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YY 0005-1990Single ring steel-plastic intrauterine devices (English PDF)

单圈式钢塑宫内节育器

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

October 16, 1990

Implementation date

April 1, 1991

Scope

YY 0005-1990 is the English-translated version of 单圈式钢塑宫内节育器.

YY 0005-1990 is a mandatory Chinese medical device standard for the single ring steel-plastic intrauterine device. It sets the product classification, the technical requirements, the test methods and the inspection rules, and the requirements for marking, packaging, transport and storage.

The device it covers is placed in the uterine cavity as a means of contraception for women. Its cited documents are GB 191, GB 2828, GB 4240 and GB 4342, and the Chinese classification C36 places the standard among contraceptive devices. Issued on 16 October 1990, it has applied since 1 April 1991.

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Document preview — YY 0005-1990

National Standard of the People's Republic of China

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

Contents

  • [Preview only]
  • 1 Scope
  • 2 Normative References
  • 2.1 Terms
  • 3 Terms and Definitions
  • 4 Overview
  • 4.1 General requirements
  • 5 Technical Requirements
  • 6 Calibration conditions
  • 6.1 Environmental conditions
  • 6.2 Measurement standards and other equipment
  • 7 Calibration items and calibration methods
  • 7.1 Calibration Items
  • 7.2 Calibration method
  • 8 Expression of calibration results
  • 9 Recalibration interval

1 Foreword

YY 0005-1990 was issued by National Medical Products Administration of the People's Republic of China on 16 October 1990 and has been in force since 1 April 1991.

The YY prefix, without a suffix, marks a mandatory standard: within its scope, compliance is required.

The document runs to 15 pages in English translation.

2 Scope Preview

This standard is a mandatory Chinese medical device standard for the single ring steel-plastic intrauterine device. It sets the product classification, the technical requirements, the test methods and the inspection rules, and the requirements for marking, packaging, transport and storage. The device it covers is placed in the uterine cavity as a means of contraception for women. Its cited documents are GB 191, GB 2828, GB 4240 and GB 4342, and the Chinese classification C36 places the standard among contraceptive devices.

YY 0005-1990 carries no ICS number and no Chinese Standard Classification code.

This catalogue holds 943 other YY standards.

Of the 199 YY standards that do carry an ICS number, 198 (99%) fall under ICS 11, in the field of health care technology.

3 Normative references

GB 191

GB 2828

GB 4240

GB 4342

4 About this standard

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

English translation: about 15 pages

5 Related standards

Standards on related subjects:

YY/T 1415-2016 — Skin stapler

YY/T 0979-2016 — Intra-uterine suction curettes for single use

YY/T 0079-2016 — Metallic clip

YY/T 0090-2014 — Uterine curette

YY 0006-2013 — Metal double-wing vagina dilator

6 Classification and status

Chinese Standard Classification (CCS): C 36

Prefix YY: mandatory standard.

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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

GB 2828 · GB 4240 · GB 4342

Similar standards

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YY 0005-1990

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