TC194 Wrap Up 2018


TC194 – The Big Wrap

The ISO Technical Committee 194 is responsible for the biological and clinical evaluation of medical devices. The Annual meeting of TC194 was recently conducted in Berlin, (2-7 Dec 2018) and I’d like to summarise the key points of the meeting to keep industry stakeholders informed.

The Technical Committee really is an international affair. There are 30 participating member countrie, and a further 19 with Observer status. This meeting was attended by about 18 P members, and they were represented by over 180 delegates. That’s about the usual number of countries, but more delegates than usual.

The TC actually meets once during the course of the week, at the end, to receive various reports, and to make decisions based on recommendations received. This is the point at which voting occurs, one vote per participating member. The vote is cast by the Heads of Delegation for each country. It’s very interesting to note that I haven’t ever seen a “vote” that needed to be counted at this “Plenary” session. Generally, the recommendations are so well constructed, and the prior negotiations of consensus so effective, that there is no contest. In addition to the 18 HoDs, there were also 11 Working Group convenors reporting, and many experts observing. The room was packed.

The bulk of the week’s meetings are actually the technical Working Groups. You could say that the WG is where the real action happens!(Although to an outsider, “action” might seem an ill-advised description…)There are 17 WGs, and a Sub Committee with another 2 WGs. Each has a fairly discrete scope, associated with a biological effect. e.g. Cytotoxicity. Some of these meetings are a mere half day, but others can be 3 full days.

Very often the WG meeting will be resolving the comments on the standard (e.g. ISO 10993-18) or another document. (e.g. ISO/TR 10993-19) In Berlin, WG 14 had to resolve 600 comments made on the draft version of ISO 10993-18, on Chemical Characterisation. This is a fairly extreme example, but it does nicely illustrate the extent and difficulty of WG meetings.

A number of WGs have interim meetings between TC meetings to get though their workload.

So, that’s enough of the context. Here is the wrap up of the key points coming out of TC 194 meeting. (Be sure to also talk to your own national committee members and nominated experts, for their take on these matters. Australians, that’s HE-030 for us.)

Over the coming weeks I will expand on many of these issues.

  1. Extraction (a major sample preparation method for biological tests) appears to be less reliable than might be expected. There were a couple of presentations showing that apparently “identical” extracts were not in fact identical. As biological testing has historically depended very heavily on extracts, this is concerning. A couple of working groups have skin in the game, so this aspect is being carefully considered, and further (practical) work eagerly anticipated.
  2. Chemical characterisation (using analytical chemistry techniques) also appears to have some challenges, particularly around reproducibility. Another presentation showed substantial (alarming) variation in both quality and quantity of chemical characterisation. Some of the laboratories compared were major players in the medical device industry, and it’s clear that not everybody was competent. There were also substantial variations in costs & timeframes, not all of which followed competence. Again, several WGs have interest in this.
  3. Cancer testing has always relied on a battery of tests, both in-vitro and in-vivo. With the progress of time, it has become apparent that the in-vivo tests are not very reliable. Accordingly, it’s likely that in-vivo tests will no longer form part of the experimental program. The battery approach to in-vitro testing will remain. Clearly, this is a positive step on the animal welfare front and is also good for manufacturers for numerous reasons.
  4. Real progress was made on the new revision of ISO 10993-18 Chemical Characterisation. Despite the huge workload of comments, and the difficulties of resolving them, it appears that the final draft will go out for voting in early 2019. This will see the standard published in 2020. The impact on the medical device industry is likely to be substantial. Many manufacturers will interpret the document to mean that they face substantial expenditure, for limited gain. I suspect a difficult transition period.
  5. The document on Physical Characterisation, ISO TR 10993-19 is moving forward to publication in 2019. This is a space to watch for everyone involved with implant devices. There is a lot of work being done in this area, including research into certain cancers which don’t seem to be chemically mediated by the device.
  6. The revision of 10993-17 is thoroughly progressing, and becoming increasingly complicated. Not to mention large. The title as changed to: “Toxicological risk assessment of medical device constituents.” Clearly, this represents a huge change from the calculation of allowable limits. Like Part 18, this revision is going to bring new participants into the field of biological evaluation, and in Part 17 it looks like they will be nominated. It also appears that how the Tox Risk Assessment is done, and the level of experience/understanding is also going to be described. If Part 18 doesn’t frighten industry, then Part 17 will. They challenge will e in the utility of the document: not just can it be used, but will it be used.
  7. WG 5 Cytotoxicity did not have a scheduled meeting for Berlin. It hasn’t met since the Annapolis meeting in 2016. As the previous convener had stepped down citing ill-health, the Plenary Session of TC 194 resolved to appoint me as the new convenor, for the next three years. I’m gratified by the confidence placed in me by the TC, but as I said to an informal meeting of WG5 in Berlin, “I’m not going to do all the work!” I look forward to working with ~60 nominated experts to further understanding of in-vitro Cytotoxicity methods, through a program of tests. Hopefully, we will be able to propose a meaningful revision of 10993-5 based on good science and real data.
  8. Quite a lot of work was done on documents relating to degradable (or absorbable) materials. This is quite an interesting field for several reasons. There are different documents for metals, polymers and ceramics, as well as one for general considerations. The whole question of nanoparticles from degradables is also becoming visible. Degradable devices are a growth industry. Even here in Australia, there are numerous manufacturers who have and are continuing to develop such devices. And there are some big cross-overs to the tissue engineering segment of medicine as well. A number of the documents will move forward for publication following this meeting.

Well, I hope you have enjoyed this wrap-up. There’s a lot I haven’t said, which should be reported on by those participating. But there are a number of topics that I will expand upon in the coming weeks. Do watch out for more articles on LinkedIn, or come straight back here to our Brandwood Biomedical blog for more info and insight into biological and clinical evaluation.


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