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YY 0600.4-2013

YY 0600.4-2013_English: PDF (YY0600.4-2013)
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YY 0600.4-2013English454 Add to Cart Days<=3 Lung ventilators for medical use-Particular requirements for basic safety and essential performance. Part 4: Coperator-powered resuscitators YY 0600.4-2013 Valid YY 0600.4-2013
 

BASIC DATA
Standard ID YY 0600.4-2013 (YY0600.4-2013)
Description (Translated English) Lung ventilators for medical use-Particular requirements for basic safety and essential performance. Part 4: Coperator-powered resuscitators
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 23,262
Quoted Standard GB/T 4999-2003; YY/T 0615.1-2007; YY 0810.1; YY 1040.1; EN 148-1; EN 868-1; EN 1041; PREN 13544-2-2000
Adopted Standard ISO 10651-4-2002, IDT
Drafting Organization Shanghai Medical Device Testing
Administrative Organization National Standardization Technical Committee anesthesia and respiratory devices
Regulation (derived from) State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Proposing organization National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC 116)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the special requirements apply to all ages of portable artificial resuscitation device used to provide breathing lung ventilation is not sufficient. For infants, children, artificial resuscitator according to weight ranges and thei

YY 0600.4-2013
Lung ventilators for medical use-Particular requirements for basic safety and essential performance. Part 4. Coperator-powered resuscitators
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
YY 0600.4-2013/ISO 10651-4..2002
Medical ventilator
Specific requirements for basic safety and main performance
Part 4. artificial resuscitator
(ISO 10651-4..2002, IDT)
2013-10-21 release
2014-10-01 implementation
Published by the State Food and Drug Administration
Contents
Foreword III
1 range 1
2 Normative references 1
3 Terms and definitions 1
4 connector 3
4.1 Patient connection port connector 3
4.2 * Exhale connector 3 for breathing gas
4.3 Mask connector 3
4.4 * Airbag valve connector 3
4.5 Airbag inlet valve connector 3
4.6 Threaded Gas Filter Connector 3
4.7 Oxygen fittings and manometer fittings 3
5 Operating requirements 3
5.1 General 3
5.2 Disassembly and assembly 3
5.3 Patient valve function after vomit contamination 3
5.4 Mechanical shock 3
5.5 Immersion in water 3
5.6 Airbag inflation valve 3
5.7 Construction materials 3
6 Ventilation requirements 3
6.1 Supplemental oxygen and delivered oxygen concentration 3
6.2 Expiratory impedance 3
6.3 Inspiratory impedance 4
6.4 Patient valve failure 5
6.5 Patient valve leak-forward leak 5
6.6 Resuscitator Dead Space and Repeated Breathing 5
6.7 Ventilation performance 5
7 Storage and handling conditions 5
7.1 Storage 5
7.2 Operating conditions 6
8 Requirements for sterile-packed resuscitators or components 6
8.1 Aseptic Assurance 6
8.2 Aseptic packaging of resuscitators or components 6
9 Mark 6
9.1 General 6
9.2 Indication of operating conditions 6
YY 0600.4-2013/ISO 10651-4..2002
9.3 Indication of pressure limit system settings 7
10 Information to be provided by the manufacturer in the operation and maintenance instructions 7
10.1 General 7
10.2 Content 7
Appendix A (Normative) Test Method 8
Appendix B (Informative) Basic Principles 16
References 18
YY 0600.4-2013/ISO 10651-4..2002
Foreword
The general title of YY 0600 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. Ventilator for emergency and transport;
--- Part 4. artificial resuscitator;
--- Part 5. Pneumatic emergency resuscitator.
This section is Part 4 of YY 0600.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This part is equivalent to the international standard ISO 10651-4..2002 "Medical ventilator Part 4. Specific requirements for artificial resuscitators" (English
Version), and made the following editorial changes.
--- Modify the standard name to "Special Requirements for Basic Safety and Main Performance of Medical Ventilators-Part 4. Artificial Resuscitators";
--- The international standards quoted in ISO 10651-4..2002 are correspondingly adopted as national standards and industry standards.
Use these national standards and industry standards as the normative use; if there is no corresponding adoption as national standards and industry standards, the
The cited international standards are used as norms.
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This part is proposed and managed by the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This section was drafted. Shanghai Medical Equipment Testing Institute.
The main drafters of this section. Wang Wei and Xu Chang.
YY 0600.4-2013/ISO 10651-4..2002
Medical ventilator
Specific requirements for basic safety and main performance
Part 4. artificial resuscitator
1 Scope
This part of YY 0600 specifies special requirements for portable artificial resuscitators applic