this involves commercial aspects that generally falls outside standards and regulations.
 

Peter Selvey

Staff member
Super Moderator
#7
The issue of accessories is one that clearly needs to be fixed.

The IEC 60601 series seems to missing a very basic point that medical systems are often built using devices from different manufacturers, where individual manufacturers have no contractual or legal agreement, or even any direct contact. For example, IEC 60601-2-34 for IBP monitors, covers both patient monitor and the sensor together. It is frequently the case that monitor and sensor manufacturers have no direct contact.

In contrast, ISO, ANSI/AAMI, JIS and EN standards seem to be comfortable separating accessories from the equipment (e.g. ANSI/AAMI BP 22, JIS T 3323 for IBP sensors, tested separated from the equipment).

This later situation reflects the real world and also the regulatory environment. Regulation allows a medical system to be built from many different medical "devices", without needing any regulatory approval of the final system. While it would be ideal to have each system tested, in practice it would be a regulatory nightmare, because of the large number of combinations.

From a product certification point of view, IEC Guide 65 also requires that manufacturer takes responsibility and reports changes to the certified product. If the product certification includes accessories with significant aspects influencing compliance (e.g. performance) from another manufacturer where no agreement exists, these requirement cannot be fulfilled.

So, the current IEC 60601 approach does not fit with regulation, product certification or the real world.

It needs to be changed so that the scope of the standard is limited to a single "medical device" for which the manufacturer takes responsibility. As with regulation, this "device" can include accessories, but this is optional and should be limited to those which the manufacturer can take responsibility for.

To make this work, the standard needs to switch to making sure interface specifications are appropriately specified, and then the device is evaluated based on these specifications.
 
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