ISO 10993 Biocompatibility Requirements - manufacturing process chemicals

#1
We have been handed a non-conformity against ISO10993 for Biocompatibility. The device is 316-grade stainless construction and is surely inherently biocompatible - the issue appears to be with manufacturing process chemicals which we had failed to consider.

How best would go about proving that chemical residues were removed (or reduced to safe levels) following manufacturer?
 
Elsmar Forum Sponsor
#3
My Medical Device complies only with ISO 10993-1:2009 regulations. What should be the steps taken to upgrade to ISO 10993-1:2018 regulations? Also, what is the last date for doing this upgrade?
 

QM_123

Starting to get Involved
#4
My Medical Device complies only with ISO 10993-1:2009 regulations. What should be the steps taken to upgrade to ISO 10993-1:2018 regulations? Also, what is the last date for doing this upgrade?
I have no answer for transition because I have performed a gap analysis and I found what is lack according to current version and I reviewed our biological assessments.

First step is gap analysis. Some new tests are included by this version, you have to assess them whether they are applicable for your device, and if you will not perform any test after your assessment then you should write a justification (if this decision is reasonable). If you have to perform new test then you have to make plan to start tests. Not additional tests, but also some new assessment requirements included. I do not know your device but this is the path generally followed by manufacturers.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
My Medical Device complies only with ISO 10993-1:2009 regulations. What should be the steps taken to upgrade to ISO 10993-1:2018 regulations? Also, what is the last date for doing this upgrade?
ISO 10993 is a standard, not a regulation. Standards are voluntary by nature, except in specific cases where they are endorsed by legislators and become mandatory (not very common). I'm not aware of ISO 10993 being mandatory anywhere, though it's certainly de-facto enforced in some prominent jurisdictions (e.g. the EU and the USA).

Anyway, the general ISO rule is a 3-years transition and I'm also not aware of ISO 10993-1:2018 already being officially endorsed for implementation. In the US, the go-to reference is the FDA's guidance document on biocompatibility which is based on ISO 10993-1:2009. In the EU, the governing reference is the harmonized standards list published on the OJEU. That list for the MDD has not been updated in over 18 months, and I doubt it ever will again. So ISO 10993-1:2018 isn't there. A list for the MDR was not published yet.

To summarise, it's probably a good idea to start your gap analysis but currently there's no hard requirement to transition.
 

QM_123

Starting to get Involved
#6
ISO 10993 is a standard, not a regulation. Standards are voluntary by nature, except in specific cases where they are endorsed by legislators and become mandatory (not very common). I'm not aware of ISO 10993 being mandatory anywhere, though it's certainly de-facto enforced in some prominent jurisdictions (e.g. the EU and the USA).

Anyway, although the general ISO rule is a 3-years transition, I'm not aware of the ISO 10993-1:2018 already being officially endorsed for implementation. In the US, the go-to reference is the FDA's guidance document on biocompatibility which is based on ISO 10993-1:2009. In the EU, the governing reference is the harmonized standards list published on the OJEU. That list for the MDD has not been updated in over 18 months, and I doubt it ever will again. So ISO 10993-1:2018 isn't there. A list for the MDR was not published yet.

To summarise, it's probably a good idea to start your gap analysis but currently there's no hard requirement to transition.
Hello Ronen,

Yes it is not harmonized yet, but our two companies got a nonconformity: " Biological assessment wasn't updated regarding ISO 10993-1:2018". I know NB cannot write any NC regarding a non-harmonized standard, but they write. I can reject this kind of NC but to be honest I do not want to cause crisis and everyone seeks for the maintenance of certificate for trading . I think our friend asked this question upon a NC and I replied accordingly.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
I know NB cannot write any NC regarding a non-harmonized standard, but they write.
That sounds like bullying.
I can reject this kind of NC but to be honest I do not want to cause crisis and everyone seeks for the maintenance of certificate for trading.
If you don't stand up to bullying it doesn't normally go away. More likely it gets worse over time.
This is what we teach our children in Australia.
 

QM_123

Starting to get Involved
#8
That sounds like bullying.

If you don't stand up to bullying it doesn't normally go away. More likely it gets worse over time.
This is what we teach our children in Australia.
Actually I cannot understand, notified bodies are also audited by competent authority and commission and they continue to do it. I hope these unreasonable demands will disappear through MDR.
 
Thread starter Similar threads Forum Replies Date
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 5
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
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
M Pre-Selecting Materials for ISO 10993-1 Biocompatibility Compliance Other ISO and International Standards and European Regulations 5
A Claiming Biocompatibility without ISO 10993-1 Other Medical Device Related Standards 19
C Differences between the biocompatibility standards ISO 7405 and ISO 10993 Other Medical Device Related Standards 2
M Biocompatibility of Medical Devices (ISO 10993 vs Japan requirement) Japan Medical Device Regulations 1
J ISO 10993: Biocompatibility and Use of Textile Materials for Skin Contact Devices Other Medical Device Related Standards 1
M Medical Device Biocompatibility Testing - End Product or Components - ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 22
E Biocompatibility/ISO 10993 training ISO 13485:2016 - Medical Device Quality Management Systems 5
T Biocompatibility Testing for Implantable Medical Devices according to ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 1
P European versions of standards - ISO 10993-1 and ISO 11607-1 EU Medical Device Regulations 6
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
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
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
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
J Biological Evaluation requirements per ISO 10993 - Medical Device Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
J ISO 10993 (Biological Compatibility) Approved Materials US Food and Drug Administration (FDA) 23
T ISO 10993-10: 2002 vs 2010 version - What are the Major Changes? 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
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
R What the difference in ISO 10993-11:2006 and 2009? Other Medical Device Related Standards 17
R Extent of Recognition of ISO 10993-1 US Food and Drug Administration (FDA) 5
D Cytotoxicity testing to ISO 10993-5 results - Is 1/ mild a pass or fail? Other Medical Device Related Standards 7
Similar threads


















































Top Bottom