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Biocompatibility for "Desktop" used Medical Device

T

tallu

#1
Hello Covers,

I faced funny statement. One medical device is used as desktop installed device. It is not in contact with patient. But still it "should be" evaluated according to ISO 10993-1. Does this make any sense?

Maybe operator or some technical staff handless the device. But is it necessary to show the biocompatibility according to ISO 10993?

What kind of statement or tests should be performed for desktop use medical device?

Tips or hints anyone?
 
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M

maaquilino

#2
Without knowing what the device is or what it does, it's hard to give a thorough answer. It depends on what the 'medical device is used as desktop installed device' is used for. The following links may provide some answers.

This document mentions software: https://law.resource.org/pub/ie/ibr/is.en.iso.10993.1.2009.pdf
3.1
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: diagnosiS, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means

Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part Evaluation and Testing"
http://www.mdic.org.tw/UserFiles/GeneralFile/20144815406.pdf

A Practical Guide to ISO 10993: Part 1—Introduction to the Standards
http://www.mddionline.com/article/p...part-1151introduction-standards?quicktabs_2=1
 
T

tallu

#3
It was like a biosignal amplifier where patient cable safety connectors are applied.

Device is placed on desktop, carrier or related place. Its not hold in hands (operator) and does not contact patien skin.

I hope this clarifies the device
 

planB

Trusted Information Resource
#4
Here is the scope of ISO 10993-1:2009, as defined in section 1:

"This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure."

Concludingly, ISO 10993-1's scope only comprises medical devices that are either in direct or indirect patient contact. If your device really has none of these patient contacts, ISO 10993-1 would not apply and you can complete your biological evaluation with a quote of section 1 and Figure 1 (the flowchart) of this standard.

As a responsible manufacturer you may also want to consider the standard's introduction which says "The primary aim of this part of ISO 10993 is the protection of humans from potential biological risks arising from the use of medical devices", and employ ISO 10993-1 to evaluate any biological risks for operators or anybody else who would have contact with the device, e.g. the personnel who installs the device on the desktop.

HTH,

Gerhard
 
A

Adele

#5
You need to evaluate and document that the device has been assessed as having neither direct or indirect contact and conclude that because of this there is no requirement to do any biocompatibilty testing according to ISO 10993-1.
With some devices it is really obvious but without that document you cannot show you have evaluated it to ISO 10993-1.
 
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