YY 1412-2026Cardiopulmonary bypass systems. Centrifugal pump (English PDF)
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Issued by
State Food and Drug Administration
Level / Type
Industry · Mandatory
Issue date
March 23, 2016
Implementation date
January 1, 2018
Scope
YY 1412-2026 (Cardiopulmonary bypass systems. Centrifugal pump) is available as an English-translated PDF.
YY 1412-2026 is the Chinese standard "Cardiopulmonary bypass systems. Centrifugal pump". This standard specifies the terms and definitions, classification, composition, parameters, requirements, test methods, marking, instructions for use, packaging, transport and storage of centrifugal pumps for cardiopulmonary bypass systems.
This standard applies to cardiopulmonary bypass centrifugal pump (hereinafter referred to as centrifugal system).
The centrifugal pump for medical units for operation and rescue, for cardiopulmonary bypass and extracorporeal membrane oxygenation in the blood perfusion or local perfusion, can be used independently and/or supporting the use of artificial heart-lung machine.
This standard does not apply to: - Roller pumps; - Out-of-cycle piping; - Oxygenators; - Gas line filters; - Suction pumps; - Centrifugal pump heads. It was issued by State Food and Drug Administration. Issued on 2016-03-23, in force from 2018-01-01. It cites 6 other standards.
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Document preview — YY 1412-2026
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C45
Issued by: State Food and Drug Administration
Contents
- Document data
- Standards quoted by this standard
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document.
GB/T 191
GB 9706.1
GB/T 14710-2009
GB/T 9969
YY/T 0466.1
YY/T 1145
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 8 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14710-2009The environmental requirement and test methods for medical electrical equipment
- GB/T 9969General principles for preparation of instructions for use of industrial products
- YY/T 0466.1Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- YY/T 1145Terms of cardiopulmonary bypass systems
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.103-2020 — Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
GB 9706.12-1997 — Medical electrical equipment Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
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YY 1412-2026
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