ISO/TR 8417:2024

Name: ISO/TR 8417:2024 — Risk management of particulate contamination for devices with intravascular access
SKU: ISO/TR 8417:2024
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Risk management of particulate contamination for devices with intravascular access

Название (английский):

ISO/TR 8417:2024

Risk management of particulate contamination for devices with intravascular access

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 3 октября 2024 г.
Издание:: ISO TR 8417 edition 1 version 1
ICS:: 11.040.20

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Описание (английский):

This document — provides information on the determination of particulate loads; — reports on established methods for a comprehensive risk analysis on potential particle sources and related risks in design, manufacturing, and application of devices. This document is applicable to medical devices that are used to provide intravenous access to patients to deliver liquids. NOTE For routes of administration that are not intravenous, the information in this document might be relevant to assist in the identification of sources of potential particulate contamination.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO/TR 8417:2024 - Risk management of particulate contamination for devices with intravascular access - is a Technical Report from ISO that guides manufacturers, regulators and healthcare stakeholders on identifying, assessing and controlling particulate contamination in devices used to provide intravenous access. The document emphasizes applying ISO 14971 risk-management methodology rather than relying solely on fixed particle-count limits, and explains approaches for determining particulate loads and for comprehensive risk analysis across design, manufacturing and clinical use.

Key topics and requirements

Risk-based approach: Apply ISO 14971 principles to identify particulate hazards, assess severity and probability, and implement risk controls specific to intravascular devices.

Determination of particulate loads: Use quantitative and qualitative testing to assess initial particle loads and to verify effectiveness of control measures. ISO/TR 8417 references applicable methods such as ISO 8536-4:2019 (A.2), European Pharmacopoeia (2.9.19, 2.9.20), USP chapters (787, 788, 790, 1790), Japanese Pharmacopoeia (6.07, 6.06) and ISO/TR 19727.

Comprehensive source analysis: Identify particle sources across the product lifecycle - design (moulding, extrusion), suppliers, packaging, assembly, sterilization, storage, transport and clinical application. Annex A provides examples of hazards and risk-control options.

Holistic exposure perspective: Recognizes that patients’ total particulate exposure is cumulative (containers, infusion sets, catheters, parallel or sequential infusions) and that fixed “tolerable” counts may be insufficient as sole assurance of safety.

Documentation expectations: Manufacturers are expected to create or update risk management files to include particulate-related hazards and feasible control measures.

Practical applications

Device design teams: integrate particulate-reduction features (material selection, geometry, barrier design) and design-for-cleanliness.

Manufacturing and quality assurance: adopt cleanroom controls, supplier qualification, incoming inspection, validated moulding/extrusion and particulate testing to monitor loads.

Regulatory and compliance: use the TR to inform risk analyses, technical files and post-market surveillance arguments about particulate risk control.

Clinical risk managers and procurement: assess device combinations and instructions for use (filters, contraindications) to reduce patient exposure.

ISO/TR 8417:2024

Abstract

Похожие стандарты

Overview

Key topics and requirements

Practical applications

Who will use this standard

Related standards and references

Технические детали

ISO 8536-4:2019

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

BS EN ISO 14971:2019+A11:2021

Medical devices. Application of risk management to medical devices.

PD ISO/TR 8417:2024

Risk management of particulate contamination for devices with intravascular access

PD ISO/TR 19727:2017

Medical devices. Pump tube spallation test. General procedure