Pre-Selecting Materials for ISO 10993-1 Biocompatibility Compliance

M

mr.mike

#1
I could use some advice regarding selection of materials given that our device will eventually be tested for ISO 10993-1 biocompatibility.

We are presently in the design/development stage, and do not yet have a prototype, however the specifications we're working from have stipulated that all materials must be "ISO 10993 compliant".

What does this even mean?

As far as my understanding of ISO10993, devices are subjected to a battery of tests depending on the final application (duration of contact, breached/in-tact skin, implantable/surface).

So to say that selected materials are ISO10993 compliant (some of our material suppliers have made this claim) before knowing the final application is questionable, no?

That being said, assuming that we do intend to get the final prototype tested, are there any guidelines that we can follow when selecting materials? Ideally we'd like to find a predicate device, but so far have been unsuccessful as companies are reluctant to divulge their own material specs and suppliers.

As always, any advice greatly appreciated.
Thanks in advance,
M
 
Elsmar Forum Sponsor
M

mr.mike

#2
Hi Again,
Boy, these forums are a fantastic resource!
Here is a thread addressing this query:
http://elsmar.com/Forums/showthread.php?t=34069

I'd still like any input regarding what others are doing with respect to pre-selecting materials to be used in a device. Do you request the relevant ISO 10993-X test reports from the materials suppliers? Do you perform your own tests? Do you provide other justification for the inherent safety of chosen materials (history of use, USP VI...etc.)?

Thanks again to all the experienced posters out there sharing their expertise!
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hi Again,
Boy, these forums are a fantastic resource!
Here is a thread addressing this query:
http://elsmar.com/Forums/showthread.php?t=34069

I'd still like any input regarding what others are doing with respect to pre-selecting materials to be used in a device. Do you request the relevant ISO 10993-X test reports from the materials suppliers? Do you perform your own tests? Do you provide other justification for the inherent safety of chosen materials (history of use, USP VI...etc.)?

Thanks again to all the experienced posters out there sharing their expertise!
Hi,

First off, the "rawness" level of the ingredient matters. if you purchase a raw resin and process it (e.g. injection moulding) the chances of creating biocomp. concerns are higher than when you purchase a finished article that is assembled with no/minor chemical / physical transformation (e.g. a bolt that is merely screwed into another part of the same material, with no aid materials etc.).

If your suppliers have any ISO 10993-X test reports, it may be a good start, so yes, asking about the availability of any is recommended. However, this would typically be far from enough. Further, lack thereof doesn't mean it's a no-goer. "USP class VI" (though formally not applicable), "Food Grade", "Food Contact", "Drug Master File", "Medical Grade", "Hi Purity" and the like are all "soft" indicators that the subject materials are more likely to meet applicable requirements, though they are usually just marketing prompts and in many cases can't be backed by the hard, concise evidence one would expect, let alone exempt from 10993 testing.

Sometimes even materials that are not associated with any of the above may qualify. Of course then the entire burden shifts to you, and you'd have to exercise lots of wits, caution and theoretical study if you choose to take this path. Nevertheless, it's been done many times before!...

The question of whether tests are required (and what tests) or justifications (of what sort) suffice is better discussed in detail with an expert toxicologist working with an accredited test lab that specializes in ISO 10993 testing. It depends on the nature of the device, the case specifics and the associated risk level.

Cheers,
Ronen.
 
M

MIREGMGR

#4
So to say that selected materials are ISO10993 compliant (some of our material suppliers have made this claim) before knowing the final application is questionable, no?
In my experience, in most cases, an "ISO 10993 compatible" statement in regard to a material that's offered to US device makers means that the material has passed third party lab testing for ISO 10993-5 and 10993-10, i.e. the cytotoxicity, sensitization and irritation tests defined in US FDA G95-1 as minimally required for surface devices with limited-duration contact with intact skin.

In the case of a material that's marketed for a particular application exceeding that level of patient contact, logically one would expect the additional testing required for such an application per G95-1. The obvious example would be for a material that's explicitly marketed for use in implantables or blood-path-communicating applications.
 
C

cadevon

#5
Hi all,

How is the biocompatibility assessment affected when working with pre-manufactured components, not raw materials?

For example:
Ordering pre-manufactured reusable breathing tubes for use with a CPAP device. If the manufacturer of the tubing can provide justification or documentation for their material selection is it still required to do testing per 10993 on that component?

It seems to me that this is considered a separate product entirely.

Thanks!
 
Thread starter Similar threads Forum Replies Date
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
H Queries: RFD & Pre-RFD Program Medical Device and FDA Regulations and Standards News 0
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
R Gauge R&R on pre-set torque wrench Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
D Pre-Production Capability Assesment Reliability Analysis - Predictions, Testing and Standards 5
M Is there any pre-defined Control plan format/template acc. VDA? VDA Standards - Germany's Automotive Standards 0
D Pre-Submission after 510(K) Submission? Other US Medical Device Regulations 4
J Pre-clinical Studies for RUO Product Other Medical Device Regulations World-Wide 1
M Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
J Custom-made implants (Class IIb) and pre-commercialization clinical trials in Spain EU Medical Device Regulations 4
C Shipping Medical Devices to US before pre market clearance US Food and Drug Administration (FDA) 1
A UDI requirements for pre-filled combination devices - Box containing a pre-filled device US Food and Drug Administration (FDA) 2
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
D Redacted pre-submission bundle that you would be willing to share US Food and Drug Administration (FDA) 3
I Bench Testing & Pre-verification vs. Formal verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D FDA Pre-Submission Meeting Advice US Food and Drug Administration (FDA) 0
M Medical Device News Health Canada – Consultation: Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
L 510 (K) Pre-Sub meeting - Does it worth? US Food and Drug Administration (FDA) 4
A Examples of Pre-Sub, SRD, PMA Shells and Templates Other US Medical Device Regulations 3
B Manufacturing site relocation of pre amendment Class II medical device Manufacturing and Related Processes 4
A Users won't return devices from pre-CE performance evaluation study EU Medical Device Regulations 3
B GM GP-12 Pre-Launch - They asking for a I chart Statistical Analysis Tools, Techniques and SPC 2
GoSpeedRacer Pre-Work and Study for ISO 13485:2016 Lead Auditor Class ISO 13485:2016 - Medical Device Quality Management Systems 1
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
V Is 'Compliance' a pre-requisite or is it ok before Batch Release to Market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Writing a Pre-Submission to the FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 44
P EASA STC (Supplemental Type Certificate) on a Pre-mod FAA STC Configuration EASA and JAA Aviation Standards and Requirements 1
H Pre compliance test for Glucometer Other Medical Device and Orthopedic Related Topics 1
V Pre-dispensed API material received in predetermined quantities & given to production Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
R Is pre-conditioning supplier component before incoming inspection tests allowed? Quality Manager and Management Related Issues 16
somashekar Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
Q FDA Consensus Standard for PMA (Pre-Market Approval) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
JoCam Format of Health Canada pre-market licence application Canada Medical Device Regulations 3
P Humidity Pre-Conditioning before leakage current and dielectric strength tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
V 510(K) Cyber Security Documentation for Pre-market Submission (Templates) Other US Medical Device Regulations 6
A Infusion Pump - Pre-Clearance Inspections Learnings US Food and Drug Administration (FDA) 4
Crimpshrine13 ISO/TS 16949 Pre-Audit Requirement IATF 16949 - Automotive Quality Systems Standard 18
Marc USA to insist on pre-flight mobe power probe Travel - Hotels, Motels, Planes and Trains 3
G 510(k) Pre-market approval Application Requirements - Effectiveness of the product Other US Medical Device Regulations 1
K Harmonisation of Global Medical Device Pre-Market Regulations Other Medical Device Regulations World-Wide 5
D Pre-Design Verification - Using Continuous / Variables Data Statistical Analysis Tools, Techniques and SPC 2
A Pre-clinical Animal Studies for long term implantable medical devices EU Medical Device Regulations 5
V Should template/formats be pre configured to claim 21 CFR part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 5
M Ownership of Pre-Clinical cGMP Stability Testing Other Medical Device and Orthopedic Related Topics 2
F Pre-written Safe Work Method Statement (SWMS) rant! Occupational Health & Safety Management Standards 13
F Definition Medical Device Contract Manufacturing PAI (Pre-Approval Inspection) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J Pre-Revenue Medical Device Company ISO 13485 Audit ISO 13485:2016 - Medical Device Quality Management Systems 1
A Does ISO/TS 16949:2009 require us to perform Final/Pre-dispatch Inspection? IATF 16949 - Automotive Quality Systems Standard 5

Similar threads

Top Bottom