Free In-Browser Worksheet

Medical Wipe Biological Evaluation Plan Scoping Worksheet

Map the finished wipe, intended use, patient and applicable user exposure, transferred-residue pathways, representative state and evidence gaps before drafting the BEP.

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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.

Exposure map

Separate the patient, applicable user and processed-device pathways.

Finished configuration

Record formulation, substrate, load, package and use condition.

Residue questions

Surface transfer, evaporation, cumulative use and downstream contact.

BEP handoff

Organise evidence, gaps, assumptions and review triggers.

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 use and pathway Define what the wipe does, what it contacts and whose exposure is relevant.

Use the controlled label or current design input—not a marketing shorthand.

Separate direct wipe contact from transfer through another device or surface.

Record generic use frequency, anatomical context and processed-device role. Do not enter client, patient or confidential identifiers.

02 Finished wipe system Treat the marketed wipe as a formulation–substrate–load–package system.

Include active and inactive constituents, formulation range and delivered liquid load.

Capture substrate construction, additives, container interaction and claimed shelf life.

Record known extractables, process aids, residues, degradation products and packaging interactions generically.

03 Exposure and cumulative use Describe transfer, repeated use and the state that reaches the patient or user.

Include applicable operator exposure without assuming every user pathway is equivalent.

Consider repeated wiping, replenishment, drying and downstream device contact.

Record what may remain, transfer, volatilise or contact the body after the labelled workflow.

04 Evidence and representative state Map available evidence to the actual finished state and preserve open decisions.

Identify fresh, aged, minimum/maximum load and use-conditioned states where relevant.

Separate chemistry, biological, efficacy, compatibility and risk-management records.

Record the unresolved questions that must move into the BEP handoff.

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 10993-1FDA De Novo DEN240075 — product-specific classification record
Continue the Review

Related evidence resources

Read the Medical Wipe BEP GuideReview Contact Type & DurationReview Chemical Characterization
What should a medical-wipe BEP scope before endpoint decisions?

It should first define the finished wipe system, intended workflow, direct and transferred exposure, applicable patient and user routes, cumulative use, representative state and evidence applicability. This worksheet organises those inputs without converting them into an automatic test list.

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 Read the Medical-Wipe Guide