ANSI AAMI ISO 7199-2016 PDF

Full title and description

ANSI / AAMI / ISO 7199:2016 — Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators). A harmonized international / U.S. adoption that specifies performance, safety, labelling and testing requirements for sterile, single‑use extracorporeal blood‑gas exchangers (oxygenators) and integral heat exchangers and arterial filters for use during cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO) and related extracorporeal gas‑exchange procedures.

Abstract

ISO 7199:2016 sets minimum requirements and test methods for the design, performance and safety of single‑use extracorporeal blood‑gas exchangers (oxygenators). It covers gas‑transfer performance (O2 supply and CO2 removal), priming volume, pressure drop, heat exchange where integral, biocompatibility and materials, sterility and packaging, connectors and tubing interfaces, labelling and instructions for use, and mechanical integrity under expected use. The standard excludes implanted oxygenators, liquid oxygenators and separate ancillary devices or separate arterial line filters that are not integral to the oxygenator.

General information

• Status: Withdrawn / superseded (replaced by ISO 7199:2024).
• Publication date: November 2016 (edition 3).
• Publisher: International Organization for Standardization (ISO); adopted in the U.S. and published/distributed by AAMI / ANSI as ANSI/AAMI/ISO 7199:2016.
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics; cardiovascular implants and artificial organs).
• Edition / version: 3rd edition (2016). An amendment addressing connectors was published in 2020; a new edition (ISO 7199:2024) subsequently replaced the 2016 edition.
• Number of pages: 13 (ISO published PDF; pagination may vary among national/adopted publications).

Scope

Applies to sterile, single‑use extracorporeal blood‑gas exchangers (oxygenators) intended to supply oxygen to and remove carbon dioxide from human blood during CPB, ECMO and other extracorporeal circulation techniques that require blood‑gas exchange. Also applies to heat exchangers and arterial filters that are integral to the oxygenator and to external equipment unique to the oxygenator's use. Does not apply to implanted oxygenators, liquid oxygenators, standalone extracorporeal tubing circuits, separate heat exchangers or separate ancillary devices and separate arterial line filters that are not integral parts of the oxygenator.

Key topics and requirements

• Definitions and device classification relevant to extracorporeal blood‑gas exchangers.
• Performance tests for gas transfer: O2 transfer capacity and CO2 removal under specified flow and blood conditions.
• Hydraulic performance: priming volume, maximum recommended flow, and pressure drop characteristics.
• Heat‑exchange performance for oxygenators with integral heat exchangers (thermal transfer requirements and tests).
• Mechanical integrity and leak resistance under expected use and pressure conditions.
• Materials and biocompatibility requirements (cytotoxicity, sensitization, irritation and other ISO 10993 considerations).
• Sterility, pyrogenicity and sterilization information for devices labelled as sterile; packaging and shelf‑life labelling.
• Connector and tubing interface specifications and tests (including connector safety and compatibility provisions introduced by amendment).
• Labelling, instructions for use, warnings, intended use statements and information for safe clinical application.
• Risk management and reporting expectations consistent with medical device best practice (design verification/validation and documentation).

Typical use and users

Primary users are medical device manufacturers, design and test engineers, regulatory and quality teams, conformity assessment bodies, notified bodies and testing laboratories that evaluate extracorporeal oxygenators. Secondary users include hospital procurement teams, clinical engineers, perfusionists, and regulators reviewing product dossiers or clearance submissions for oxygenators intended for CPB, ECMO or extracorporeal gas‑exchange support.

Related standards

Standards commonly referenced alongside ISO 7199 include: ISO 7199 (new edition 2024) which supersedes the 2016 edition; ISO 10993 series for biological evaluation of medical devices; ISO 13485 for medical device quality management systems; standards and guidance on sterilization and packaging (e.g., ISO 11135, ISO 11607) and national/adopted AAMI/ANSI implementations. Device‑specific connector and tubing interface standards and relevant regulatory guidance (FDA, MDR) are also commonly consulted.

Keywords

oxygenator; blood‑gas exchanger; extracorporeal; ECMO; CPB; priming volume; gas transfer; pressure drop; heat exchanger; biocompatibility; sterility; connectors; AAMI; ANSI; ISO 7199.

FAQ

Q: What is this standard?

A: ISO 7199:2016 (issued as ANSI/AAMI/ISO 7199:2016 when adopted in the U.S.) is a performance and safety standard for sterile, single‑use extracorporeal blood‑gas exchangers (oxygenators) and integral components used in cardiopulmonary bypass, ECMO and similar procedures.

Q: What does it cover?

A: It covers definitions, design and performance requirements (gas transfer, hydraulic and thermal characteristics), materials and biocompatibility, sterility and packaging, connector/tubing interfaces, labelling and required test methods and documentation to demonstrate conformity.

Q: Who typically uses it?

A: Device manufacturers, design verification and test laboratories, regulatory and quality teams, conformity assessment bodies, perfusionists and hospital procurement/clinical engineering professionals.

Q: Is it current or superseded?

A: ISO 7199:2016 has been superseded by a later edition (ISO 7199:2024). The 2016 edition and its 2020 amendment remain part of the historical record but users should refer to the 2024 edition for the current normative requirements.

Q: Is it part of a series?

A: ISO 7199 sits within ISO/TC 150 (cardiovascular implants and artificial organs) outputs and is commonly used with other medical device and biocompatibility standards (for example the ISO 10993 series and ISO 13485). National adoptions and AAMI/ANSI publications reflect the international text adjusted for national publication practices.

Q: What are the key keywords?

A: oxygenator, blood‑gas exchanger, extracorporeal, ECMO, CPB, gas transfer, priming volume, pressure drop, heat exchanger, sterility, biocompatibility, connectors, ISO 7199.