What is ISO 9713 - Self-closing intracranial aneurysm clips about?
An aneurysm is a ballooning at a weak spot in an artery wall. ISO 9713 discusses neurosurgical implants.
ISO 9713 establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization, and for labeling and accompanying documentation.
Note 1: ISO 9713 is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).
Note 2: In ISO 9713 when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.
Who is ISO 9713 - Self-closing intracranial aneurysm clips for?
ISO 9713 on self-closing intracranial aneurysm clips is useful for:
- The medical industry
- Hospital management
- Manufacturers of neurosurgical implants
- Product designers / innovation teams
- Quality control / testing personnel
- Medical laboratories
- Neurosurgeons
- Researchers
- Health and safety authorities
Why should you use ISO 9713 - Self-closing intracranial aneurysm clips?
ISO 9713 provides you with guidelines for the characteristics of self-closing intracranial aneurysm clips, and also gives a method for the measurement of closing force.
ISO 9713 is intended to help to ensure that appropriate and comparable information is supplied for each clip to facilitate the choice of the correct clip by the surgeon.
The closing force of the clip is an important factor in the selection process, and ISO 9713 requires that the manufacturers determine the actual closing force in a uniform manner and state this value on the labelling.
The effect of magnetic fields is another aspect discussed in ISO 9713 from a perspective of material selection.
With compliance and obedience to ISO 9713, you can enhance the efficacy self-closing intracranial aneurysm clips and produce a standardized product.
What’s changed since the last update?
BS EN ISO 9713 supersedes BS EN ISO 9713:2009, which is withdrawn. BS EN ISO 9713 includes some technical changes with respect to BS EN ISO 9713:2009. These include:
- The terms and definitions in Clause 3 have been revised to more accurately define the information contained within the document
- The MRI safety assessment in Clause 7 has been revised so as to better align with the recommendations provided in the most recent MRI related ASTM standards
- The closing force assessments in Clause 8 have been revised to better clarify the procedures
- The sterilization and packaging clauses (Clauses 9 and 10) have been revised to align with ISO 14630 and to reduce the likelihood of future conflicts