YY 1273-2016Roller pump for auxiliary blood purification (English PDF)
血液净化辅助用滚压泵
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
March 23, 2016
Implementation date
January 1, 2018
Scope
YY 1273-2016 is the English-translated version of 血液净化辅助用滚压泵.
YY 1273-2016 is the Chinese pharmaceutical industry standard for the roller pump used as an auxiliary device in blood purification, the pump that cannot be used on its own to purify blood.
It specifies the terms and definitions, the requirements, the test methods, the signs, the instruction manual and the rules for packaging, transport and storage, covering the flow rate and its accuracy, the occlusion of the rollers and the tubing they take, the alarms and the protection against reverse flow, the mechanical safety of the moving parts and the electrical safety. Issued on 23 March 2016, it applies from 1 January 2018.
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Document preview — YY 1273-2016
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 45
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions
- 4 Requirements
Foreword
The technical content of this standard is mandatory.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the terms and definitions, requirements, test methods, signs, and use of the blood purification auxiliary rolling pump (hereinafter referred to as rolling pumps) Brochures and packaging, transportation and storage.
This standard applies to the oil purification auxiliary roller pump defined in 3.1. The roller can not be used independently for blood purification. This standard does not apply to.
--- blood perfusion equipment; Blood cell separation equipment --- continuous blood purification equipment;
--- immune adsorption equipment;
--- hemodialysis device;
--- hemodiafiltration device;
--- centrifugal pump;
--- artificial heart-lung machine rolling blood pump.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191 packaging and storage icon Medical electrical equipment - Part 1. General requirements for safety GB 9706.1 General rules for the use of industrial products GB/T 9969 Glacier for blood purification GB/T 13074 Environmental requirements and test methods for medical appliances GB/T 14710-2009
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
3 Terms and definitions
The following definitions and definitions as defined in GB/T 13074 apply to this document.
3.1 Blood purification assist roller pump
In the blood purification treatment, with rolling to assist the blood circulation therapy of a power device.
4 Requirements
4.1 Normal working conditions
Shall meet the manufacturer's requirements or the following conditions.
a) Ambient temperature 5 °C ~ 40 °C;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
YY/T 0466.1-2009 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0466.1-2016 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
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YY 1273-2016
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