Health Care Technology Official British Standard

BS EN ISO 10993-23:2021

Comprehensive standard for biocompatibility testing of medical devices. Ensures safety and compliance with ISO 10993-23:2021. Hardcopy and PDF formats available.

Comprehensive Biocompatibility Testing for Medical Devices

BS EN ISO 10993-23:2021 is the essential standard for evaluating the biocompatibility of medical devices. Developed by the International Organization for Standardization (ISO), this standard provides a robust framework for assessing the biological safety and compatibility of materials used in the manufacture of medical products.

Ensure Compliance and Patient Safety

Compliance with BS EN ISO 10993-23:2021 is crucial for medical device manufacturers and healthcare providers. This standard outlines the necessary tests and evaluation methods to determine the potential biological risks associated with medical device materials, ensuring the safety and well-being of patients.

Comprehensive Biocompatibility Assessment

  • Covers a wide range of biocompatibility endpoints, including cytotoxicity, sensitization, irritation, and systemic toxicity
  • Provides guidance on sample preparation, test methods, and data interpretation
  • Aligns with the latest scientific advancements and regulatory requirements
  • Ensures consistent and reliable biocompatibility evaluation across the medical device industry

Streamline Your Biocompatibility Testing

BS EN ISO 10993-23:2021 is an invaluable resource for medical device manufacturers, R&D teams, and quality assurance professionals. By following the standardized procedures outlined in this document, you can streamline your biocompatibility testing process, reduce the risk of non-compliance, and ultimately bring safer medical products to market.

Key Benefits:

  • Ensures the biological safety of medical devices through comprehensive testing
  • Aligns with the latest regulatory requirements and industry best practices
  • Provides a consistent and reliable framework for biocompatibility evaluation
  • Helps manufacturers identify and mitigate potential biological risks early in the development process
  • Supports the development of innovative and safe medical technologies

Trusted Resource for Medical Device Professionals

BS EN ISO 10993-23:2021 is an essential reference for medical device manufacturers, regulatory authorities, and healthcare professionals. By adhering to this standard, you can demonstrate your commitment to patient safety and regulatory compliance, ultimately enhancing the trust and confidence in your medical products.

Invest in the latest edition of BS EN ISO 10993-23:2021 and ensure your medical devices meet the highest standards of biocompatibility and safety.

Technical Information

Health Care Technology
BSI Group
978 0 580 99743 3
Specification Details
  • Biological evaluation of medical devices - Tests for irritation
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