ANSI/AAMI/ISO 15674-2016 pdf download.Cardiovascular implants and artifcial organs— Hard-shell cardiotomy/ venous reservoir systems (with/without flter) and soft venous reservoir bags.
This document specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery.
This document applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1 0993-1 , Biological evaluation of medical devices — Part 1 : Evaluation and testing within a risk management process
ISO 1 0993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 1 0993-1 1 , Biological evaluation of medical devices — Part 1 1 : Tests for systemic toxicity
ISO 1 1 1 35, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 1 1 1 37-1 , Sterilization of health care products — Radiation — Part 1 : Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 1 1 607-1 , Packaging for terminally sterilized medical devices — Part 1 : Requirements for materials, sterile barrier systems and packaging systems
ISO 1 1 607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 1 4937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 1 7665-1 , Sterilization of health care products — Moist heat — Part 1 : Requirements for the development, validation and routine control of a sterilization process for medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1 hard-shell cardiotomy reservoir
extracorporeal device consisting of rigid walls designed to collect, defoam and filter suctioned blood
3.2 hard-shell venous reservoir
extracorporeal device consisting of rigid walls designed to collect and defoam venous blood
3.3 soft-bag venous reservoir
extracorporeal device consisting of collapsible, pliable walls designed to collect venous blood
3.4 hard-shell cardiotomy/venous reservoir system
extracorporeal device designed to function simultaneously as both a venous reservoir and cardiotomy reservoir.ANSI/AAMI/ISO 15674 pdf download.