Valid

YY/T 1304.1-2015Detection system of time-resolved fluoroimmunoassay - Part 1: Semi-auto time-resolved fluoroimmunoassay analyser (English PDF)

时间分辨荧光免疫检测系统第1部分：半自动时间分辨荧光免疫分析仪

Preview PDF

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 1304.1-2015 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 2, 2015

Implementation date

January 1, 2016

Scope

YY/T 1304.1-2015 is the English-translated version of 时间分辨荧光免疫检测系统第1部分：半自动时间分辨荧光免疫分析仪.

YY/T 1304.1-2015 is the Chinese pharmaceutical industry standard for the semi-automatic time-resolved fluoroimmunoassay analyser.

It is the first part of the YY/T 1304 series and specifies the terms and definitions, the requirements, the test methods, the marking, the labelling, the instructions for use and the rules for packaging, transport and storage, covering the detection limit and the linearity of the fluorescence measurement, the accuracy and repeatability, the cross-talk between wells, the stability of the source and the electrical safety. Issued on 2 March 2015, it has applied since 1 January 2016.

Found what you need?

Document preview — YY/T 1304.1-2015

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

Foreword
1 Scope
2 Normative references
3 Terms and Definitions
4 Requirements

Foreword

YY/T 1304 "time-resolved fluorescence immunoassay system" intended to publish in parts, currently plans to release the following components.

--- Part 1. semi-automatic time-resolved fluorescence immunoassay analyzer;

--- Part 2. Time-resolved fluorescence immunoassay quantitative assay reagent (kit);

--- Part 3. Automatic time-resolved fluorescence immunoassay analyzer. This section YY/T 1304 Part 1. This section drafted in accordance with GB/T 1.1-2009 given rules.

1 Scope

YY/T 1304 This section provides a semi-automatic time-resolved fluorescence immunoassay analyzer (hereinafter referred to as the analyzer) terms and definitions, to Sum test methods, marking, labeling and instructions for use, packaging, transport and storage. This section applies to a single mark time-resolved fluorescence immunoassay.

This section does not apply to more than double labeling and marking time-resolved fluorescence immunoassay.

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 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

GB/T 18268.1 measurement, control and laboratory use EMC requirements for electrical equipment Part 1. General requirements

GB/T 18268.26 measurement, control and laboratory use EMC requirements for electrical equipment Part 26. Particular requirements for body External diagnostic (IVD) medical equipment

YY 0648 measurement, control and laboratory safety requirements for electrical equipment - Part 2-101. In vitro diagnostic (IVD) medical equipment Special requirements

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Time-resolved fluorescence immunoassay

The time-resolved fluorescence immunoassay and combine rare earth ions and their chelates as tracers, labeled antigen or antibody test Was subjected to a series of immune reactions, the final product was measured to obtain the fluorescence intensity of the analyte concentration analysis.

3.2 Semi-automatic time-resolved fluorescence immunoassay analyzer

Manual or otherwise finished adding the sample, add reagents, mixing, washing, incubation and other parts or all of the work, and then automatically by the instrument Testing, calculations, report the result of time-resolved fluorescence immunoassay analyzer.

4 Requirements

4.1 Appearance

Appearance should meet the following requirements. […]

......
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

Similar standards

YY/T 1304.2-2015|YY/T 1533-2017|GB/T 28062-2025|GB/T 23902-2021|GB/T 40192-2021|GB/T 40254-2021

How to Download YY/T 1304.1-2015

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.