YY/T 1492-2016Cardiopulmonary bypass systems—General requirement for coating products (English PDF)

Foreword

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

This standard uses the re-drafting method to modify the use of ISO 11658.:2012 "cardiovascular implants and artificial organs in the extracorporeal circulation system Blood/tissue contact with the surface coating ".

The main technical differences between this standard and ISO 11658.:2012 are as follows.

- the scope of the removal of the temperature range requirements; Normative reference documents using domestic standards;

--- sterile and pyrogen-free according to our common standards for testing;

--- shelf life (stability of the stability) according to China's common standards for testing;

--- delete the original English version of c), d) terms.

Introduction

The purpose of this standard is to ensure that the surface coating device in contact with the blood, in terms of safety performance, integrity and function are fully And the characteristics of the extracorporeal circulation device are properly displayed on the device label. This standard also includes the content that must be reported Low demand, which will allow users to compare performance characteristics in a standard way.

In order to be used for the evaluation of surface coatings, this standard contains recommended procedures. Surface coverage determination requirements, leaching and biological activity Sex, if required, surface coating treatment, although these requirements are not specified.

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

The standard does not include requirements for animal and clinical research.

1 Scope

This standard specifies the technical requirements, test methods, labeling, marking and other requirements of the surface coating on the cardiopulmonary bypass system. This standard Suitable for delivery of blood cardiopulmonary bypass devices, in vitro life support devices and surface coating products in contact with blood or tissue.

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

GB/T 16886.7-2015 Biological evaluation of medical devices - Part 7. Residue of ethylene oxide (ISO 10993-7. 2008, IDT)

GB 18279.1 Sterilization of health care products Ethylene oxide - Part 1. Development, validation and routine control of sterilization of medical devices (GB 18279.1-2015, ISO 11135-1.:2007, IDT)

GB 18280.1 Sterilization of medical care products - Part 1. Development, validation and routine control of sterilization of medical devices (GB 18280.1-2015, ISO 11137-1.:2007, IDT)

YY 0580-2011 Cardiovascular implants and artificial organs Cardiopulmonary bypass system Arterial line Blood filters (ISO 15675. 2009, MOD)

YY 0603-2015 Cardiovascular Implants and Artificial Organs Cardiac Surgery Hard Shell Regulators/Venous Regulators System (with or without) Filter) and the vein storage soft bag (ISO 15674.:2009, MOD)

YY 0604-2016 Cardiopulmonary bypass system Blood gas exchanger (oxygenator) (ISO 7199.:2009, MOD)

Test methods for packaging of sterile medical devices - Part 1. Guidelines for accelerated aging testing (ASTMF 1980.:2002, MOD)

Cardiovascular surgery implants and artificial organs Cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

The requirements for the use of pipe fittings (ISO 15676.:2005, MOD)

3 Terms and definitions

The following terms and definitions apply to this document.