YY 0670-2008Non-invasive automated sphygmomanometer (English PDF)
无创自动测量血压计
This is a limited preview
Buy now to download the full PDF (48 pages)
Need quotation for your management?
Get a formal quotation for YY 0670-2008 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 17, 2008
Implementation date
June 1, 2010
Scope
YY 0670-2008 is the English-translated version of 无创自动测量血压计.
YY 0670-2008 is the Chinese pharmaceutical industry standard for the non-invasive automated sphygmomanometer, the electronic device that measures arterial blood pressure indirectly with an occluding cuff.
It sets the safety and performance requirements for such equipment and the tests that show them, covering the accuracy of the pressure indication and of the determined systolic and diastolic values, the cuff and its sizes, the inflation and deflation and the limits on them, the leakage of the pneumatic system, the display and the markings, and the electrical safety. Issued on 17 October 2008, it has applied since 1 June 2010.
Found what you need?
Document preview — YY 0670-2008
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 30
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Introduction
- 1 Scope
- 1.1 Standard equipment included
- 1.2 This standard does not include equipment
- 2 Normative references
- 3 Terms and definitions Requirement
- 3
- 4.1 Operating Conditions
- 4.2 Marking Requirements
- 4.3 life
- 5
- 4.4 Safety Requirements
- 4.5 Performance Requirements
- 4.6 Requirements pneumatic source and a pressure control valve
- 4.76 airbags and cuff requirements
- 4.8 System Leaks
- 4.9 Environmental Requirements
- 4.10 Electrical safety
- 4.11 Electromagnetic compatibility
- 5 Test
- 5.1 Test conditions
- 5.2 marks
- 5.3 life
- 8
- 5.4 Safety Requirements
- 5.5 Performance Requirements
- 5.6 Requirements pneumatic source and a pressure control valve
- 5.7 balloon and cuff claim
- 5.8 system leak
- 10
- 5.9 Environmental Testing
- 5.10 Electrical safety
- Annex B (informative) Comparison with artificial auscultation to confirm the effectiveness of the system
- Annex C (informative) and IBP to determine the effectiveness of the entire system
- Annex D (informative) data analysis and reporting Assess matters requiring special consideration Annex E (informative) ambulatory blood pressure monitoring system
- Annex F (informative) statistical considerations
- Annex G (informative) describes the clinical approach
- References
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.
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.
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.2 Auscultatory gap
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 48 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14710-1993The environmental requirement and test methods for medical electrical equipment
- YY 0505-2005Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- YY 0667-2008Medical electrical equipment - Part 2-30: Particular requirements for the safety including essential performance of automatic cycling non-invasive blood pressure monitoring equipment
Similar standards
How to Download YY 0670-2008
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
YY 0505-2005 — Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
YY 0667-2008 — Medical electrical equipment - Part 2-30: Particular requirements for the safety including essential performance of automatic cycling non-invasive blood pressure monitoring equipment
YY 0017-2026 — Implants for osteosynthesis - Metallic bone plates
Secure payment via Stripe
Payments accepted
YY 0670-2008
$650.00