ISO 10993-1:2018 has just been published


Super Moderator
... superseding the fourth edition ISO 10993-1:2009.

The foreword says:

This fifth edition cancels and replaces the fourth edition (ISO 10993-1:2009), which has been technically revised. It also incorporates the Technical Corrigendum ISO 10993-1:2009/Cor.1:2010.

The main changes compared to the previous edition are as follows:

a) revised Annex A “Endpoints to be addressed in a biological risk assessment” with new columns for “physical and/or chemical information” and “material mediated pyrogenicity” as well as columns for “chronic toxicity,” “carcinogenicity,” “reproductive/developmental toxicity,” and “degradation” which now indicates “endpoints” to be considered with “E” (instead of “tests” to be conducted with an “X”);

b) replaced Annex B “Guidance on the risk management process” with “Guidance on the conduct of biological evaluation within a risk management process” (formerly ISO TR 15499);

c) additional definitions for terms used throughout the ISO 10993 series of standards;

d) additional information on the evaluation of “Non-contacting medical devices” and new information on the evaluation of “Transitory-contacting medical devices”;

e) additional information on the evaluation of nanomaterials, and absorbable materials;

f) additional reference to ISO 18562 (all parts) for “Biocompatibility evaluation of breathing gas pathways in healthcare applications”;

g) significant editing changes throughout the document;


Involved In Discussions
Following message is shown at the website of Japanese standard store.

"Due to the possibility of data incompleteness, we're temporarily suspendind sale."

Does anyone know what is happening in the new standard?



Thank for providing the comparison. I am trying to come up with interpretation of the updated ISO 10993-1:2018 for our class IIa device.
Can you please share/suggest any information you have.
A comparison between the previous version and current would be great to do the gap analysis.

Last edited by a moderator:
Top Bottom