Free In-Browser Worksheet

Catheter & Fluid-Path Biocompatibility Scoping Worksheet

Build a component-to-patient pathway, separate direct and indirect contact, define the finished configuration, and record variant and evidence questions before BEP review.

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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.

Pathway map

Connect every patient-relevant component to the clinical pathway.

Contact boundary

Separate direct, indirect and non-contact components.

Finished configuration

Capture joints, coatings, additives, residues and sterilisation.

Variant coverage

Expose family and representative-state decisions.

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 Intended system and pathway Define the connected system and how each fluid or component can reach the patient.

Include the device, supplied accessories and labelled connections.

Trace direct contact, fluid-mediated transfer, backflow and downstream contact.

Record generic anatomical route, fluids, dwell/use pattern and flow direction.

02 Components and finished state Map everything in the finished patient-relevant configuration.

Include shafts, lumens, hubs, valves, connectors, adhesives and markings.

Include processing aids and substances that can migrate into the path.

Record assembly, cleaning, sterilisation, packaging, ageing and relevant residuals.

03 Contact and use profile Define contact type, duration, frequency and relevant populations.

Use cumulative exposure and distinguish tissue, blood and indirect fluid contact.

Check whether evidence represents the actual assembled, processed device.

Record generic flow, temperature, medicines/fluids, vulnerable populations and repeated use where applicable.

04 Variants and evidence Compare family differences by the biological question they can change.

Compare surface area, path length, lumen, materials, joints, residues and processing.

Map evidence to lengths, diameters, coatings, sites and manufacturing routes.

Record unresolved pathway, chemistry, representative and lifecycle 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 Catheter & Fluid-Path GuideInspect the Catheter Documentation PackReview Contact Type & DurationReview Chemical Characterization
Is every catheter component automatically patient-contacting?

No. The relevant boundary depends on the clinical pathway, including direct contact, fluid-mediated transfer, backflow and connected components. The worksheet helps document that pathway; it does not assign a regulatory contact category automatically.

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 Catheter Documentation Pack