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YY 0786-2010

YY 0786-2010_English: PDF (YY0786-2010)
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YY 0786-2010English834 Add to Cart Days<=5 Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems YY 0786-2010 Valid YY 0786-2010
 

BASIC DATA
Standard ID YY 0786-2010 (YY0786-2010)
Description (Translated English) Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 42,413
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Quoted Standard GB/T 3767-1996; GB/T 4999-2003; GB/T 5332-2007; GB 9706.1-2007; GB 11243-2008; YY 0461-2003; YY 0505-2005; YY 1040.1-2003; YY 0709-2009; YY/T 0735.1; YY/T 0735.2; ISO 7396-1-2002; ISO 10524-1-2006; IEC 60601-1-6-2004
Adopted Standard ISO 8185-2007, IDT
Drafting Organization Beijing Yi Ann Medical Systems Inc.
Administrative Organization National Standardization Technical Committee of Anaesthetic and respiratory equipment
Regulation (derived from) State Food and Drug Administration Notice 2010 No. 97
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 humidification system's basic safety and essential performance requirements. Humidification system also includes the use of certain independent devices such as breathing circuit heating (breathing pipe heating wire) and the breathing circuit heating control device (breathing circuit heating controller). Breathing circuits other aspects of security and performance requirements refer to YY 0461. This standard also includes an active HME (heat and moisture exchanger) requirements, namely through active heated humidification to increase interest rates by HME gas delivered to the humidity level of the device. This standard does not apply to passive HMEs, namely in the inspiratory phase as part of the patient exhaled moisture and heat again to return to the breathing circuit without increasing the moisture and heat of the device. YY/T 0735. 1 and YY/T 0735. 2 provides passive HMEs safety and performance requirements, and performance test methods are described. Breathing tube humidifier can be pneumatic, electric or a combination of both. However, this standard applies to based on GB 9706. 1 based on a specific standard, which takes into account all of the general requirements for safety, not just electrical safety, but also including non-electric humidifier for many of the requirements. This standard specifies GB 9706. 1 shall apply in a wet system means that only relevant when considering the needs of the application of that section to save, This standard does not apply to commonly referred to as "indoor humidifier" those devices, or use the heating, ventilation and air conditioning systems humidification, does not apply to infant incubator has been integrated into the humidifier. This standard does not apply to patients with drug delivery atomizer.

YY 0786-2010
Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
YY 0786-2010/ISO 8185..2007
Medical respiratory tract humidifier
Specific requirements for respiratory humidification systems
(ISO 8185..2007, IDT)
Published on December 27,.2010
2012-06-01 Implementation
Published by the State Food and Drug Administration
Contents
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and definitions 2
4 General requirements and test requirements 3
5 Classification 4
6 Identification, marking and documentation 4
7 Input power 5
8 Basic safety type 5
9 Removable protective device 5
10 Ambient conditions 5
11 No general requirements 6
12 No general requirements 6
13 Overview 6
14 Classification requirements 6
15 Limitations of voltage and/or energy 6
16 Housing and protective cover 6
17 Isolation 6
18 Protective earth, functional earth and potential equalization 6
19 Continuous Leakage Current and Patient Auxiliary Current 6
20 Dielectric strength 6
21 Mechanical strength 6
22 Moving parts 6
23 Faces, corners and edges 7
24 Stability during normal use 7
25 Splash 7
26 Vibration and noise 7
27 Pneumatic and hydraulic power 7
28 Hanging 7
29 X-ray radiation 7
30 α, β, γ, neutron radiation and other particle radiation 7
31 Microwave radiation 7
32 Optical radiation (including laser) 7
33 Infrared radiation 7
34 UV radiation 7
35 Acoustic energy (including ultrasound) 7
36 Electromagnetic compatibility 8
YY 0786-2010/ISO 8185..2007
37 Location and basic requirements 8
38 Logo, random file 8
39 Common requirements for AP and APG equipment 8
40 Requirements and tests for AP-type equipment, its parts and components 8
41 Requirements and tests for APG equipment and its parts and components 8
42 over temperature 8
43 * Fire 8
44 Overflow, liquid spills, leaks, moisture, ingress, cleaning, disinfection, sterilization and compatibility
45 Pressure vessels and pressure parts 9
46 Human error 9
47 Electrostatic Charge 9
48 Biocompatibility 10
49 Power supply interruption 10
50 Accuracy of working data 10
51 * Prevention of Dangerous Outputs 10
52 Abnormal operation and fault conditions 11
53 Environmental test 11
54 Overview 11
55 Housings and covers 11
56 Components and Components 11
57 Network power supply section, components and wiring 12
58 Protective Earth--Terminals and Connections 12
59 Structure and wiring 12
101 * Humidification System Output 13
102 Water storage tank 13
103 Alarm system 13
Appendix AA (Informative) Basic Principles 14
Appendix BB * (Normative Appendix) Measurement of Display Temperature Accuracy 19
Appendix CC (informative) Specific enthalpy calculation 20
Appendix DD (Normative) Temperature Sensors and Interfaces 24
Appendix EE (Normative) Determination of Humidification System Output 25
Appendix FF * (Normative) Standard temperature sensor 27
Appendix GG (informative) Environmental aspects 28
Appendix HH (Informative) Basic Principles of Safety and Performance 30
Appendix II (Informative) Terminology-Index 32
References 33
YY 0786-2010/ISO 8185..2007
Foreword
This standard is equivalent to ISO 8185..2007 "Special Requirements for Respiratory Humidification Systems for Medical Respiratory Humidifiers" (English version).
The main differences between this standard and ISO 8185..2007 are as follows.
--- The IEC and ISO international standards cited in ISO 8185..2007 have been converted into national standards and industry standards.
China standards are cited as normative use; if there is no corresponding translation into national standards and industry standards, the cited IEC
And ISO international standards are used as norms.
--- ISO 7396-1..2002 "Medical Gas Piping System Part 1 Medical Compressed Gas an