BS ISO 15674:2016 pdf download

BS ISO 15674:2016 pdf download.Cardiovascular implants and artificial organs — Hard- shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
1 Scope
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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 14937, 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 17665-1, 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/
5.3.4.2 Procedure
Two sets of appropriate, identical circuit components, including a pump, connecting tubing, a reservoir (as specified by the manufacturer and of suitable size relative to the device under test) and a heat exchanger, shall be assembled. The device under test shall be placed in one of the circuits. A predicate device shall be placed in the second test circuit. Priming and debubbling of the circuits by recirculating with an appropriate solution is recommended before blood is added. The blood pathway test-liquid volumes shall, at the initiation of the test, be within 1 % of each other. Perform the test in vitro using the conditions given in Table 1. A sufficient number of paired tests should be performed to support a statistical analysis. The predicate reservoir should be tested under the same conditions.