SIST EN ISO 10993-2:2023 PDF

Overview

EN ISO 10993-2:2022 - Biological evaluation of medical devices: Part 2: Animal welfare requirements (ISO 10993-2:2022) specifies minimum requirements to ensure and demonstrate humane care for animals used in biocompatibility testing of medical device materials. Adopted by CEN and aligned with the ISO 10993 series, this standard focuses on tests performed on living vertebrate animals (other than humans) and promotes scientific validity through high standards of animal welfare, including the principles of Replacement, Reduction and Refinement (3Rs).

Key topics and requirements

• Scope and applicability: Applies to in vivo tests on live vertebrate animals to assess biocompatibility; excludes invertebrates and generally excludes isolated tissues/organs from euthanized animals except for limited provisions.
• Justification for animal tests: Requires clear scientific justification for using animals and encourages validated non-animal (in vitro) alternatives where possible.
• Competence of personnel: Specifies responsibilities and required competence for investigators, veterinary staff and animal care personnel.
• Test strategy: Recommends sequencing of in vitro and in vivo methods to minimize animal use and improve study design.
• Animal care and accommodation: Minimum requirements for housing, monitoring, restraint, surgical procedures, aseptic technique and post-operative care to reduce pain, distress and variability.
• Humane endpoints and euthanasia: Defines pre-determined humane endpoints, criteria to terminate suffering, and requirements for humane euthanasia methods.
• Documentation and data validity: Emphasizes study documentation, traceability, and considerations for mutual acceptance of data across labs and regulatory bodies.
• Promotion of 3Rs: Guidance and recommendations to support replacement, reduction and refinement of animal tests over time.

Practical applications

• Designing compliant biocompatibility test protocols for medical device materials.
• Preparing regulatory submissions that demonstrate ethical and scientific animal testing practices.
• Implementing institutional animal care and use procedures (ethics committees, CROs, notified bodies).
• Auditing and qualifying animal testing laboratories and veterinary oversight for device evaluation.
• Integrating non-animal assays into a test strategy to reduce the number of animals used.

Who should use this standard

• Medical device manufacturers and R&D teams
• Contract research organizations (CROs) performing biocompatibility studies
• Institutional Animal Care and Use Committees (IACUCs) and ethics boards
• Laboratory veterinarians and trained animal care staff
• Regulatory affairs professionals and notified bodies

Related standards

• ISO 10993-1 (Biological evaluation - Part 1: Evaluation and testing within a risk management process) - normative reference
• Other parts of the ISO 10993 series covering specific biological endpoints and test methods

EN ISO 10993-2:2022 helps align animal testing for device biocompatibility with ethical, scientific and regulatory expectations while promoting alternatives and better animal welfare.