Traditionally (but not currently the case), the scope of ISO 10993-1 has been focused only on patient-contacting aspects. That's likely the basis of your corresponding interpretation. Indeed, prior versions of ISO 10993-1 dating back as far as the 2003 version (and probably even further) generally contained the scope statement (or similar), that ISO 10993-1, "...does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body..." [emphasis added].
But in the current (2018) version of ISO 10993-1, the scope was broadened to include user-contacting aspects, yet with certain, albeit ambiguous, limitations (with even more such limitations and course reversal currently drafted into the upcoming 202x version of ISO 10993-1; more about that in a moment). Specifically, the 2018 version now specifically includes user-contacting medical devices in the scope, but only those that are for the user's personal protection (e.g., gloves, masks, etc.).
But beware: The current (2018) version also contains a normative note, stating that, "...If [skin-contacting user interfaces] can be shown to be made from materials in common use for other consumer products with a similar nature of contact, no further biological evaluation is needed..." [emphasis added]. We need to be careful interpreting this exception; specifically, a desk-top biological evaluation would in my practice still be expected for formally establishing the organization's common-use material basis for not undergoing further, more involved, biological evaluation.
The good news is that this 2018 normative note along with its ambiguity have, in the current draft of the upcoming 202x version of ISO 10993-1, been clarified by being converted to fully normative text (rather than a normative note), and by being placed in a new dedicated subclause called "Non-contacting medical devices". The new drafted sub-clause would plainly establish that medical device surfaces (e.g., external surfaces and housings of equipment and control interfaces such as keyboards, buttons, switches, dials, touch screens, etc.) which have only transitory contact with a user's intact skin during normal handling, and whose skin-contacting components are made from materials in common use for consumer products with a similar nature of contact, will be plainly considered to have no significant body contact, and be simply classified as "non-contacting medical devices" intrinsically accepted as having no biological hazards or risks. For these, the drafted provision intends that no biological evaluation at all is required for such non-contacting medical devices.
Until then we are left with the 2018 version. And for that in the context of your specific question, regardless of 2018's ambiguities, my practice has been that if a device is intended to be handled/contacted only by gloved users, then such a device (but not the gloves themselves) would generally be considered in my experience to be a device that doesn't contact the user, and that therefore doesn't need biocompatibility testing for that aspect of the device's contact profile.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 31-Mar-2022 17:38
From: Anonymous Member
Subject: Biocompatibility Testing
This message was posted by a user wishing to remain anonymous
I have never run into this before. Our technical documentation was being reviewed by a Notified Body. The device is handheld but never comes in contact with a patient. We justified not having to do biocompatibility testing (per ISO 10993) because the device never comes in contact with a patient. The NB is arguing that it comes in contact with the user as the user is holding the device. I have never considered this, as many devices are touched by the user. Is the NB being reasonable in their request? Also consider that the user of the device will always be wearing gloves while holding the device. Therefore, the device never actually comes in contact with the user.