This part of YY 0636 specifies the safety and performance requirements for medical suction equipment powered by negative pressure or pressure sources (see Figure 1). Particularly suitable for pipe connections and venturi attachments. Suction equipment containing electrical control components (such as electronic timers) should also comply with the requirements of GB 9706.1-2007. This part of YY 0636 does not apply to the electric suction equipment powered by mains power or battery as discussed in YY 0636.1; nor to the manually driven suction equipment discussed in YY 0636.2; nor to the following equipment: a) Centrally powered systems (using negative pressure/compressed gas generating devices), vehicle and building ductwork, and wall connectors; b) Catheters, drainage tubes, scrapers and suction heads; c) Syringes; d) Dental suction equipment ; e) Waste gas removal systems; f) Laboratory suction devices; g) Automatic infusion systems; h) Passive urination devices; i) Closed systems for wound drainage; j) Gravity gastric drainage devices; k) Oral surgery mucus aspirators ; l) Suction equipment with a collection container downstream of a negative pressure pump; m) Equipment labeled suction for permanent tracheostomy; n) Suction cup equipment (for obstetric use); o) Neonatal mucus aspirators; p) Breast pump; q) Fat suction device; r) Urine suction.
YY 0636.3-2008 Referenced Document
GB 3785-1983 Electrical and acoustic performance and side test method of sound level meter
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB/T 3767-1996 Acoustics--Determination of sound power levels of noise sources using sound pressure--Engineering method in an essentially free field over a reflecting plane
ISO 5359:1989 Low-pressure flexible connecting assemblies (hose assemblies) for use with medical gas systems
YY 0339-2002 Suction catheter for use in the respiratory tract
YY 0636.1-2008 Medical suction equipment.Part 1:Electrically powered suction equipment.safety requirements
YY 1040.1-2003 Anaesthetic and respiratory equipment-Conical connectors-Part 1:Cones and sockets
YY 0636.3-2008 history
2021YY/T 0636.3-2021 Medical suction equipment Part 3: Suction equipment powered by a vacuum or positive pressure source
2008YY 0636.3-2008 Medical suction equipment.Part 3:Suction equipment powered from a vacuum or pressure source