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YY/T 1007-2018 English PDF

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YY/T 1007-2018: Vertical steam sterilizers
Status: Valid

YY/T 1007: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1007-2018English379 Add to Cart 4 days [Need to translate] Vertical steam sterilizers Valid YY/T 1007-2018
YY 1007-2010English759 Add to Cart 4 days [Need to translate] Vertical mode steam sterilizers Obsolete YY 1007-2010
YY 1007-2005English479 Add to Cart 4 days [Need to translate] Vertical mode steam sterilizers Obsolete YY 1007-2005

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Basic data

Standard ID YY/T 1007-2018 (YY/T1007-2018)
Description (Translated English) Vertical steam sterilizers
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C47
Classification of International Standard 11.080.10
Word Count Estimation 19,180
Date of Issue 2018-09-29
Date of Implementation 2019-10-01
Older Standard (superseded by this standard) YY 1007-2010
Quoted Standard GB 150.1; GB 150.2; GB 150.3; GB 150.4; GB/T 191; GB/T 1226; GB 4793.1; GB 4793.4; GB/T 7307; GB 8599-2008; GB/T 12244; GB/T 14710; GB/T 16839.2-1997; GB/T 18268.1; GB 18281.3; GB/T 19971; GB/T 30121-2013; YY 0154; YY/T 0158; YY/T 0646-2015
Regulation (derived from) State Drug Administration Announcement No. 72 of 2018
Issuing agency(ies) State Drug Administration
Summary This standard specifies the terms and definitions, classification, requirements, test methods and nameplates, instructions for use, packaging, transportation and storage of vertical steam sterilizers. This standard is applicable to steam sterilizers (hereinafter referred to as sterilizers) with a volume of not less than 30 L in the sterilization chamber and an upward opening. The sterilizer is mainly used for sterilization of medical devices. This standard does not apply to portable steam sterilizers.

YY/T 1007-2018: Vertical steam sterilizers

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Vertical steam sterilizers ICS 11.080.10 C47 People's Republic of China Pharmaceutical Industry Standard Replacing YY 1007-2010 Vertical steam sterilizer Published on.2018-09-28 2019-10-01 implementation State Drug Administration issued

Content

Foreword III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Category 2 5 Requirements 2 6 Test method 7 7 Nameplate, instruction manual, packaging, transportation, storage 12 Appendix A (informative) Quality indicators for water and steam condensate supply 14 Appendix B (Normative Appendix) Test Instruments and Equipment 15

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 1007-2010 "Vertical Steam Sterilizer". Compared with YY 1007-2010, the main changes are as follows. ---Modified the description of "Sterilizer Door" and "Synchronized Alarm Function" in the safety interlock device clause (see 5.4); --- Removed the contents of the deflation valve and trap (see 5.3.3 and 5.3.4 of YY 1007-2010); --- Deleted the original 5.4.2 clause, because the special safety standard GB 4793.4 has provisions for opening the pressure vessel after pressure relief (See 5.4.2 of YY 1007-2010); --- Revised the version number of the electromagnetic compatibility standard GB/T 18268.1 (see 5.17.2); --- Modified the timer test method (see 6.6.5); --- Modified the anti-dry function test method (see 6.9.2); --- Increased sterilization temperature control solid load, liquid load test method, and solid load, liquid load sterilization effect test Method (see 6.10.1.2, 6.10.1.3, 6.13.2, 6.13.3). Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200). This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Shandong Xinhua Medical Instrument Co., Ltd., Jiangyin Binjiang Medical Treatment Equipment Co., Ltd. The main drafters of this standard. Gong Yuling, Liu Fei, Cha Shihong, Qiu Weiyu. The previous versions of the standards replaced by this standard. ---YY 1007-2010, YY 1007-2005; ---YY 91125-1999, WS2-85-83, WS2-85-73, WS2-85-64; ---YY 91007-1999, GB 4027.2-83. Vertical steam sterilizer

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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