YY/T 0636.3-2021Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (English PDF)

1 Scope

This part of YY/T 0636 specifies the safety and performance requirements for medical suction equipment driven by a vacuum or positive pressure source (Venturi suction).

Including additional requirements for suction equipment used in the field and/or transport.

This section applies to equipment connected to medical gas piping systems or gas cylinders and Venturi accessories. This equipment can be a stand-alone device or

So it is part of the integrated system.

Note. Appendix A illustrates the three parts of YY/T 0636 by providing a schematic diagram of a typical system.

This section does not apply to.

a) Central power system (generated by negative pressure/compressed air), piping systems of vehicles and buildings, and wall connectors;

b) Suction catheter, Yankee suction tube and suction head and other end pieces;

c) Syringe;

d) Dental suction equipment;

e) Anesthetic gas purification system;

f) Laboratory attraction equipment;

g) Autologous infusion system;

h) Closed system for wound drainage;

i) Mucus extractor, including neonatal mucus extractor;

j) Cup suction equipment (for obstetrics);

k) Breast pump;

l) Fat suction equipment;

m) Uterine suction equipment;

n) Plume evacuation system.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article

Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 3767 Acoustic sound pressure method to determine the sound power level and sound energy level of noise sources. Engineering method for the approximate free field above the reflecting surface (GB/T 3767-2016, ISO 3744.2010, IDT)

GB/T 3785.1 Electroacoustic Sound Level Meter Part 1.Specifications (GB/T 3785.1-2010, IEC 61672-1.2002, IDT)

GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (GB 9706.1-2020,

IEC 60601-1.2005 A1.2012,MOD)

GB/T 16273.1 Graphical symbols for equipment Part 1.General symbols (GB/T 12673.1-2008, ISO 7000.2004,

NEQ)

YY/T 0297 Clinical Investigation of Medical Devices (YY/T 0297-1997, ISO 14155.1996, IDT)

YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007, IDT)

YY/T 0466.1 Medical devices are used for medical device labeling, marking and providing information symbols. Part 1.General requirements […]