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YY/T 1007-2018Vertical steam sterilizers (English PDF)

立式蒸汽灭菌器

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 28, 2018

Implementation date

October 1, 2019

Scope

YY/T 1007-2018 is the English-translated version of 立式蒸汽灭菌器.

YY/T 1007-2018 is the Chinese standard "Vertical steam sterilizers". Its scope clause reads: This standard specifies the terms and definitions, classification, requirements, test methods and nameplates, instructions for use, packaging, and transportation of vertical steam sterilizers.

Loss and storage. This standard is applicable to steam sterilizers (hereinafter referred to as sterilizers) with a volume of not less than 30L in the sterilization chamber and an upward opening.

The sterilizer master To be used for sterilization of medical devices. This standard does not apply to portable steam sterilizers. Its clauses include terms and definitions.

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Document preview — YY/T 1007-2018

National Standard of the People's Republic of China

ICS
11.080.10
Classification
C 47
Replacing
YY 1007-2010

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

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Category
  • 5 Requirements
  • 6 Test method
  • 7 Nameplate, instruction manual, packaging, transportation, storage
  • Appendix A (informative) Quality indicators for water and steam condensate supply
  • Appendix B (Normative Appendix) Test Instruments and Equipment

1 Scope

This standard specifies the terms and definitions, classification, requirements, test methods and nameplates, instructions for use, packaging, and transportation of vertical steam sterilizers.

Loss and storage.

This standard is applicable to steam sterilizers (hereinafter referred to as sterilizers) with a volume of not less than 30L in the sterilization chamber and an upward opening. The sterilizer master

To be used for sterilization of medical devices.

This standard does not apply to portable steam sterilizers.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.

Pieces. For undated references, the latest edition (including all amendments) applies to this document.

GB 150 (all parts) pressure vessel

GB/T 191 packaging storage and transportation pictorial signs (ISO 780.1997, MOD)

GB/T 1226 general pressure gauge

GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements (IEC 61010-1.

2001, IDT)

GB 4793.4 Safety requirements for measuring, control and laboratory electrical equipment - Particular requirements for autoclaves for the treatment of medical materials (IEC 61010-2-041..1995, IDT)

GB/T 7307 55° unsealed pipe thread (ISO 228-1.1994, EQV)

GB 8599-2008 Large steam sterilizer technical requirements Automatic control type

GB/T 12244 pressure reducing valve general requirements

GB/T 14710 Medical electrical requirements and test methods

GB/T 16839.2-1997 Thermocouple Part 2. Tolerance (IEC 584-2.1982, IDT)

GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment - Part 1 . General requirements

61326-1.2005, IDT)

GB 18281.3 Sterilization of biological indicators for health care products - Part 3. Biological indicators for moist heat sterilization (ISO 11138-3.

2006, IDT)

GB/T.19971 Terminology of sterilization of health care products (ISO /T S11139.2006, IDT)

GB/T 30121-2013 industrial platinum thermal resistance and platinum temperature sensing element

YY 0154 Spring full-open safety valve for pressure steam sterilization equipment

YY/T 0158 Gasket for pressure steam sterilization equipment

YY/T 0646-2015 Small steam sterilizer automatic control type

3 Terms and definitions

The following terms and definitions as defined in GB/T.19971 and GB 8599-2008 apply to this document.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of YY/T 1007

EditionTitleRevisionStatus
YY/T 1007-2018Vertical steam sterilizerscurrent editionCurrent
YY 1007-2010Vertical steam sterilizersprevious editionSuperseded

This page sells the current edition, YY/T 1007-2018. Earlier editions are listed for reference only.

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