Best Biocompatibility Testing Labs for Medical Devices (ISO 10993)

Medical devices and IVDs that contact the human body must demonstrate biological safety through biocompatibility testing at accredited biocompatibility labs^[1][2][3]. ISO 10993 testing labs provide the required testing services.

This requirement applies to:

• Medical devices with patient contact — devices that contact skin, mucous membranes, or internal tissues require medical device biocompatibility testing at ISO 10993 testing labs^[1][2]
• Devices for US market (FDA) — FDA requires biocompatibility testing per ISO 10993-1 for most medical devices^[2]
• Devices for EU market (MDR) — MDR requires biological safety evaluation using ISO 10993 standards^[3]
• Surface contact devices — devices that contact intact skin (e.g., wound dressings, electrodes) need cytotoxicity testing per ISO 10993-5^[1]
• External communicating devices — devices that contact body orifices or breached surfaces (e.g., catheters, endoscopes) require testing at biocompatibility testing labs^[1]
• Implant devices — devices placed inside the body (e.g., pacemakers, joint replacements, stents) need comprehensive ISO 10993 testing^[1]
• Respiratory devices — devices for respiratory applications may also require ISO 18562 testing in addition to ISO 10993^[1]
• Limited duration contact — devices with contact < 24 hours^[1]
• Prolonged contact — devices with contact 24 hours to 30 days^[1]
• Permanent contact — devices with contact > 30 days^[1]
• Devices with new materials — devices using materials not previously used in similar applications^[1]

Note: The extent of testing required depends on device contact type, contact duration, and device category. A biological evaluation plan (BEP) helps determine which tests are needed from biocompatibility labs. Some devices may be able to use prior data or material equivalency to reduce testing requirements.

Biocompatibility testing labs and ISO 10993 testing services typically include:

• Cytotoxicity Testing for Medical Devices (ISO 10993-5): Cytotoxicity testing using ISO 10993-5 methods to assess cell damage or death^[1] — typically the first test performed at biocompatibility labs and required for most devices. ISO 10993-5 cytotoxicity testing is the foundation of medical device biocompatibility testing.
• Sensitization testing (ISO 10993-10): Testing to assess potential for allergic reactions^[1] — required for devices with prolonged or permanent contact
• Irritation testing (ISO 10993-10): Testing to assess local tissue irritation^[1] — required for devices with surface or external communicating contact
• Systemic toxicity testing (ISO 10993-11): Testing to assess systemic effects^[1] — required for devices with prolonged or permanent contact
• Genotoxicity testing (ISO 10993-3): Testing to assess potential for genetic damage^[1] — required for devices with prolonged or permanent contact
• Implantation testing (ISO 10993-6): Testing to assess local tissue response to implants^[1] — required for implant devices
• Hemocompatibility testing (ISO 10993-4): Testing for devices that contact blood^[1] — required for blood-contacting devices
• Pyrogenicity testing (ISO 10993-11): Testing to assess fever-inducing potential^[1] — required for devices with systemic exposure
• ISO 18562 Testing (Respiratory Devices): ISO 18562 testing for biocompatibility evaluation of breathing gas pathways in healthcare applications^[1] — required for respiratory devices and anesthesia equipment in addition to standard ISO 10993 testing
• USP <87> and USP <88> testing: Alternative test methods accepted by FDA^[2] — may be used instead of or in addition to ISO 10993 tests
• Biological evaluation plan (BEP) development: Guidance on test selection and evaluation strategy per ISO 10993-1^[1]
• Toxicology evaluation: Risk assessment and toxicological evaluation of test results^[1] — may require in-house toxicology expertise at biocompatibility testing labs
• Test reports: Comprehensive test reports suitable for regulatory submissions from accredited ISO 10993 testing labs

Additional services may include:

• Material characterization and analysis
• Extract preparation and analysis
• Literature review and prior data evaluation
• Regulatory strategy and pathway guidance

Pricing for biocompatibility testing varies based on several factors:

• Number and type of tests: Cytotoxicity is typically the least expensive ($1,000 - $3,000), while systemic toxicity, genotoxicity, and implantation tests are more expensive ($5,000 - $15,000+ each) — more tests = higher total cost
• Contact type and duration: Devices with permanent contact or implant contact typically require more extensive testing than surface contact devices^[1] — affects test selection and cost
• Device class: Class III devices and implants typically require more extensive testing than Class I devices^[2]
• GLP compliance: GLP-compliant testing is required for some regulatory submissions and typically costs 20-30% more than non-GLP testing
• Toxicology evaluation: In-house toxicology expertise adds value but may increase cost — some laboratories include toxicology, while others charge separately
• Sample requirements: Number of samples needed varies by test type — more samples = higher material costs
• Test complexity: Complex devices or materials may require custom test protocols, adding to cost
• Prior data evaluation: If you have prior biocompatibility data, laboratories can help evaluate its adequacy, potentially reducing testing needs — evaluation services may cost $2,000 - $5,000
• Accreditation requirements: Accredited testing (ISO/IEC 17025) may cost more but is required for regulatory submissions
• Lead time: Rush services (testing within 4-8 weeks) typically cost 20-50% more than standard lead times (8-12 weeks)
• Regulatory support: Additional regulatory consulting or BEP development may add $3,000 - $10,000

Typical pricing ranges:

• Basic package (cytotoxicity + sensitization + irritation): $5,000 - $12,000
• Standard package (add systemic toxicity + genotoxicity): $15,000 - $30,000
• Implant package (add implantation + hemocompatibility): $25,000 - $50,000+
• Full ISO 10993 program: $40,000 - $100,000+ depending on device complexity
• With GLP compliance: Add 20-30% to above ranges
• With toxicology evaluation: Add $5,000 - $15,000

Tip: Request quotes from multiple laboratories and compare not just price, but also test scope, accreditation status, GLP compliance, toxicology capabilities, and lead times. Accredited, GLP-compliant test reports are essential for regulatory submissions.

When selecting a biocompatibility testing laboratory, consider these factors:

1. Accreditation status: Verify ISO/IEC 17025 accreditation^[1] and review the accreditation scope document to ensure your specific ISO 10993 test methods are covered — accredited test reports are required for regulatory submissions
2. GLP compliance: Determine if GLP-compliant testing is required for your device category and regulatory pathway^[2] — GLP compliance is often required for Class III devices and implants
3. Test type coverage: Verify the laboratory offers all the test types you need (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, pyrogenicity, etc.)^[3]
4. ISO 10993 standards support: Confirm the laboratory can test to the specific ISO 10993 parts you need (ISO 10993-5, -10, -11, etc.)^[3] and USP <87>/<88> if applicable^[2]
5. Toxicology expertise: Determine if you need in-house toxicology evaluation — some laboratories offer toxicology services, while others focus on testing only
6. Contact type and duration support: Verify the laboratory has experience with your device's contact type (surface, external communicating, implant) and duration (limited, prolonged, permanent)^[3]
7. Prior data evaluation: If you have prior biocompatibility data, confirm the laboratory can help evaluate its adequacy and determine if additional testing is needed
8. BEP development: Some laboratories offer biological evaluation plan (BEP) development services to help determine test requirements^[3]
9. Lead time and availability: Compare lead times (standard vs. rush) and availability windows — biocompatibility testing typically takes 8-16 weeks per test
10. Regulatory acceptance: Confirm test reports are accepted by your target regulatory authorities (FDA, EU notified bodies, etc.) — accredited, GLP-compliant laboratories generally provide reports suitable for multiple markets
11. Sample requirements: Understand sample requirements and whether samples are returned or disposed — affects total project cost
12. Response time and communication: Check quote response SLAs and communication quality — fast, clear communication is essential for project success
13. Pricing transparency: Look for laboratories that provide detailed quotes with clear breakdowns of included services, test methods, exclusions, and potential additional costs

Red flags: Laboratories that cannot provide accreditation scope documents, lack GLP compliance when required, cannot test to your required ISO 10993 parts, or lack experience with your device category or contact type.

Getting quotes through Cruxi is simple and fast:

1. Submit one request: Fill out a single form with your device details, contact type, duration, target markets, test requirements, timeline, and budget
2. Routed to Pro laboratories: Your request is automatically sent to Pro testing laboratories that match your requirements (typically 3-5 laboratories)
3. Compare quotes: Receive detailed quotes directly from laboratories and compare pricing, lead times, test scope, accreditation status, GLP compliance, toxicology capabilities, and included services

Benefits:

• Save time by avoiding individual laboratory outreach
• Compare multiple options side-by-side
• Pro laboratories respond fastest (typically within 24-48 hours)
• No obligation to accept any quote
• Access to accredited, GLP-compliant laboratories with proven track records

Alternative: You can also request quotes directly from individual laboratories via their profile pages.

Recommendation: For fastest response times and best quote comparison, prioritize Pro laboratories when requesting multiple quotes.

To get accurate quotes and start testing efficiently, laboratories typically request:

• Device information: Device name, category, class, intended use, and regulatory pathway
• Contact type and duration: Surface contact, external communicating, or implant; limited, prolonged, or permanent duration^[1] — affects test selection
• Material composition: Complete material list, including polymers, metals, ceramics, adhesives, coatings, and any additives^[1]
• Target markets: Where you plan to market the device (US/FDA, EU/MDR, etc.)^[2][3]
• Prior biocompatibility data: Any existing test reports, literature data, or material equivalency information — may reduce testing requirements
• Test requirements: Which tests you believe are needed (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, pyrogenicity, etc.)^[1] — laboratories can help determine requirements
• GLP requirements: Whether GLP-compliant testing is required for your regulatory pathway^[2]
• Sample readiness: When samples will be available, how many units, and sample form (finished device vs. material samples)
• Timeline: Desired start date and any hard deadlines (e.g., regulatory submission deadline, market launch date)
• Attachments: Device specifications, material safety data sheets (MSDS), prior test reports, or other relevant documentation

Tip: More complete information leads to more accurate quotes and faster project kickoff. If you're unsure about test requirements, use the "Help me scope" option in the RFQ form — laboratories can help develop a biological evaluation plan (BEP).