Biocompatibility testing of our applied part seems redundant

EMC_noob

Starting to get Involved
#1
Hello people, my class II medical device has one applied part in the form of a so-called enabling switch which allows the user to interrupt our therapy if he/she experiences any discomfort. Following the ISO Materials Biocompatibility Matrix (sorry, can't post a link), I conclude that we are in the absolute lowest risk since we have limited contact with intact skin. We know the materials used in the off-the-shelf enabling switch that we are using.

Is it really necessary to conduct a biocompatibility test with a lab? And if not, how would I argue for that in my 510k application?

Thank you
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
Yu may want to have a look into ISO 10993-1:2018, sections 5.2.2 NOTE and 5.3.2 - quote:
NOTE 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, [...] 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.
5.3.2 Transitory-contacting medical devices
Some medical devices with limited exposure (A) have very brief/transitory contact with the body (e.g. lancets, hypodermic needles, capillary tubes that are used for less than one minute). These generally would not require testing to address biocompatibility.
HTH,
 
Thread starter Similar threads Forum Replies Date
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7
R What is the expectation for Biocompatibility Testing when switching Suppliers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
S Biocompatibility testing for nasal prongs made of medical grade silicone 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
J Biocompatibility Evaluation component other than Testing Other Medical Device Regulations World-Wide 1
J Grouping Products and Testing Sterile and Biocompatibility - Validating Products Other Medical Device Regulations World-Wide 3
R Is Biocompatibility Testing required for Implantable Class III Devices sent to China China Medical Device Regulations 3
C Biocompatibility Evaluation Testing on Single Use Tube Sets Other Medical Device Related Standards 9
I Biocompatibility Testing Requirements for a Class I device - Does not contact patient 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Do we have to use an FDA recognized lab for Biocompatibility testing of 510k devices? Other US Medical Device Regulations 2
S Biocompatibility - Complement System Testing US Food and Drug Administration (FDA) 1
W Biocompatibility of Implantable Component - What testing, if any? Other Medical Device and Orthopedic Related Topics 5
M Medical Device Biocompatibility Testing - End Product or Components - ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 22
T Animals for biocompatibility testing? Other Medical Device Related Standards 10
V Biocompatibility testing centre in Montreal QC ? Other Medical Device and Orthopedic Related Topics 3
A Biocompatibility testing & Registration in China ISO 13485:2016 - Medical Device Quality Management Systems 5
M Predicate Device - Question on Biocompatibility and IEC 60601-1 Testing Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
T Biocompatibility Testing for Implantable Medical Devices according to ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 4
A Biocompatibility: Selection of worst-case device Medical Device and FDA Regulations and Standards News 1
Judy Abbott Biocompatibility requirements for submission to Chile Other Medical Device Related Standards 1
J Biocompatibility for endoscope external handle/grip US Food and Drug Administration (FDA) 3
S Validity of biocompatibility reports ISO 13485:2016 - Medical Device Quality Management Systems 4
O ISO10993 - Biocompatibility in medical vacuum systems (vacuum pumps) Medical Device and FDA Regulations and Standards News 2
S Biocompatibility requirement for electrode adapters Other Medical Device Related Standards 1
S ASTM F86 x Biocompatibility Issues Medical Device and FDA Regulations and Standards News 1
Judy Abbott The impact of laser power on biocompatibility of the products Manufacturing and Related Processes 6
Watchcat Summary of De Novo Biocompatibility Information, 2015-2018 Other US Medical Device Regulations 0
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
F Biocompatibility evaluation for Hardware/Interface Components? Other Medical Device Related Standards 13
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
K Biocompatibility evaluation of gas pathways Medical Device and FDA Regulations and Standards News 5
Judy Abbott Activation of complement at 90 min - BSI requested for justifications to support the biocompatibility of the device EU Medical Device Regulations 2
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
R 510(k) Biocompatibility vs Cleaning Validation Other Medical Device Related Standards 4
K Biocompatibility classification for Lancet CE Marking (Conformité Européene) / CB Scheme 7
F Sample Size for Biocompatibility Tests Other Medical Device Related Standards 4
F Biocompatibility Device Categorization: Priming with Blood Other Medical Device Related Standards 1
W Biocompatibility Risk Analysis for Clinical Practitioner 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F Biocompatibility on aged devices Other Medical Device Related Standards 4
Gamula Biocompatibility GLP conform tests outside China China Medical Device Regulations 1
I Biocompatibility Impact on Autoclaved Silicone Other Medical Device Related Standards 3
D Should Biocompatibility Tests be performed on Production Samples? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9

Similar threads

Top Bottom