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?