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YY/T 0298-1998General specification for medical oxygen generator with molecular sieve (English PDF)

医用分子筛制氧设备通用技术规范

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

April 8, 1998

Implementation date

October 1, 1998

Scope

YY/T 0298-1998 is the English-translated version of 医用分子筛制氧设备通用技术规范.

YY/T 0298-1998 is the Chinese standard "General specification for medical oxygen generator with molecular sieve".

Its scope clause reads: 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. Its clauses include definitions.

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Document preview — YY/T 0298-1998

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • 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

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 […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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