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Pressure regulators for use with medical gases. Part 2-Manifold and line pressure regulators
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Basic data Standard ID | YY/T 1439.2-2016 (YY/T1439.2-2016) | Description (Translated English) | Pressure regulators for use with medical gases. Part 2-Manifold and line pressure regulators | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C46 | Classification of International Standard | 11.040.10 | Word Count Estimation | 28,297 | Date of Issue | 2016-01-26 | Date of Implementation | 2017-01-01 | Quoted Standard | GB/T 1226-2010; GB 50751-2012; YY/T 0316-2008; YY/T 0882-2013; ISO 7396-1-2007; EN 837-1-1996 | Adopted Standard | ISO 10524-2-2005, MOD | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies a busbar pressure regulator (defined in 3.6) and a maximum inlet pressure of 3 000 kPa, which is expected to be connected to a cylinder with a maximum nominal filling pressure of 25 000 kPa at 15 �� C. 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); - breathing air; - carbon dioxide; - oxygen/nitrous oxide (nitrous oxide) mixture; - air for driving surgical instruments; - nitrogen for driving surgical instruments; - oxygen-enriched air (93% oxygen) produced by oxygen concentrators. YY/T 1439 of this standard applies to individual or with the relevant components assembled together |
YY/T 1439.2-2016: Pressure regulators for use with medical gases. Part 2-Manifold and line pressure regulators ---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Pressure regulators for use with medical gases.Part 2-Manifold and line pressure regulators
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
Medical gas pressure regulators
Part 2. busbar pressure regulators and
Pipe pressure regulator
Part 2. Manifoldandlinepressureulators
(ISO 10524-2..2005, MOD)
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
Introduction IV
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 symbol 3
5 General requirements 4
5.1 security 4
5.2 Optional structure 4
5.3 Materials 4
5.4 Design Requirements 5
5.5 Assembly requirements 8
Test Method 8
6.1 Condition 8
6.2 Test method of busbar pressure regulator 9
6.3 Pipeline pressure regulator test method 13
6.4 Test methods for self-ignition temperature of sealing materials and lubricants 14
6.5 Identification and color identification Durability test method 16
7 mark, color identification and packaging 16
7.1 mark 16
7.2 Color identification 17
7.3 Packaging 17
8 Information provided by the manufacturer 18
Appendix A (informative) Pressure Regulator Example 19
Appendix B (informative) Basic principles 21
Appendix C (informative) Differences in color and medical gas terms reported between regions and countries 22
Reference 24
Foreword
YY/T 1439 "Medical gas pressure regulator" for the series of standards, consists of the following components.
- Part 1. Pressure regulators and pressure regulators with flow meters;
- Part 2. Busbar pressure regulators and piping pressure regulators;
- Part 3. Pressure regulators integrated with cylinder valves;
- Part 4. Low - voltage regulators.
This part is part 2 of YY/T 1439.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section uses the re-drafting method to modify the use of international standards ISO 10524-2..2005 "Medical gas pressure regulators Part 2.
Flow Pressure Regulators and Pipe Pressure Regulators "(English version).
The technical differences between this section and ISO 10524-2..2005 are as follows.
--- on the normative reference documents, the standard made a technical differences in the adjustment to meet China's technical conditions, adjust the situation
The situation is reflected in Chapter 2, "Normative references", as follows.
• Replace ISO 32. 1977 (see Table 3 and Appendix C) with GB 50751-2012 and delete the "or region or"
National standard";
• Replace ISO 14971..2000 with YY/T 0316-2008 equivalent to ISO 14971..2007 (see
5.1);
• Increased normative reference documents GB/T 1226-2010 (see 5.4.1.1, 5.4.1.2, 5.4.1.5);
• Replace ISO 7396-1..2002 (see 5.4.5.5, 8.2) with the international standard ISO 7396-1..2007.
This section is subject to the following editorial changes as compared to ISO 10524-2..2005.
--- According to the national drug standard WSl-XG-008-2012, will 1.1 "oxygen concentrator production of oxygen" to "oxygen concentrator Health
(93% oxygen), "Table 2, Table 3," Oxygen from Oxygen Concentrator "was replaced by" Oxygen Concentrator
Oxygen Air (93% Oxygen) ";
--- removed in 5.3.2 "Note. The temperature range required by environmental conditions in each country or region may be different."
- the deletion of "regional or national regulations" in 5.4.7;
- the deletion of the second paragraph of appendix C, "the corresponding table for the corresponding country of the country, the corresponding table provides for the normative appendix, for its
His country is informative. ";
--- ISO 10524-2..2005 cited in the ISO standards and EN standards, there are corresponding to be used as the industry standard, this part
To refer to these industry standards as a normative use; there is no corresponding to be used as a national standard and industry standards,
Using the ISO standard and the EN standard as a standard use;
--- in the standard text after the reference to the document to increase the number;
--- reference to the international standards involved in the literature, there are corresponding to be used as national standards and industry standards, the standard to the corresponding national standard
The quasi-industry standard is used as a reference and adjusts the order of the references.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This section is headed by the National Standardization Technical Committee on Anesthesia and Respiratory Equipment (SAC/TC116).
This part of the drafting unit. Shenzhen Mindray Biomedical Electronics Co., Ltd., Shanghai Medical Devices Testing Institute, Shanghai Draeger Medical
Equipment Co., Ltd., Jie Rui Enterprise (Shanghai) Co., Ltd.
The main drafters of this part. Li Xinsheng, Fu Guoqing, Ding Deping, Hu Yuegang, Ma Xiaojian, Wang Wei.
Introduction
The busbar pressure regulator is used to reduce the cylinder pressure to a lower pressure as the source pressure of the medical gas piping system.
The pipe pressure regulator is used to reduce the pressure generated by the busbar pressure regulator or cryogenic vessel to a lower pressure as a medical
Pressure of the gas pipeline system terminal.
These functions involve pressure and flow in various ranges of air intake and outlet ports, and therefore require specialized design features.
It is important to specify and test the operating characteristics of the busbar pressure regulators and piping pressure regulators in a clear manner.
It is indispensable to ensure that the pressure regulator continues to meet the requirements of this part of YY/T 1439 by periodic inspection and maintenance.
YY/T 1439 This section is of particular concern.
The use of suitable materials;
--- safety (mechanical strength, leakage, overpressure safety emissions and flame retardant);
--- cleanliness;
--- type test;
--- logo;
The information provided by the manufacturer.
Appendix B contains the basic principles of certain requirements for this part of YY/T 1439. After the number is marked with an asterisk (*) terms and sub
The terms have the appropriate basic principles, including the reasons for the requirements and recommendations of this part of YY/T 1439. The reasons for these requirements are stated
That is not only conducive to the correct application of this standard, but also to simplify the subsequent version of the amendment.
Medical gas pressure regulators
Part 2. busbar pressure regulators and
Pipe pressure regulator
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).
1.2 * YY/T 1439 This part applies to separate or with the associated components assembled with the busbar pressure regulator and pipe pressure
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.
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