ISO 10993-17:2023/Amd 1:2025 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — AMENDMENT 1

Foreword

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This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of medical devices, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 206, Biological and clinical evaluation of medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

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Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — AMENDMENT 1

Clause 2, Normative references

Add a footnote to the following reference:

ISO 10993-18:2020¹, Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

¹ As amended by ISO 10993-18:2020/Amd 1:2022.

5.2, Figure 2

In the first diamond, remove ‘or’ in ‘or ‘TQ>TSL’.

In the second box, remove ‘of’ in ‘Apply of TTC (7.2)’.

7.1, NOTE 1

Move NOTE 2 above NOTE 1 and renumber the notes accordingly.

Clause B.1, sixth paragraph

In the sixth paragraph, replace the second bullet with the following:

Clause B.1, seventh paragraph

Replace the seventh paragraph with the following:

Toxicological screening limits shall not apply to medical devices used for a prolonged or long-term duration in preterm or very young infants, or the following types of constituents:

Clause B.2, first paragraph

In the first paragraph, replace the first sentence with the following:

Toxicological screening limits are based on mutagenic TTC values applicable to the duration of exposure to any single constituent.

In the first paragraph, replace the second sentence with the following:

The toxicological screening limit shall be calculated using Formula (B.1).

Clause B.2, Formula (B.1)

Under Formula (B.1), replace the description of ‘D’ with the following:

D is the minimum assumed duration of exposure expressed in days (d) for the time period of assumed exposure considered for the constituent in accordance with ISO 10993-1:2018.

Clause B.2, Table B.1

In the table header for the TTC column, replace the unit ‘g/d’ with ‘µg/d’.

Clause B.3, Formula (B.2)

Replace the description of ‘SF’ for Formula (B.2) with the following:

SF is a unitless value that represents the ratio of the maximum number or quantity (e.g. cm², g or ml) of medical devices that are in contact with the body during the period of assumed exposure to the number or quantity of either medical device(s) used in the extraction study or from information gathered from formulation and manufacturing process data (e.g. cm², g or ml).

Clause B.3, EXAMPLES 1 to 5

In EXAMPLES 1 to 5, replace each description of ‘1’ in the TSL formulae with the following:

1 is the minimum number of days that applies to ≤30 d assumed exposure time period (see Table B.1).

Clause B.3, EXAMPLE 6

In EXAMPLE 6, replace the description of ‘10’ with the following:

10 is the SF where 500 cm² (50 cm² × 10 devices) is the maximum device surface area, in cm², that is in contact with the body divided by the 50 cm² device surface area extracted.

Clause E.1, b) and c)

In the first sentence for each item, replace ‘6.2.1’ with ‘6.2.2’ and replace ‘total quantity’ with ‘maximum total quantity (TQ_max, in µg, the cumulative exposure dose)’.

Clause E.2, Tables E.2 and E.3

In the table headers for the HQ_r.k. column of Table E.2 and Table E.3, replace the unit "μg" with "μg/d".

E.3.1, fifth paragraph

Replace the fifth paragraph with the following:

When the TQ of a constituent is obtained by extraction and quantification methods that are conservative relative to the medical device intended use, the TQ of each reportable constituent may be assumed to represent a cumulative exposure dose (TQ_max) and is adequate for calculating a worst-case estimated exposure dose, EED_max.

Clause F.3

In the second sub-list item of the thirtheenth list item, replace ‘TQ’ with ‘TQ_max’.

Clause F.4, Table F.3

In the table header of the third column, replace ‘TQ extracted’ with ‘TQ_max’.

In the table header of the fifth, and sixth columns, replace ‘TQ’ with ‘TQ_max’.

In footnote c, replace ‘total quantity’ with ‘maximum total quantity’.