General Specification for Medical Oxygen Generator with Molecular Sieve
1 Scope
This standard specifies the definitions, classification, requirements, test methods, inspection rules, markings, instructions for use, packaging, transportation, storage and guarantee period of medical oxygen generator with molecular sieve.
This standard is applicable to the medical oxygen generator with molecular sieve (hereinafter referred to as oxygen generator) for generation of medical oxygen by pressure swing adsorber (PSA) system with zeolite molecular sieve as an adsorbent.
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below.
GB/T 191-90 Packaging — Pictorial Marking for Handling of Goods
GB 5832.2-86 Determination of Trace Water in the Gases — Dew Point Method
GB 8986-88 Testing Methods of Gaseous Oxygen Supplies for Medicine and Gaseous Breathing Oxygen Supplies for Aircraft
GB 9706.1-1995 Medical Electrical Equipment — Part 1: General Requirements for Safety
GB 9969.1-88 General Principles for Preparation of Instructions for Use of Industrial Products
GB/T 14436-93 General Principles of Industrial Products Guarantee Documents
GB/T 14710-93 The Environmental Requirements and Test Methods for Medical Electrical Equipment
3 Definitions
For the purposes of this standard, the following definitions apply.
3.1 adsorption
enrichment produced by the component at phase boundary when gas phase and solid phase constitute the adsorption system (adsorption phase)
3.2 desorption
phenomenon of molecules of gas (liquid) adsorbed by an adsorbent being released back into the gas (liquid) phase
3.3 pressure swing adsorption
cyclic operation of pressurized adsorption and decompressed desorption under adiabatic conditions
3.4 oxygen 93 percent
oxygen produced by pressure swing adsorption of molecular sieve process and using air as raw material oxygen-enriched air containing not less than 90% and not more than 96% (V/V) oxygen, the remainder comprising predominantly argon and/or nitrogen
Foreword I
ISO Foreword II
1 Scope
2 Normative References
3 Definitions
4 Classification
5 Requirements
6 Test Methods
7 Inspection Rules
8 Marking and instructions for Use
9 Packaging, Transportation and Storage
10 Warranty Period
