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GB 12263-2017: Cardiopulmonary bypass systems -- Water heating/cooling system
Status: Valid GB 12263: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB 12263-2017 | English | 198 |
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1 days [Need to translate]
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Cardiopulmonary bypass systems -- Water heating/cooling system
| Valid |
GB 12263-2017
|
| GB 12263-2005 | English | 319 |
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3 days [Need to translate]
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Artificial heart-lung machine -- Water heating/cooling system
| Obsolete |
GB 12263-2005
|
| GB 12263-1990 | English | 199 |
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2 days [Need to translate]
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Artificial heart-lung machine--Water heating/cooling system
| Obsolete |
GB 12263-1990
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PDF similar to GB 12263-2017
Basic data | Standard ID | GB 12263-2017 (GB12263-2017) | | Description (Translated English) | Cardiopulmonary bypass systems -- Water heating/cooling system | | Sector / Industry | National Standard | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,138 | | Date of Issue | 2017-12-29 | | Date of Implementation | 2019-07-01 | | Older Standard (superseded by this standard) | GB 12263-2005 | | Regulation (derived from) | National Standards Bulletin 2017 No. 32 | | Issuing agency(ies) | General Administration of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 12263-2017: Cardiopulmonary bypass systems -- Water heating/cooling system---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 - Water heating/cooling system
ICS 11.040.40
C45
National Standards of People's Republic of China
Replacing GB 12263-2005
Cardiopulmonary bypass system heat exchange water tank
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
Foreword Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Requirements 1
5 test methods 3
6 logo, packaging, transportation, storage 5
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).
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 was drafted by the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Wu Shaohai, Fan Xiang, Wang Peilian, Feng Jie Ting.
This standard replaces the standards previously issued as.
--- GB 12263-1983, GB 12263-1990, GB 12263-2005.
Cardiopulmonary bypass system heat exchange water tank
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 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/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
4.1 normal working conditions
4.1.1 Unless otherwise specified by the manufacturer in the accompanying documents, the ambient conditions shall meet the following requirements.
--- Ambient temperature range. 5 ℃ ~ 40 ℃.
--- Relative humidity range. ≤ 80%.
--- Atmospheric pressure range. 50kPa ~ 106kPa.
4.1.2 Power .ac220V ± 22V, 50Hz ± 1Hz.
4.2 Appearance and structure
4.2.1 tank shape should be correct; the outer surface should be clean, the coating should be smooth, uniform, without obvious sharp edges, scratches; parts of the coating
No rusting or spalling is allowed.
4.2.2 water tank at the inlet, outlet should be marked, the surface of the text, symbols and signs should be clear and accurate.
4.2.3 tank control and adjustment mechanism should be flexible and reliable, fasteners should be no loose.
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