YY/T 1839-2022Cardiopulmonary bypass systems-Venous bubble traps (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

This document uses the redrafted method to modify and adopt ISO 18241:2016 "Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Static Pulse Bubble Trap" and Amendment No. 1..2019 "Joint".

There are technical differences between this document and ISO 18241:2016 and Amendment No. 1, and the clauses involved in these differences have been adopted on the outside The vertical line (|) in the blank position of the page number is marked, and Appendix A gives a list of the corresponding technical differences and their reasons.

1 Scope

This document specifies a single-use sterile venous bubble trap for evacuating venous air bubbles during surgery supported by extracorporeal circulation requirements and test methods.

This document applies to single-use sterile venous bubble traps.

NOTE. Surgical procedures requiring cardiopulmonary bypass support can include cardiopulmonary bypass, extracorporeal membrane oxygenation, and venous bypass for living transplants.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment - Part 1: Chemical analysis methods

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in Risk Management Process (GB/T 16886.1- 2011, ISO 10993-1:2009, IDT)

GB/T 16886.11 Biological Evaluation of Medical Devices Part 11: Systemic Toxicity Test (GB/T 16886.11-2011,

ISO 10993-11:2006, IDT)

GB 18279.1 Sterilization of Healthcare Products Ethylene Oxide Part 1: Development, Validation and Routine Control of Sterilization Processes for Medical Devices requirements (GB 18279.1-2015, ISO 11135-1:2007, IDT)

GB 18280.1 Sterilization Radiation for Healthcare Products Part 1: Requirements for Development, Validation and Routine Control of Sterilization Processes for Medical Devices Seek (GB 18280.1-2015, ISO 11137-1:2006, IDT)

GB/T.19974 Characterization of Sterilization Factors for Sterilization of Healthcare Products and Development, Validation and Routine Control of Sterilization Processes for Medical Devices General requirements for (GB/T.19974-2018, ISO 14937:2009, IDT)

YY/T 0681.1 Sterile Medical Device Packaging Test Methods Part 1: Guidelines for Accelerated Aging Test

YY/T 1556-2017 Test method for particle contamination of medical infusion, blood transfusion and injection equipment

ISO 80369-7:2016 Small bore connectors for medical liquids and gases - Part 7: Connectors for intravascular or subcutaneous applications Pharmacopoeia of the People's Republic of China

3 Terms and Definitions

The following terms and definitions apply to this document.