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YY 0786-2010

Chinese standards (related to): 'YY 0786-2010'
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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.