YY/T 0791-2018Medical steam generators (English PDF)

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).

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 document. 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.

4 Classification and composition