ANSI AAMI ISO 18241-2016 pdf free download.Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems— Venous bubble traps
1 Scope
This document specifies requirements for sterile, single-use, venous bubble traps intended to remove air entering the venous line during surgical procedures requiring extracorporeal circulatory support, which may include cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), or venovenous bypass for liver transplantation.
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 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2:Lock fittings
ISO 1 0993-1 , Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 1 0993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interaction with blood
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 11: Tests for systemic toxicity
ISO 1 1 1 35-1 , Sterilization of health care products — Ethylene oxide — Part 1: Requirements for 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 https://www.iso.org/obp/
— IEC Electropedia: available at http://www.electropedia.org/
3.1 venous bubble trap
device for removing air from the venous line of an extracorporeal circuit
3.2 blood pathway
blood-contacting surfaces of the venous bubble trap during its intended clinical use
3.3 blood cell damage
loss or destruction of cellular components of the blood
3.4 platelet reduction
percentage reduction of platelets contained in a circuit incorporating a venous bubble trap, as a function of time
3.5 plasma-free hemoglobin level
difference between the concentration of plasma-free hemoglobin in a circuit incorporating a venous bubble trap, as a function of time
3.8 blood analogue
test solution which simulates blood viscosity between 2.0 × 1 0 −3 Pa·s (2.0 cP), to 3.5 × 1 0 −3 Pa·s (3.5 cP)
3.9 predicate venous bubble trap
similar venous bubble trap to the test venous bubble trap that has previously been approved and used for the same intended clinical use
4 Requirements
4.1 Biological characteristics
4.1.1 Sterility and non-pyrogenicity
The blood pathway shall be sterile and non-pyrogenic. Compliance shall be verified in accordance with 5.2.1 .
4.1.2 Biocompatibility
The parts of the blood pathway shall be biocompatible with respect to their intended use. Compliance shall be verified in accordance with 5.2.2.
4.2 Physical characteristics
4.2.1 Blood pathway integrity
When tested in accordance with 5.3.1 , the blood pathway shall not leak.
4.2.2 Prime volume
The volume of the blood pathway shall be within the tolerances specified by the manufacturer (see 6.3).
4.2.3 Connectors
Connectors for connection to the blood pathway shall, when tested in accordance with 5.3.3, allow a secure connection.
NOTE 1 Connectors of a type that allows connection of tubes with an inside diameter of 4.8 mm,
6.3 mm, 9.5 mm or 1 2.7 mm, or a type that complies with ISO 8637:201 0, Figure 1 , or a type that
complies with ISO 594-2, have been found satisfactory.Connection for accessory ports shall meet the requirements of ISO 594-2.
NOTE 2 Connectors corresponding to ISO 8637:201 0, Figure 3, are considered as one way to comply
with this requirement.
