SIST EN ISO 10993-4:2018 PDF

Overview

SIST EN ISO 10993-4:2018 (ISO 10993-4:2017) - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - specifies general requirements for evaluating how medical devices interact with blood. It provides a framework to classify blood‑contacting devices (based on intended use and duration as defined in ISO 10993‑1), describes fundamental principles for assessing blood interactions, and presents the rationale for a structured selection of tests. The standard is descriptive rather than prescriptive: detailed test procedures are not specified because of limitations in current knowledge and test precision.

Key topics and technical requirements

• Device classification for blood contact
  • Categories follow ISO 10993‑1: non‑blood‑contact, external communicating, and implant devices, with subcategories defined by intended use and contact duration.
• Principles for biological evaluation
  • Outlines the factors to consider when assessing hemocompatibility and blood interactions, including device function, materials, exposure routes and clinical context.
• Structured test selection rationale
  • Explains how to choose appropriate tests based on device category and risk profile rather than prescribing fixed test lists.
• Types of tests described
  • In vitro (laboratory hemocompatibility assays), ex vivo, and in vivo methods are referenced as approaches for characterizing blood interactions.
• Limitations and scope
  • Emphasizes that this part of ISO 10993 provides general guidance and may not fully define specific methods for a given device. Changes in the 2017 edition do not invalidate testing performed to earlier editions; additional testing for devices with a proven history of safe clinical use is not generally recommended.
• Regulatory context
  • Linked to EU directives via Annex ZA/ZB and to other ISO standards (e.g., ISO 10993‑1, ISO 10993‑12); users should integrate this standard with risk management (ISO 14971 referenced in the foreword).

Practical applications

• Develop a hemocompatibility testing strategy for catheters, blood pumps, extracorporeal circuits, vascular implants and other blood‑contacting devices.
• Inform preclinical test selection during device development and design verification.
• Support regulatory submissions and conformity assessments (e.g., CE marking) by documenting a rationale for chosen blood interaction tests.
• Guide contract testing laboratories and study designers on appropriate in vitro/ex vivo/in vivo approaches for blood interaction evaluation.

Who should use this standard

• Medical device manufacturers (design, R&D, regulatory affairs)
• Biocompatibility engineers and toxicologists
• Clinical and preclinical testing laboratories
• Notified bodies and regulatory reviewers

Related standards (use together)

• ISO 10993‑1 (biological evaluation framework)
• ISO 10993‑12 (sample preparation and reference materials)
• EN ISO 10993‑4:2017 as the endorsed European version

Keywords: ISO 10993-4, hemocompatibility, biological evaluation, blood-contacting devices, medical device testing, biocompatibility, test selection, regulatory conformity.