Free In-Browser Worksheet

Wound Dressing Biocompatibility Scoping Worksheet

Separate intact-skin, breached-surface and deeper-tissue routes; record cumulative use, released substances, finished-dressing evidence and family questions.

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Worksheet strengths

Private by Design

Answers stay in the current tab; the worksheet has no upload, account or email gate.

Question-Led Scope

Record controlled facts, missing evidence, unresolved decisions and review triggers.

Printable Handoff

Generate a structured scoping record and print or save it with the browser dialog.

What It Organises

Build the evidence map before fixing the answer

This worksheet helps a project team structure device-specific inputs and expose gaps before those inputs are used in a Biological Evaluation Plan, report, testing rationale or submission response. It does not calculate compliance or prescribe a test programme.

Prepared by Arvind Rathore, founder of MedDev Advisory and former Marie Skłodowska-Curie Early Stage Researcher at INSERM U1026 Biotis within the ImplantSens network.

Contact-route screen

Keep intact skin, breached surface and deeper tissue distinct.

Cumulative profile

Record change frequency, total use and repeated exposure.

Released-substance questions

Map actives, leachables, degradation and exudate interaction.

Finished-dressing handoff

Structure configuration, family and evidence gaps.

Browser-Only Working Record

Capture the controlled state and the uncertainty

Choose the closest documented state and add only generic, non-confidential notes. Blank inputs remain visible as evidence needs in the generated record.

01 Product purpose and contact routes Define the wound context, claims and every tissue interface.

Separate physical wound management from antimicrobial, hemostatic or other active claims.

Map intact skin, breached surface, wound bed, blood and deeper tissue separately.

Record generic wound type, anatomical context, wear/change pattern and population.

02 Finished dressing and released substances Map the entire layered configuration and what can transfer or change in use.

Include backing, absorbent layer, adhesive, hydrogel, liner and joining process.

Consider intended actives, leachables, degradation, swelling and exudate interaction.

Record generic material, process, sterilisation, ageing and residue evidence.

03 Duration and cumulative exposure Move beyond a single wear period to the labelled treatment pattern.

Include replacement frequency, total treatment period and overlapping exposure.

Consider hydration, exudate, pH, swelling, wear, fragmentation and removal.

Record change frequency, overlap, removal residues and adjacent-skin contact.

04 Evidence and family coverage Trace evidence to finished configurations and meaningful product differences.

Check composition, processing, sterilisation, ageing and use-conditioned relevance.

Compare contact route, active load, area, layers, process and wear duration.

Record route, composition, release, duration and representative questions.

No answer is uploaded. The generated record remains in this page until you reset or close it.

Primary References

Use the record with controlled sources

The worksheet is a navigation aid. Confirm decisions against the purchased/current standard, applicable market requirements and the device’s controlled evidence.

ISO 10993-1:2025 — official ISO standard pageFDA guidance on use of ISO 10993-1
Continue the Review

Related evidence resources

Read the Wound-Dressing GuideInspect the Wound-Dressing PackReview Contact Type & DurationReview Chemical Characterization
Why separate intact skin from a breached wound surface?

The tissue interface, exposure conditions and relevant biological questions can differ materially. This worksheet preserves those distinctions so that the later evaluation is based on the actual intended use rather than a generic dressing label.

Are my answers uploaded or saved?

No. The worksheet runs in the current browser tab and does not store or transmit the answers. You may print the generated scoping record or save it as a PDF using the browser print dialog.

Is the generated record a BEP, BER or regulatory conclusion?

No. It is a preliminary scoping record for structured review. It is not a Biological Evaluation Plan, Biological Evaluation Report, compliance decision, biological-safety conclusion, regulatory classification or approval.

Need Device-Specific Review?

Turn the scoping record into a controlled evidence plan

Share a generic device description and the unresolved evidence questions. I will outline the likely review scope, priorities and next step before any engagement.

Discuss Your Project Inspect the Wound-Dressing Pack