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GB 42125.11-2025: Safety requirements for electrical equipment for measurement, control and laboratory use - Part 11: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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Safety requirements for electrical equipment for measurement, control and laboratory use - Part 11: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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GB 42125.11-2025
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Basic data | Standard ID | GB 42125.11-2025 (GB42125.11-2025) | | Description (Translated English) | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 11: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials | | Sector / Industry | National Standard | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.10 | | Word Count Estimation | 34,311 | | Date of Issue | 2025-04-25 | | Date of Implementation | 2028-05-01 | | Older Standard (superseded by this standard) | GB 4793.4-2019 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 42125.11-2025: Safety requirements for electrical equipment for measurement, control and laboratory use - Part 11: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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ICS 11.080.10
CCSC47
National Standard of the People's Republic of China
Replaces GB 4793.4-2019
Safety of electrical equipment for measurement, control and laboratory use
Requirements Part 11.For use in processing medical materials
Particular requirements for sterilizers and washer-disinfectors
medical materials,IDT)
Published on April 25, 2025, implemented on May 1, 2028
State Administration for Market Regulation
The National Standardization Administration issued
Table of contents
Preface III
Introduction V
1 Scope and purpose 1
2 Normative references 2
3 Terms and Definitions 2
4 Experiment 3
5 Logo and Documentation 4
6 Protection against electric shock 8
7 Protection against mechanical hazards and hazards associated with mechanical functions 9
8 Mechanical stress resistance 12
9 Prevent the spread of fire12
10 Temperature limits and heat resistance of equipment 13
11 Protection against hazards from fluids and solid foreign matter 13
12 Protection against radiation (including laser sources), sound pressure and ultrasonic pressure 16
13 Protection against released gases, substances, explosions and implosions 16
14 Components and Assemblies20
15 Protection by interlocking device 22
16 Hazards caused by application 22
17 Risk Assessment22
Appendix 23
Appendix G (Informative) Leakage and rupture caused by fluid pressure 24
Appendix L (Informative) Index of defined terms 25
Reference 26
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document is Part 11 of GB (/T)42125 "Safety requirements for electrical equipment for measurement, control and laboratory use". GB (/T)42125
The following parts have been published.
--- Part 1.General requirements;
--- Part 2.Particular requirements for laboratory equipment for material heating;
--- Part 3.Particular requirements for refrigeration equipment;
--- Part 4.Special requirements for climate and environmental tests and other temperature regulation equipment;
--- Part 5.Particular requirements for laboratory centrifuges;
--- Part 7.Safety requirements for hand-held and hand-operated probe assemblies for electrical measurement and test;
--- Part 10.Particular requirements for insulation resistance measurement and dielectric strength test equipment;
--- Part 11.Particular requirements for sterilizers and washer-disinfectors for processing medical materials;
--- Part 14.Particular requirements for automatic and semi-automatic equipment for laboratory use for analytical and other purposes;
--- Part 17.Particular requirements for equipment used by children in educational institutions;
--- Part 18.Particular requirements for control equipment;
--- Part 19.Particular requirements for electric control valve actuators.
This document replaces GB 4793.4-2019 "Safety requirements for electrical equipment for measurement, control and laboratory use Part 4.
Compared with GB 4793.4-2019, in addition to structural adjustments and editorial changes,
The main technical changes are as follows.
--- Changed the equipment not included in the scope of this document and deleted "environmental chamber" (see 1.1.2, 1.1.2 of the.2019 edition);
--- Added the terms and definitions "cleaner-disinfector" and "operator" (see Chapter 3, Chapter 3 of the.2019 edition);
--- Added technical content on applying fault conditions (see 4.4.2.1);
--- Deleted the technical content of the heating device (see 4.4.2.10 of the.2019 edition);
--- Added technical content of the mark (see 5.1.2);
--- Added technical content for pressure vessels and shell boilers (see 5.1.102);
--- The technical content of warning signs has been changed (see 5.2, 5.2 of the.2019 edition);
--- Changed the technical content of the general document (see 5.4.1, 5.4.1 of the.2019 edition);
--- Changed the technical content of equipment rating (see 5.4.2, 5.4.2 of the.2019 edition);
--- Changed the technical content of equipment installation (see 5.4.3, 5.4.3 of the.2019 edition);
--- Changed the technical content of equipment operation (see 5.4.4, 5.4.4 of the.2019 edition);
--- Changed the technical content of equipment maintenance and repair (see 5.4.5, 5.4.5 of the.2019 edition);
--- Deleted the technical content of protection against electric shock requirements (see 6.1.1 of the.2019 edition);
--- Added technical content of AC voltage test (see 6.8.3.1);
--- Added technical content of insulating materials (see 6.9.2);
--- Deleted the technical content of the installation of non-detachable power cords and wire entry (see 6.10.2 of the.2019 edition);
--- Deleted the technical content of failure or partial failure of mains power supply (see 6.101 of the.2019 edition);
--- Deleted the technical content of the emergency shutdown device (see 7.1.101 of the.2019 edition);
--- Deleted the technical content of moving parts (see 7.2 of the.2019 edition);
--- Changed the technical content of the lifting and handling devices (see 7.5, 7.4 of the.2019 edition);
--- Changed the title and content of 7.103 (see 7.103, 7.103 of the.2019 edition);
--- Changed the technical content of preventing the start of a new operating cycle (see 7.104, 7.104 of the.2019 edition);
--- Changed the title and content of the door for equipment with fluid containers (see 7.106, 7.106 of the.2019 edition);
--- Changed the technical content of double-door equipment (see 7.107, 7.107 of the.2019 edition);
--- Added technical content on transportation and packaging (see 7.108);
--- Added technical content of protective devices and panels (see 7.109);
--- Added the technical content of emergency stop device (see 7.110);
--- Added technical content for equipment equipped with or using flammable gases (see 9.5.101);
--- Changed the technical content of the surface temperature limit for burn prevention (see 10.1, 10.1 of the.2019 edition);
--- Changed the technical content of other temperature measurements (see 10.3, 10.3 of the.2019 edition);
--- Deleted the technical content of overflow (see 11.4 of the.2019 edition);
--- Changed the title and content of 11.7.4 (see 11.7.4, 11.7.4 of the.2019 edition);
--- Deleted the technical content of non-electrical supply and service failure or partial failure (see 11.103 of the.2019 edition);
--- Added technical content of sound waves and ultrasonic pressure (see 12.5);
--- Changed the title and content of 13.1 (see 13.1, 13.1 of the.2019 edition);
--- Changed the title and content of Chapter 14 (see Chapter 14, Chapter 14 of the.2019 edition);
--- Deleted the requirements for motor temperature (see 14.2.1 of the.2019 edition);
--- The title and content of 14.101 have been changed (see 14.101, 14.101 of the.2019 edition);
--- Changed the technical content of protection using interlocking devices (see Chapter 15, Chapter 15 of the.2019 edition);
--- Changed the title and content of Chapter 16 (see Chapter 16, Chapter 16 of the.2019 edition);
--- Added technical content of risk assessment (see Chapter 17).
This document is equivalent to IEC 61010-2-040.2020 "Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-040
Part 1.Particular requirements for sterilizers and washer-disinfectors used to process medical materials.
The following minimal editorial changes were made to this document.
--- In order to coordinate with the existing standards, the name of the document was changed to "Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 11
Part 1.Particular requirements for sterilizers and washer-disinfectors used to process medical materials.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed and coordinated by the State Food and Drug Administration.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2001 as GB 4793.4-2001;
---In the first revision in.2019, GB 4793.8-2008 "Safety requirements for electrical equipment for measurement, control and laboratory use" was incorporated.
Part 2-042.Special requirements for autoclaves and sterilizers for treating medical materials with toxic gases and for laboratory use
Requirements” (the previous versions of GB 4793.8-2008 are. GB 4793.8-2008);
Introduction
GB (/T)42125 "Safety requirements for electrical equipment for measurement, control and laboratory use" is planned to consist of 20 parts.
--- Part 1.General requirements. The purpose is to specify the general safety requirements of electrical equipment for measurement, control and laboratory use and their accessories
Require.
--- Part 2.Particular requirements for laboratory equipment for material heating. The purpose is to specify the special requirements for laboratory material heating equipment.
Security requirements.
--- Part 3.Particular requirements for refrigeration equipment. The purpose is to specify the special safety requirements for refrigeration equipment used in measurement, control and laboratories
Require.
--- Part 4.Special requirements for climate and environmental tests and other temperature regulation equipment. The purpose is to specify climate and environmental tests
Special safety requirements for testing and other temperature regulating equipment.
--- Part 5.Particular requirements for laboratory centrifuges. The purpose is to specify special safety requirements for laboratory centrifuges.
--- Part 6.Particular requirements for test or measuring circuit equipment. The purpose is to specify the special safety requirements of test or measuring circuit equipment.
Require.
--- Part 7.Safety requirements for hand-held and hand-operated probe assemblies for electrical measurement and testing. The purpose is to specify the safety requirements for hand-held and hand-operated probe assemblies.
Safety requirements for head assemblies and related accessories.
--- Part 8.Particular requirements for hand-held and hand-operated current sensors for electrical measurement and testing. The purpose is to specify the requirements for hand-held and hand-operated current sensors.
Special safety requirements for current sensors.
--- Part 9.Particular requirements for hand-held multimeters and other instruments for household and professional use capable of measuring mains supply voltage.
It is used to specify special safety requirements for hand-held multimeters and other instruments for household and professional use that can measure mains supply voltage.
--- Part 10.Particular requirements for insulation resistance measurement and dielectric strength test equipment. The purpose is to specify the output voltage AC 50V
Safety requirements for equipment used for insulation resistance measurement and dielectric strength testing at or above 120V DC.
--- Part 11.Particular requirements for sterilizers and washer-disinfectors used to process medical materials.
Particular safety requirements for sterilizers and washer-disinfectors using materials.
--- Part 12.Particular requirements for laboratory mixing and stirring equipment. The purpose is to specify electric stirring and agitation equipment used for mechanical stirring and agitation.
Particular safety requirements for laboratory equipment and its accessories.
--- Part 13.Particular requirements for laboratory atomic spectrometers with thermal atomization and ionization. The purpose is to specify the requirements for laboratory atomic spectrometers with thermal atomization and ionization.
Particular safety requirements for atomic spectrometers for atomization and ionization.
--- Part 14.Particular requirements for automatic and semi-automatic equipment for laboratory analysis and other purposes. The purpose is to specify laboratory
Particular safety requirements for automatic and semi-automatic equipment for analytical and other purposes.
--- Part 15.Particular requirements for cabinet X-ray systems. The purpose is to specify special safety requirements for cabinet X-ray systems.
--- Part 16.Particular requirements for in vitro diagnostic (IVD) medical devices. The purpose is to specify the intended use for in vitro diagnostic medical purposes
Special requirements for medical devices.
--- Part 17.Particular requirements for equipment used by children in educational institutions. The purpose is to specify the requirements for equipment used by student operators in educational institutions.
Particular safety requirements for equipment and accessories.
--- Part 18.Particular requirements for control equipment. The purpose is to specify the special requirements and related requirements for control equipment used in industrial environments
identification test.
--- Part 19.Particular requirements for electric control valve actuators. The purpose is to specify the requirements for electric control valve actuators installed in industrial processes or discrete control
Safety requirements for electric control valve actuators and solenoid coils in environments.
--- Part 20.Particular requirements for industrial communication circuits and communication port interconnections. The purpose is to specify the requirements for installation in process or discrete control
Special safety requirements for industrial communication circuits in an environment.
Note. The correspondence between each part and the IEC 61010 series standards is as follows.
--- Part 1 corresponds to IEC 61010-1;
--- Part 2 corresponds to IEC 61010-2-010;
--- Part 3 corresponds to IEC 61010-2-011;
--- Part 4 corresponds to IEC 61010-2-012;
--- Part 5 corresponds to IEC 61010-2-020;
--- Part 6 corresponds to IEC 61010-2-030;
--- Part 7 corresponds to IEC 61010-031;
--- Part 8 corresponds to IEC 61010-2-032;
--- Part 9 corresponds to IEC 61010-2-033;
--- Part 10 corresponds to IEC 61010-2-034;
--- Part 11 corresponds to IEC 61010-2-040;
--- Part 12 corresponds to IEC 61010-2-051;
--- Part 13 corresponds to IEC 61010-2-061;
--- Part 14 corresponds to IEC 61010-2-081;
--- Part 15 corresponds to IEC 61010-2-091;
--- Part 16 corresponds to IEC 61010-2-101;
--- Part 17 corresponds to IEC 61010-2-130;
--- Part 18 corresponds to IEC 61010-2-201;
--- Part 19 corresponds to IEC 61010-2-202;
--- Part 20 corresponds to IEC 61010-2-203.
This document should be combined with GB/T 42125.1-2024 "Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General
Requirements》.
The part marked "Applicable" in this document indicates that the corresponding clauses of GB/T 42125.1-2024 apply to this document;
The part marked "replace" or "modify" indicates that the provisions of this document shall prevail. The part marked "add" in this document indicates that in addition to complying with
In addition to the corresponding clauses of GB/T 42125.1-2024, the additional clauses in this document must also be complied with.
2024, the numbering of the clauses added by this document begins with 101, for example 3.2.101.
Safety of electrical equipment for measurement, control and laboratory use
Requirements Part 11.For use in processing medical materials
Particular requirements for sterilizers and washer-disinfectors
1 Scope and purpose
Except for the following contents, Chapter 1 of GB/T 42125.1-2024 applies.
1.1.1 Equipment to which this document applies
replace.
Replace the existing entry with the following entry.
This document is applicable to medical materials intended for use in medical institutions, veterinary medicine, pharmaceutical and laboratory fields under the environmental conditions of 1.4.
Safety requirements for electrical equipment that is sterilized, cleaned, and disinfected.
For example.
a) sterilizers and disinfectors using steam and/or hot water as sterilization media;
b) Sterilizers and disinfectors using toxic gases, toxic aerosols or toxic steam as sterilization media;
c) sterilizers and disinfectors using hot air or hot inert gas as sterilization medium;
d) Washer-disinfector.
1.1.2 Equipment not included in the scope of this document
Increase.
Add the following note after item f).
Note. IEC 60601-1.2005 3.63 defines medical electrical equipment as follows (item comments are ignored).
Electrical equipment having an applied part that transmits or extracts energy to a patient or detects such energy transmitted or extracted, such electrical equipment.
a) has no more than one connection to a designated electricity supply network; and
b) its manufacturer intends it to be used.
1) diagnosis, treatment and monitoring of patients; or
2) Eliminate or alleviate disease, injury or disability.
Increase.
Add a second paragraph after the alphabetical items.
This document also does not apply to the following types of equipment.
aa) Equipment used in hazardous atmospheres [see IEC 60079 (all parts)], where a flammable sterilizing agent is used to produce such an atmosphere inside the equipment
Except for equipment in the environment (see 13.2.101 and 13.2.102);
bb) Laboratory equipment for heating materials for purposes other than sterilization or disinfection (see GB/T 42125.2);
cc) Laundry appliances [see IEC 60335-2-4, IEC 60335-2-7, IEC 60335-2-11 and ISO 10472 (all parts)], unless
It is designed for sterilization of medical materials;
dd) Dishwashers (see IEC 60335-2-5 and IEC 60335-2-58).
1.2.1 Aspects included in the scope of this document
replace.
Replace item g with the following).
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