YY/T 1439.2-2016Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (English PDF)
医用气体压力调节器 第2部分：汇流排压力调节器和管道压力调节器
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1439.2-2016 is the English-translated version of 医用气体压力调节器 第2部分：汇流排压力调节器和管道压力调节器.
YY/T 1439.2-2016 is the Chinese standard "Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators".
Its scope clause reads: * This part of YY/T 1439 specifies the exchange rate of the cylinder which is expected to be connected with a cylinder with a maximum nominal filling pressure of 25000 kPa at 15 ° C The flow regulator (defined in 3.6) and the maximum inlet pressure of 3000 kPa, the piping pressure regulator used in the piping system (Defined in 3.4), the pressure regulator is intended for use in the following medical gases. ---oxygen; --- nitrous oxide (nitrous oxide); --- breathe air; ---carbon dioxide; --- oxygen/nitrous oxide (nitrous oxide) mixture; Driving air for surgical instruments; - Driving surgical instruments with nitrogen; Oxygen concentrator produces oxygen-enriched air (93% oxygen).
Regulator. This part of YY/T 1439 does not apply to pressure regulators used in vacuum piping systems. Note. The requirements for the pressure regulator used in the vacuum piping system are contained in YY 0636.3 [3]. Its clauses include normative reference documents; terms and definitions.
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Document preview — YY/T 1439.2-2016
National Standard of the People's Republic of China
- ICS
- 11.040.10
- Classification
- C 46
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- Introduction
- 1 Scope
- 2 normative reference document
- 3 Terms and definitions
- 4 symbol
- 5 General requirements
- 5.1 security
- 5.2 Optional structure
- 5.3 Materials
- 5.4 Design Requirements
- 5.5 Assembly requirements
- 6.1 Condition
- 6.2 Test method of busbar pressure regulator
- 6.3 Pipeline pressure regulator test method
- 6.4 Test methods for self-ignition temperature of sealing materials and lubricants
- 6.5 Identification and color identification Durability test method
- 7 mark, color identification and packaging
- 7.1 mark
- 7.2 Color identification
- 7.3 Packaging
- 8 Information provided by the manufacturer
- Appendix A (informative) Pressure Regulator Example
- Appendix B (informative) Basic principles
- Appendix C (informative) Differences in color and medical gas terms reported between regions and countries
1 Scope
1.1
* This part of YY/T 1439 specifies the exchange rate of the cylinder which is expected to be connected with a cylinder with a maximum nominal filling pressure of 25000 kPa at 15 ° C
The flow regulator (defined in 3.6) and the maximum inlet pressure of 3000 kPa, the piping pressure regulator used in the piping system (Defined in 3.4), the pressure regulator is intended for use in the following medical gases.
---oxygen;
--- nitrous oxide (nitrous oxide);
--- breathe air;
---carbon dioxide;
--- oxygen/nitrous oxide (nitrous oxide) mixture;
Driving air for surgical instruments;
- Driving surgical instruments with nitrogen;
Oxygen concentrator produces oxygen-enriched air (93% oxygen).
Regulator.
1.3
This part of YY/T 1439 does not apply to pressure regulators used in vacuum piping systems.
Note. The requirements for the pressure regulator used in the vacuum piping system are contained in YY 0636.3 [3].
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 article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
General pressure gauge GB/T 1226-2010
Technical specification for medical gas engineering GB 50751-2012
YY/T 0316-2008 Medical Device Risk Management for Medical Devices (ISO 14971..2007, IDT)
YY/T 0882-2013 Compatibility of anesthesia and breathing equipment with oxygen (ISO 15001..2003, IDT)
ISO 7396-1..2007 Medical gas piping systems - Part 1. Pipes for medical compressed gas and vacuum (Medicalgas pipelinesystems-Part 1. Pipelinesforcompressedmedicalgasesandvacuum)
EN 787-1..1996 Pressure gauges - Part 1. Bourdon tube pressure gauges Dimensions, metering, requirements and tests (Pressuregauges-
Part 1. Bourdontubepressuregauges-Dimensions, metrology, requirementsandtesting)
3 terms and definitions
The following terms and definitions apply to this document.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- YY/T 0316-2008Medical devices-Application of risk management to medical devices
- YY/T 0882-2013Anaesthetic and respiratory equipment—Compatibility with oxygen
ISO 7396-1 · EN 787-1
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Related Standards
YY/T 0316-2008 — Medical devices - Application of risk management to medical devices
YY/T 0882-2013 — Anaesthetic and respiratory equipment—Compatibility with oxygen
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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