Overview
ISO 15674:2016 - Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags - specifies requirements for sterile, single‑use extracorporeal blood reservoirs used during cardiopulmonary bypass (CPB) surgery. The standard covers the blood reservoir aspects of both hard‑shell and soft‑bag reservoirs and applies to multifunctional systems only insofar as the reservoir function is concerned (oxygenators, pumps and other integral parts are out of scope for this document).
Key topics and requirements
ISO 15674:2016 focuses on biological, physical and performance characteristics, and on testing and labeling. Major technical points include:
- Sterility and non‑pyrogenicity: Blood pathways must be sterile and non‑pyrogenic; compliance verified per the standard’s test clauses.
- Biocompatibility: All parts in contact with blood must meet biocompatibility requirements (referenced to ISO 10993 series).
- Blood pathway integrity: Soft‑bag and sealed hard‑shell reservoirs shall not leak when tested.
- Volume controls: Static, dynamic and priming volumes must be measured and reported within manufacturer tolerances; minimum and maximum volumes identified.
- Connectors and interfaces: Connectors must allow secure connections to standard tubing sizes or conform to referenced connector figures.
- Performance metrics: Includes testing and documentation of
- blood cell damage at maximum flow,
- air‑handling capacity,
- defoaming characteristics,
- filtration efficiency (for reservoirs with filters),
- break‑through volume,
- volume calibration and dynamic priming volume across flow ranges.
- Shelf life, packaging and labeling: Requirements for unit and shipping containers, information on product labels and accompanying documents.
Applications and users
ISO 15674:2016 is practical for:
- Manufacturers of hard‑shell cardiotomy/venous reservoir systems and soft venous reservoir bags - to design, test and document CPB blood reservoirs for regulatory submissions.
- Quality, regulatory and R&D teams - to structure validation protocols, biocompatibility testing and shelf‑life studies.
- Test laboratories - to perform performance and integrity tests specified by the standard.
- Hospitals, perfusionists and procurement specialists - to assess product compliance, labeling and suitability for clinical CPB use.
Keywords: ISO 15674:2016, cardiotomy/venous reservoir systems, soft venous reservoir bags, cardiopulmonary bypass (CPB), blood reservoir, sterile single‑use, priming volume, filtration efficiency, biocompatibility.
Related standards
ISO 15674 references and aligns with several normative standards used in testing and documentation, including:
Use ISO 15674:2016 to ensure blood reservoir design and testing meet recognized international safety and performance expectations for CPB applications.