ISO 9713:2022 PDF

Name: ISO 9713:2022 — Neurosurgical implants — Self-closing intracranial aneurysm clips
SKU: ISO 9713:2022
Price: 25 EUR
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Neurosurgical implants — Self-closing intracranial aneurysm clips

Название (английский):

ISO 9713:2022

Neurosurgical implants — Self-closing intracranial aneurysm clips

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 12 января 2022 г.
Издание:: ISO IS 9713 edition 3 version 1
ICS:: 11.040.40

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Описание (английский):

This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force. This document 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 In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 9713:2022 - Neurosurgical implants - Self-closing intracranial aneurysm clips defines requirements for permanent, self-closing aneurysm clips intended for intracranial implantation. The standard covers design characteristics, materials, measurement of closing force, MRI safety assessment, and requirements for marking, packaging, sterilization, labelling and accompanying documentation. It explicitly excludes malleable clips and temporary clips removed before wound closure.

Key topics and technical requirements

Scope and definitions: Clarifies terms such as aneurysm clip, blade closing surface, nominal and actual closing force to ensure consistent communication between manufacturers, clinicians and regulators.

Geometry and dimensions: Requires manufacturers to indicate overall length, blade length/width, fenestration and internal diameters, and to show measurement points on diagrams.

Materials: Accepts implant materials conforming to ISO 5832 series (titanium and cobalt-chromium alloys). Stainless steel is excluded for aneurysm clips.

Closing force: Requires a uniform method to measure and report actual closing force for each clip model and to specify a nominal closing force and tolerances. Also addresses force reduction after actuation and verification methods.

Blade surface and opening limits: Specifies verification of blade contact surfaces and assessment of maximum blade opening to ensure performance and vessel safety.

MRI safety assessment: Requires testing of finished implants (worst-case sample) for magnetically induced forces, torque, heating and image artefacts. References ASTM methods for MRI-related testing (e.g., ASTM F2052, F2213, F2182, F2119).

Sterilization, packaging and labelling: Aligns sterilization and packaging requirements with ISO 14630 and requires manufacturer-supplied processing information per ISO 17664-1. Mandates instructions for use, patient information, patient card and record label.

Documentation: Specifies required labelling elements and accompanying documentation to support safe clinical selection and use.

Applications and users

Medical device manufacturers of intracranial aneurysm clips - for product design, testing, labelling and regulatory compliance.

Neurosurgeons and clinical procurement teams - to compare clip characteristics (closing force, geometry, MRI compatibility) and select appropriate implants for aneurysm occlusion.

Regulatory authorities and testing laboratories - for conformity assessment, performance testing and MRI-safety evaluation.

Hospitals and sterilization units - to follow manufacturer processing instructions and preserve sterility and traceability.

Related standards

ISO 5832 series (implant materials: titanium and cobalt-chrome alloys)

ISO 14630 (non‑active surgical implants - general requirements)

ISO 15223-1 (symbols for medical device information)

ISO 17664-1 (processing information for medical devices)

ASTM F2052, F2213, F2182, F2119 (MRI-induced force, torque, RF heating, artefacts)

ISO 9713:2022 helps ensure consistent performance data, MRI safety, and clear labelling-critical for patient safety and effective clinical decision-making when using self-closing intracranial aneurysm clips.

ISO 9713:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 5832-11:2024

Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy

SIST EN ISO 14630:2025

Non-active surgical implants - General requirements (ISO 14630:2024)

SIST EN ISO 17664-1:2021

Processing of health care products - Information to be provided by the medical device manufacturer for the pr…

SIST EN ISO 15223-1:2021/A1:2026

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General re…