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YY 0732-2009: Oxygen concentrators for medical use. Safety requirements
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Oxygen concentrators for medical use. Safety requirements
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YY 0732-2009
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Basic data | Standard ID | YY 0732-2009 (YY0732-2009) | | Description (Translated English) | Oxygen concentrators for medical use. Safety requirements | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 22,266 | | Date of Issue | 2009-06-16 | | Date of Implementation | 2010-12-01 | | Quoted Standard | GB/T 3767-1996; GB/T 3785-1983; GB/T 5332-2007; GB 9706.1-2007; GB 9706.29-2006; YY 0505-2005; YY 0574.1-2005; YY 0574.2-2005 | | Adopted Standard | ISO 8359-1996, IDT | | Regulation (derived from) | Industry standard filing Notice 2009 No. 9 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard provides for continuous flow oxygen concentrator (see 1. 3. 8 of this standard) safety requirements. This standard does not apply to medical gas pipeline through the tape device to the number of patients with supply of oxygen concentrator, does not apply in a flammable anesthetic gases and/or cleaning agents used under conditions of oxygen concentrators. Scope of this standard is not limited to film and PSA oxygen concentrator oxygen concentrator (see "Introduction", because there may be other ways of oxygen enrichment, and that the standards should not limit future development. | YY 0732-2009: Oxygen concentrators for medical use. Safety requirements---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.
Oxygen concentrators for medical use.Safety requirements
ICS 11.040.10
C46
People's Republic of China pharmaceutical industry standards
YY 0732-2009/ISO 8359.1996
Safety requirements for medical oxygen concentrators
(ISO 8359.1996, IDT)
Posted 2009-06-16
2010-12-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
Chapter 1 Overview 1
1.1 Scope and purpose 1
1.2 Normative references 1
1.3 Terms and Definitions 1
1.4 General requirements 2
1.5 General test requirements 2
1.6 Category 2
1.7 Identification, marking and documents 2
1.8 Input power 4
4 Section 2 - Safety requirements
2.1 Basic Safety Type 4
2.2 removable protection means 4
4 2.3 Environmental conditions
The first three pairs of shock hazard protection 4
3.1 Overview 4
3.2 Requirements concerning classification of 4
3.3 limit voltage and (or) energy of 4
3.4 housing and protective cover 4
Isolated 4 3.5
3.6 protective earthing, functional earthing and potential equalization 4
3.7 Continuous leakage currents and patient auxiliary current 4
3.8 Dielectric strength 5
The first four pairs of mechanical hazards Protection 5
4.1 Mechanical strength 5
4.2 moving part 5
4.3 surface, corners and edges 5
Stability in normal use 4.4 5
4.5 spatter 5
4.6 vibration and noise 5
4.7 pneumatic and hydraulic power 5
4.8 pedants 5
The first five pairs of unwanted or excessive radiation hazard protection 5
5.1 X-ray radiation 5
5.2 α, β, γ, neutron radiation and other particle radiation 6
5.3 Microwave 6
5.4 optical radiation (including visible light and laser) 6
YY 0732-2009/ISO 8359.1996
5.5 6 infrared radiation
5.6 UV radiation 6
5.7 acoustic energy (including ultrasound) 6
5.8 Electromagnetic Compatibility 6
The first six pairs of the risk of explosion protection medical room 6
6.1 6 position and basic requirements
6.2 mark, random file 6
6.3 Requirements common type of the AP and APG-type apparatus 6
6.4 pairs AP type equipment and parts and components requirements and testing 6
6.5 pairs APG-type devices and their parts and components requirements and testing 6
The first seven pairs of ultra-mild other security risk protection 7
7.1 overtemperature 7
7.2 Fire 7
7.3 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection and sterilization 7
7.4 pressure vessels and pressure parts 7
7 7.5 Human Error
7.6 electrostatic charge 8
7.7 material in contact with the body of a patient application of section 8
7.8 power supply interruption 8
8 accuracy and prevent the risk of the output of the operational data of 8
The accuracy of the data work 8 8.1
8.2 to prevent the risk of output 9
Article 9 abnormal operation and fault conditions; environmental testing 10
9.1 abnormal operation and fault status 10
10 9.2 Environmental Testing
Article 10 Structural requirements 10
10.1 Overview 10
10.2 housings and covers 10
10.3 10 components and subassemblies
10.4 net power supply section, components and wiring 10
10.5 --- protective earthing terminals and connectors 10
10.6 and the wiring structure 10
Supplementary Provisions Article 11 11
11.1 audible alarm 11
11.2 lose 11 grid voltage indicator
Appendix 11
Annex N (normative) Test Instrument 12
Appendix P (informative) Fundamentals 13
References 16
YY 0732-2009/ISO 8359.1996
Foreword
This standard is equivalent to international standards ISO 8359.1996 "medical oxygen concentrators safety requirements."
The standard ISO 8359.1996 made the following editorial changes.
--- "This International Standard" be replaced by "this standard";
--- With a decimal point '. 'Instead of a comma as the decimal point,' ';
--- Delete foreword international standards;
The standard 5.8 Electromagnetic compatibility and YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety juxtaposition
Standard. Electromagnetic Compatibility - Requirements and test the implementation of the same period. "
Appendix Appendix A ~ N form an integral part of this standard, normative appendix, Appendix P informative appendices.
This standard by the National Standardization Technical Committee of anesthesia and respiratory equipment and focal points.
This standard was drafted. Shandong Pioneering medical technology Limited.
The main drafters of this standard. Mayen Yan, Zhang Xiaoliang.
YY 0732-2009/ISO 8359.1996
Introduction
Oxygen concentrators oxygen enriched air to provide security for the patient. Such devices by separating nitrogen or oxygen from ambient air can be improved
Inhaled oxygen concentration.
The gas separated manner, oxygen concentrators can be divided into two categories.
a) oxygen selectively permeates through the membrane or mesh or sieve oxygen concentrators;
b) pressure swing adsorption (PSA) oxygen concentrator, air under pressure in contact with the molecular sieve materials, the molecular sieve material selectively absorbing
Attached nitrogen or other ingredients, and then, when you reduce the pressure to release it.
Appendix N to give a detailed description of a series of trials to test experimental equipment arrangement meets the specific requirements.
The most important requirement is given in Appendix P of the basic principles. The basic principle of such requirements is not only conducive to the proper use of this standard, and can be
Simplify subsequent modifications.
Test methods may also be used in this standard does not specify to verify compliance with the requirements given, but these methods must have the same or more
High accuracy. Any discrepancy, the method specified in this standard as a reference method.
YY 0732-2009/ISO 8359.1996
Safety requirements for medical oxygen concentrators
Chapter 1 Overview
1.1 Scope and purpose
Note 1. See Appendix P of the basic principles.
This standard is based on a series of standard GB 9706.1-2007 one. GB 9706.1-2007 (General Standard) in such
Standard is called "specific standard" (ParticularStandard). According to the provisions of GB 1.3 9706.1-2007, advantages of the present standard requirements
GB 9706.1-2007 prior to the request.
In addition to the following section to replace 1.1, GB 9706.1-2007 Chapter 1 apply.
This standard specifies the safety requirements for continuous flow oxygen concentrator (see 1.3.8 of this standard) in. This standard is not applicable with pipe
Medical gas installation path to a number of patients supply of oxygen concentrator, nor applied in a flammable anesthetic gas and/or cleaning agents conditions
Oxygen concentrators used.
The scope of the standard is not limited to film and PSA oxygen concentrators oxygen concentrator (see "Introduction"), because there may be other
Concentrated oxygen method, and the present standard should not limit future development.
1.2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequently
Some amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Study whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/Determination of sound power levels of noise sources reflecting plane free field engineering law (eqv T 3767-1996 Acoustics sound pressure
ISO 3744.1994)
GB/T 3785-1983 electric sound level meter, acoustic performance and test methods
Temperature test method GB/T 5332-2007 ignition of flammable liquids and gases (IEC 60079-4. 1975, IDT)
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 9706.29-2006 Medical electrical equipment - Part 2. anesthesia system security and essential performance (IEC 60601-
2-13.2003, MOD)
YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests
(IEC 601-1-2.2001, IDT)
YY 0574.1-2005 anesthesia and respiratory care alarm signals - Part 1. Visual alarm signals (ISO 9703-1.1992, IDT)
YY 0574.2-2005 anesthesia and respiratory care alarm signals - Part 2. audible alarm signal (ISO 9703-2.1992, IDT)
1.3 Terms and Definitions
In addition to the following section to replace 2.1.5, GB 9706.1-2007 Chapter 2 apply.
2.1.5
Oxygen concentrator outlet.
The following terms and definitions apply to this same standard.
1.3.1
The product gas is transferred from the oxygen concentrator outlet to annex all patients, but does not include any fixed extension tube.
YY 0732-2009/ISO 8359.1996
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