Regulatory Open Forum

Can anyone see if they can find the  ISO 10993-1:2012 standard?  Biological evaluation of medical devices - Part 1 Evaluation & testing within a risk management process.  We are trying to close out a NC and cannot trace this standard
I do understand It has been replaced by ISO10993-1:2018.
It will be great if anyone can trace this standard and attach to the thread
Thanks

Hi Anon

The ISO website shows that the 2018 edition followed the 2009 edition (and corrigendum 1 of 2010).
https://www.iso.org/standard/68936.html

For the EN ISO version, the 2009 edition was followed by the 2020 edition.
https://knowledge.bsigroup.com/products/biological-evaluation-of-medical-devices-evaluation-and-testing-within-a-risk-management-process-1/tracked-changes

ISO 10993-12 did have a 2012 edition. (Part 12 on Sample preparation and reference materials)

Do you maybe have a typo?

Can anyone see if they can find the  ISO 10993-1:2012 standard?  Biological evaluation of medical devices - Part 1 Evaluation & testing within a risk management process.  We are trying to close out a NC and cannot trace this standard
I do understand It has been replaced by ISO10993-1:2018.
It will be great if anyone can trace this standard and attach to the thread
Thanks

Anon,

Have to coincide with Anne that maybe there was a typo.  There was not a "2012" version of ISO 10993-1 or EN ISO 10993-1.  There were 2009 or 2010 versions, but there was no 2012 version either as an Amendment or Corrigendum.

Hi Anon

The ISO website shows that the 2018 edition followed the 2009 edition (and corrigendum 1 of 2010).
https://www.iso.org/standard/68936.html

For the EN ISO version, the 2009 edition was followed by the 2020 edition.
https://knowledge.bsigroup.com/products/biological-evaluation-of-medical-devices-evaluation-and-testing-within-a-risk-management-process-1/tracked-changes

ISO 10993-12 did have a 2012 edition. (Part 12 on Sample preparation and reference materials)

Do you maybe have a typo?

Can anyone see if they can find the  ISO 10993-1:2012 standard?  Biological evaluation of medical devices - Part 1 Evaluation & testing within a risk management process.  We are trying to close out a NC and cannot trace this standard
I do understand It has been replaced by ISO10993-1:2018.
It will be great if anyone can trace this standard and attach to the thread
Thanks

Anon,

Have to coincide with Anne that maybe there was a typo.  There was not a "2012" version of ISO 10993-1 or EN ISO 10993-1.  There were 2009 or 2010 versions, but there was no 2012 version either as an Amendment or Corrigendum.

Hi Anon

The ISO website shows that the 2018 edition followed the 2009 edition (and corrigendum 1 of 2010).
https://www.iso.org/standard/68936.html

For the EN ISO version, the 2009 edition was followed by the 2020 edition.
https://knowledge.bsigroup.com/products/biological-evaluation-of-medical-devices-evaluation-and-testing-within-a-risk-management-process-1/tracked-changes

ISO 10993-12 did have a 2012 edition. (Part 12 on Sample preparation and reference materials)

Do you maybe have a typo?

Can anyone see if they can find the  ISO 10993-1:2012 standard?  Biological evaluation of medical devices - Part 1 Evaluation & testing within a risk management process.  We are trying to close out a NC and cannot trace this standard
I do understand It has been replaced by ISO10993-1:2018.
It will be great if anyone can trace this standard and attach to the thread
Thanks

Hi Anon

The ISO website shows that the 2018 edition followed the 2009 edition (and corrigendum 1 of 2010).
https://www.iso.org/standard/68936.html

For the EN ISO version, the 2009 edition was followed by the 2020 edition.
https://knowledge.bsigroup.com/products/biological-evaluation-of-medical-devices-evaluation-and-testing-within-a-risk-management-process-1/tracked-changes

ISO 10993-12 did have a 2012 edition. (Part 12 on Sample preparation and reference materials)

Do you maybe have a typo?

Can anyone see if they can find the  ISO 10993-1:2012 standard?  Biological evaluation of medical devices - Part 1 Evaluation & testing within a risk management process.  We are trying to close out a NC and cannot trace this standard
I do understand It has been replaced by ISO10993-1:2018.
It will be great if anyone can trace this standard and attach to the thread
Thanks