ISO 10993-1:2025 Revision: Material-Mediated Pyrogenicity Beyond the Table

The absence of material-mediated pyrogenicity (MMP) from the biological effects tables in ISO 10993-1:2025 does not automatically justify removing it from a product's evaluation plan.
The revised edition addresses it under “other biological effects.”
Clause 6.5.10.5 describes circumstances requiring evaluation and the use of a justification.
FDA's official September 2026 presentation identifies this change and publicly quotes the clause.
[1, slides 9 and 21]

This article focuses on that single change.
Contact categorization, including skin and blood contact, and implantation control selection are covered separately in earlier articles.
Here, the question “Is it in the table?” is followed by “What conditions does the text address?”

Read the table change together with the text

ISO identifies the 2025 edition as the sixth edition, published in November 2025.
Its revision includes structural alignment with the ISO 14971 risk management process.
This does not mean that risk-based evaluation was introduced for the first time.
[2]

FDA's comparison explains that MMP, previously addressed in the tables, is now addressed under other biological effects.
Comparing only the rows of the two editions and marking an item “deleted” can miss the conditions addressed in the text.
[1, slide 9]

Evaluation conditions in 6.5.10.5

The clause publicly quoted by FDA calls for evaluation when a device contains constituents that have previously caused a pyrogenic response, or chemical constituents with unknown pyrogenic potential.
New materials are given as an example of the latter.
The label “new material” alone does not determine a test method for every situation.
[1, slide 21]

The same clause also describes circumstances in which a justification can often be sufficient.
This encompasses an explanation that the finished device composition, including processing aids and manufacturing contaminants, does not present a significant biological risk from MMP, together with adequate controls to prevent pyrogenic contamination during manufacture.
[1, slide 21]

These points should be read together.
Treating “a justification can be sufficient” as a blanket reason to omit testing, or interpreting “evaluate” as a requirement to perform a particular animal test, changes the scope of the judgment.
An evaluation plan can clearly connect the risk under review, available evidence and remaining uncertainty, then use those findings to determine whether additional testing is needed.

Distinguish MMP from microbial pyrogens

MMP concerns the potential for fever caused by chemicals that may be released from a device during use.
FDA includes manufacturing residues in its explanation.
The causal scope differs from microbial pyrogens such as bacterial endotoxins.
The publicly quoted note to 6.5.10.5 states that assessment of bacterial endotoxins and other microbial pyrogens is outside this document's scope and is addressed in ISO 11737-3.
[1, slides 19 and 21]

Consequently, saying that “pyrogenicity data are available” does not identify which question those data answer.
First distinguish an evaluation of material constituents from results addressing microbial pyrogens.
State the evaluation target and method so that a result for one category is not extended to the whole of another.

Hypothetical case: missing information about a new material

Assume that a development team is reviewing a new material R for product P.
Its existing plan includes MMP, but a team member proposes deleting it after not finding it in the revised table.
The available information about R does not yet allow a judgment about pyrogenic potential.
This is a hypothetical MedQraft review example, not an actual product evaluation.

At this stage, the conclusion is neither that R is unsuitable nor that a particular test must be ordered immediately.
Retain the status that there is not yet a basis for deleting the evaluation, and narrow down the missing information.
When discussing the issue with a laboratory, provide product and material information, available evidence and the conditions that remain unexplained, rather than asking only whether omission is permitted because the item disappeared from the table.

Record the judgment and its rationale in the plan

The following is an in-house practical suggestion, not a mandatory form prescribed by the standard.
Record the applicable edition and clause, the scope of evidence reviewed, remaining questions and the next judgment in the relevant part of the evaluation plan.
As evidence becomes available, show how the initial information gap was resolved.

Three questions remain at the end of the review: What evidence addresses MMP? Does the explanation cover the finished device and manufacturing controls? Can the reason for needing additional information or testing be specified? Absence from the table does not answer these questions.

Scope and sources

Sources were checked on October 19, 2026.
This article was prepared from ISO's official publication information and the revision explanations and clause excerpts publicly available in FDA's official educational material.
It is not a commentary based on reading the entire ISO standard.
Product-specific conformity judgments require lawful access to the applicable edition and product-specific evidence.

FDA's discussion of US evaluation and recognition is not presented as a Korean authorization requirement.
Publication of an international standard and its application or recognition in a sales jurisdiction must be checked separately.
This article establishes neither a general exemption criterion nor a sample size.

1. FDA, Biocompatibility Town Hall #1, official slides.
   September 9, 2026, slides 9, 19 and 21.
   Original tables and figures have not been reproduced.
2. ISO 10993-1:2025, official publication information.
   Sixth edition, November 2025.
3. FDA, official transcript of the same event.
   Used to cross-check the revision and MMP explanation.