GB 12260-2017 English PDF

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GB 12260-2017: Cardiopulmonary bypass systems -- Roller blood pump
Status: Valid

GB 12260: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 12260-2017	198	Add to Cart	1 days	Cardiopulmonary bypass systems -- Roller blood pump	Valid
GB 12260-2005	399	Add to Cart	3 days	Artificial heart-lung machine -- Roller blood pump	Obsolete
GB 12260-1990	239	Add to Cart	2 days	Artificial heart-lung machine--Roller pump	Obsolete

Similar standards

GB/T 39381.1   YY/T 1680   YY/T 1571   GB/T 20405.4   GB 12263   

Basic data

Standard ID: GB 12260-2017 (GB12260-2017)
Description (Translated English): Cardiopulmonary bypass systems -- Roller blood pump
Sector / Industry: National Standard
Classification of Chinese Standard: C45
Classification of International Standard: 11.040.40
Word Count Estimation: 10,117
Date of Issue: 2017-12-29
Date of Implementation: 2019-07-01
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China

GB 12260-2017: Cardiopulmonary bypass systems -- Roller blood pump

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Cardiopulmonary bypass systems - Roller blood pump ICS 11.040.40 C45 National Standards of People's Republic of China Replacing GB 12260-2005 Cardiopulmonary bypass system rolling blood pump Cardiopulmonary bypass systems-Rolerbloodpump 2017-12-29 Posted 2019-07-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China China National Standardization Administration released Directory Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 type, composition and basic parameters 1 5 Requirements 2 6 test methods 3 7 logo, packaging, transportation and storage 6

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). Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard is proposed and managed by the State Food and Drug Administration. This standard is drafted by the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Tu Rong, Fan Xiang, once pretty, Wang Peilian. This standard replaces the standards previously issued as follows. --- GB 12260-1990, GB 12260-2005. Cardiopulmonary bypass system rolling blood pump

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 article Pieces. 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) Environmental requirements and test methods for medical electrical appliances GB/T 14710-2009 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; ......

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