ISO 7197:2024

Name: ISO 7197:2024 — Neurosurgical implants — Sterile, single-use hydrocephalus shunts
SKU: ISO 7197:2024
Price: 25 EUR
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Neurosurgical implants — Sterile, single-use hydrocephalus shunts

Название (английский):

ISO 7197:2024

Neurosurgical implants — Sterile, single-use hydrocephalus shunts

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 7
Дата публикации:: 31 июля 2024 г.
Издание:: ISO IS 7197 edition 4 version 1
ICS:: 11.040.40

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Описание (английский):

This document specifies the performance requirements for sterile, single-use non-active hydrocephalus shunts. This includes not only the valve, but also additional components such as tubes and reservoirs. This document does not provide any recommendations on which type of valve is most suitable for any specific context of use. This document specifies the mechanical and technical requirements to manufacture shunts and the technical information of the valve to be supplied by the manufacturer. This document does not apply to active implants for the treatment of hydrocephalus.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 7197:2024 - Neurosurgical implants - Sterile, single‑use hydrocephalus shunts is the fourth edition of the international standard that specifies performance, mechanical and technical information requirements for sterile, single‑use non‑active hydrocephalus shunts. The standard covers the complete implant assembly (valve, tubing, reservoirs and related components), testing and required manufacturer information, but does not recommend which valve type to use and does not apply to active implants.

Key topics and technical requirements

Scope and applicability: Applies to non‑active, single‑use shunt systems (ventriculo‑peritoneal, ventriculo‑atrial, lumbo‑peritoneal configurations typically implied).

Pressure‑flow characteristics: Manufacturers must test and report valve pressure/flow curves in the relevant flow range (5–50 ml/h). If the complete system alters valve performance (e.g., catheter ID < 1 mm), full-system characteristics must be supplied.

Radiopacity: Shunts and components must be radiopaque or carry radiopaque markers so all parts are identifiable on X‑ray.

Biocompatibility: Materials must be assessed per ISO 10993‑1 principles; biological safety data are required.

Leakage resistance: Leakage testing using air is required (differential pressure equivalent to 1 m water column).

Overpressure and mechanical strength: Shunts must withstand specified overpressure and dynamic breaking‑strength requirements without functional change.

In‑vivo identification and control: Valve type, flow direction and, for adjustable devices, information to interpret settings (including X‑ray images) must be supplied. Methods for non‑invasive identification must be described.

Marking, labelling and information: Requirements for instructions for use, implant card and mandatory technical information for clinicians and regulators.

Packaging and sterilization: Packaging and sterility considerations are included to ensure the device is supplied in final, sterilized form for implantation.

Practical applications - who uses this standard

Medical device manufacturers: Guide design, testing protocols, product labeling and documentation for hydrocephalus shunts.

R&D and quality assurance teams: Establish acceptance criteria, sample selection and post‑sterilization testing.

Regulatory and compliance professionals: Support technical dossiers, CE/510(k)/MDR submissions and conformity assessment.

Clinical engineers, neurosurgeons and hospitals: Interpret manufacturer information (pressure/flow graphs, implant cards) for device selection and patient management.

Testing laboratories: Implement standardized test methods for radiopacity, leakage, pressure/flow and mechanical strength.

Related standards

ISO/TR 14283 - Implants for surgery - Essential principles of safety and performance

ISO 14630:2024 - Non‑active surgical implants - General requirements

ISO 10993‑1 - Biological evaluation of medical devices (biocompatibility)

Keywords: ISO 7197:2024, neurosurgical implants, hydrocephalus shunts, sterile single‑use shunt, pressure‑flow characteristics, biocompatibility, radiopacity, shunt manufacturers, regulatory compliance.

ISO 7197:2024

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications - who uses this standard

Related standards

Технические детали

ISO 14630:2024

Non-active surgical implants — General requirements

ISO 10993-12:2012

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

ISO/TR 14283:2004

Implants for surgery — Fundamental principles