Medical Device Biocompatibility Testing & Regulatory Compliance

Biological Safety Evaluation for Market Approval

Medical devices must be designed and manufactured to minimize risks to patients, healthcare professionals and end users. Manufacturers are responsible for demonstrating safety and biocompatibility for FDA premarket submissions (510(k) and PMA filings), EU MDR technical documentation and other international approvals.

A foundation for regulatory compliance
Regulatory submissions require complete biocompatibility data, biological safety testing and risk assessments that meet FDA expectations, ISO 10993 standards and EU MDR requirements. Hohenstein delivers accredited testing, GLP-compliant documentation and scientific expertise — giving you one partner for FDA, EU and global market approval.

Biological Safety Testing Framework

ISO 10993

ISO 10993-1 defines the specific biological endpoints required for your regulatory submissions across all markets, establishing the framework for biocompatibility assessment across all device classifications and approval pathways.

ISO 10993-1 defines the biological endpoints needed for regulatory submissions, forming the framework for biological safety evaluation across device classes.

Tests for Biological Safety of Medical Devices

Our testing portfolio delivers the biocompatibility data and documentation required for global market approval.

Pre-market
Post-market
Biological Assessment
Ventilators

Pre-market

Pre-Market Submission Support

Material Selection Validation - Confirm biological safety for 510(k), PMA, De Novo and EU MDR submissions
Toxicological Risk Assessment (TRA) - Biological safety evaluation using ISO 10993-17 and ICH guidelines
Material Performance Analysis - Test properties after aging, degradation and real-world use
Cleaning & Reprocessing Validation - ISO 17664 protocols recognized by regulators worldwide

Post-market

Post-Market Compliance & Monitoring

Ongoing Safety Monitoring - Product performance and safety assessment per global post-market surveillance requirements
Multi-Market Documentation - FDA, EU MDR and international filing requirements
Quality System Integration - Alignment with FDA QSR, ISO 13485 and global quality standards

Biological Assessment

In-Vitro Biological Safety Testing

Testing for Cytotoxic, Allergenic and Irritant Effects

We provide GLP-compliant, in-vitro testing methods that reduce the need for animal studies. Services include:

ISO 10993-5: Cytotoxicity testing
Cell culture assays for cytotoxic substances
ISO 10993-10, Annex C: Sensitization testing
In-chemico and in-vitro methods (DPRA, KeratinoSens™, U-SENS™)
ISO 10993-23: Irritation testing
Human 3D skin model for irritation potential
HET-CAM (DB-ALM Method No. 96): Skin irritation and mucosal damage testing
Validated alternative to animal irritation models
DIN EN ISO 10993-12: Sample preparation
Standardized extraction and test protocols

Ventilators

Biocompatibility of Breathing Gas Pathways

For ventilators, inhalation devices and respiratory pathways, ISO 18562 offers the recognized framework for assessing biological safety. Testing is performed as part of the risk management process and includes:

ISO 18562-2: Particle emissions
ISO 18562-3: Volatile organic compound (VOC) emissions
ISO 18562-4: Leachables in condensates

Factsheet - Biocompatibility Testing - Respiratory Gas Pathways (ISO 18562)pdf

Find ISO 10993 Biocompatibility Test Requirements by Medical Device Type

Accredited for Regulatory Confidence

Hohenstein is ISO/IEC 17025 accredited and Good Laboratory Practice (GLP) certified for biological, chemical and physical testing. This ensures validated methods, reliable data and regulatory-accepted reports for FDA, EU MDR and other global submissions.

Hohenstein GLP Certificate