Medical Device Biocompatibility Testing - End Product or Components - ISO 10993

#1
Hi Guys ,

i need your input regarding Biocompatibility testing on a medical device, whats need to be consider . we have to follow the ISO10993 for the selection of the test. My questions is that

If all the material which used to manufacture a madical device are biocompatible according to the certificates provided by the supplier . Is is enough to comply with the requirement or do we have to once again perform all the tests on finished device.

most of our component are USP calss VI compatible. do we have to test the finished product or the component as well if they are not biocompatible.

what happen to the component who don,t ave any certificate of conformity from supplier . do we have to perform biocompatibility testing on these component before use them in production?

Thanks in advance
 
Elsmar Forum Sponsor

bio_subbu

Super Moderator
#2
Re: Biocompatibility testing end product or components

Please brief product category whether sterile or non sterile. Are all your product components directly touch with the human body?
 
#3
Re: Biocompatibility testing end product or components

Please brief product category whether sterile or non sterile. Are all your product components directly touch with the human body?

The product is Class IIa product which is an accessory needs to provide sterile and its come in indirect blood contact for less then 30 days.
 
S

SteveK

#4
From my experience from pharmaceutical packaging and drug delivery systems (e.g. Metered Dose Inhalers) – it was the final product that was tested (on bunnies etc) to comply e.g. with USP VI requirements – well all the component parts that could be in contact with the body, secretions, blood or drug substance. I guess the rationale was it was the (possible) effect of the processing (e.g. injection moulding, blow moulding etc) and post processing (e.g. sterilisation – gamma, ETO, autoclave etc) - even if the material(s) itself was ‘approved’.:2cents:
 
#5
From my experience from pharmaceutical packaging and drug delivery systems (e.g. Metered Dose Inhalers) – it was the final product that was tested (on bunnies etc) to comply e.g. with USP VI requirements – well all the component parts that could be in contact with the body, secretions, blood or drug substance. I guess the rationale was it was the (possible) effect of the processing (e.g. injection moulding, blow moulding etc) and post processing (e.g. sterilisation – gamma, ETO, autoclave etc) - even if the material(s) itself was ‘approved’.:2cents:

Thanks steve , I am also on the same opinion, but if the materials are not biocompatible then ?
Do we have to perform biocomp testing on component first and then after manufacturing again on final product?????

secondly if the component are USP Class VI registered. But it doesnot fully comply with the ISO10933 for europe. what we do in this case?
 
S

SteveK

#6
Hi Waziz,

Bit difficult to give any more advice because I am not too familiar with ISO10933 - just various pharmacopeia requirements. You could possibly sterilize each component separately using the same procedure as the final product (I assume there is some assembly process) and then have them individually tested to USP. If they pass USP but do not meet ISO 10933 – do not know.

Steve
 

bio_subbu

Super Moderator
#7
Hope that you are following ISO 10993: 2003 and finalized your product testing requirements as per Table 1- initial evaluation tests for consideration which basis on your product contact duration. If your supplier provide certificate against biocompatibility test carried out for supplied components are meeting the requirements of ISO 10993. It’s accept for consideration, if you perform yourself for same tested material it will worth acknowledging that your components are safe material and it will not cause any harm to the end user.

I understand from your previous post that you are going to export your product in European countries, if you perform the biocompatibility test yourself; you have to choose a laboratory which should accredited by ISO/IEC 17025 and perform the tests as per ISO 10993.

Please be noted that if your end product is do not contact the patient’s body directly or indirectly are not included in the scope of ISO 10993.

Thanks and Regards
S. Subramaniam
 
M

MIREGMGR

#8
"Class VI" is a material characterization per US Pharmacopeia, of course.

This is a current material regulatory classification for packaging and other systems that contact pharmaceuticals.

It however is two FDA regulatory systems old in regard to medical devices. Since 1995, the FDA has utilized ISO 10993 for materials biocompatibility qualification for devices. USP material categorization is obsolete and irrelevant for current FDA device approvals.

USP categorization has never been relevant for MDD device conformance.

It is acceptable to establish biocompatibility for individual materials rather than the fabricated whole device, for the FDA and to show conformance with MDD, as long as it can be objectively shown that the fabrication process(es) utilized to make the device do not change the biocompatibility of the materials. In practice, this may not be a useful course-option unless the maker of the raw materials is providing the results of 10993 biocompatibility testing, and they also have done testing of the fabrication method you will use and have data to show that that method is acceptable.
 
D

dcraig

#9
I am unsure of specifically what your device is or how it is assembled. It has been my experiance that 10993 is to be perfomred on the finished device post sterilization. But on our devices any part of the device "could" contact the patient. If you are using a material which has been tested to 10993 and then subjecting that material to another process such as sterilization you need to show its continued ability to pass 10993. By sterilizing that material you are adding another variable and as such would need to show it does not change the toxicity of that material. Also if you are taking two parts and joining them togther with glue for example even if all three components have 10993 data you would need to show there is no change when all are combined together in your manufacturing process. This basically what was stated below hope it helps.
 
Thread starter Similar threads Forum Replies Date
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7
C Biocompatibility Test for a Non Contact Medical Device US Food and Drug Administration (FDA) 11
D Biocompatibility requirements for a Class IIa medical device CE Marking (Conformité Européene) / CB Scheme 7
T Biocompatibility for "Desktop" used Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 4
J Biocompatibility for Class I Non-Sterile Medical Device EU Medical Device Regulations 2
V Biocompatibility of Medical Device Internal Parts Other US Medical Device Regulations 9
M Biocompatibility 10993-1 vs. Sterilization Cycle - Medical Device in EU ISO 13485:2016 - Medical Device Quality Management Systems 6
L Biocompatibility of Medical Device Other Medical Device and Orthopedic Related Topics 8
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
M Medical device substance based-leachables Other Medical Device Related Standards 2
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4

Similar threads

Top Bottom