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YY 0600.3-2007

YY 0600.3-2007_English: PDF (YY0600.3-2007)
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YY 0600.3-2007English649 Add to Cart Days<=5 Lung ventilators for medical use. Particular requirements for basic safety and essential performance -- Part 3: Emergency and transport ventilators YY 0600.3-2007 Valid YY 0600.3-2007
 

BASIC DATA
Standard ID YY 0600.3-2007 (YY0600.3-2007)
Description (Translated English) Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 3: Emergency and transport ventilators
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 27,284
Date of Issue 2007-01-31
Date of Implementation 2008-02-01
Quoted Standard GB/T 2423.6-1995; GB/T 2423.8-1995; GB/T 2423.10-1995; GB/T 4999-2003; GB/T 5332-1985; GB 7144-1999; GB 9706.1; GB 9706.28-2006; YY 0461-2003; YY 0505-2005; YY 0574.1-2005; YY 0574.2-2005; YY 1040.1-2003; ISO 5356-2-1987; ISO 5359-1989; ISO 5362-1986; ISO 9170-1990; IEC 68-8-36
Adopted Standard ISO 10651-3-1997, MOD
Drafting Organization Beijing Science and Technology Development Co., Ltd. Yi Metroplex
Administrative Organization National Standardization Technical Committee of Anaesthetic and respiratory equipment
Regulation (derived from) Chinese industry standards for record 2007 of 4 (total of 88)
Summary This standard specifies in case of emergency and patient transport used when the portable ventilator requirements. This section is based on GB 9706. 1 "Medical electrical equipment Part 1: General requirements for safety, " the specific standard. As the 1. 3 GB 9706. 1 expressed, the requirements of this than the relevant requirements of GB 9706. 1 more effective. If this part of the statement of GB 9706. 1 certain conditions apply, it refers only to the terms of the demands made by the considered first aid and the use of ventilator-associated transfer when applicable. This section and GB 9706. 28 "Medical electrical equipment Part 2: Safety requirements for treatment of ventilator ventilator" There is a common requirement. GB 9706. 1-2007 given in Chapter 1 Scope and purpose are applicable. First aid and transferred using a portable ventilator (hereinafter referred to as "breathing machine") is often installed in ambulances or other emergency vehicles, but also outside of the vehicle must be used by the operator or other personnel onboard the occasion. These devices are often highly trained personnel to varying degrees outside the hospital or home use. This section also applies to be permanently installed in the ambulance or aircraft ventilator. This section does not apply artificial respiration (such as artificial resuscitator).

YY 0600.3-2007
Lung ventilators for medical use.Particular requirements for basic safety and essential performance.Part 3. Emergency and transport ventilators
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
YY 060.3-2007
Medical ventilator
Specific requirements for basic safety and main performance
Part 3. Respirators for emergency and transport
(ISO 10551-3..1997, MOD)
2007-01-31 released
2008-02-01 implementation
Published by the State Food and Drug Administration
Contents
Foreword III
Introduction IV
First article overview 1
1 Scope 1
2 Terms and definitions 2
3 General requirements 3
4 General requirements for testing 3
5 Classification 3
6 Identification, marking and documentation 3
7 Input power 6
Part II Environmental Conditions 6
8 Basic safety type 6
9 Removable protective device 6
10 Environmental Conditions 6
11 Not used 6
12 Not used 6
Chapter III Protection against electric shock hazards 7
13 Overview 7
14 Requirements for classification 7
15 Limitation of Voltage and/or Energy 7
16 Housing and protective cover 7
17 Isolation 7
18 Protective earth, functional earth and potential equalization 7
19 Continuous leakage current and patient auxiliary current 7
20 Dielectric strength 7
Chapter 4 Protection against Mechanical Hazards 7
21 Mechanical strength 7
222 Moving parts 8
23 Faces, corners and edges 8
24 Stability during normal use 8
25 Splash 8
26 Vibration and noise 8
27 Pneumatic and Hydraulic Power 8
28 Hanging objects 8
Chapter 5 Protection against Unwanted or Excessive Radiation Hazards 8
29 X-Ray Radiation 8
30 α, β, γ, neutron radiation and other particle radiation 9
31 microwave radiation 9
YY 060.3-2007
32 Light radiation (including laser radiation) 9
33 Infrared radiation 9
34 ultraviolet radiation 9
35 sound energy (including ultrasound) 9
36 Electromagnetic Compatibility 9
Chapter 6 Protection against the danger of ignition of flammable anesthetic mixtures 9
37 Location and basic requirements 9
38 mark, random file 9
39 Common requirements for AP and APG equipment 9
40 Requirements and tests for AP-type equipment and its parts and components
41 Requirements and tests for APG-type equipment and its parts and components
Chapter 7 Protection against overtemperature and other dangers 10
42 over temperature 10
43 fire protection 10
44 Overflow, liquid spill, leak, dampness, ingress of liquid, cleaning, disinfection and sterilization
45 Pressure vessels and pressure parts 10
46 Human error 10
47 electrostatic charge 11
48 Materials for application parts in contact with the patient's body 11
49 Power supply interruption 11
Chapter 8 Accuracy of Work Data and Prevention of Dangerous Outputs 11
50 Accuracy of working data 11
51 Prevention of Dangerous Outputs 11
Chapter IX Abnormal Operation and Failure State; Environmental Test 13
52 Abnormal operation and fault status 13
53 Environmental Test 13
Chapter 10 Structural Requirements 13
54 Overview 13
55 Housing and cover 14
56 Components and Assemblies 14
57 network power supply parts, components and wiring 15
58 Protective Earth --- Terminals and Connections 15
59 Structure and wiring 15
Appendix 16
Appendix AA (Informative) Basic Principles 16
Appendix BB (informative) Reference 19
Appendix CC (informative appendix) The chapter number in this part is compared with ISO 10651-3..1997 chapter number
YY 060.3-2007
Foreword
The general title of Y600 is "Special Requirements for Basic Safety and Main Performance of Medical Ventilators", which consists of the following parts.
--- Part 1. Household respiratory support equipment;
--- Part 2. Home ventilator for ventilator dependent patients;
--- Part 3. Respirators for emergency and transport.
Other parts of Y600 will be formulated one after another.
--- Part 4. artificial breathing equipment;
--- Part 5. P