Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1

Kuldeep Singh

Involved In Discussions
#1
Hello Everyone,

We searched this forum related to applicability of biocompatibility testing as per ISO 10993-1 . As we are manufacture of Diagnostic X-Ray medical Devices like C-Arm, Full Field Digital Mammography machines etc. in which there is patient contact categorized as Class A (less than 24 hours) as per ISO 10993-1. Can anyone share his experience for below of my queries.

As per ISO 10993-1 , if there is patient contact(s) for less 24 Hours ,then it will be categorized as Class A and testing need to perform as per ISO 10993-5 and ISO 10993-10 .

In our cases, There is Patient contact for 5 to 10 minutes during diagnosis ,also there is always a patient gown or cloths were present in between patient and applied part of our machine or we can say there is no direct contact with patient.is there any alternate to skip these tests by considering this justification. Further, Patient contact is not so critical as compare to Surgical tables.
 
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planB

Trusted Information Resource
#2
You may check whether ISO 10993-1:2018, section 5.2.2 a) NOTE applies - quote:

Some medical devices used in either sterile or non-sterile environments include components that can come into contact with a user’s ungloved hands such as human interfaces for electronic equipment (e.g. computer keyboards, dials or buttons, touch screens, SD cards, USB sticks); housings for electronic monitors or programmers that can come into contact with any intact skin (e.g. electronic devices like cell phones, tablets); or components that can come into contact with a user’s gloved hand (e.g. catheter handles). If these types of components 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.
The last sentence in this note could provide you with a rationale for omitting testing for these kind of intact-skin contacting devices.

HTH,
 

indubioush

Quite Involved in Discussions
#3
ISO 10993 is only for devices that have direct or indirect contact with the user. If there is no direct or indirect contact, biocomp does not apply. (Indirect contact would be for example a fluid that passes over the medical device before the fluid comes in contact with the patient.)

If there is user contact, you need to either test or follow planB's recommendation.
 
Last edited:

planB

Trusted Information Resource
#4
... a word of caution: while traditionally the scope of ISO 10993-1 indeed was patient-contacting devices only, the scope has been expanded in the latest revision to _any_ body contact, be it patient or professional user (which, btw, is also FDA's view in their guidance document from 2016).
 
#7
Regarding the excerpt from 10993-1. What documents are needed to show "to be made from materials in common use for other consumer products with a similar nature of contact". Is REACH and/or RoHS necessary?
thanks
 

planB

Trusted Information Resource
#8
cwiesener,

European regulations REACH and RoHS, restricting hazardous substances, will not help you in this context. You may contact your supplier asking for a confirmation that your sourced material (including the used colours) is also used for other consumer products like cell phones, automotive parts, household goods etc. Sometimes, you find this information also on the supplier web-site.

HTH,
 
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