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YY 91048-1999Silicone rubber pump tubes for artificial heart-lung machines (English PDF)

人工心肺机用硅橡胶泵管

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

January 8, 1990

Implementation date

July 1, 1991

Scope

YY 91048-1999 is the English-translated version of 人工心肺机用硅橡胶泵管.

YY 91048-1999 is the Chinese pharmaceutical industry standard covering silicone rubber pump tubes for artificial heart-lung machines. It was issued on 8 January 1990 and has been in force since 1 July 1991, replacing GB 12264-1990.

The document is under the responsibility of the National Medical Products Administration. This page is published from the official record of the 1999 edition. The figures, limits and tables the standard contains are those of the document itself, delivered in full with the English translation.

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Document preview — YY 91048-1999

National Standard of the People's Republic of China

Replacing
GB 12264-1990

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 91048-1999 was issued by National Medical Products Administration of the People's Republic of China on 8 January 1990 and has been in force since 1 July 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

YY 91048-1999 carries no ICS number and no Chinese Standard Classification code.

This catalogue holds 944 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 About this standard

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

English translation: about 15 pages

4 Related standards

Standards on related subjects:

YY/T 1680-2020 — Allogeneic grafts—In vivo evaluation of osteoinductive potential for materials containing demineralized bone

YY/T 1561-2017 — Tissue engineering medical device products - Residual alpha-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives

YY/T 1571-2017 — Tissue engineering medical device products—Sodium hyaluronate

YY/T 1274-2025 — Peritoneal dialysis equipment

YY/T 1925-2024 — Cardiovascular implants and endovascular devices - Neurovascular thrombectomy stent retrievers

5 Classification and status

Chinese Standard Classification (CCS): C 45

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.

Similar standards

Editions of YY 91048

EditionTitleRevisionStatus
YY 91048-1999Silicone rubber pump tubes for artificial heart-lung machinescurrent editionCurrent
GB 12264-1990Silicone rubber pump tubes for artificial heart-lung machinesprevious editionSuperseded

This page sells the current edition, YY 91048-1999. Earlier editions are listed for reference only.

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YY 91048-1999

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