Oxygen Concentrators for Medical Use — Safety Requirements
Section 1 General
1.1 Scope and object
Note 1: See the rationale in Annex P.
This standard is one of a series of standards based on GB 9706.1-2007. In GB 9706.1-2007 (the “General Standard”), this type of standard is referred to as a “Particular Standard”. As stated in 1.3 of GB 9706.1-2007, the requirements of this standard take precedence over those of GB 9706.1-2007.
The scope and object given in Clause 1 of GB 9706.1-2007 apply, except that 1.1 shall be replaced by the following:
This standard specifies safety requirements for continuous-flow oxygen concentrators, as defined in 1.3.8 (in this standard). This standard does not apply to oxygen concentrators intended to supply gas to several patients via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic and/or cleaning agents.
The scope of this standard is not restricted to membrane oxygen concentrators and pressure swing absorbers (see Introduction), as alternative methods of concentrating oxygen may become available and it is not intended that this standard should restrict future developments.
1.2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. However parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
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 (eqv ISO 3744: 1994)
GB/T 3785-1983 Electric, Sonic Properties and Measuring Methods for Sound Level Meters
GB/T 5332-2007 Method of Test for Ignition Temperature of Flammable Liquids and Gases (IEC 60079-4:1975, IDT)
GB 9706.1-2007 Medical Electrical Equipment — Part 1: General Requirements for Safety (IEC 60601-1: 1988, IDT)
GB 9706.29-2006 Medical Electrical Equipment — Part 2: General Requirements for the Safety and Essential Performance of Anaesthetic Systems (IEC 60601-2-13:2003, MOD)
YY 0505-2005 Medical Electrical Equipment — Part 1-2: General Requirements for Safety — Collateral Standards: Electromagnetic Compatibility — Requirements and Tests (IEC 601-1-2:2001, IDT)
YY 0574.1-2005 Anaesthesia and Respiratory Care Alarm Signals — Part 1: Visual Alarm Signals (ISO 9703-1:1992, IDT)
YY 0574.2-2005 Anaesthesia and Respiratory Care Alarm Signals — Part 2: Auditory Alarm Signals(ISO 9703-2:1992, IDT)
1.3 Terms and Definitions
For the purposes of this standard, the definitions given in Clause 2 of GB 9706.1-2007 apply, except that the definition given in 2.1.5 shall be replaced by the following:
