SBS - The best value in QMS software

ISO 10993 (Biological Compatibility) Approved Materials

Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#21
#21
SRavi said:
@ Ronen,

Thank you for the suggestions.Also thank you for the supplier information. I sent them a mail regarding my query and hope to hear from them soon. <snip>
Click to expand...
Hi Ravi,

If you can justify that changing the component's shape doesn't alter its biocompatibility status, you generally don't have to re-test or otherwise show compliance. For example, die cutting out of a supplied (already certified) sheet is likely to pass, but injection molding typically won't because the high temperatures, shear and pressure might cause significant changes.

As far as I know, position on the body doesn't affect ISO 10993 requirements, as long as we're only discussing intact skin.

The "formal" way I know for "getting away with it" is contacting one of the accredited 3rd party ISO 10993 test labs, and asking for a written opinion from their expert toxicologist. Otherwise it's just trial and error - document your justifications and see what happens when you make a regulatory submission / go through audit (not recommended but might still work).

You are very welcome to send me a private message if you're interested in further specific consultation regarding sourcing this component / material. Other than that I'll be glad to answer any general questions here.

Cheers,
Ronen.
 
Popular whitepapers from DISCUS
Elsmar Forum Sponsor
R

robert.beck

Involved In Discussions
#22
#22
Re: Certification with respect to ISO 10993 (Biological Compatibility)

Did you ever find any acceptable materials? I'm wondering how to handle a situation that is very low risk, limited contact, but there is no biocompatibility information available on the material.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#23
#23
Re: Certification with respect to ISO 10993 (Biological Compatibility)

robert.beck said:
Did you ever find any acceptable materials? I'm wondering how to handle a situation that is very low risk, limited contact, but there is no biocompatibility information available on the material.
Click to expand...
Hi,

In ISO 10993 terms, risk level is determined by type of contact (=contacting tissue type) and contact duration. The risk is then translated into the number and type of tests required. As far as I understand, the lowest risk (shortest duration, in tact skin) translates into the 3 basic tests. If you wish to avoid these, you could try and follow the routes I suggested in previous posts.

Cheers,
Ronen.

PS If you refer to risk in ISO 14971 (rather than ISO 10993) terms then you might be able to justify that the risk is acceptable without further testing. However, according to EN ISO 14971:2012 you must reduce all risks as much as possible to comply with the MDD's ER, hence you'll probably have to test (the 3 basic tests are not very expensive or lengthy).
 
Last edited:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
L Biological Assessment (ISO 10993-1) Other Medical Device Related Standards 1
J Biological Evaluation requirements per ISO 10993 - Medical Device Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
W ISO 10993 (Biological Evaluation of Medical Devices) for Suppliers Other ISO and International Standards and European Regulations 8
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
R ISO 10993-18 Medical Device and FDA Regulations and Standards News 1
M ISO 10993-17 - Ancillary Medicinal substance leachables Medical Device and FDA Regulations and Standards News 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 3
P European versions of standards - ISO 10993-1 and ISO 11607-1 EU Medical Device Regulations 6
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
T ISO 10993-7 - Ethylene oxide sterilization residues Other Medical Device Related Standards 1
planB ISO 10993-1:2018 has just been published Other Medical Device Related Standards 2
M Does ISO 10993 Apply to Packaging? (e.g. Travel Case) Other Medical Device Related Standards 4
K ISO 10993 Requirements For 510k - Substantial Equivalence Other US Medical Device Regulations 11
T Using Risk Management in ISO 10993 - Medical Device Accessory 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P ISO 10993 - Sterile (Irradiation) Polypropylene Syringe Question Other Medical Device Related Standards 6
D Actual Definition of Non-Contact for ISO 10993 Other Medical Device Related Standards 1
R Biocompatibility - ISO 10993 and SVHC Requirements Other Medical Device Related Standards 4
S ISO 10993-1: External Communicating Device biocompatibility test requirements Other ISO and International Standards and European Regulations 4
S Selecting materials for implants to comply with ISO 10993 biocompatibility Other Medical Device Related Standards 4
T Plastic of an infusion pump enclosure and ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 2
E Upcoming changes for ISO 10993 and IEC 60601 in South Korea Other Medical Device Regulations World-Wide 2
M FDA issues draft guidance to replace G95-1 (Application of ISO 10993) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Verify GB/T 16886 is the same as ISO 10993 US Food and Drug Administration (FDA) 5
B New ISO 10993-12 - Consistency of Extraction Conditions through different Assays Other ISO and International Standards and European Regulations 1
S Suppliers of ISO 10993 compliant Material for Skin Contact Other ISO and International Standards and European Regulations 3
M ISO 10993 - Repeat tests necessary if colour changes slightly? Other Medical Device Related Standards 11
M Pre-Selecting Materials for ISO 10993-1 Biocompatibility Compliance Other ISO and International Standards and European Regulations 5
F ISO 10993-10 - Removed from List of Harmonized Standards Other Medical Device Related Standards 4
S ISO 10993 Cytotox Testing - Direct Contact rather than Extractables Other Medical Device Related Standards 4
E Meeting ISO 10993-1 2009 Material Risk Assessment Requirements Other Medical Device Related Standards 13
M ISO 10993 Labs which can test Cytotoxicity, Sensitizaton and Irritation Other Medical Device Related Standards 10
M ISO 10993 for Fabric based Electrode - Finding already FDA Approved Materials Other Medical Device Related Standards 11
A Claiming Biocompatibility without ISO 10993-1 Other Medical Device Related Standards 19
T ISO 10993-10: 2002 vs 2010 version - What are the Major Changes? ISO 13485:2016 - Medical Device Quality Management Systems 2
I EO (Ethylene Oxide) Residuals - EN ISO 10993-7:2008 EU Medical Device Regulations 5
D Does anyone know of a biocompatible ABS tested & certified to ISO 10993-1 Other Medical Device Related Standards 5
W ISO 10993 - Replacing Sensitization Test with Systemic Toxicity Test? Other Medical Device Related Standards 4
I ISO 10993-10:2010 Guidance Document for Irritation and Sensitization Test - Changes ISO 13485:2016 - Medical Device Quality Management Systems 3
M EO (Ethylene Oxide) and ECH (Ethylene Chlorohydrin) Residual as per ISO 10993-7:2008 ISO 13485:2016 - Medical Device Quality Management Systems 15
I ISO 10993-1:2009 Sensitization (Initial Evaluation Test) vs. USP Other Medical Device Related Standards 3
B What ISO 10993 considers Non-Invasive vs. Invasive MDD 93/42/EEC EU Medical Device Regulations 3
C Differences between the biocompatibility standards ISO 7405 and ISO 10993 Other Medical Device Related Standards 2

Similar threads

Top Bottom