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Biological Evaluation Plan and Report (ISO 10993)

A biological evaluation plan and report kept as cited rows, so a supplier's material change reopens only the justifications that rest on it, and the toxicologist signs.

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Follow one colorant change from replay to signature ↓
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The problem

A colorant swap in one tubing jacket, and the whole report read again

Each device family that touches a patient keeps a plan and a report: how the device meets the body, which endpoints apply, and how each one is covered. Cover can be a test, chemistry with a risk assessment, literature or a written reason. What the report seldom records is which material each justification stands on.

So when a supplier changes the carrier resin or the dispersant in a masterbatch, a specialist reads the old report from the first page to find what moved. Or the family goes back to the lab for animal tests that chemistry could have answered. The standard's new edition counts contact in days, so each family's categorization needs a second look too.

Built forToxicologistsBiocompatibility specialistsRegulatory affairs teamsMaterials engineersHeads of biocompatibility

The Problem Today

A material change can reopen a biological evaluation, and today someone rereads the whole report to find what moved.

1,275
patient-contacting families to re-check, at our sample company our estimate
Nov 2025
sixth edition of the standard, with new contact tables published

Read again by hand at each change

  • Tests
  • Chemistry
  • Materials
  • Old report
  • Tests rerun by defaultA full lab battery where chemistry could answer
  • The why goes missingWhich material a row rests on is rarely written down

The Solution

  1. Each row citedEach endpoint shows its test, chemistry or written reason, with the source
  2. A change replayedAgents trace the changed material to the rows resting on it
  3. Only chemistry rows reopenTested rows stay closed, tied to one comparison study
  4. The toxicologist signsShe opens each reopened row, adds the study and signs with its meaning

Built-in controls

  • Agents never conclude a device is safe
  • Closures wait for a second person who read them
  • Post-production input arrives sealed and unread

What You Get

Evaluations that move with the device, and a signed answer when someone asks why a row still stands.

9,000
specialist hours a year saved, at our sample company our estimate
  • Edition re-checks in batchesFamilies co-signed after a drawn sample is opened
  • Submission text from signed rowsNothing unsigned goes into the biocompatibility section
  • Each number shows its sumThresholds and margins of safety, cited to the chemistry
One supplier notice, twelve rows

A biological evaluation plan reopened by the blue masterbatch in a shaft

An irrigated ablation catheter family with 22 product codes, 14 materials and 31 test reports. The tubing supplier changes the carrier resin and dispersant behind the shaft's blue color.

demoThe catheter family, the supplier, the people, the study numbers and the chemistry values are sample data.

  1. 01Morning

    12 rows closed in revision C, and a change record against the shaft jacket

    Biocompatibility specialist

    The map draws the catheter from the femoral vein to the left atrium, with four numbered contacts: tip and ring electrodes, shaft, irrigation fluid path, and the handle in a gloved hand. Beside it sit the rows the plan must address, each with its kind of cover and its sources. A yellow banner says a change record alters the shaft jacket colorant.

  2. 02Replay

    9 of 12 rows rest on evidence made with the old masterbatch

    Biocompatibility specialist

    He runs the replay. The agents read the change record and supplier notice, find the proximal jacket material in 22 of 22 product codes, and pull the chemistry and finished-device tests made with the old masterbatch. Then they split the rows by what each stands on: 4 on chemistry, 5 on tests of the finished device, 3 untouched because the handle holds no PEBA.

  3. 0309:11

    Four rows reopen at once; five stay closed, waiting for the toxicologist

    Biocompatibility specialist

    Reopening is the safer move, so it takes effect when he clicks. Keeping the five tested rows closed is the looser move, so each one now reads closed, to confirm, and waits for the toxicologist to open it and agree. Their test article was the finished catheter with the old masterbatch, so they stand only if the new jacket proves chemically equivalent.

  4. 0409:14

    Revision D leaves the four reopened rows open for a study she will choose

    Biocompatibility specialist

    The drafter writes plan revision D from the replay: what changed, the four rows reopened, the eight that stay closed, the ethylene oxide residual check on the first three lots with the new jacket, and who signs. Each reopened row is to be closed on a study the toxicologist adds. The specialist sends it for signature. He cannot sign a revision he drafted.

  5. 0509:20

    The old animal test ran on one curve only, so it cannot close this row

    Toxicologist

    Acute systemic toxicity rests on chemistry. Her screen shows the sum: a threshold of 3.0 µg/mL, which is 60 µg per device, and margins of safety of 17, 14 and 162 for the three compounds above it. The animal test covered the unidirectional U1 curve only, so it stays as support. A row counts as read only after 3 seconds on screen.

  6. 0609:35

    Signed at 09:35, after she opened all four rows and added the comparison

    Toxicologist

    Signing stayed locked until each reopened row had been read. She adds CC-26-058 to the plan: the new jacket against the old, polar, semi-polar and non-polar solvents, the same 3.0 µg/mL threshold. She re-enters her password and signs with the meaning shown: approval of this plan revision as the basis for the biological evaluation. Both study requests can now go to the lab.

  7. 0709:38

    The filing question goes to the change team; the agents decide no filing

    Regulatory affairs specialist

    She logs FQ-26-212 in the regulatory information system: does the masterbatch change need a premarket supplement or a 30-day notice, and a change notification for this class III family. Beside it sit the checks the planner proposed, three devices each with the same solvents, and residues on the first three lots. The panel says plainly that the toxicologist adds studies, and nothing else does.

  8. 0809:38

    The trail holds four separate reads before the one signature

    Regulatory affairs specialist

    Twenty entries so far. Each read of a reopened row is its own line, three minutes apart, each marked as on screen for more than 3 seconds before deciding. Then the study added, the signature with its meaning, and her filing question in her own words. Agent steps are logged too. The trail is kept for the life of the device plus 10 years and downloads as a CSV.

  9. 09Afternoon

    The map now marks the changed jacket in orange, and the report waits

    Biocompatibility specialist

    Back on the map, the changed proximal jacket runs in orange along the shaft, and the row list counts 4 reopened and 5 to confirm. The banner says revision D is signed and that the report stays blocked until each planned study returns: the residual check and the extractables comparison. His next stop is the study requests.

The threshold sum for the old jacket, line by line

The chemistry the acute systemic toxicity row stands on, as the row shows it beside its citations.

LineValue
Dose-based threshold, three devices extracted in 60 mL, one device a day, uncertainty factor 2120 µg/day
Analytical evaluation threshold3.0 µg/mL, or 60 µg per device
N-butylbenzenesulfonamide: 142 µg per device against 2,400 µg tolerable intakeMargin 17
2,4-di-tert-butylphenol: 88 µg per device against 1,200 µg tolerable intakeMargin 14
Copper, screened apart from the threshold: 2.1 µg against 340 µgMargin 162

demoSample data, from the working solution. Margin of safety is tolerable intake over exposure, rounded to a whole number. All three compounds came from the old masterbatch, which is why the row reopens.

Around the plan

Sources, materials and lab requests behind the biocompatibility assessment

What the specialist, the materials engineer and the head of biocompatibility open between replays.

44 sources31 test reports, 2 chemistry reports, 2 risk assessments, 4 literature summaries and 5 written justifications, each showing which row uses it.
The jacket's chemistryThe extractables study the reopened rows rest on, with the threshold passage highlighted and three compounds above it.
A row closed to confirmCytotoxicity stays closed only if the comparison shows no new extractable. Agreeing waits for the toxicologist; a regulatory specialist cannot.
14 materialsEach material with its contact, supplier and declaration. The mapper asks whether a cured adhesive fillet is exposed to blood; an expired declaration shows as an error.
Study requestsThe lab acknowledges within 3 working days and returns within 15. The report cannot be signed while a study is out.
The team queue38 open evaluations with clocks, 214 of 320 edition re-checks done this year, and a batch of 41 intact-skin families waiting on a sample of 5.

demoSample data, from the working solution.

Who signs a biological evaluation plan revision, and who only reads it

Each person starts from a different part of the record.

Biocompatibility specialist
Sees
Replays, the rows they reopen and the team queue
Signs
Reopens rows, drafts revisions, sends study requests; signs nothing he drafted
Toxicologist
Sees
Each reopened row with its trace, its sources and its sum
Signs
Adds studies, signs the plan, closes rows in her own words
Head of biocompatibility
Sees
Closures with the exact words typed, and the drawn sample of each batch
Signs
Co-signs the report, agrees closures, approves rule changes
Regulatory affairs specialist
Sees
What changed and where each conclusion is cited
Signs
Logs filing questions; exports the section once the report is co-signed
Materials engineer
Sees
Agent questions about contacts, and declarations that failed to refresh
Signs
Answers questions and attaches current declarations
Test lab liaison
Sees
Which studies are requested, how many samples, and by when
Signs
Nothing: the view is read only
Who reads the evidence

Seven agents map, cite and replay; the safety conclusion stays blank for her

They trace and draft from cited sources. A toxicologist decides what the evidence means.

Material mapper

Reads the bill of materials and drawings, and maps each material to its contact.

  • Never classifies a contact without a cited line
  • Asks the materials engineer when unclear
Contact categorizer

Proposes the nature and duration of contact under both editions.

  • Never final: the specialist confirms and the toxicologist signs
Endpoint planner

Lists the endpoints from the customer's licensed standard and proposes how each is covered.

  • Never removes an endpoint
  • Never decides a justification is enough
Evidence reader

Reads test reports, chemistry, risk assessments and declarations, and cites the passage.

  • Never edits a report
  • Never opens post-production records
Change replayer

Traces a change from material to evidence to row, and reopens or ties rows with the reason.

  • Never closes a row
  • Never decides a filing
Plan and report drafter

Drafts plan and report sections with citations.

  • Never writes the biological safety conclusion
Submission section assembler

Builds the biocompatibility section from signed records.

  • Never exports unsigned content

Conclusions, filings and closures stay with the people who answer for them

The agents find and draft. These calls have a named owner.

Whether the device is biologically safeThe report's conclusion box is left blank for the toxicologist to write.
Closing a reopened rowOnly the toxicologist closes it, on the evidence its endpoint needs, and the head of biocompatibility agrees.
Which filing a change needsRegulatory affairs logs the question; the change team decides.
Clinical use and lot releaseThe assistant names the medical affairs director or the quality release manager and gives no answer.
Post-production informationIt arrives as one signed input from the team that owns it, shown as a sealed reference that no agent opens.

What toxicologists ask before trusting a biological evaluation plan

What is a biological evaluation plan?

A biological evaluation plan says how a device family touches the body and which biological endpoints must be addressed; the report says how each one is covered. Here the biological evaluation plan is kept as cited rows, so each endpoint points to the test, chemistry, literature or written reason it rests on.

What happens when a supplier changes a material?

The agents trace the change to the evidence made with the old material and to the rows resting on that evidence. Rows on its chemistry reopen at once, rows tested on the finished device are tied to one comparison study, and the rest stay closed with their sources.

Will it tell us whether a device is biologically safe?

No. The agents cite and draft. The toxicologist writes the conclusion and signs, and the head of biocompatibility co-signs the report.

How does it handle the new edition of the standard?

The contact categorizer proposes each family's contact in days under the new edition beside the old categorization. Families that do not change are re-checked in batches, and the head of biocompatibility opens a drawn sample before co-signing.

Can the toxicologist sign the plan without reading the reopened rows?

No. Signing stays locked until each reopened row has been on screen long enough to count as read, and each read is written to the audit trail.

Where does the evidence come from?

From the product lifecycle management system, change records, the laboratory system, document management and regulatory submissions. The customer loads its own licensed copies of the standards.

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Send us one device family
and its last supplier change notice.

We will trace the change to the rows that rest on it and show which ones reopen.

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