YY 0604-2016Cardiopulmonary bypass systems - Blood-gas exchangers (oxygenators) (English PDF)

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This standard adopts the re-drafting method to modify ISO 7199.:2009 "cardiovascular implants and artificial organs blood-gas exchangers (oxygenated Device ".

The main technical differences between this standard and YY 0604-2007 are as follows.

--- increase the chemical performance, validity and other requirements and the corresponding test methods.

The main technical differences between this standard and ISO 7199.:2009 are shown in Table A.1.

Introduction

This standard is designed to effectively exchange gas, auxiliary or replace the lungs of the normal respiratory function of the device, to ensure its safety performance And functional aspects are fully tested, and the characteristics of the cardiopulmonary device to be properly displayed on the device mark.

Therefore, this standard contains the steps to evaluate the cardiopulmonary bypass blood gas exchanger (oxygenator), which describes the measurement of gas conversion, blood Cell failure and the performance of such devices, such as heat exchangers, but not the limits of these characteristics set. The rapid identification of performance characteristics should help the user to select the oxygenator for the patient's needs.

This standard also covers the minimum requirements for the content that must be reported so that the user can add to the performance characteristics of the various standard oxygenators To compare.

This standard refers to other international standards in which a method for determining the common characteristics of various medical devices can be found.

There was no provision for determining the number of microbubbles and the number of unformed components in bovine blood, which is due to the fact that The test method has not yet reached a consensus.

This standard does not include requirements for animal and clinical research, which can be used as part of the manufacturer's quality system. Cardiopulmonary bypass system Blood gas exchanger (oxygenator)

1 Scope

This standard specifies the use of a blood gas exchanger (oxygenator) (hereinafter referred to as oxygenator) for a sterile, disposable cardiopulmonary bypass system It is required that the device be used to oxygenate the blood of the human body and to remove carbon dioxide in the blood (auxiliary or alternative to the extracorporeal circulation of the lung Device).

This standard also applies to heat exchangers as part of the overall oxygenator. This standard does not apply to.

--- implantable oxygenator;

--- liquid oxygenator; Extracorporeal circulation Separate heat exchangers; Separate accessories.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods

GB/T 14233.2-2005 Methods of examination for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (GB/T 16886.1-2011, ISO 10993-1.:2009, IDT)

GB 18279 Sterilization and routine control of ethylene oxide for medical devices (GB 18279-2000, idtISO 11135..1994)

GB 18280 Sterilization and routine control of health care products Requirements for radiation sterilization (GB 18280-2000, idtISO 11137.

1995) General technical conditions for disposable blood use products GB 19335-2003

GB/T 19633-2005 Packaging of final sterilized medical devices (GB/T 19633-2005, ISO 11607.:2003, IDT)

Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic requirements for medical devices YY/T 0466.1-2009 (YY/T 0466.1-2009, ISO 15223.:2007, IDT)

YY/T 0681.1-2009 Test methods for packaging of sterile medical devices - Part 1. Guidelines for accelerated aging testing (YY/T 0681.1-2009, ASTM F1980.:2002, MOD)

3 Terms and definitions

The following terms and definitions apply to this document.