Standard Operating Procedure (SOP) for Biocompatibility Testing

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Introduction:
Ensure the safety and regulatory compliance of your medical devices and materials with our Standard Operating Procedure (SOP) for Biocompatibility Testing. This SOP is essential for organizations operating under ISO 10993, FDA 21 CFR Part 58 (GLP), and ISO 13485 standards. It provides a detailed, step-by-step guide for assessing the interaction between medical device materials and biological systems, ensuring that products are safe for their intended use.

Overview:
The SOP for Biocompatibility Testing outlines a structured approach to planning, conducting, and documenting biological safety evaluations of materials that come into direct or indirect contact with the human body. The document aligns with international regulatory expectations and supports preclinical testing strategies required for product submissions to agencies such as the FDA, EMA, and other notified bodies.

Key Sections Included in the SOP:

1. Purpose:
   Defines the objective of conducting biocompatibility testing to evaluate potential adverse biological responses from device materials.
2. Scope:
   Applies to all new products, design changes, and materials used in manufacturing or packaging that come into contact with human tissue, fluids, or systems.
3. Responsibilities:
   • Regulatory Affairs: Ensures testing meets submission requirements.
   • R&D/Design Teams: Identify applicable tests based on device classification and use.
   • Quality Assurance: Reviews protocols, results, and ensures compliance with GLP.
   • Testing Facilities: Conduct validated studies in accordance with ISO 10993 and GLP standards.
4. Test Selection Process:
   • Guides how to select appropriate biocompatibility tests based on device classification, duration of contact, and type of tissue exposure.
   • Refers to ISO 10993-1: Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process.
5. Types of Biocompatibility Tests Covered:
   • Cytotoxicity
   • Sensitization
   • Irritation or Intracutaneous Reactivity
   • Acute Systemic Toxicity
   • Subchronic/Chronic Toxicity
   • Genotoxicity
   • Implantation Studies
   • Hemocompatibility
   • Carcinogenicity (if applicable)
6. Test Planning and Protocol Development:
   • Describes the process for protocol generation, including test rationale, sample preparation, controls, and acceptance criteria.
   • Requires QA review and formal approval before execution.
7. Sample Preparation and Handling:
   • Defines material conditioning, sterilization requirements, and extraction protocols per ISO 10993-12.
   • Ensures consistency and traceability in all test samples.
8. Study Execution:
   • Requires tests to be performed by qualified personnel at GLP-compliant laboratories.
   • Ensures adherence to pre-approved protocols and proper documentation practices.
9. Data Analysis and Reporting:
   • Describes how raw data is reviewed, analyzed, and summarized into formal study reports.
   • Includes comparison to acceptance criteria and risk-based justifications.
10. Acceptance Criteria and Result Interpretation:

• Defines pass/fail criteria per applicable standards and provides guidance on interpreting borderline results.
• Triggers further investigation or testing if results are inconclusive or fail.

1. Deviations and CAPA:

• Requires documentation of any protocol deviations.
• Mandates root cause analysis and CAPA for failed or inconclusive tests.

1. Documentation and Recordkeeping:

• All test protocols, raw data, reports, and communications must be archived according to regulatory and internal record retention policies.

1. Audit and Regulatory Readiness:

• Ensures biocompatibility testing documentation is readily accessible for audits and regulatory submissions.
• Aligns with 21 CFR Part 820, Part 58, and ISO 13485 QMS requirements.

1. Training Requirements:

• Personnel involved in biocompatibility planning, execution, or review must be trained in ISO 10993 requirements, GLP, and risk-based evaluation methodologies.

Why Download This SOP?

• Meet Global Regulatory Standards: Ensure your biocompatibility testing program complies with FDA, ISO, and EU MDR requirements.
• Support Device Submissions: Provides documentation and protocols required for 510(k), PMA, CE Marking, and other regulatory filings.
• Minimize Safety Risks: Confirms biological safety of materials prior to human use.
• Ensure Traceability and Compliance: Establishes a repeatable, auditable testing process.
• Improve Collaboration: Facilitates consistent practices between internal teams and external testing laboratories.

Support and Contact Information:
For questions or additional guidance on implementing a biocompatibility testing strategy, please reach out to our support team. We’re here to help you ensure your products are biologically safe and fully compliant.