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YY/T 0657-2017Medical centrifuge (English PDF)

医用离心机

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 28, 2017

Implementation date

April 1, 2018

Scope

YY/T 0657-2017 is the English-translated version of 医用离心机.

YY/T 0657-2017 is the Chinese pharmaceutical industry standard for the medical centrifuge.

It gives the terms and definitions, the classification of the products, the requirements, the test methods, the marking and instructions for use and the rules for packaging, transport and storage, covering the accuracy of the speed and of the relative centrifugal force, the timer, the temperature control where the machine is refrigerated, the balance and vibration, the rotor and its retention, the lid interlock and the braking, the noise and the electrical safety. Issued on 28 March 2017, it has applied since 1 April 2018.

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Document preview — YY/T 0657-2017

National Standard of the People's Republic of China

Replacing: YY/T 0657-2008

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

Foreword3
1 Scope4
2 Normative references4
3 Terms and definitions4
4 Product classifications5
5 Requirements5
6 Test methods8
7 Labels, markings and instructions for use11
8 Packaging, transportation and storage12

Foreword

This Standard is drafted in accordance with the rules given GB/T 1.1-2009.

This Standard is the revision of YY/T 0657-2008; the main technical content changes are as follows.

- ADD the requirements for electromagnetic compatibility;

- ADD the requirements for labels, labelling and information to be supplied;

- ADD the terms and definitions;

- MODIFY the acceleration and deceleration time of centrifuge.

1 Scope

This Standard specifies the terms and definitions, product classification, requirements, test methods, marking and instructions for use, packaging, transportation and storage of medical centrifuges (hereinafter referred to as centrifuges).

This Standard applies to the design, production and testing of centrifuges.

This Standard does not apply to super speed centrifuges (with the speed greater than 30 000 r/min).

2 Normative references

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

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 4793.7 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 7: Particular requirements for laboratory centrifuges

GB/T 14710 The environmental requirement and test methods for medical electrical equipment

3 Terms and definitions

For the purpose of this document, the following terms and definitions apply.

3.1 Low speed centrifuge

Centrifuge with the rated maximum speed less than 10 000 r/min. [GB/T 30099-2013, definition 3.4]

3.2 High speed centrifuge

Centrifuge with the rated maximum speed between >= 10 000 r/min and <= 30 000 r/min. [GB/T 30099-2013, definition 3.5]

3.4 Large capacity centrifuge

Centrifuge with the maximum rotor capacity greater than 3 000 mL.

4 Product classifications

According to the type, centrifuges are divided into desktop type and floor type.

According to the speed, centrifuges are divided into low speed, high speed and super speed.

5 Requirements

5.1 Working conditions

Working conditions of centrifuges.

5.2 Relative speed deviation

At the rated voltage, the maximum load and the corresponding maximum speed, the relative speed deviation of centrifuges shall comply with the provisions of Table 1.

5.3 Speed stability accuracy

At the rated voltage, the maximum speed and the corresponding maximum load, the speed stability accuracy shall be within ± 1 %.

5.4 Complete machine noise

At the maximum speed and the corresponding maximum load, the noise of centrifuges shall not exceed 70 dB (A).

5.6 Temperature rise of sample solution

For non-refrigerated centrifuges at the maximum speed and the corresponding maximum load, after operating for a specified period of time, the temperature rise of the sample solution in the centrifuge tube (bottle) shall meet the requirements of Table 2.

5.8 Acceleration and deceleration time of centrifuges

The acceleration and deceleration time of centrifuges shall meet the requirements of

5.12 Environmental test

The environmental test of centrifuges shall be carried out according to the provisions of GB/T 14710.

6 Test methods

6.1 Appearance

Visual observation, which shall comply with the provisions of 5.11.

6.3 Speed stability accuracy

ADJUST the centrifuge installed with a fully loaded rotor TO the maximum speed. After the operation is smooth, USE a speedometer of one-thousandth accuracy to measure the speed of the centrifuge every 5 min; MEASURE five times; CALCULATE the average value; CALCULATE the speed stability accuracy according to equation (2), take whichever is the maximum value or the minimum value, which shall comply with the provisions of 5.3.

6.5 Amplitude

USE a vibration meter or dial indicator to measure in the middle of the centrifuge enclosure, take whichever is the maximum value, which shall comply with the provisions of 5.5.

6.6 Temperature rise of sample solution

TAKE the sample solution with the same temperature as ambient temperature into a centrifuge tube (bottle); MEASURE with a point thermometer with the accuracy of 1 °C.

After operating for the operating time as specified in 5.4.3, the difference between the measured sample solution temperature and the ambient temperature shall comply with the provisions of 5.6.

6.9 Refrigeration effect of refrigerated centrifuge

6.9.1 Refrigeration time

6.9.1.1 INSTALL the centrifuge with the maximum rotor corresponding to the maximum speed; SET the maximum speed;

6.9.2 Temperature fluctuation deviation

6.9.2.1 ADJUST the centrifuge installed with the maximum rotor corresponding to the maximum speed TO the maximum speed;

6.9.2.2 SET the temperature of the centrifuge chamber or the sample TO 5 °C, 10 °C, 15 °C respectively. Under each setting condition, when the temperature display or the indicator reading reaches the set value, start reading after it is stable. READ the display temperature every 5 min; READ five times per gear; CALCULATE the average value of 5 temperatures of each gear; MINUS the set value. It shall meet the requirements of 5.9.3.

6.11 Environmental test

Test according to the provisions of GB/T 14710.

7 Labels, markings and instructions for use

7.1 General

Characters of instructions, labels and packaging markings shall be in Chinese, other languages may be attached. The use of Chinese shall comply with the national language specification. Characters, symbols, graphics, tables, pictures, etc. of instructions, labels and packaging markings shall be accurate, clear and standardized.

Symbols used in instructions and markings shall meet the requirements of YY/T 0466.1.

7.2 Instrument markings

The centrifuge shall have the following markings.

7.3 Packaging box markings

The packaging box shall have the following markings.

7.4 Instructions for use

The instructions for use shall meet the relevant requirements of national standards or industry standards. Generally, it shall include the following.

8 Packaging, transportation and storage

8.1 Packaging

8.1.1 Each centrifuge shall have outer packaging, which shall be moisture-proof and shock-proof.

8.1.2 The attached documents shall include at least.

8.2 Transportation

Centrifuges, at the packaging state, shall be transported according to the requirements of the order contract. During the transportation, they shall be protected against severe shocks, rain and exposure.

8.3 Storage

Fully packaged centrifuges shall be stored in well-ventilated rooms with relative humidity less than 80 %, and without corrosive gases.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

Referenced standards

Normative references

Cited by

Editions of YY/T 0657

Edition	Title	Revision	Status
YY/T 0657-2017	Medical centrifuge	current edition	Current
YY/T 0657-2008	Medical centrifuge	previous edition	Superseded

This page sells the current edition, YY/T 0657-2017. Earlier editions are listed for reference only.

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