EO & ECH Acceptance Limits

ISO 10993-7:2026

EO & ECH Acceptance Limits.

Choose the exposure category for your device and confirm the patient and use parameters. The maximum allowable ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals per device appear instantly, ready to print as a report.

Select the device category: limited, prolonged, long-term adult, long-term paediatric, or surface contact (TCL).
Confirm the patient body mass, the concomitant exposure factor (CEF) and the number of devices used at the same time. For TCL, enter the contact surface area instead.
Read the first-24-hour and total cumulative limits for EO and ECH in mg per device. They recalculate as you type.
Add the device reference and preparer if you want them on the report, then print it or save it as a PDF.

Device category

The exposure category from ISO 10993-7 Table 1 sets the tolerance indices and the duration behind the limits.

Limited contact≤ 24 hSingle or multiple use, up to 24 hours cumulative contactProlonged contact1 – 30 daysCumulative patient contact between 1 and 30 daysLong-term contact — adult> 30 days · adultPermanent or long-term devices for adult patientsLong-term contact — paediatric> 30 days · 0 – 16 yPermanent or long-term devices for patients aged 0 to 16 yearsSurface contact (TCL)surface areaThreshold concentration limit from the device's contact surface area

Acceptance limits

Choose a device category

The maximum allowable EO and ECH residuals per device appear here as soon as a category is selected, and update as you change the parameters.

Report details

Optional. Printed in the report header; not used in the calculation.

Device name or product reference

Prepared by

Date

Reference standard: ISO 10993-7:2026, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals. Tolerance indices from Annex D (D.3, D.5, D.7, D.9); TCL limits from Annex E (E.3, E.5); body-mass defaults from §8.2; CEF guidance from §8.3.

These limits are the maximum allowable residuals per device. Actual test results must be compared against them by a qualified person.

EO & ECH Acceptance Limits