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YY/T 1529-2017ELISA analytical instruments (English PDF)

酶联免疫分析仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 2, 2017

Implementation date

April 1, 2018

Scope

YY/T 1529-2017 is the English-translated version of 酶联免疫分析仪.

YY/T 1529-2017 is the Chinese standard "ELISA Analytical Instruments".

Its scope clause reads: This Standard defines the terms and definitions of ELISA analytical instruments (hereinafter referred to as the analytical instruments), and specifies the classification, requirements, test method, marking, labelling, operating manual, packaging, storage and transportation.

This Standard applies to the reading modules of ELISA analytical instruments and full-automatic ELISA analytical instruments. Its clauses include application scope; terms and definitions; classification; requirements; experimental method; marking, labelling and operating manual; packaging, storage and transportation.

It was issued by the China Food and Drug Administration on MAY 2, 2017 and took effect on APRIL 1, 2018.

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Document preview — YY/T 1529-2017

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword3
  • 1 Application Scope4
  • 2 Normative References4
  • 3 Terms and Definitions5
  • 4 Classification5
  • 5 Requirements6
  • 6 Experimental Method7
  • 7 Marking, Labelling and Operating Manual12
  • 8 Packaging, Storage and Transportation12
  • Substance for the ELISA Analytical Instruments13
  • Bibliography14

1 Application Scope

This Standard defines the terms and definitions of ELISA analytical instruments (hereinafter referred to as the analytical instruments), and specifies the classification, requirements, test method, marking, labelling, operating manual, packaging, storage and transportation.

This Standard applies to the reading modules of ELISA analytical instruments and full- automatic ELISA analytical instruments.

2 Normative References

The following referenced documents are indispensable for the application of this document. For dated references, only the edition dated applies to this document. For undated references, the latest edition of the referenced documents (including all amendments) applies to This Standard.

GB/T 191, Packaging - Pictorial Marking for Handling of Goods

GB 4793.1, Safety Requirements for Electrical Equipment for Measurement,

Control and Laboratory Use - Part 1: General Requirements

GB/T 14710, Environmental Requirement and Test Methods for Medical Electrical

Equipment

GB/T 18268.1, Electrical Equipment for Measurement, Control and Laboratory Use

- EMC Requirements - Part 1: General Requirements

GB/T 18268.26, Electrical Equipment for Measurement, Control and Laboratory

Use - EMC Requirements - Part 26: Particular Requirements - In Vitro Diagnostic (IVD) Medical Equipment

GB/T 29791.3, In Vitro Diagnostic Medical Devices - Information Supplied by the

Manufacturer (Labelling) - Part 3: In Vitro Diagnostic Instruments for Professional

Use

JJG 861-2007, Verification Regulation of ELISA Analytical Instruments

YY 0648, Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use

The stability of absorbance of the instruments shall not exceed ± 0.005.

5.2.6 Sensitivity

Use the sensitivity concentration standard substance of concentration 5 mg/l for the

ELISA analytical instruments; and the measured absorbance value of the instruments shall be not less than 0.01.

5.2.7 Difference of channels

Using the air as the reference, measure the absorbance difference between 8 channels;

and the required result shall not be greater than 0.02.

5.3 Electrical safety requirements

As specified in the applicable clauses of GB 4793.1 and YY 0648.

5.4 Environmental test requirements

As specified in the applicable clauses of GB/T 14710.

5.5 EMC requirements

As specified in the applicable clauses of GB/T 18268.1 and GB/T 18268.26.

5.6 Software functions

The ELISA analytical instruments shall, at least, have the following functions:

a) having the data display function;

b) being capable of setting up test items, test methods and test dates flexibly;

c) being capable of continuously storing the test items and results in succession;

d) being capable of displaying and printing the test items, test data and test time.

6 Experimental Method

6.1 Operating conditions

6.1.1 Power supply requirements: voltage 220 V ± 22 V (a.c.); frequency 50 Hz ± 1

Hz.

6.1.2 Environmental temperature: + 10°C ~ +40°C.

6.1.3 Relative humidity: 30% ~ 80%.

6.1.4 The following items shall be carried out after the instrument is started and stabilized for 30 min. When the following experiments are carried out on the instrument,

Annex A (Informative)

Preparation Method of Sensitivity Solution Standard Substance for the

ELISA Analytical Instruments

For the sensitivity solution standard substance for the ELISA analytical instruments, use pure substance of potassium dichromate and sulfuric acid 0.05 mol/l as the matrix to prepare the solution standard substance 5 mg/l.

A.1 Preparation of sulfuric acid solution 0.05 mol/l

Add 400 ml of distilled water into a 500 ml beaker; use a pipette to absorb 2.7 ml of concentrated sulfuric acid into the beaker; stir up before pouring into a 1 000 ml volumetric flask; add distilled water to dilute to the scale line; and shake up as standby.

A.2 Preparation of potassium dichromate solution standard substance of

chromium content 5 mg/l

A.2.1 Step 1

Weigh accurately 0.282 9 g of potassium dichromate on the analytical balance to place into a 100 ml beaker; use sulfuric acid solution 0.05 mol/l to dissolve before transferring to a 500 ml volumetric flask; use a small amount of sulfuric acid solution 0.05 mol/l to wash the beaker for several times; pour the washings into the volumetric flask; use sulfuric acid solution 0.05 mol/l to dilute to the scale line; and shake up as standby.

The concentration of the solution is 200 mg/l.

A.2.2 Step 2

Use a pipette to transfer 2.5 ml of potassium dichromate solution 200 mg/l into a 100 ml volumetric flask; use sulfuric acid solution 0.05 mol/l to dilute to the scale line; and shake up. Then, the concentration of the solution is 5 mg/l.

......
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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