YY 0670-2008 English PDF

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YY 0670-2008: Non-invasive automated sphygmomanometer

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0670-2008	1699	Add to Cart	7 days	Non-invasive automated sphygmomanometer

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Basic data

Standard ID: YY 0670-2008 (YY0670-2008)
Description (Translated English): Non-invasive automated sphygmomanometer
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.30
Word Count Estimation: 53,566
Date of Issue: 2008-10-17
Date of Implementation: 2010-06-01
Quoted Standard: GB 9706.1-2007; GB/T 14710-1993; YY 0505-2005; YY 0667-2008
Adopted Standard: ANSI/AAMI SP-10-2002, NEQ
Regulation (derived from): SFDA [2008] No. 605
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the use of blocking all indirect cuff on human arterial blood pressure measurement automated, electronic sphygmomanometer artery safety and efficacy requirements. 1. 1 standard includes equipment. This standard applies to the use of oscillometric method or other similar methods to complete non-invasive blood pressure measurement electronic device or other devices with this feature. Including all through the cuff inflated, deflated, and the help of the resulting vibration, flow, sound to measure, display and record blood pressure instruments. This standard specifies all from newborns to adults of all ages, blood pressure measuring devices. This standard also applies to ambulatory blood pressure monitoring. Patients may carry such equipment worn or carried, or living in the course of daily activities repeated measurement of blood pressure and heart rate, and save the results obtained. 1. 2 standard does not include equipment. This standard does not apply to direct, invasive arterial blood pressure measurement device. This standard does not apply through the fingers, chest impedance method for measuring blood pressure automatic blood pressure monitor.

YY 0670-2008: Non-invasive automated sphygmomanometer

---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.
Non-invasive automated sphygmomanometer ICS 11.040.30 C30 People's Republic of China pharmaceutical industry standards Non-invasive blood pressure measurements automatically Posted 2008-10-17 2010-06-01 implementation State Food and Drug Administration issued

Table of Contents

Introduction Ⅲ 1 Scope 1 1.1 Standard equipment included 1 1.2 This standard does not include equipment 1 2 Normative references 1 3 Terms and definitions Requirement 3 4 3 4.1 Operating Conditions 4.2 Marking Requirements 3 4.3 life 5 5 4.4 Safety Requirements 4.5 Performance Requirements 5 4.6 Requirements pneumatic source and a pressure control valve 6 4.7 6 airbags and cuff requirements 4.8 System Leaks 7 4.9 Environmental Requirements 7 4.10 Electrical safety 7 4.11 Electromagnetic compatibility 7 5 Test 7 5.1 Test conditions 8 5.2 marks 8 5.3 life 8 8 5.4 Safety Requirements 5.5 Performance Requirements 8 5.6 Requirements pneumatic source and a pressure control valve 8 5.7 balloon and cuff claim 9 10 5.8 system leak 10 5.9 Environmental Testing 5.10 Electrical safety 10 Electromagnetic Compatibility 10 5.11 The basic principles of Appendix A (informative) This standard 11 Annex B (informative) Comparison with artificial auscultation to confirm the effectiveness of the system 22 Annex C (informative) and IBP to determine the effectiveness of the entire system 26 Annex D (informative) data analysis and reporting 29 Assess matters requiring special consideration Annex E (informative) ambulatory blood pressure monitoring system 36 Annex F (informative) statistical considerations 40 Annex G (informative) describes the clinical approach 43 References 48

Foreword

This standard is a reference to American National Standard ANSI/AAMISP-10. Non-invasive blood Electronics 2002 "manual, automatic or electronic sphygmomanometer" in Safety and performance requirements for pressure gauge portion prepared noninvasive electronic sphygmomanometer standards. This standard appendix A ~ Appendix G is informative appendix. This standard was proposed by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee. This standard by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee. This standard was drafted. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shanghai Medical Device detection, Kinmen and Matsu Medical Devices (Wuxi) Co., Ltd. The main drafters of this standard. Ye Jilun Yu and Dai Xiaohua, east, Wang. Non-invasive blood pressure measurements automatically

1 Scope

This standard specifies the use of all human blocking cuff indirect arterial blood pressure measurement automatic, electronic security arterial blood pressure It requires full and effectiveness. 1.1 Standard equipment includes This standard applies to the use of oscillometric or other similar methods to complete the non-invasive blood pressure measurement or electronic sphygmomanometer having this feature other devices. Including all through cuff inflation, deflation, and by means of vibration generated by the flow of sound to measure, display and record blood pressure instrument. This standard covers all blood pressure measuring apparatus from newborns to adults of all ages. This standard also applies to ambulatory blood pressure monitoring. Such patients may carry equipment worn or carried, or activities of daily living may be in the process Repeated measurement of blood pressure and heart rate, and save the results obtained. Note. Appendix A contains the basic principles concerning the interpretation of the requirements of the standard and its provisions. 1.2 This standard does not include equipment This standard does not apply to direct, invasive arterial blood pressure measurement devices. This standard does not apply to the measurement of blood pressure by finger, thoracic impedance method for automated blood pressure monitor.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests (IEC 60601-1-2.2001, IDT) YY 0667-2008 Medical electrical equipment - Part 2-30. automatic cycling non-invasive blood pressure safety and essential performance special monitoring equipment With requirements (IEC 60601-2-30.1999, IDT)

3 Terms and Definitions

The following terms and definitions apply to this standard. 3.1 People older than 12 years of age. 3.2 Early sound auscultation auscultation between the late first phase and the second phase appears momentarily disappear. Note. In some of the object, especially in patients with hypertension who, in the case of very high cuff pressure arm artery auscultation, auscultation sound disappears when the pressure is reduced. When the pressure is reduced to a certain extent, the auscultation sound reappears. This often causes a low systolic blood pressure measurements, it may also cause diastolic Measuring high values. ......

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