GB 12263-2017Cardiopulmonary bypass systems - Water heating/cooling system (English PDF)

Foreword

The technical content of this standard is mandatory.

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

This standard replaces GB 12263-2005 "artificial heart-lung machine heat exchange water tank." The main differences between this standard and GB 12263-2005 are as follows:

--- Modify the standard name for "cardiopulmonary bypass system heat exchange water tank";

--- Modify the normal working conditions (see 4.1, 2005 version 4.1);

--- Modify the appearance and structure requirements (see 4.2, 2005 version 4.2);

--- Modify the connection test method of robustness (see 5.2.2, 2005 version 5.2.2);

--- Modify the tank capacity requirements and test methods (see 4.4, 5.2.3, 2005 edition of 4.4, 5.2.3);

--- Modify the water tank flow requirements and test methods (see 4.5, 5.2.4, 2005 edition of 4.5, 5.2.4);

--- Increased water tank temperature control requirements and test methods (see 4.6, 5.2.5);

--- Modify the temperature display requirements and test methods (see 4.7, 5.2.6, 2005 version 4.6,5.2.5);

--- Modify the requirements and test methods over-temperature tips (see 4.8, 5.2.7, 2005 version 4.7,5.2.6);

--- Modify the water heating/cooling rate requirements and test methods (see 4.9, 5.2.8, 2005 version 4.8,5.2.7);

--- Increase the prompt sound requirements and test methods (see 4.11 and 5.2.10);

--- Increased pipeline pressure requirements and test methods (see 4.13 and 5.3);

--- Modify the sound pressure level of normal working noise requirements and test methods (see 4.10,5.2.9, 2005 version 4.9,5.2.8);

--- Modify the requirements of environmental test conditions and applicable provisions (see 5.5, 2005 edition 5.3);

--- Modify the leakage test test method (see 5.2.1.11, 2005 edition of 5.2.9).

1 Scope

This standard specifies the terms and definitions, requirements, test methods, signs, instructions, packaging, transportation, storage.

This standard applies to cardiopulmonary bypass system heat exchange water tank (hereinafter referred to as water tank), the water tank is for extracorporeal circulation blood heat exchange system Of the heat exchanger to provide heating water, cooling water and raw water drive for medical institutions to carry out extracorporeal perfusion temperature regulation.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 191 Packaging - Pictorial signs (GB/T 191-2008, ISO 780:1997, MOD)

GB 9706.1 medical electrical equipment Part 1: General requirements for safety (GB 9706.1-2007, IEC 60601-1:1988, IDT)

GB/T 9969 Industrial Products Manual General

Environmental requirements and test methods for medical electrical appliances GB/T 14710-2009

YY/T 0466.1 Medical Devices Labeling, Marking and Notification of Use for Medical Devices Part 1: General Requirements (YY/T 0466.1-2016, ISO 15223-1:2012, IDT)

YY/T 1145 cardiopulmonary bypass system terminology

3 Terms and definitions

YY/T 1145 defined terms and definitions apply to this document.

4 Requirements