GB 10035-2017 English PDF

US$358.00 · In stock
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GB 10035-2017: Air-bag type sequential external counter-pulsation device
Status: Valid

GB 10035: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 10035-2017	358	Add to Cart	1 days	Air-bag type sequential external counter-pulsation device	Valid
GB 10035-2006	919	Add to Cart	5 days	Air-bag type sequential external counter-pulsation device	Obsolete
GB 10035-1994	399	Add to Cart	3 days	The alr-bag type sequential external counter-pulsation device	Obsolete
GB 10035-1988	RFQ	ASK	3 days	The air-bag type sequential external counter-pulsation device	Obsolete

Similar standards

GB/T 39381.1   YY/T 1680   YY/T 1571   GB/T 20405.5   GB/T 20405.4   

Basic data

Standard ID: GB 10035-2017 (GB10035-2017)
Description (Translated English): Air-bag type sequential external counter-pulsation device
Sector / Industry: National Standard
Classification of Chinese Standard: C45
Classification of International Standard: 11.040.40
Word Count Estimation: 18,193
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 10035-2017: Air-bag type sequential external counter-pulsation device

---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.
Air-bag type sequential external counter-pulsation device ICS 11.040.40 C45 National Standards of People's Republic of China Replacing GB 10035-2006 Airbag EECP device 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 Categories and Structure 2 5 Requirements 2 6 test method 6 7 logo, instruction manual 12 8 packaging, transportation, storage 13

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 10035-2006 "balloon-type external pacing device." The main differences between this standard and GB 10035-2006 are. --- Deleted part of the electronic system terms and working hours (see the.2006 edition of 5.3.1 ~ 5.3.4,5.6); --- Remove the safety requirements, test methods and inspection rules (see.2006 edition of Appendix A); --- Increased part of the relevant requirements and test methods ECG (see 5.4); --- Increased normative references YY0784 (see Chapter 2); --- Increased part of the pulse oximeter, trigger waves, pressure stability, display content, heart rate protection, anti-Bo bed fixed, flame retardant Sex, load bearing capacity, airbag, pressure indication, electromagnetic compatibility, etc. (see 5.3, 5.5.1, 5.5.7, 5.6, 5.7.1, 5.8.3 ~ 5.8.6, 5.9, 5.12.2); --- The terms of Chapter 3 of this standard in the text with bold on the 5th. 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. Chongqing Pu Shikang Technology Development Co., Ltd., the State Food and Drug Administration Guangzhou medical equipment quality Supervision and Inspection Center, Guangzhou Yi Code Medical Devices Co., Ltd., China Professional Committee of EECP. The main drafters of this standard. Wang Zhihui, Xu Yuchun, Wei Fang, Xu Zhaohua, Zhu Pengzhi, Huang Xiulian, Liang Xiaoming, Wu Guifu. This standard replaces the standards previously issued as follows. --- GB 10035-1988, GB 10035-1994, GB 10035-2006. Airbag EECP device

1 Scope

This standard specifies the terms and definitions of balloon-type external pacing device, classification and structure, requirements, test methods, signs, instructions for use, Packaging, transportation, storage. This standard applies to the balloon-type external pacing device (hereinafter referred to as counter-pumping device). The counterpulsation device is currently being used by patients in medical units Ischemic disease treatment and rehabilitation.

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..1998, IDT) GB/T 9969 Industrial Products Manual General GB/T 14710 medical appliances environmental requirements and test methods 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) YY0505 Medical electrical equipment Part 1-2. General requirements for safety Collateral standards. EMC requirements and tests (YY0505-2012, IEC 60601-1-2..2004, IDT) YY0784 Medical electrical equipment Medical pulse oximeter equipment basic safety and performance requirements (YY0784-2010, ISO 9919..2005, IDT)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Controlling the balloon to exert on the body during diastole by a physiological signal synchronized with the heart (including but not limited to electrocardiogram, etc.) Appropriate pressure, the human arterial pressure increase during diastole, and to cancel the pressure before systole, reducing systolic blood pressure of the auxiliary circulation device. 3.2 Sequential From distal to proximal to the heart, air pressure applied sequentially. 3.3 Enhanced In addition to the body balloon, but also increased the buttocks balloon. 3.4 Working pressure operationpressure Peak pressure in the airbag during normal operation. ......

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