Regulatory Open Forum

Hi Anonymous,

With respect to gas pathway devices, I have seen a considerable shift in practice over the past few years.  I don't know the background, but I understand that industry/regulators started to recognize that the classification categories in ISO 10993 do not really fit respiratory devices well, thus leading to the development of ISO 18562 (as you pointed out).

I have not personally dealt with any testing to ISO 18562, however I did have a lot of involvement with testing while ISO 18562 was in development, when FDA was making requests for additional testing (above what was required by ISO 10993 and what I believe to have previously been common practice), which included E&L testing and VoCs.  During the period when ISO 18562 was in development, the large test labs were pretty well aware/involved, so I would think that most, if not all, would be able to give you advice and conduct testing for you (since it is in their best interest to be able to provide services that meet current regulations/practices/expectations).  NAMSA and WuXi Apptec are both pretty large and might be worth reaching out to - I am not familiar with others but I'm sure there are tons!

Hope this helps!

Liz

Hi Anonymous,

With respect to gas pathway devices, I have seen a considerable shift in practice over the past few years.  I don't know the background, but I understand that industry/regulators started to recognize that the classification categories in ISO 10993 do not really fit respiratory devices well, thus leading to the development of ISO 18562 (as you pointed out).

I have not personally dealt with any testing to ISO 18562, however I did have a lot of involvement with testing while ISO 18562 was in development, when FDA was making requests for additional testing (above what was required by ISO 10993 and what I believe to have previously been common practice), which included E&L testing and VoCs.  During the period when ISO 18562 was in development, the large test labs were pretty well aware/involved, so I would think that most, if not all, would be able to give you advice and conduct testing for you (since it is in their best interest to be able to provide services that meet current regulations/practices/expectations).  NAMSA and WuXi Apptec are both pretty large and might be worth reaching out to - I am not familiar with others but I'm sure there are tons!

Hope this helps!

Liz

Hi Anonymous,

With respect to gas pathway devices, I have seen a considerable shift in practice over the past few years.  I don't know the background, but I understand that industry/regulators started to recognize that the classification categories in ISO 10993 do not really fit respiratory devices well, thus leading to the development of ISO 18562 (as you pointed out).

I have not personally dealt with any testing to ISO 18562, however I did have a lot of involvement with testing while ISO 18562 was in development, when FDA was making requests for additional testing (above what was required by ISO 10993 and what I believe to have previously been common practice), which included E&L testing and VoCs.  During the period when ISO 18562 was in development, the large test labs were pretty well aware/involved, so I would think that most, if not all, would be able to give you advice and conduct testing for you (since it is in their best interest to be able to provide services that meet current regulations/practices/expectations).  NAMSA and WuXi Apptec are both pretty large and might be worth reaching out to - I am not familiar with others but I'm sure there are tons!

Hope this helps!

Liz

Hi Anonymous,

With respect to gas pathway devices, I have seen a considerable shift in practice over the past few years.  I don't know the background, but I understand that industry/regulators started to recognize that the classification categories in ISO 10993 do not really fit respiratory devices well, thus leading to the development of ISO 18562 (as you pointed out).

I have not personally dealt with any testing to ISO 18562, however I did have a lot of involvement with testing while ISO 18562 was in development, when FDA was making requests for additional testing (above what was required by ISO 10993 and what I believe to have previously been common practice), which included E&L testing and VoCs.  During the period when ISO 18562 was in development, the large test labs were pretty well aware/involved, so I would think that most, if not all, would be able to give you advice and conduct testing for you (since it is in their best interest to be able to provide services that meet current regulations/practices/expectations).  NAMSA and WuXi Apptec are both pretty large and might be worth reaching out to - I am not familiar with others but I'm sure there are tons!

Hope this helps!

Liz

Hi Anonymous,

With respect to gas pathway devices, I have seen a considerable shift in practice over the past few years.  I don't know the background, but I understand that industry/regulators started to recognize that the classification categories in ISO 10993 do not really fit respiratory devices well, thus leading to the development of ISO 18562 (as you pointed out).

I have not personally dealt with any testing to ISO 18562, however I did have a lot of involvement with testing while ISO 18562 was in development, when FDA was making requests for additional testing (above what was required by ISO 10993 and what I believe to have previously been common practice), which included E&L testing and VoCs.  During the period when ISO 18562 was in development, the large test labs were pretty well aware/involved, so I would think that most, if not all, would be able to give you advice and conduct testing for you (since it is in their best interest to be able to provide services that meet current regulations/practices/expectations).  NAMSA and WuXi Apptec are both pretty large and might be worth reaching out to - I am not familiar with others but I'm sure there are tons!

Hope this helps!

Liz