ISO 10993 Biological Evaluation of Medical Devices Testing
ISO 10993 is designed to reduce errors and increase operational efficiency. This powerful software suite has been tested and certified to meet international safety standards for use in health care applications. It offers advanced features for data collection, storage, analysis and reporting of patient information.
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- Overview
- Scope, Applications, and Benefits
- Test Process
- Specifications
- Instrumentation
- Results and Deliverables
Overview
ISO 10993 is the internationally recognised framework for biological evaluation of medical devices, covering the full range of biocompatibility assessments required to demonstrate that a device — or any material in contact with the human body — does not pose an unacceptable biological risk. The framework is structured as a multi-part series, each part addressing a specific biological endpoint: cytotoxicity, sensitisation, irritation, systemic toxicity, genotoxicity, implantation, haemocompatibility, and carcinogenicity, among others. Selection of applicable tests is determined by the nature, duration, and anatomical location of device-body contact — not by blanket application of all parts.
ISO 10993 is the primary biocompatibility standard referenced by the PMA applications, by the EU MDR (Regulation 2017/745) for CE marking, and by Health Canada, TGA, and PMDA for device registration in their respective jurisdictions. A biological evaluation plan (BEP) and biological evaluation report (BER) structured per ISO 10993-1 are now mandatory components of regulatory submissions globally, making ISO 10993 not just a testing standard but a risk management framework that governs the entire biocompatibility strategy for a medical device.
Scope, Applications, and Benefits
Scope
ISO 10993 applies to medical devices that come into contact with the body, whether for a short or extended period. It provides a framework for evaluating the biological risks that may arise from the materials used in the medical device, taking into consideration the negative reactions that could result from exposure to the materials when in contact with body tissues.
Some of the most important biological risks that need to be evaluated include:
– Cytotoxicity
– Irritation
– Sensitization
– Chemical toxicity
– Material characterisation
Applications
- Biocompatibility evaluation of medical devices
- Regulatory submission support (including CE marking)
- Clinical trial material assessment
- Product design verification
- Sterilisation validation impact assessment
- Packaging compatibility studies
- Shelf-life evaluation
Benefits
- Enhances patient safety
- Provides a structured biological risk assessment
- Identifies potential toxicological hazards
- Improves material selection decisions
- Assists in documentation for CE marking
- Strengthens product performance validation
- Reduces risk of adverse biological reactions
Test Process
Biological Risk Assessment
Review device materials and intended use to define required biological endpoints.
1Material Characterization
Assess chemical constituents, extractables, and leachable.
2Biocompatibility Testing
Conduct cytotoxicity, sensitization, and irritation tests as applicable.
3Toxicological Evaluation & Reporting
Perform chemical risk assessment and analyse data to determine compliance.
4Technical Specifications
| Parameter | Details |
|---|---|
| Applicable Products | Medical devices with body contact |
| Evaluation Areas | Cytotoxicity, irritation, sensitization, toxicity |
| Regulatory Alignment | Supports CE marking and global regulatory submissions |
| Risk Approach | Material characterization and toxicological risk assessment |
| Output | Biological safety assessment report |
| Contact categories | Surface-contacting, externally communicating, implantable |
| Contact duration | Limited (≤24 h), prolonged (24 h–30 days), permanent (>30 days) |
| Primary endpoints | Cytotoxicity, sensitisation, irritation, systemic toxicity, genotoxicity, haemocompatibility, implantation, carcinogenicity |
Instrumentation Used for Testing
- Cell culture laboratory equipment
- Incubators and biosafety cabinets
- Microscopes
- Analytical chemistry instruments (GC, HPLC, ICP, where applicable)
- Extraction apparatus
- Sterility testing systems
- Statistical analysis software
Results and Deliverables
- Biocompatibility assessment report
- Cytotoxicity test results
- Sensitisation and irritation findings
- Toxicological risk assessment summary
- Material characterisation data
- CE marking support reports
- Risk management and validation reports
Frequently Asked Questions
ISO 10993 is the international standard that is used to assess the interaction of medical devices with the human body. This standard guides how to assess the biocompatibility and biological safety of a device depending on how and how long the device will be in contact with the body.
This is not a statutory requirement but is widely accepted by the regulatory authorities across the globe. This is usually required for CE marking and other international approvals.
ISO 10993-18 chemical characterisation identifies extractable and leachable chemicals from the device material. Per the current ISO 10993-1 framework, chemical characterisation and toxicological risk assessment must be performed before defaulting to in vivo biological testing, potentially reducing or eliminating animal study requirements.
Extractables are chemicals released from a device under aggressive laboratory extraction conditions. Leachables are chemicals that migrate into the patient under realistic clinical use conditions. ISO 10993-18 addresses both; leachables are the clinically relevant subset used in toxicological risk assessment per ISO 10993-17.
ISO 10993 also provides guidance on devices that will be in contact with the body for a long time or permanently, although the details of the testing required depend on the classification of the device and the results of the risk assessment.
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