Free In-Browser Worksheet

Implantable Device Biocompatibility Scoping Worksheet

Structure the contact and duration profile, finished-device boundary, early-to-late hazards, degradation questions, family coverage and evidence uncertainties for an implant.

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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 profile

Separate tissue, bone, blood and delivery-system exposure.

Finished boundary

Capture coatings, residues, surface and sterilised configuration.

Time windows

Organise early, steady-state, late, wear and degradation questions.

Family coverage

Expose representative-device and equivalence assumptions.

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 Clinical exposure profile Define every anatomical interface, duration and delivery-related exposure.

Separate tissue, bone, blood, delivery-system and temporary procedural contact.

Include permanent, long-term, temporary and repeated procedural exposure as applicable.

Record generic anatomical site, fixation, loading, delivery and vulnerable populations.

02 Finished implant boundary Define the supplied, processed and patient-contacting configuration.

Include assembled parts, surface finish, porosity, coatings, packaging and sterilisation.

Include manufacturing residues, wear-relevant features and surface treatments.

Record generic processes, cleaning, sterilisation, ageing and component interfaces.

03 Time-dependent hazards Consider how exposure and the device can change across clinically relevant periods.

Include implantation trauma, chronic contact, revision and removal where applicable.

Consider intended degradation, unintended corrosion, particles and changing surfaces.

Record generic early, steady, late, degradation, wear and revision scenarios.

04 Family coverage and evidence Compare variants and historical evidence against the finished implant question.

Compare materials, area, mass, coating, porosity, process, wear and degradation.

Trace differences in finished configuration, manufacture, use and population.

Record contact, surface, degradation, representative and post-market 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 Implantable-Device GuideReview Implantable-Device SupportReview Contact Type & DurationReview Chemical Characterization
Why does an implant worksheet need several time windows?

An implant’s exposure and physical state can differ during implantation, stable use, wear, degradation, revision or removal. The worksheet records those distinct questions so one early or unused state is not assumed to represent the full lifecycle.

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.

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