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YY/T 1529-2024ELISA analytical instruments (English PDF)

酶联免疫分析仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 29, 2024

Implementation date

October 15, 2025

Scope

YY/T 1529-2024 is the English-translated version of 酶联免疫分析仪.

YY/T 1529 is the product standard for the ELISA analyser, the instrument that automates the plate-based immunoassay still underpinning a large share of routine and infectious disease testing.

It sets the requirements for enzyme-linked immunosorbent assay instruments and the corresponding test methods.

The properties that decide whether an ELISA result is trustworthy sit in the instrument as much as in the reagent: photometric accuracy and linearity, well-to-well and plate-to-plate consistency, wash performance and incubation temperature control.

It is the instrument counterpart of YY/T 1183, the standard for the ELISA kits themselves, revised in the same period. For a manufacturer or an importer of ELISA readers and washers seeking Chinese registration, this is the standard the type testing is run against.

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Document preview — YY/T 1529-2024

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

This document was issued on 29 September 2024 by the National Medical Products Administration and takes effect on 15 October 2025.

It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.

1 Scope

YY/T 1529 is the product standard for the ELISA analyser, the instrument that automates the plate-based immunoassay still underpinning a large share of routine and infectious disease testing. It sets the requirements for enzyme-linked immunosorbent assay instruments and the corresponding test methods. The properties that decide whether an ELISA result is trustworthy sit in the instrument as much as in the reagent: photometric accuracy and linearity, well-to-well and plate-to-plate consistency, wash performance and incubation temperature control. It is the instrument counterpart of YY/T 1183, the standard for the ELISA kits themselves, revised in the same period. For a manufacturer or an importer of ELISA readers and washers seeking Chinese registration, this is the standard the type testing is run against.

Remaining clauses in the full document

2 Normative references
3 Terms and definitions

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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