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YY/T 0822-2011Ethylene oxide liquefied gas for sterilization (English PDF)

灭菌用环氧乙烷液化气体

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY/T 0822-2011 is the English-translated version of 灭菌用环氧乙烷液化气体.

YY/T 0822-2011 is the Chinese pharmaceutical industry standard for the liquefied ethylene oxide gas used for sterilization.

It specifies the terms and definitions, the classification, the requirements, the test methods, the inspection rules, the marks and the rules for packaging, transport, storage and safety, covering the purity of the gas and the limits on its impurities, the water content, the residue on evaporation, the cylinder and its marking and the precautions its handling requires. Issued on 31 December 2011, it has applied since 1 June 2013.

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Document preview — YY/T 0822-2011

National Standard of the People's Republic of China

ICS
11.080.01
Classification
C 47

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

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

1 Scope

This standard specifies the terms and definitions liquefied gas sterilization with ethylene oxide, classification, requirements, test methods, inspection rules, marks, packages Loading, transport, storage and security.

This standard applies to liquefied gas sterilization with ethylene oxide (hereinafter referred to as the product). Products include ethylene oxide and ethylene liquefied gas Dioxane, carbon dioxide was mixed liquefied gas formation.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB 190 packaging and marking of dangerous goods

GB 5099 seamless steel gas cylinders

GB 5100 welded steel cylinders

GB/T 6052-2011 industrial liquid carbon dioxide

GB/T 8979-2008 nitrogen, high purity nitrogen and ultra pure nitrogen

GB/T 11640 seamless aluminum alloy gas cylinders

GB/T 12137-2002 Test method for airtightness of cylinders

GB/T 13098-2006 industrial with ethylene oxide

GB 14193 Rules for filling of liquefied gas cylinders

GB/T 25164 containers 25.4mm diameter aluminum aerosol cans JJF 1070-2005 prepackaged goods measured net content inspection rules TSGRF001 cylinders Accessories Safety Technology Supervision Gas Cylinder Safety Supervision regulations (2003) the State Administration of Quality Supervision, Inspection and Quarantine

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Ethylene oxide gas (EOG)

Ethylene oxide gas ethyleneoxidegas; EOG Gaseous form ethylene oxide, molecular formula C2H4O.

3.2 Mixed liquefied gas

Ethylene oxide or propylene oxide with liquefied carbon dioxide, liquefied gas formed by the mixing ratio.

3.3 Protective gas

Pressurized filling 100% protection when using ethylene oxide gas, such as 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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