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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?
 
#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
Super 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
Super 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.
 
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