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YY 0600.5-2011

YY 0600.5-2011_English: PDF (YY0600.5-2011)
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YY 0600.5-2011English854 Add to Cart Days<=5 Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 5: Gas-powered emergency resuscitators YY 0600.5-2011 Valid YY 0600.5-2011
 

BASIC DATA
Standard ID YY 0600.5-2011 (YY0600.5-2011)
Description (Translated English) Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 5: Gas-powered emergency resuscitators
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 43,435
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Quoted Standard GB 3100; GB 3102.1; GB 3102.2; GB 3102.3; GB 3102.4; GB 3102.5; GB 3102.6; GB 3102.7; GB 3102.8; GB 3102.9; GB 3102.10; GB 3102.11; GB 3102.12; GB 3102.13; GB 4208-2008; GB/T 4999-2003; GB 7144-1999; GB 9706.1-2007; GB 15382-2009; GB 19633; YY/T 0316-2008; YY 0461; YY 0466.1-2009; YY/T 0753.1-2009; YY/T 0753.2-2009; YY/T 0799; YY 0801.1; YY/T 0802-2010; YY 1040.1; YY 1040.2; ISO 10524-1; ISO 10524-3
Adopted Standard ISO 10651-1-2006, IDT
Drafting Organization Shanghai Medical Device Testing
Administrative Organization National Standardization Technical Committee of Anaesthetic and respiratory equipment
Regulation (derived from) State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Proposing organization National Standardization Technical Committee of anesthesia and respiratory equipment (SAC/TC 116)
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the use of first responders who left with a pneumatic resuscitation for the basic safety and essential performance requirements. The device for emergency spaces, in normal use, continuous monitoring by the operator. YY 0600 This part also provides for recovery of component (3. 22) requirements. YY 0600 This part does not apply to electric resuscitators.

YY 0600.5-2011
Lung ventilators for medical use.Particular requirements for basic safety and essential performance.Part 5. Gas-powered emergency resuscitators
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
YY 0600.5-2011/ISO 10651-5..2006
Dedicated to basic safety and main performance of medical ventilator
Requirements Part 5. Pneumatic First Aid Resuscitator
(ISO 10651-5..2006, IDT)
2011-12-31 release
2013-06-01 Implementation
Published by the State Food and Drug Administration
Contents
Foreword I
Introduction Ⅱ
1 * range 1
2 Normative references 1
3 Terms and definitions 2
4 General requirements 4
4.1 Overview 4
4.2 Other test methods 5
4.3 Acceptance Criteria 5
5 Structural requirements 5
5.1 Overview 5
5.2 Connector 6
6 Operating requirements 7
6.1 Overview 7
6.2 Environmental resistance 8
6.3 Resistance to typical use 8
6.4 Dimensions and quality 9
6.5 Air source 9
7 Performance 10
7.1 Ventilation requirements 10
7.2 * Ventilation performance 11
8 Identification, marking and documentation 14
8.1 Overview 14
8.2 Mark 14
8.3 Operation and maintenance information provided by the manufacturer 16
Appendix A (Informative) Basic Principles 19
Appendix B (Normative) Test Method 24
Appendix C (informative) Relationship between this part of YY 0600 and CPR guidelines 33
Appendix D (informative) Clause 34 of this part of YY 0600 that discusses basic principles
Appendix E (Informative) Terminology-Index of Defined Terms 36
References 38
YY 0600.5-2011/ISO 10651-5..2006
Foreword
YY 0600 `` Special Requirements for Basic Safety and Main Performance of Medical Ventilators '' is divided into five 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 5 of YY 0600.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This part is equivalent to ISO 10651-5..2006 "Special requirements for basic safety and main performance of medical ventilators. Part 5. Pneumatics
First Aid Resuscitator.
Compared with ISO 10651-5..2006, this section has the following editorial changes.
--- The introduction of ISO 10651-5..2006 was modified into the introduction of this part;
--- The international standards quoted in ISO 10651-5..2006 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 ISO 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 Fu Guoqing.
YY 0600.5-2011/ISO 10651-5..2006
introduction
Resuscitation committees and associations point out that for patients at risk of life
Perform on-site cardiopulmonary resuscitation and start a series of continuous ambulances until the patient can get professional medical care and will get the most effective
Ambulance results. To improve possible ambulances at an early stage, experts and organizations train non-professionals in key locations, such as
Where they gather or where danger arises, they can provide a higher level of ambulance in the shortest possible time.
There is increasing awareness that the use of basic equipment can greatly improve efficiency, such as avoiding mouth-to-mouth contact while providing ventilation
device of. Simply put, pneumatic rescue resuscitators can deliver controlled ventilation, and this section specifies the standard