YY 0786-2010 Replaced Industry standards-Medicine

YY 0786-2010 Respiratory tract humidifiers for medical use—Particular requirements for respiratory humidification systems

Publish Date: 2010-12-27 Implement Date: 2012-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0786-2010

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Surgical room equipment

ICS Name: Anesthesia, respiration, and resuscitation equipment

Publish Date: 2010-12-27

Implement Date: 2012-06-01

Pages: 44 pages

Scope

This standard specifies the basic safety and performance requirements for humidification systems (as defined in 3.6). It also includes specific standalone devices used in humidification systems, such as respiratory tube heating (respiratory tube heating wires) and respiratory tube heating control devices (respiratory tube heating controllers). Safety and performance requirements for other aspects of respiratory tubes are referenced in YY 0461. Note: Respiratory tube heating devices are considered medical electrical equipment and should comply with the provisions of GB 9706.1. *This standard also includes requirements for active HMEs (heat and moisture exchangers), which actively heat and humidify the air delivered to patients to increase the humidity level. This standard does not apply to passive HMEs, which recycle some of the moisture and heat exhaled by patients during inhalation without adding additional moisture and heat. YY/T 0735.1 and YY/T 0735.2 specify the safety and performance requirements for passive HMEs and describe the methods for performance testing. Respiratory tube humidifiers can be pneumatic, electric, or a combination of both. However, this standard is a dedicated standard based on GB 9706.1, which takes into account all general safety requirements, not just electrical safety, but also many requirements applicable to humidifiers that are not electric. The application of certain provisions in GB 9706.1 specified in this standard means that these provisions are only considered applicable to the requirements related to humidification systems. This standard does not apply to devices commonly referred to as "indoor humidifiers", or to humidification used in heating, ventilation, and air conditioning systems, nor to humidifiers integrated into infant incubators. This standard does not apply to nebulizer devices used to deliver medication to patients. When planning and designing products according to this standard, consideration should be given