YY/T 1173-2010Polymerase chain reaction analyzer (English PDF)
聚合酶链反应分析仪
This is a limited preview
Buy now to download the full PDF (15 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1173-2010 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 27, 2010
Implementation date
June 1, 2012
Scope
YY/T 1173-2010 is the English-translated version of 聚合酶链反应分析仪.
YY/T 1173-2010 is the Chinese pharmaceutical industry standard for the polymerase chain reaction analyzer.
It specifies the terms and definitions, the classification and nomenclature, the requirements, the test methods, the signs and the instructions and the rules for packaging, transport and storage, covering the accuracy and uniformity of the block temperature, the ramp rate and the overshoot, the lid and the optical channels where the instrument reads fluorescence, the cross-contamination and the electrical safety. Issued on 27 December 2010, it applies from 1 June 2012.
Found what you need?
Document preview — YY/T 1173-2010
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard is to evaluate the polymerase chain reaction analyzer product quality basis.
1 Scope
This standard specifies the polymerase chain reaction analyzer (hereinafter referred to as PCR instrument) terms and definitions, classifications and nomenclature, requirements, test side Law, signs and instructions, packaging, transportation and storage and so on.
This standard applies to the sample nucleic acid amplification, detection, analysis of PCR instrument.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment - Part 1. General requirements
GB/T 14710 medical electrical environmental requirements and test methods Symbols - Part 1 YY/T 0466.1-2009 medical equipment used with medical device labels, labeling and information. General Claim
YY 0648-2008 measurement, control and laboratory safety requirements for electrical equipment - Part 2-101. In vitro diagnostic (IVD) Medical With special equipment requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Polymerase chain reaction PCR or
polymerase chain reaction is a specific DNA or RNA fragments in vitro method of rapid amplification, the Denaturation - annealing - extension of three basic reaction steps constitution.
3.2 Polymerase chain reaction analyzer
Based on PCR (polymerase chain reaction) technology principle, simulate DNA or RNA replication in a template, primers, and so the presence of a polymerase
Under the conditions, the specific amplification of known sequences, its detection and analysis of equipment.
3.3 The maximum heating rate
The heating process module unit time of maximum temperature rise in degrees.
3.4 The average heating rate
Within the heating process module per unit time of rising average temperatures in degrees.
3.5 The maximum cooling rate
Cooling process module unit time decrease the maximum degree of temperature.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 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
- YY 0648-2008Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Similar standards
How to Download YY/T 1173-2010
- 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 191-2025 — Graphical symbols marking for handling and storage of packages
Secure payment via Stripe
Payments accepted
YY/T 1173-2010
$195.00