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
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 1226General pressure gauge
- GB 4793.1Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
- GB 4793.4Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 4: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
- GB/T 7307Pipe threads with 55-degree thread angle where pressure-tight joints are not made on the threads
- GB 8599-2008Technical requirements for large steam sterilizers
GB 150 · GB/T 16839.2-1997 · GB 18281.3
Similar standards
Editions of YY/T 1007
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 1007-2018 | Vertical steam sterilizers | current edition | Current |
| YY 1007-2010 | Vertical steam sterilizers | previous edition | Superseded |
This page sells the current edition, YY/T 1007-2018. Earlier editions are listed for reference only.
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Related Standards
GB 4793.1-2007 — Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
GB 4793.4-2019 — Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 4: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
GB 8599-2008 — Technical requirements for large steam sterilizers
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