ISO 7197:2024
Neurosurgical implants — Sterile, single-use hydrocephalus shunts
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
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
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
Технические детали
- Технический комитет
- ISO/TC 150 - Implants for surgery
- SKU
- ISO 7197:2024
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