ISO 7199:2016

Overview

ISO 7199:2016 - "Cardiovascular implants and artificial organs - Blood‑gas exchangers (oxygenators)" is an international standard that specifies requirements for sterile, single‑use, extracorporeal blood‑gas exchangers (oxygenators) intended to oxygenate human blood and remove carbon dioxide. Published as the third edition (2016), the standard also covers integral heat exchangers, integral arterial filters, and external equipment unique to oxygenator use. It does not apply to implanted or liquid oxygenators, separate heat exchangers, extracorporeal tubing, or separate ancillary devices.

Key topics and technical requirements

ISO 7199:2016 focuses on device safety, performance, testing and labeling. Major technical topics include:

• Biological characteristics

  • Sterility and non‑pyrogenicity requirements
  • Biocompatibility assessment in line with ISO 10993 guidance

• Physical characteristics

  • Integrity of blood and heat‑exchanger fluid pathways
  • Blood volumes (priming and residual blood volume)
  • Connectors and integral part definitions

• Performance characteristics

  • Oxygen and carbon dioxide transfer rates (gas transfer performance)
  • Heat exchanger performance factor (temperature control capability)
  • Integral arterial filtration: filtration efficiency, flow capacity and air‑handling capability
  • Blood cell damage metrics (e.g., plasma‑free hemoglobin, platelet and white blood cell reduction; normalized index of hemolysis)
  • Time‑dependent performance changes and shelf life

• Tests and measurements

  • Type test procedures for gas transfer, hemolysis and heat‑exchanger performance
  • Test methods for sterility, biocompatibility and packaging validation
  • Minimum reporting requirements to enable objective comparison between oxygenator designs

• Information and packaging

  • Required manufacturer information, labeling and packaging requirements for sterile barrier systems

Practical applications - who uses ISO 7199:2016

• Medical device manufacturers designing or marketing extracorporeal oxygenators and integrated components
• Regulatory authorities and conformity assessment bodies reviewing safety and performance data
• Quality assurance and R&D teams conducting type tests (gas transfer, hemolysis, heat exchange)
• Test laboratories performing standardized evaluations and performance reporting
• Procurement specialists and clinicians comparing oxygenator performance for cardiopulmonary bypass and extracorporeal support

Related standards

ISO 7199:2016 references several normative standards relevant to testing and compliance, including:

• ISO 10993 series (biological evaluation of medical devices)
• ISO 11135, ISO 11137‑1, ISO 17665‑1 (sterilization processes)
• ISO 11607‑1/2 (packaging for terminally sterilized devices)
• ISO 15675 (arterial blood line filters)

ISO 7199:2016 provides a consistent framework for evaluating extracorporeal oxygenators, ensuring safety, measurable performance, and transparent manufacturer information for clinical use and regulatory compliance. Keywords: ISO 7199:2016, blood‑gas exchangers, oxygenators, extracorporeal, oxygenator testing, biocompatibility, sterilization, heat exchanger performance, arterial filter, hemolysis.