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YY/T 0791-2018: Medical steam generators
Status: Valid YY/T 0791: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0791-2018 | English | 279 |
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Medical steam generators
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YY/T 0791-2018
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| YY 0791-2010 | English | 439 |
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Steam generators for medical use
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YY 0791-2010
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PDF similar to YY/T 0791-2018
Standard similar to YY/T 0791-2018 YY/T 0802.1 YY 0451 YY/T 1268 YY/T 0802.2 Basic data | Standard ID | YY/T 0791-2018 (YY/T0791-2018) | | Description (Translated English) | Medical steam generators | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.99 | | Word Count Estimation | 14,177 | | Date of Issue | 2018-09-29 | | Date of Implementation | 2019-10-01 | | Older Standard (superseded by this standard) | YY 0791-2010 | | Quoted Standard | GB 150.1; GB 150.2; GB 150.3; GB 150.4; GB/T 151; GB/T 191; GB 4793.1; GB/T 9969; GB/T 18268.1; GB/T 19971; JB/T 2379; JB/T 9243; YY/T 1612-2018 | | Regulation (derived from) | State Drug Administration Announcement No. 72 of 2018 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the classification and composition of medical steam generators, requirements, test methods, signs and instructions for use. This standard is applicable to medical steam generators (hereinafter referred to as steam generators) that generate steam at a working pressure of not more than 0.8 MPa and use electric heating or steam heating. The steam generator is an independently controlled, external device that produces steam for use in medical equipment in medical facilities. This standard does not apply to steam generators that generate steam in other ways. | YY/T 0791-2018: Medical steam generators---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.
Medical steam generators
ICS 11.080.99
C47
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0791-2010
Medical steam generator
Published on.2018-09-28
2019-10-01 implementation
State Drug Administration issued
Content
Foreword I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and composition 1
5 Requirements 2
6 Test method 5
7 logo and instruction manual 8
Appendix A (informative) Quality indicators for water supply 10
Reference 11
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0791-2010 "medical steam generator", compared with YY 0791-2010, the main changes are as follows.
--- Modify the scope of application (see Chapter 1, Chapter 1 of the.2010 edition);
--- Modify the definition of saturated steam (see 3.1, 3.1 of.2010 edition);
--- Modify classification and composition (see Chapter 4, Chapter 4 of the.2010 edition);
--- Increase the steam condensate sampling port and drain requirements (see 5.2.4 and 5.2.5);
--- Remove the requirements for safety valves (see 5.5 of.2010 edition);
--- Modify the requirements of the heating device (see 5.6, 5.6 of the.2010 edition);
--- Increase the requirements of the heat exchange system (see 5.7);
--- Modify the requirements of the work indicating device (see 5.9, 5.8 of.2010 edition);
--- Modify the requirements of the liquid level display device (see 5.10, 5.9 of.2010 edition);
--- Modify the requirements of the water tank (see 5.11, 5.10 of the.2010 edition);
--- Remove the requirement to reach the maximum saturated steam pressure (see 5.11 of the.2010 edition);
--- Increase the requirements of the recording device (see 5.13);
--- Increase the requirements for high water level protection devices (see 5.14);
--- Increase the requirements for low water level protection devices (see 5.15);
---Modify the requirements for anti-dry protection devices (see 5.16, 5.13 for.2010 edition)
--- Modify the requirements of the warning signal (see 5.17, 5.14 of the.2010 edition);
--- Increase the demand for steam production (see 5.20);
--- Increase the requirements for output steam quality (see 5.21);
--- Increase emission requirements (see 5.22);
---Modify the security requirements (see 5.23, 5.17 of the.2010 edition);
--- Increase electromagnetic compatibility requirements (see 5.24);
--- Remove environmental test requirements (see 5.18 of the.2010 edition);
---Delete inspection rules (see Chapter 7 of the.2010 edition);
--- Remove packaging, transportation, storage (see Chapter 9 of the.2010 edition).
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. Shandong Xinhua Medical Devices Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Ningbo Chunan Medical
Medical Device Manufacturing Co., Ltd.
The main drafters of this standard. Xu Rongkai, Li Shining, Tao Weihua, Han Jiankang, Zhou Yuxin, Liu Zhenjian.
The previous versions of the standards replaced by this standard are.
---YY 0791-2010.
Medical steam generator
1 Scope
This standard specifies the classification and composition of medical steam generators, requirements, test methods, signs and instructions for use.
This standard is applicable to medical steam generators that generate steam at a working pressure of not more than 0.8 MPa and use electric heating or steam heating (below
Referred to as steam generator). The steam generator is an independently controlled, external device that produces steam for use in medical equipment in medical facilities.
This standard does not apply to steam generators that generate steam in other ways.
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 151 heat exchanger
GB/T 191 packaging storage and transportation pictorial signs (GB/T 191-2008, ISO 780.1997, MOD)
Safety of electrical equipment for measurement, control and laboratory use - Part 1 . General requirements (GB 4793.1-2007,
IEC 61010-1.2001, IDT)
GB/T 9969 General guidelines for the use of industrial products
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment - Part 1 . General requirements
(GB/T 18268.1-2010, IEC 61326-1.2005, IDT)
GB/T.19971 Terminology of sterilization of health care products (GB/T.19971-2015, ISO /T S11139.2006, IDT)
JB/T 2379 metal tubular electric heating element
JB/T 9243 glass tube level gauge
YY/T 1612-2018 Test method for medical sterilization steam quality
3 Terms and definitions
The terms and definitions defined in GB/T.19971 apply to this document.
3.1
Saturated steam sataturatedteam
Evaporation and condensation are in dynamic equilibrium when the number of molecules entering the vapor space per unit time is equal to the number of molecules in the return liquid.
steam.
4 Classification and composition
4.1 Classification
4.1.1 The steam generator can be divided into vertical and horizontal according to the way the container is placed.
4.1.2 The steam generator can be divided into automatic control type and manual control type according to the control mode.
4.1.3 Steam generators can be divided into electric heating type and steam heating type according to heating mode.
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