YY 0732-2009 in English

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:

2.1.5
applied part
oxygen concentrator outlet

Foreword III
Introduction IV
Section 1 General
1.1 Scope and object
1.2 Normative References
1.3 Terms and Definitions
1.4 General requirements
1.5 General requirements for tests
1.6 Classification
1.7 Identification, marking and documents
1.8 Power input
Section 2 Safety Requirements
2.1 Basic safety categories
2.2 Removable protective means
2.3 Environmental conditions
Section 3 Protection against Electric Shock Hazards
3.1 General
3.2 Requirements related to classification
3.3 Limitation of voltage and/or energy
3.4 Enclosures and protective covers
3.5 Separation
3.6 Protective earthing, functional earthing and potential equalization
3.7 Continuous leakage currents and patient auxiliary currents
3.8 Dielectric strength
Section 4 Protection against Mechanical Hazards
4.1 Mechanical strength
4.2 Moving parts
4.3 Surfaces, corners and edges
4.4 Stability in normal use
4.5 Expelled parts
4.6 Vibration and noise
4.7 Pneumatic and hydraulic power
4.8 Suspended masses
Section 5 Protection against Hazards from Unwanted or Excessive Radiation
5.1 X-Radiation
5.2 α, β, γ, neutron radiation and other particle radiation
5.3 Microwave radiation
5.4 Light radiation (including visual radiation and lasers)
5.5 Infrared radiation
5.6 Ultraviolet radiation
5.7 Acoustical energy (including ultrasonics)
5.8 Electromagnetic compatibility
Section 6 Protection against Hazards of Explosions in Medically Used Rooms
6.1 Locations and basic requirements
6.2 Marking, accompanying documents
6.3 Common requirements for category AP and category APG equipment
6.4 Requirements and tests for category AP equipment, parts and components thereof
6.5 Requirements and tests for category APG equipment, parts and components thereof
Section 7 Protection against Excessive Temperatures and Other Safety Hazards
7.1 Excessive temperatures
7.2 Fire prevention
7.3 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
7.4 Pressure vessels and parts subject to pressure
7.5 Human errors
7.6 Electrostatic charges
7.7 Materials in applied parts in contact with the body of the patient
7.8 Interruption of the power supply
Section 8 Accuracy of Operating Data and Protection against Hazardous Output
8.1 Accuracy of operating data
8.2 Protection against hazardous output
Section 9 Abnormal Operation and Fault Conditions; Environmental Tests
9.1 Abnormal operation and fault conditions
9.2 Environmental test
Section 10 Constructional Requirements
10.1 General
10.2 Enclosures and covers
10.3 Components and general assembly
10.4 Mains parts, components and layout
10.5 Protective earthing — Terminals and connections
10.6 Construction and layout
Section 11 Additional Clauses
11.1 Auditory indicators
11.2 Indication of loss of mains power
Annexes
Annex N (Normative) Test Apparatus
Annex P (Informative) Rationale Statement
Bibliography