SIST EN ISO 7197:2025 PDF

Overview

EN ISO 7197:2024 - "Neurosurgical implants - Sterile, single‑use hydrocephalus shunts" is the updated European adoption of ISO 7197:2024. It specifies performance, mechanical and technical requirements for sterile, single‑use non‑active hydrocephalus shunts, including valves and additional components such as tubes and reservoirs. The standard applies to non‑active implants only, does not recommend specific valve types for clinical use, and requires manufacturers to supply technical information about the valve.

Key topics and technical requirements

The standard defines essential performance and safety criteria relevant to design, manufacture, testing and labelling of hydrocephalus shunts. Major technical topics include:

• General requirements: overall construction, traceability and control of the implanted shunt.
• Radiopacity: visibility of shunt components under imaging for identification in vivo.
• Biocompatibility: material compatibility with the patient.
• Resistance to leakage and bursting pressure requirements to ensure fluid containment.
• Pressure‑flow characteristics: valve and assembled shunt flow behaviour and related testing.
• Dynamic breaking strength and ability to withstand overpressure for mechanical durability.
• Magnetic resonance (MRI) behaviour: magnetically induced forces, heating and image artefacts under worst‑case conditions.
• Component‑specific requirements: valve performance (reflux prevention, long‑term stability, posture influence) and tubing/component resistance.
• Marking, labelling and packaging: requirements for identification, directions for flow, non‑fibrous packaging materials and sterilization status.
• Information supplied by the manufacturer: instructions for use, implant card, pre/postoperative testing and MR‑related instructions.

Applications and practical value

EN ISO 7197:2024 is a practical tool for:

• Designing and testing sterile single‑use hydrocephalus shunt systems.
• Establishing manufacturing quality criteria and production controls.
• Preparing technical documentation for regulatory submissions (supports conformity to EU MDR General Safety and Performance Requirements where cited).
• Developing clinical instructions, implant cards and labelling that meet regulatory and safety expectations.
• Specifying procurement requirements for hospitals and supply chain stakeholders.

Who uses this standard

• Medical device manufacturers (R&D, QA/RA, production)
• Test laboratories and certification bodies (conformity assessment)
• Regulatory affairs professionals preparing CE marking or MDR dossiers
• Clinical engineers, neurosurgeons and hospital procurement teams

Related standards

• ISO 14630 (General requirements for non‑active surgical implants)
• ISO/TR 14283 (Principles of safety and performance for implants) EN ISO 7197:2024 supersedes the 2009 edition and is intended to be used alongside applicable normative references to achieve presumption of conformity with relevant regulatory requirements.