US$379.00 · In stock Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1007-2018: Vertical steam sterilizers Status: Valid YY/T 1007: Evolution and historical versions
Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
YY/T 1007-2018 | English | 379 |
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Vertical steam sterilizers
| Valid |
YY/T 1007-2018
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YY 1007-2010 | English | 759 |
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Vertical mode steam sterilizers
| Obsolete |
YY 1007-2010
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YY 1007-2005 | English | 479 |
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Vertical mode steam sterilizers
| Obsolete |
YY 1007-2005
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PDF similar to YY/T 1007-2018
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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| Word Count Estimation | 19,180 | Date of Issue | 2018-09-29 | Date of Implementation | 2019-10-01 | Older Standard (superseded by this standard) | YY 1007-2010 | Quoted Standard | GB 150.1; GB 150.2; GB 150.3; GB 150.4; GB/T 191; GB/T 1226; GB 4793.1; GB 4793.4; GB/T 7307; GB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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