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GB 12260-2017Cardiopulmonary bypass systems - Roller blood pump (English PDF)

心肺转流系统滚压式血泵

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Issued by

AQSIQ; SAC

Level / Type

National · Mandatory

Issue date

December 29, 2017

Implementation date

July 1, 2019

Scope

GB 12260-2017 is the English-translated version of 心肺转流系统滚压式血泵.

GB 12260-2017 is the Chinese national standard for the roller blood pump used in cardiopulmonary bypass systems. It gives the terms and definitions, the types, composition and basic parameters of the pump, the requirements it must satisfy, the test methods and the rules for marking, packaging, transport and storage.

Two working types are covered, constant-flow and pulsatile, and the pump is treated as a unit made of the pump head, a monitoring system and a base with its bracket.

It fixes basic parameters such as the maximum flow of the main pump and the minimum rotational speed, and it adds safety monitoring requirements. It applies to pumps used by medical units for surgery, rescue, temporary cardiopulmonary bypass and regional perfusion.

It replaces GB 12260-2005, was issued on 29 December 2017 and has applied since 1 July 2019.

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Document preview — GB 12260-2017

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C 45
Replacing: GB 12260-2005

Issued by: General Administration of Quality Supervision, Inspection and Quarantine; Standardization Administration of the PRC

Preface
1 Scope
2 Normative references
3 Terms and definitions
4 Type, composition and basic parameters
5 Requirements
6 Test methods
7 Logo, packaging, transportation and storage

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 12260-2005 "artificial heart-lung machine rolling blood pump." The main differences between this standard and GB 12260-2005 are as follows.

--- Modify the definition of constant current operation and pulsating operation (see 4.3, 2005 version 4.3);

--- Modify the maximum constant flow requirements, only the main pump requirements (see 5.3.2, 2005 version 5.3.2);

--- Modify the maximum pulsatile flow requirements, only the main pump requirements (see 5.4.4, 2005 version 5.4.4);

--- Increased safety monitoring requirements (see 5.7).

1 Scope

This standard specifies the cardiopulmonary bypass system rolling blood pump terms and definitions, type, composition, basic parameters, requirements, test methods, standard log, packaging, transportation and storage.

This standard applies to cardiopulmonary bypass system roller blood pump (hereinafter referred to as blood pump), the product for medical units for surgery and rescue, temporary cardiopulmonary bypass for cardiac function or local perfusion.

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 9706.15 Medical electrical equipment - Part 1-1: General safety requirements Collateral standards. Medical electrical system safety requirements (GB 9706.15-2008, IEC 60601-1-1:2000, IDT)

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

YY/T 0466.1 Medical Devices Labeling, Labeling and Information Symbols for Use in 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 Type, composition and basic parameters

4.1 Type

Constant current rolling, rolling pulsating.

4.2 Composition

Rolling blood pump by the blood pump (such as single head pump or double head pump), monitoring system, the base includes the bracket (if any).

4.3 Basic parameters

4.3.1 Constant current operation

a) The maximum flow of the main pump should not be less than 6000mL/min;

b) The minimum speed should not exceed 1r/min.

4.3.2 Pulsating operation

a) beat frequency should meet the manufacturer's requirements;

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB 12263-2017|GB 9706.1|YY/T 1145|GB 10035-2017|GB/T 14710|YY/T 0466.1

Editions of GB 12260

Edition	Title	Revision	Status
GB 12260-2017	Cardiopulmonary bypass systems - Roller blood pump	second revision	Current
GB 12260-2005	Artificial heart-lung machine - Roller blood pump	first revision	Superseded
GB 12260-1990	Artificial heart-lung machine - Roller blood pump	first issue	Superseded

This page sells the current edition, GB 12260-2017. Earlier editions are listed for reference only.

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