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GB 3053-1993Sphygmomanometer (English PDF)

血压计和血压表

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Issued by

State Bureau of Technical Supervision

Level / Type

National · Mandatory

Issue date

October 16, 1993

Implementation date

June 1, 1994

Scope

GB 3053-1993 is the English-translated version of 血压计和血压表.

GB 3053-1993 specifies the product classification, technical requirements, test methods, inspection rules and marking, packaging, transport and storage of mercury-column and mechanical elastic-element (aneroid) sphygmomanometers used for measuring human blood pressure; it does not apply to electronic sphygmomanometers.

Instruments are of desk, stand or wall-mounted type with a measuring range of 0 to 40 kPa (0 to 300 mmHg) and dual kPa/mmHg scales; the permissible basic error is ±0.5 kPa (±3.75 mmHg), with requirements for zero position, rubber bags of 225 ± 4 mm by 120 ± 3 mm, cuffs, mercury quality and leak-tightness, pointer movement and 15 000 cycles of alternating pressure for aneroid instruments.

Test methods cover zero position, indication error against a reference instrument, air tightness at 38 kPa, cuff retention, mercury column sensitivity, mercury leakage, alternating pressure and a vibration or road transport test.

Lot-by-lot inspection follows GB 2828 with AQL values per nonconformity group and periodic inspection follows GB 2829 with RQL values; marking, inner and outer packaging, storage at up to 80% relative humidity and -5 to +35 °C, and an 18-month manufacturer's warranty are also specified.

It replaces GB 3053-82, GB 4727-84 and GB 8049-87 and was issued on 16 October 1993, in force since 1 June 1994. Classification: ICS 71.060.20, CCS C38. The document runs to 6 pages, delivered complete in English translation.

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Document preview — GB 3053-1993

National Standard of the People's Republic of China

ICS
71.060.20
Classification
C38
Replacing
GB 3053-1982, GB 4727-1984 and 1 other standard

Issued by: State Bureau of Technical Supervision

Contents

  • 1 Subject content and scope of application
  • 2 Referenced standards
  • 3 Product classification
  • 4 Technical requirements
  • 5 Test methods
  • 6 Inspection rules
  • 7 Marking, packaging, transport and storage
  • 8 Other provisions

3 Product classification

4 Technical requirements

5 Test methods

6 Inspection rules

7 Marking, packaging, transport and storage

8 Other provisions

Foreword

Approved by the State Bureau of Technical Supervision on 1993-10-16; implemented from 1994-06-01.

This standard replaces GB 3053-82, GB 4727-84 and GB 8049-87.

Additional notes:

This standard was proposed by the State Pharmaceutical Administration of China.

This standard is under the jurisdiction of the technical centralized unit for medical device standardization of the State Pharmaceutical Administration of China.

This standard was drafted by Shanghai Medical Equipment Factory.

Main drafter of this standard: Zhang Xuefen.

From the date of implementation of this standard, the professional standard ZB C38 001-87 Vertical sphygmomanometers, issued by the former State Pharmaceutical Administration of China, is abolished.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 6 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of GB 3053

EditionTitleRevisionStatus
GB 3053-1993Sphygmomanometercurrent editionCurrent
GB 4727-1984Aneroid sphygmomanometermerged into this editionSuperseded

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