YY/T 1078-2008Direct impedance blood flow recorder (English PDF)
直接式阻抗血流图仪
This is a limited preview
Buy now to download the full PDF (12 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1078-2008 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
April 25, 2008
Implementation date
June 1, 2009
Scope
YY/T 1078-2008 is the English-translated version of 直接式阻抗血流图仪.
YY/T 1078-2008 is the Chinese standard "Direct impedance blood flow recorder". Its scope clause reads: This standard specifies the basic parameters of the instrument, technical requirements, test methods, inspection rules and signs, packaging, transportation and storage requirements.
The instrument is mainly used for brain, limbs, internal organs and other flow imaging examination, diagnosis for use of clinical or physiological research. This standard applies to direct blood flow impedance analyzer (hereinafter referred to as the instrument). Its clauses include basic parameters.
Found what you need?
Document preview — YY/T 1078-2008
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C39
- Replacing
- YY 91078-1999
Issued by: National Medical Products Administration
Contents
- Introduction
- 1 Scope
- 2 Normative references
- 3 basic parameters
- 4 technical requirements
- 5 Test Method
- 6 7 inspection rules
- 7 signs, packaging, transportation and storage
1 Scope
This standard specifies the basic parameters of the instrument, technical requirements, test methods, inspection rules and signs, packaging, transportation and storage requirements.
The instrument is mainly used for brain, limbs, internal organs and other flow imaging examination, diagnosis for use of clinical or physiological research.
This standard applies to direct blood flow impedance analyzer (hereinafter referred to as the instrument).
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/T 191-2008 Packaging - Pictorial signs
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)
3 basic parameters
3.1 Warm-up time
2min.
3.2 Continuous working time
>=6h.
3.3 tracings recorded the most significant
>= ± 20mm.
4. Technical Requirements
4.1 Instrument Operating Conditions
Ambient temperature. 5 °C ~ 40 °C;
Relative humidity. <=80%;
Atmospheric pressure. 860hPa ~ 1060hPa;
Power supply. AC 220V ± 22V, 50Hz ± 1Hz;
4.2 Input impedance
Instrument input impedance is not less than 40kohm.
4.3 base impedance Z0
4.3.1 Z0 measuring range
5ohm ~ 100ohm.
4.3.2
Z0 measurement error of ± 4%.
4.5 sensitivity
4.5.1 Maximum sensitivity
4.5.1.1 deltaZ file
>=20mm/0.1ohm;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 12 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191-2008Graphical symbols marking for handling and storage of packages
- 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
IEC 60601
Editions of YY/T 1078
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 1078-2008 | Direct impedance blood flow recorder | current edition | Current |
| YY 91078-1999 | Direct impedance blood flow recorder | previous edition | In force until 2009-06-01 |
This page sells the current edition, YY/T 1078-2008. Earlier editions are listed for reference only.
How to Download YY/T 1078-2008
- 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/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
Secure payment via Stripe
Payments accepted
YY/T 1078-2008
$135.00