ISO 15676:2016

Overview

ISO 15676:2016 - "Cardiovascular implants and artificial organs - Requirements for single‑use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)" specifies safety, performance and information requirements for medical tubing used in CPB and ECMO. The standard applies to all single‑use tubing intended for extracorporeal blood circuits and focuses on tubing characteristics, testing, labelling and manufacturer reporting. It is intended to help manufacturers, regulators and clinical users ensure tubing safety and functional compatibility with extracorporeal systems.

Key topics and technical requirements

• Scope and applicability

  • Covers tubing packs and tubing aspects of multifunctional systems (oxygenators, reservoirs, filters, pumps, etc.).
  • Includes specific provisions for tubing used with peristaltic/roller pumps in short‑term CPB and longer‑term ECMO applications.
  • Sterility and non‑pyrogenicity requirements apply when tubing packs are labelled as “sterile.”

• Biological requirements

  • Sterility and non‑pyrogenicity verified per the standard’s test clauses.
  • Biocompatibility requirements for all components contacting blood; compliance typically demonstrated in line with ISO 10993 series.

• Physical and material characteristics

  • Blood‑path integrity (no leakage) and dimensional conformity (inner diameter, wall thickness, segment lengths) per user specifications.
  • Material properties to be tested/reported: durometer hardness, ultimate elongation, tensile strength, tear strength, brittle point, specific gravity.

• Performance characteristics

  • Priming volume: measured or calculated and reported across supplied tubing sizes.
  • Life‑to‑failure testing and spallation (particle generation) assessment, particularly for tubing used in roller/peristaltic pumps.
  • Shelf life and cleanliness reporting.

• Information and packaging

  • Minimum labelling and manufacturer information requirements, including technical data, packaging, and shipping details to support clinical selection and quality processes.

Applications and who uses ISO 15676:2016

• Tubing and medical device manufacturers - design verification, material selection, production QA, and regulatory submissions.
• OEMs of CPB/ECMO systems - component selection and system compatibility testing.
• Regulatory and quality teams - conformity assessment, risk management, and clinical documentation.
• Hospitals, perfusionists and clinical engineers - informed procurement, device selection (priming volume, intended pump compatibility), and safe clinical use.

Related standards (examples)

ISO 15676 references standards commonly used together for testing and sterilization, such as:

• ISO 10993 series (biological evaluation),
• ISO 11135 / ISO 11137 / ISO 17665 (sterilization processes),
• ISO 11607 (packaging for sterile devices),
• ASTM and ISO material test methods (tensile, durometer, tear tests).

ISO 15676:2016 helps bridge material and performance testing with clinical needs, enabling safer extracorporeal blood circuits and clearer manufacturer-to‑user information.