Which ISO 10993 tests does my device need?

Required tests depend on your device's nature, body contact category (surface/external communicating/implant), and contact duration (limited 30d). Common tests include cytotoxicity (ISO 10993-5), sensitization and irritation (ISO 10993-10), and systemic toxicity (ISO 10993-11).

Do I need to send physical device samples to the lab?

Yes. For most biological tests (cytotoxicity, sensitization, implantation), physical samples or extracts derived from the device materials are required. Labs provide specific sample preparation and shipping guidance after booking.

Will the lab report be accepted by FDA and EU notified bodies?

Labs accredited to ISO 17025 by A2LA, UKAS, DAkkS, or equivalent national accreditation bodies produce reports that are generally accepted by FDA and EU notified bodies. Confirm acceptance with your chosen lab and regulatory body.

How long does biocompatibility testing take?

Standard turnaround is typically 14–35 business days after sample receipt depending on the test panel. Rush options (7–14 days) are available from some labs for select test types.

Is chemical characterization (ISO 10993-18) required?

ISO 10993-18 chemical characterization is increasingly required as an input to ISO 10993-17 toxicological risk assessment, and FDA recommends it for most device types. Some labs offer it as part of a comprehensive biocompatibility package.

Book ISO 10993 Biocompatibility Testing — Compare Accredited Labs

Book ISO 10993 biocompatibility testing for your medical device online. Compare A2LA, UKAS, and DAkkS-accredited labs with instant scope-based pricing. Results accepted by FDA and EU notified bodies.

✓ 3 active providers available right now · USD 2,300 – 2,850

Why this page is different

Instant pricing: See a price estimate immediately (no back-and-forth RFQ needed for these services).
Compare before booking: Review inclusions, exclusions, turnaround, and communication channels.
Charged only when accepted: You are charged only after a provider accepts your order and scope.
Live availability: 3 active providers available right now for this service.

What you can compare here

Total price: See live price ranges and instant pricing rules where available.
Coverage & scope: Markets served, what is included, and what is explicitly excluded.
SLA & responsiveness: Acceptance SLAs and typical turnaround windows.
Add-ons: Optional extras you can book next (shown as add-on chips).
Onboarding time: How quickly providers can start and what you need to supply.

Compare providers (instant pricing + book)

Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 2,500	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 2,850	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 2,300	24h	3–7 days	Within 2 business days

Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

markets (Required)
min 1; e.g. US|EU|UK (eligibility + documentation expectations)
deviceContactType (Required)
intactSkin|breachedSurface|mucosal|bloodPathIndirect|bloodPathDirect|tissueBoneDentin|implant
contactDuration (Required)
limited|prolonged|permanent
endpointPreset (Required)
surfaceLimited|surfaceProlonged|surfacePermanent|externalCommLimited|externalCommProlonged|bloodDirect|implantPermanent
deviceFamiliesCount (Required)
Distinct device/material configurations to be tested; min 1
sampleCount (Required)
Physical test-article sets provided; min 1
turnaround (Required)
standard|rush|rush_30d|rush_14d|rush_7d
studyCompliance (Required)
standard|glp
deviceForm (Optional)
finishedDevice|rawMaterial|both
materialType (Optional)
polymer|metal|ceramic|silicone|hydrogel|coated|combination|unknown
isSterile (Optional)
If sterile, may affect handling/extraction assumptions
includeChemicalCharacterization (Optional)
ISO 10993-18 (if offered)
includeToxicologicalRiskAssessment (Optional)
ISO 10993-17 (if offered)
includeAdditionalExtracts (Optional)
If more than one extraction condition is required
includeMethodSuitability (Optional)
If matrix/device needs suitability or interference checks
addCytotoxicity (Optional)
ISO 10993-5
addSensitization (Optional)
ISO 10993-10 / relevant method
addIrritation (Optional)
ISO 10993-10 / relevant method
addAcuteSystemicToxicity (Optional)
ISO 10993-11
addSubacuteSubchronicToxicity (Optional)
ISO 10993-11
addGenotoxicity (Optional)
ISO 10993-3
addImplantation (Optional)
ISO 10993-6
addHemocompatibility (Optional)
ISO 10993-4
addPyrogenicity (Optional)
If offered / required
countries (Optional)
Optional; shipping / import constraints
buyerNotes (Optional)

🔬

Standard

ISO 10993 series

✅

Accreditation

ISO 17025 (A2LA / UKAS / DAkkS)

⏱️

Results by

14–35 days after sample receipt

📋

Reports

Accepted by FDA + EU NBs

How it works

1

Describe your device contact type and duration

Select your device's body contact type (surface, external communicating, implant) and exposure duration (limited, prolonged, permanent) to get a recommended test panel.
2

Compare accredited labs with instant pricing

See scope-based pricing, turnaround times, and ISO 17025 accreditation details from labs that accept FDA, EU MDR, and NMPA reports.
3

Book and ship your samples

Confirm your chosen lab, receive shipping instructions, and send your device samples. The lab returns a signed, accredited test report within the agreed timeline.

What is ISO 10993 biocompatibility testing?

ISO 10993 is a series of international standards published by ISO/TC 194 that defines a framework and test methods for evaluating the biological safety of medical devices. The core document, ISO 10993-1, provides a risk-based approach to biocompatibility evaluation: you identify the nature and duration of patient contact, then determine which biological endpoints need to be addressed — either through existing data, literature review, or laboratory testing. The goal is not to test everything, but to demonstrate that the risks from device materials are acceptable for the intended use.

Which biocompatibility tests does my device need?

The required tests are driven by three factors: (1) the nature of body contact — surface-contacting devices (skin, mucosal membrane, breached/compromised surface), externally communicating devices (blood path, tissue/bone/dentine, circulating blood), or implant devices (tissue/bone, blood); (2) the contact duration — limited (<24 hours), prolonged (24 hours to 30 days), or permanent (>30 days); and (3) the material type. For a typical short-term skin-contact device, cytotoxicity and sensitization are the minimum. For a long-term implant, a full battery including genotoxicity, implantation, subacute/subchronic toxicity, and potentially carcinogenicity testing is required. ISO 10993-1 Table 1 maps contact type/duration to required endpoints.

How much does ISO 10993 testing cost?

Biocompatibility testing costs vary significantly by scope. A basic cytotoxicity and sensitization panel for a surface-contact device may cost USD 2,800–5,000. A comprehensive implant panel including systemic toxicity, genotoxicity, implantation, and hemocompatibility studies typically ranges from USD 12,000–18,000 or more. Chemical characterization (ISO 10993-18), which is increasingly required as an input to toxicological risk assessment, adds USD 3,000–8,000 depending on extraction conditions and analytical scope. On Cruxi Bridge, you configure your device's contact type and duration and see actual lab pricing before committing.

Sample preparation and shipping requirements

Labs will provide specific sample preparation instructions after booking. In general, you should expect to provide a minimum of 3–6 device samples or equivalent material quantities per test method. Samples must be representative of the finished, sterilized device (where applicable). Most labs accept international shipments, but controlled materials (e.g., those requiring CITES permits or USDA import permits for animal-derived components) need additional lead time. Ship with temperature control if your device is sensitive to heat or humidity during transit.

ISO 10993 and FDA biocompatibility expectations

FDA's 2016 guidance on "Use of International Standard ISO 10993-1 Biocompatibility Evaluation of Medical Devices" aligns closely with the ISO 10993 framework. FDA emphasizes a risk-based, least-burdensome approach: if existing material safety data and literature adequately address a biological endpoint, new testing may not be needed. However, FDA has been increasingly strict about chemical characterization data as input to toxicological risk assessment, particularly for novel materials and high-risk device classes. Reports from ISO 17025-accredited labs are generally accepted in 510(k), PMA, and EU MDR technical files.

EU MDR and biocompatibility requirements

Under EU MDR 2017/745, biocompatibility evaluation is required as part of the device's biological safety assessment within the technical documentation. Annex I (General Safety and Performance Requirements) Chapter II specifically addresses biological safety. MDCG guidance recommends following ISO 10993 as the state-of-the-art framework. Notified bodies will scrutinize the biological evaluation report, the chemical characterization data, and the toxicological risk assessment during conformity assessment audits. Using an EU-recognized, ISO 17025-accredited lab and ensuring your reports align with current MDCG guidance significantly reduces notified body queries.

Frequently asked questions

What is ISO 10993 biocompatibility testing?: ISO 10993 is the international standard series for evaluating the biological safety of medical devices. Testing assesses whether device materials or extractables can cause adverse biological responses (toxicity, sensitization, genotoxicity, etc.) at the point of patient contact.
Which ISO 10993 tests does my device need?: Required tests depend on your device's nature, body contact category (surface/external communicating/implant), and contact duration (limited <24h, prolonged 24h–30d, permanent >30d). Common tests include cytotoxicity (ISO 10993-5), sensitization and irritation (ISO 10993-10), and systemic toxicity (ISO 10993-11).
Do I need to send physical device samples to the lab?: Yes. For most biological tests (cytotoxicity, sensitization, implantation), physical samples or extracts derived from the device materials are required. Labs provide specific sample preparation and shipping guidance after booking.
Will the lab report be accepted by FDA and EU notified bodies?: Labs accredited to ISO 17025 by A2LA, UKAS, DAkkS, or equivalent national accreditation bodies produce reports that are generally accepted by FDA and EU notified bodies. Confirm acceptance with your chosen lab and regulatory body.
How long does biocompatibility testing take?: Standard turnaround is typically 14–35 business days after sample receipt depending on the test panel. Rush options (7–14 days) are available from some labs for select test types.
Is chemical characterization (ISO 10993-18) required?: ISO 10993-18 chemical characterization is increasingly required as an input to ISO 10993-17 toxicological risk assessment, and FDA recommends it for most device types. Some labs offer it as part of a comprehensive biocompatibility package.

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