Biocompatibility Selection Tree

ISO 10993-1:2026

Biocompatibility Selection Tree.

A guided, ISO 10993-1-aligned decision tool. Describe the device, choose its body-contact category and exposure duration, flag any special factors, and the biological effects and test methods to evaluate appear with their standard references, ready to print as an evaluation record.

Enter the device identification. These details appear on the printed record exactly as typed.
Select the body-contact category that matches the device's most invasive direct or indirect tissue contact (§6.4.4).
Select the exposure duration from the total exposure period on a single patient (§6.4.2/6.4.3). The duration helper converts hours or days into a category.
Check any special factors that apply. Each can add biological effects beyond the default matrix or add documentation notes to the record.
Review the result. Required effects are pre-ticked; override any row and add notes, then print the record or save it as a PDF.

Device identity
Body contact
Duration
Special factors
Result

STEP 01

Device identification

These details are fixed inputs: they appear on the printable evaluation record exactly as entered below.

Product / device name(required)

Manufacturer

Model / catalogue / reference no.

Evaluator

Date of evaluation

Intended use(indication, part of body / tissue, operating principle)

Patient population / use environment

STEP 02

Body contact category

Per §6.4.4 — select the category that matches the device's most invasive direct or indirect tissue contact.

Non-contactingNo direct or indirect contact with the body.e.g., diagnostic software, IVD analysers, imaging hardwareIntact skinDirect or indirect contact with intact, uncompromised skin only.e.g., electrodes, external prostheses, fixation tapeIntact mucosal membraneDirect or indirect contact with intact mucosa.e.g., contact lenses, urinary catheters, endotracheal tubesBreached surface / internal tissueBreached or compromised skin/mucosa, OR bone, dentin, internal soft tissue or organs (non-blood).e.g., wound dressings, orthopaedic implants, pacemakersCirculating bloodDirect or indirect contact with circulating blood.e.g., catheters, stents, heart valves, dialysis sets

STEP 03

Exposure duration

Per §6.4.2/6.4.3 — based on the total exposure period on a single patient, not a single use.

Limited≤ 24 hTotal exposure period ≤ 24 hours.Prolonged> 24 h to 30 dTotal exposure period > 24 hours, up to 30 days.Long-term> 30 dTotal exposure period > 30 days.

Duration helper

Optional — estimate the category from a total exposure value. This does not change your selection above automatically.

STEP 05

Biological evaluation — required effects & tests

Auto-generated from Steps 2–4. Checkboxes are pre-filled per the standard's default logic; override any row manually — your choice is preserved.

0 / 15

biological effects included

No pathway selected yet

Complete Steps 2 & 3 to generate results.

Required (shall)Consider (should)Not flagged

Table 4

≤24 h

≤30 d

>30 d

Skin

Mucosa

Tissue

Blood

Default effects per pathway before blood footnotes and special factors.

Biological effect	Status	Standard reference
Cytotoxicity	Not flagged	ISO 10993-5
Sensitization	Not flagged	ISO 10993-10
Irritation	Not flagged	ISO 10993-23
Systemic toxicity	Not flagged	ISO 10993-11 / ISO 10993-17
Local effects after tissue contact	Not flagged	ISO 10993-6
Genotoxicity	Not flagged	ISO 10993-3 / ISO 10993-17
Carcinogenicity	Not flagged	ISO 10993-3 / ISO 10993-17
Haemocompatibility	Not flagged	ISO 10993-4
Reproductive & developmental toxicity	Not flagged	ISO 10993-3
Neurotoxicity	Not flagged	ISO 10993-6 / ISO 10993-11
Immunotoxicity	Not flagged	ISO/TS 10993-20
Material-mediated pyrogenicity	Not flagged	ISO/TR 21582
Degradation product characterization	Not flagged	ISO 10993-9 / 10993-13 / -14 / -15
Particulates — local & systemic effects	Not flagged	ISO/TS 10993-19 / ISO/TR 10993-22
Toxicokinetic study (ADME)	Not flagged	ISO 10993-16

The printed record adds sign-off lines for prepared, reviewed and approved by.

This calculator's output may contain errors. Please verify results before relying on them.

Biocompatibility Selection Tree — Evaluation Record

ISO 10993-1:2026. Biological effects and test methods relevant to the device below.

IETQAN Toolbox
Version 1.0
Printed

Device identification

Product / device name —	Manufacturer —
Model / catalogue / reference no. —	Evaluator —	Date of evaluation —
Intended use —
Patient population / use environment —

Categorisation

Body contact (§6.4.4): —Exposure duration (§6.4.2/6.4.3): —

No pathway selected yet. Complete Steps 2 & 3 to generate results.

Special factors identified

None identified.

Biological evaluation — 0 of 15 effects included

No pathway selected: complete Steps 2 and 3 on screen to generate the default set.

Biological effect	Status	Standard reference	Include
Cytotoxicity	Not flagged	ISO 10993-5	—
Sensitization	Not flagged	ISO 10993-10	—
Irritation	Not flagged	ISO 10993-23	—
Systemic toxicity	Not flagged	ISO 10993-11 / ISO 10993-17	—
Local effects after tissue contact	Not flagged	ISO 10993-6	—
Genotoxicity	Not flagged	ISO 10993-3 / ISO 10993-17	—
Carcinogenicity	Not flagged	ISO 10993-3 / ISO 10993-17	—
Haemocompatibility	Not flagged	ISO 10993-4	—
Reproductive & developmental toxicity	Not flagged	ISO 10993-3	—
Neurotoxicity	Not flagged	ISO 10993-6 / ISO 10993-11	—
Immunotoxicity	Not flagged	ISO/TS 10993-20	—
Material-mediated pyrogenicity	Not flagged	ISO/TR 21582	—
Degradation product characterization	Not flagged	ISO 10993-9 / 10993-13 / -14 / -15	—
Particulates — local & systemic effects	Not flagged	ISO/TS 10993-19 / ISO/TR 10993-22	—
Toxicokinetic study (ADME)	Not flagged	ISO 10993-16	—

Sign-off

Prepared byName / Signature / Date

Reviewed byName / Signature / Date

Approved byName / Signature / Date

Reference standard

ISO 10993-1:2026, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. Default matrix from Table 4 (§6.4.4); duration categories from §6.4.2/6.4.3; special-factor clauses from §6.5.10–6.5.11.

This tool provides a structured starting point for biological risk analysis and does not replace a complete biological evaluation under ISO 14971 by a competent assessor.

Generated by the IETQAN Toolbox Biocompatibility Selection Tree, version 1.0, built on ISO 10993-1:2026. Results to be reviewed by a qualified person. © IETQAN 2026

Reference standard: ISO 10993-1:2026, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. Default matrix from Table 4 (§6.4.4); duration categories from §6.4.2/6.4.3; special-factor clauses from §6.5.10–6.5.11.

This tool provides a structured starting point for biological risk analysis and does not replace a complete biological evaluation under ISO 14971 by a competent assessor.

Biocompatibility Selection Tree