Overview
EN ISO 9713:2022 (identical to ISO 9713:2022) defines requirements for neurosurgical implants in the form of self-closing intracranial aneurysm clips intended for permanent implantation. The standard specifies the characteristics, labelling, packaging, sterilization and accompanying documentation for these clips and provides a uniform method for measuring closing force. It does not apply to malleable clips or temporary clips removed before wound closure. EN ISO 9713:2022 supersedes the 2009 edition and was adopted by CEN in 2022.
Key Topics
- Scope and definitions - clarifies applicability to self-closing permanent intracranial aneurysm clips.
- Description and geometry - terminology for clip mechanism, geometry and blade surfaces.
- Materials - references accepted implant materials and emphasizes material selection for biocompatibility and magnetic behavior.
- MRI safety assessment - guidance to assess clip behavior and image artefacts in magnetic resonance environments.
- Design requirements - including the standardised measurement of closing force, tolerances, possible reduction of force due to actuation, blade surface verification and maximum blade opening.
- Sterilization and supplying condition - requirements for sterilization methods and supplying states, aligned with ISO 14630.
- Packaging and marking - rules to ensure sterility, traceability and safe transport.
- Information for users and patients - labelling, instructions for use, patient card and patient record label requirements to support clinical decision-making and post-implant follow-up.
- Measurement method - a uniform procedure to determine actual closing force so surgeons can compare products consistently.
Applications
EN ISO 9713:2022 is used by:
- Medical device manufacturers designing and producing self-closing intracranial aneurysm clips to meet regulatory and market requirements.
- Quality and regulatory teams preparing technical files, labelling and sterilization validation.
- Test laboratories and R&D groups that perform closing force measurements, MRI safety testing and mechanical verification.
- Hospitals and neurosurgeons choosing appropriate clips based on documented closing force, MRI compatibility and labelling information.
- Notified bodies and conformity assessors evaluating compliance for CE marking and market access in Europe.
Related standards
Relevant referenced documents include:
- ISO 5832 series (implant metallic materials)
- ISO 14630 (non-active surgical implants - general requirements)
- ISO 15223-1 (medical device symbols)
- ISO 17664-1 (processing and sterilization information)
EN ISO 9713:2022 supports safer clinical selection and consistent testing of self-closing intracranial aneurysm clips by standardizing key technical parameters such as closing force, MRI behavior, sterilization and labelling.