ISO 10993 compliance and requirements, so the biological safety of your device is argued on evidence, not assumed.

What it is

What is the ISO 10993 series and what is it used for?

ISO 10993 is a family of International Standards, developed by ISO technical committee ISO/TC 194, for the biological evaluation of medical devices. Part 1 sets out the requirements and general principles for judging whether a device is biologically safe, and places that judgement inside a risk management process. The remaining parts are more specialised: some describe how to test for particular biological effects, others cover sample preparation, chemical characterisation of materials, toxicological risk assessment of device constituents, degradation products, nanomaterials and animal welfare.

In practice the series answers one question a regulator will always ask about a device that contacts the body: what could the materials, and anything that leaches from them, do to the patient or user, and how do you know? The answer is rarely a list of tests. It starts with what the device is made of, how it is processed and sterilised, where it touches the body and for how long, then uses existing data and chemistry before any new biological testing is chosen. Part 1 works alongside ISO 14971, so the biological evaluation becomes one strand of the device's wider risk management file.

Current edition. ISO 10993-1:2025, the sixth edition of Part 1, was published by ISO in November 2025 and replaces ISO 10993-1:2018. Its title changed from "Evaluation and testing within a risk management process" to "Requirements and general principles for the evaluation of biological safety within a risk management process". Other parts are revised on their own schedules: new editions of Part 3 and Part 6 were published in 2026, and revisions of Parts 2, 4, 11 and 16 are at draft International Standard stage. How and when your regulator or notified body expects existing evaluations to move to the 2025 edition should be confirmed with them directly.

Who it is for

Who needs ISO 10993 compliance?

Any manufacturer whose device, or part of it, contacts the human body directly or indirectly needs a biological evaluation, whether the device is an implant, a catheter, a wound dressing, a wearable sensor or the tubing that carries fluid to a patient. Organisations usually come to Sterling for ISO 10993 support from one of four directions:

• A customer or distributor asks for the evaluation. Hospital groups, tender panels and distributors may ask to see the biological evaluation report, not a single test certificate, before they list a product.
• A tender or new market needs a submission. Entering a new jurisdiction means the file will be read by a different reviewer; gaps that passed years ago are found quickly.
• A regulator or notified body has raised questions. Findings on biocompatibility often concern missing justifications, outdated chemistry or an evaluation that no longer matches the device as it is made today.
• A group company or supplier changed something. A new resin grade, a different colourant, a moved production line or a new sterilisation site can reopen the evaluation, and group quality teams want one consistent approach across sites.

Component and material suppliers are affected too: their data sheets, formulation disclosures and change notices are often the weakest evidence in a manufacturer's file.

Requirements

What are the main ISO 10993 requirements?

ISO 10993 is not organised as clauses of one document but as numbered parts, each with its own scope. Part 1 carries the overall requirements for the evaluation; the other parts are called on when the device, its materials or its contact with the body make them relevant. The list below summarises the current parts by subject; which ones apply to your device is decided in the evaluation plan, not by working through every part.

• Part 1 General principles and requirements: evaluate biological safety within a risk management process and reach a documented, justified conclusion.
• Part 2 Animal welfare: requirements for any animal testing that is still judged necessary.
• Parts 3, 11 and 20 Systemic and long-term effects: genotoxicity, carcinogenicity, reproductive and developmental toxicity, systemic toxicity and immunotoxicology.
• Part 4 Blood interactions: selecting tests for devices that contact blood.
• Parts 5, 10 and 23 Local and cellular effects: in vitro cytotoxicity, skin sensitisation and irritation.
• Part 6 Implantation: tests for local effects after implantation.
• Part 7 Sterilisation residuals: ethylene oxide residues on sterilised devices.
• Part 12 Sample preparation: preparing test samples and reference materials.
• Parts 9 and 13 to 16 Degradation and toxicokinetics: identifying degradation products from device materials, including ceramics, metals and alloys, and studying how leachables behave in the body.
• Parts 17, 18 and 19 Chemistry and toxicology: chemical and physical characterisation of materials, and toxicological risk assessment of the constituents found.
• Part 22 Nanomaterials: guidance where a device contains or generates nanomaterials.

Getting compliant

How do you comply with ISO 10993?

Compliance is shown through a documented biological evaluation, not an audit certificate. Your organisation owns the evaluation; laboratories perform the testing; a qualified toxicologist often contributes to the risk assessment; and the regulator or notified body reviews the result. Sterling supports the process and the documentation around it.

1. 01
   Characterise the device and its body contact.Confirm materials, suppliers, manufacturing and sterilisation steps, the nature and duration of contact and the markets in scope.
2. 02
   Gap analysis: compare existing files with ISO 10993-1:2025.Review current plans, reports and test data against the 2025 edition and agree what is reusable, what needs justification and what is missing.
3. 03
   Write the biological evaluation plan.Gather existing data and material information, identify the biological effects to address and record the rationale for any testing, chemistry or literature route.
4. 04
   Commission and integrate the testing.Your chosen laboratories perform the tests and chemical analyses; results are reviewed against the plan and deviations handled before conclusions are drawn.
5. 05
   Conclude in the biological evaluation report and keep it current.The report states the conclusion and links into the ISO 14971 file; later changes to materials, suppliers or processes are assessed for their effect on it.

Check the route before you sign. Ask each laboratory whether the specific test methods you need sit within its accreditation scope, and confirm that scope directly with the accreditation body; laboratory accreditation is recognised internationally through the Global ACI arrangement. Be wary of offers of an "ISO 10993 certificate": no such certificate exists, and a document of that name will not replace an evaluation a reviewer can follow.

Cost

How much does ISO 10993 compliance cost?

The spend on a biological evaluation is dominated by what the device is and what evidence already exists. A short-contact device made from well-documented materials may need little new testing; a long-term implant in a novel material may need a wide programme of chemistry and biology. Our proposal separates Sterling's work from laboratory costs so you can see both.

Timeline

How long does an ISO 10993 biological evaluation take?

Documentation work moves as fast as material information arrives; testing moves at the laboratory's pace. The critical path is usually supplier disclosures, sample availability and test slots, followed by any repeat testing when results raise questions.

As an estimate, a single device family often takes three to nine months from characterisation to signed report, with long-duration studies extending that. Tell us your submission date at the start and we will show what must happen first.

Your engagement

What your ISO 10993 engagement includes

Sterling's engagement is built on Sterling OS™. Design™ is guided support, where your team writes the evaluation with our review; Drive™ is managed support, where we prepare the documents with your engineers. You choose one or the other for the scope. Sustain™ keeps the evaluation current after the report is signed, and Automate™ is Effivity. Sterling does not perform biological testing, and does not certify, approve or validate devices.

• Device characterisation and gap analysis

  Materials, processes and body contact documented, and existing files compared with ISO 10993-1:2025.

• Biological evaluation plan support

  Structure, rationale and evidence map for each biological effect, prepared with your engineers.

• Effivity ISO & GRC software

  Plans, evidence, supplier data and actions held in Effivity, included with the engagement at no additional cost.

• Training for your team

  Internal auditor training, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.

• Laboratory coordination support

  Help preparing the testing brief from the plan and reviewing reports against it; the laboratory remains responsible for its results.

• Biological evaluation report support

  A report structure that states the conclusion and links into your ISO 14971 risk management file.

Testing is performed by laboratories; review and acceptance of the evaluation rest with the regulator or notified body.

Often combined with

Standards organisations pair with ISO 10993 series

• 21 CFR Part 11 / EU Annex 1121 CFR Part 11 and Annex 11 compliance for GxP systems: requirements, validation, audit trails and e-signatures, with evidence ready for FDA and EU inspectors.
• ADHICS (Abu Dhabi)ADHICS compliance consulting for DoH-regulated healthcare entities in Abu Dhabi: patient information, systems and devices protected, with audit-ready evidence.
• CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
• EU IVDR 2017/746EU IVDR compliance consulting for IVD manufacturers: performance evidence, QMS, traceability and post-market follow-up prepared for your notified body.
• EU MDR 2017/745EU MDR compliance consulting for CE marking: QMS, technical documentation, traceability and post-market surveillance prepared for your notified body.
• FDA QMSR (21 CFR 820)FDA QMSR compliance consulting for device makers selling in the US: a quality management system ready for FDA inspection, wherever you manufacture.