YY/T 1784-2021Blood gas analyzer (English PDF)
血气分析仪
This is a limited preview
Buy now to download the full PDF (19 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1784-2021 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 6, 2021
Implementation date
May 1, 2023
Scope
YY/T 1784-2021 is the English-translated version of 血气分析仪.
YY/T 1784-2021 is the Chinese pharmaceutical industry standard for the blood gas analyser that uses ion-selective and amperometric electrodes to measure pH, carbon dioxide partial pressure and oxygen partial pressure in blood and other body fluids.
It sets the basic parameters, the requirements and the test methods, and the marks, labels, instructions for use, packaging, transport and storage, covering the measuring ranges, the accuracy and repeatability against control materials, the carry-over between samples, the response and the stability of the calibration, and the alarms and quality control functions of the instrument. Issued on 6 December 2021, it has applied since 1 May 2023.
Found what you need?
Document preview — YY/T 1784-2021
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Requirements
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the basic parameters, requirements, test methods, signs, labels, instructions for use and packaging, transportation and storage of blood gas analyzers.
This standard applies to the use of selective electrodes as sensors, through electrochemical technology, blood samples of human blood or other body fluid samples.
A blood gas analyzer for the detection of pH, partial pressure of carbon dioxide (pCO2), and partial pressure of oxygen (pO2).
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1. General Requirements
GB 4793.9 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 9. Laboratory Analysis and Other Purposes Automatic and special requirements for semi-automatic equipment
GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Equipment
GB/T 18268.1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1. General Requirements
GB/T 18268.26 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 26. Special Requirements In vitro diagnostic (IVD) medical devices
GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 3. In vitro diagnostic instruments for professional use
YY 0648 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101. In Vitro Diagnostic (IVD) Medical Equipment specific requirements
3 Requirements
3.1 Performance Requirements
3.1.1 Accuracy
The accuracy of the instrument should meet the accuracy requirements in Table 1.
3.1.2 Precision
The precision of the instrument should meet the precision requirements in Table 1.
3.1.3 Linear
The linearity of the instrument should meet the linearity requirements in Table 1.
3.1.4 Stability
Instrument stability should meet the stability requirements in Table 1.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 4793.1Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- GB/T 18268.1Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
- GB/T 18268.26Electrical equipment for measurement, control and laboratory use -- EMC requirements -- Part 26: Particular requirements -- In vitro diagnostic (IVD) medical equipment
- GB/T 29791.3In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
GB 4793.9
Similar standards
How to Download YY/T 1784-2021
- 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
GB 4793.1-2007 — Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 18268.1-2025 — Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
Secure payment via Stripe
Payments accepted
YY/T 1784-2021
$150.00