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Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 9: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
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GB 4793.9-2013: PDF in English GB 4793.9-2013
Safety requirements for electrical equipment for measurement, control and laboratory use. Part 9. Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
ICS 13.100
N09
National Standards of People's Republic of China
Electrical equipment for measurement, control and laboratory use
Safety requirements. Part 9. Analysis and laboratory use
Special requirements for automatic and semi-automatic equipment for other purposes
controlandlaboratoryuse-Part 9. Particular requirementsforautomaticand
(IEC 61010-2-081..2009, IDT)
2013-12-17 release
2014-11-01 Implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
Published by China National Standardization Administration
Contents
Foreword I
1 Scope and purpose 1
2 Normative references 2
3 Terms and definitions 2
4 Test 3
5 Logos and documents 3
6 Protection against electric shock 6
7 Protection against mechanical hazards 6
8 Resistance to mechanical shock and impact 7
9 Preventing the spread of flames 7
10 Equipment temperature limits and heat resistance 7
11 Protection against liquid hazards 7
12 Radiation protection (including laser source), sound pressure and ultrasonic pressure 7
13 Protection against released gases, explosions and implosions 7
13 Protection against released gases and substances, explosions and implosions 7
14 Components 8
15 Protection with interlocks 8
16 Test and measurement equipment 8
Appendix AA (Normative Appendix) Risk Management 9
References 11
Foreword
The entire technical content of this section is mandatory.
GB 4793 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
--- Part 1. General requirements;
--- Part 2. Particular requirements for handheld and hand-held current sensors for electrical measurement and testing;
--- Part 3. special requirements for laboratory mixing and stirring equipment;
--- Part 4. special requirements for autoclaves for medical materials used in laboratories;
--- Part 5. special requirements for handheld probe assemblies for electrical measurement and testing;
--- Part 6. special requirements for laboratory heating equipment;
--- Part 7. special requirements for laboratory centrifuges;
--- Part 8. Special requirements for the use of toxic gases for the treatment of medical materials and for pressure sterilizers and sterilizers for laboratory use;
--- Part 9. Particular requirements for laboratory and other purposes of automatic and semi-automatic equipment for analysis and other purposes.
Note. The names of the above parts will change with the change of IEC standard names.
This part is Part 9 of GB 4793.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This section uses the translation method equivalent to IEC 61010-2-081..2009 "Safety requirements for electrical equipment for measurement, control, and laboratory use
Part 2-081. Particular requirements for automatic and semi-automatic equipment for analytical and other purposes in laboratories. Its technical content is in accordance with IEC 61010-2-
081..2009 is completely equivalent.
The following editorial changes have been made in this section.
--- Omit the foreword of IEC 61010-2-081..2009 and the content of "Appendix H (informative appendix) definition index";
--- For other international standards referenced by IEC 61010-2-081..2009 that have been equivalent or modified and adopted as our standards, this
Some of these national standards or industry standards in China are cited instead of corresponding international standards, and the rest are not equivalent or modified as
International standards of Chinese standards are directly cited in this section;
--- In the standard text 1.2.1, the numbers of two new entries a) and b) were changed to h) and i).
The Chinese documents that have a consistent correspondence with the international documents referenced normatively in this section are as follows.
--- GB/T 4025-2003 Basic and safety rules for human-machine interface signs and identification Coding rules for indicators and operators
(IEC 60073..1996, IDT)
--- GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control and laboratory use-Part 1. General requirements
(IEC 61010-1..2001, IDT)
--- GB/T 16273.1-1996 Graphical symbols for equipment (General symbol (ISO 7000. 1989, NEQ)
--- YY/T 0316-2003 Application of medical device risk management to medical devices (ISO 14971..2000, IDT)
--- YY0648-2008 Safety requirements for electrical equipment for measurement, control and laboratory use-Part 2-101. In vitro diagnostics
(IVD) Specific requirements for medical equipment (IEC 61010-2-101..2002, IDT)
This section shall be combined with GB 4793.1 "Safety requirements for electrical equipment for measurement, control and laboratory use-Part 1. General requirements"
use. The part that says "applicable" in this part means that the corresponding provisions of GB 4793.1 apply to this part; the part that says "delete"
The “replaced” or “modified” part means that the terms of this part shall prevail; the part that says “added” in this part indicates that except for compliance
In addition to the corresponding provisions of GB 4793.1, it shall also comply with the terms added in this section.
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This section is proposed by China Machinery Industry Federation.
This part is under the jurisdiction of the National Technical Committee for Standardization of Measurement Control and Laboratory Electrical Equipment Safety (SAC/TC338).
The main drafters of this section. Beijing Medical Device Inspection Institute, Institute of Comprehensive Technology and Economics of Machinery Industry Instrumentation, National Food
Medical Device Technical Evaluation Center of Drug Administration, Shenzhen Mindray Biomedical Electronics Co., Ltd., Antu Experimental Instruments (Zhengzhou) have
Co., Ltd., Beijing Prolong New Technology Co., Ltd.
The main drafters of this section. Zeng Ning, Wang Yumin, Sun Jingsheng, Wu Zheng, Wang Pei, Gao Yancai, Zhao Fantang, Zhang Zhaoyuan, Liang Zhenshi, Liao Xiaoman.
Electrical equipment for measurement, control and laboratory use
Safety requirements. Part 9. Analysis and laboratory use
Special requirements for automatic and semi-automatic equipment for other purposes
1 Scope and purpose
Except for the following, Chapter 1 of GB 4793.1-2007 applies.
1.1 Scope
instead.
This section applies to laboratory and other automated and semi-automatic equipment for analytical and other purposes.
Automatic and semi-automatic laboratory equipment consists of instruments or systems for measuring and changing one or more characteristics or parameters of a sample, performing
All or part of the process does not require manual intervention. The equipment forming part of this system is applicable to this part.
Examples of equipment included in the scope of this section.
--- Analytical equipment;
--- Automatic sampler (pipette, dispenser);
--- Sample replication and amplification equipment.
Note 1. For analytical equipment, the entire process usually includes the following steps.
--- take a certain amount of sample;
--- Prepare samples by chemical, thermal, mechanical or other methods;
---measuring;
--- Display, transmit or print the measurement results.
Note 2. If all or a part of the equipment falls within the scope of this part, but also falls within the scope of other parts of the GB 4793 series of standards, this equipment
It also needs to meet the requirements of the corresponding GB 4793 series standards.
1.2 Purpose
1.2.1 What is included in the scope of this section
instead.
Replace the first sentence with the following.
The purpose of this section is to ensure that the design and construction methods used provide a high level of
Protection, specific clauses using risk management (see 7.2.101 and Appendix AA).
increase.
Add two new columns.
h) biological hazards;
i) Hazardous chemicals.
1.2.2 What is not included in the scope of this section
increase.
Add a new column item and the following note.
g) Handling or handling of materials outside the equipment.
Note. The requirements to cover these contents are the responsibility of the committee that develops the corresponding standards.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
Except for the following, Chapter 2 of GB 4793.1-2007 applies.
increase.
GB/T 2423.55-2006 Environmental test for electric and electronic products Part 2. Test test Eh. Hammer test
(IEC 60068-2-75..1997, IDT)
IEC 60073..1996 Basic and Safety Rules for Human Machine Interface Marking Indicators and Coding Rules for Operators (Basic
andsafetyprinciplesforman-machineinterface, markingidentification-codingprinciplesforinduction
devicesandactuators)
IEC 61010-1..2001 Safety requirements for electrical equipment for measurement, control and laboratory use-Part 1. General requirements (Safetyre-
quirementsforelectricalequipmentformeasurement, controlandlaboratoryuse-Part 1. Generalre-
quirements)
ISO 7000. 1989 General Symbols for Graphical Symbols for Equipment (Graphicalsymbolsforuseonequipment-indexand
synopsis)
ISO 14971..2000 Medical Device Risk Management for Medical Devices
managementtomedicaldeviceslaboratorybiosafetymanual, WorldHealthOrganization, 1984)
IEC 61010-2-101..2002 Safety requirements for electrical equipment for measurement, control and laboratory use-Part 2-101. In vitro diagnostics
[Safetyrequirementsforelectricalequipmentformeasurement, controlandlaboratoryusePart 2-101.
particularrequirementsforinvitrodiagnostic (IVD) medicalequipment]
3 terms and definitions
The terms and definitions defined in GB 4793.1 and the following apply to this document.
3.1 Equipment and equipment categories
Added definition.
3.101
Damage harm
Actual injury or damage to human health, or damage to property or the environment.
[ISO /IEC Guide 51..1999, definition 3.3]
3.102
Risk
The probability of the damage being combined with the severity of the damage.
[ISO /IEC Guide 51..1999, definition 3.2]
3.103
Tolerablerisk
Acceptable risk for a given content based on current social consensus.
[ISO /IEC Guide 51..1999, definition 3.7]
Note. Allowing risks is the idealized absolute safety, the requirements to be met by the product, process or service, and factors such as the benefit to the user, the suitability of the purpose, the
The result of a balance between factors such as efficiency, risk assessment, relevant social habits, and current technology.
4 Test
Except for the following, Chapter 4 of GB 4793.1-2007 is applicable.
4.4.2 Application of fault conditions
increase.
Added bars.
4.4.2.101 Incorrect voltage selection
Multi-voltage equipment that can be set to different supply voltages by the operator should be set to each voltage in turn and then connected to
All other rated supply voltages.
5 Logos and documents
Except for the following, Chapter 5 of GB 4793.1-2007 applies.
5.1.1 Overview
instead.
Replace the third paragraph with the following.
Quantitative and unit text symbols shall comply with IEC 60027. Wherever possible, internationally recognized symbols including Table 1 should be used
number. If other additional symbols are required, they should not be confused with internationally recognized symbols. Except for symbol 101 (see Table 1),
There is no color requirement for symbols. Graphical symbols should be explained in the document.
Table 1 Symbols
increase.
Add the following new symbols.
Serial number symbol standard description
background color
---yellow;
Symbols and outlines
---black
GB/T 16273.1-1996
Biohazard
5.1.5 Terminals, connectors and operating devices
increase.
Add the following new Note 3.
Note 3. All necessary connectors, controls and indicators used by the operator should be marked.
increase.
Added bars.
5.1.5.101 Gas and liquid connections
Clear markings should be made near the connectors of the equipment.
a) Identification of the gas or liquid used. If there is no international common symbol (including chemical formula), the equipment should be applied in Table 1.
The symbol 14 carries the sign.
b) Maximum allowable pressure or select symbol 14 in Table 1 (see 5.4.3).
Compliance is checked by visual inspection.
5.2 Warning signs
instead.
Replace the fifth paragraph with the following five paragraphs.
Equipment that may be potentially infectious due to samples or reagents used should be marked marked 101 in Table 1.
Equipment that may be hazardous due to the use of chemical substances should be marked with the appropriate symbol, or the symbol 14 of Table 1 (if not applicable
symbol).
Except as permitted in 7.2.101 or 7.2.102, the protective cover shall be marked to warn the operator that it cannot be opened or moved.
Any part of the equipment containing biohazard waste, if it can be removed during normal use, should be marked with the symbol 101 in Table 1.
Other warning signs are in 5.1.5.1c), 6.1.2b), 6.5.1.2g), 6.6.2, 7.2c), 7.2.101f), 7.2.102c), 7.3, 10.1,
Specified in 13.2.2.
5.3 Sign durability
instead.
Replace the first paragraph with the following new paragraph.
The signs required by 5.1.2 to 5.2 shall be permanently affixed and kept legible under normal conditions of use, capable of withstanding temperature, friction and normal use.
Effects of solvents and reagents that may be encountered during use, including cleaning agents and disinfectants specified by the manufacturer.
increase.
Add a new paragraph after the first paragraph of the compliance test method, which reads as follows.
Where solvents or reagents specified for use with the equipment may affect the durability of a particular mark, the mark should also use each
Wipe with a solvent or reagent for 30 seconds (or use a representative sample from the solvent or reagent category that may have a similar effect).
5.4.1 Overview
delete.
Delete the note in the second paragraph.
increase.
Add a new third paragraph with the following content.
Information should be provided on any risk that cannot be reduced to the level of allowable risk through the protective measures specified in this section. If you need training
Or use additional protective devices or personal protective equipment to reduce the risk to a permissible level of risk, which should be specified.
5.4.3 Equipment installation
instead.
Replace the title and original text with the following.
5.4.3 Equipment transportation, installation and assembly instructions
If applicable, the responsible person's documents should include the following.
a) instructions for transportation after delivery to the person responsible;
b) ground bearing requirements;
c) the mass (weight) of each major heavy component;
d) positioning and placement instructions, including the space required for ventilation and the safe and effective maintenance of the operator;
e) assembly instructions;
f) instructions for protective earthing;
g) sound data required in 12.5.1;
h) a description of the handling, containment and discharge of hazardous substances, including requirements to prevent backflow;
i) drainage systems required when biological, chemical substances and hot liquids may be dangerous;
j) details on protective measures for hazardous radiation (see Chapter 12);
k) instructions for connection to the power supply;
l) Only for permanently connected equipment.
1) Details of grid power requirements and connections, including the rated temperature of the cables required at the highest rated ambient temperature;
2) Requirements for any external switches, circuit breakers (see 6.11.2.1) or overcurrent protection devices (see 9.5). If it is for security
It is necessary to install these switches or circuit breakers near the equipment.
m) Special maintenance requirements (eg air, coolant), including pressure limits.
Compliance is checked by visual inspection of the documents.
5.4.4 Equipment operation
instead.
If applicable, the instructions for use should include.
a) the operating controls and the details of their use in any operating sequence in all operating modes;
Note 1. GB/T 4025 gives guidelines for the colors and symbols of operating controls.
b) instructions not to place the equipment in a location where it is difficult to operate the disconnect device (see 6.11);
c) instructions for interconnection with accessories and other equipment, including details of suitable accessories, removable parts and any special materials
content;
d) limits for intermittent operation;
e) an explanation of the symbols used on the equipment, and the reasons for using the symbols in each special case where danger is involved;
f) a description of any actions taken by the operator at the time of the failure;
g) instructions and recommendations for the use of recommended materials for cleaning and disinfection (see 11.2);
h) instructions for waste disposal;
i) if normal use involves handling of hazardous substances, instructions for proper use and training or personal protective measures;
j) when handling potentially infectious substances (such as human samples or reagents), if it is possible to contact the skin, protective gloves are required
k) instructions for the protection of the mouth, nose or eyes if the equipment may release dangerous aerosol vapors during normal use;
l) instructions and requirements for protective devices, such as protection, if potentially hazardous visible or invisible radiation may be released
glasses;
m) Instructions for touching moving parts (see 7.2.101 and 7.2.102).
Note 2. Manufacturers should be aware of the internationally recognized Laboratory Biosafety Manual issued by the World Health Organization. It provides information about disinfectants,
Information on releases and potential applications. There are also national guidance documents covering these areas.
Note 3. When equipment and their accessories are maintained, repaired or moved, cleaning and disinfection may be necessary as a safety measure. Manufacturer should provide
Give the responsible person a way to confirm that the equipment after maintenance, repair, or movement has been treated as such.
Compliance is checked by visual inspection of the documents.
Added bars.
5.4.101 Disabling the equipment due to maintenance or disposal
Responsible persons should be provided with instructions to eliminate or reduce the risks posed by the discontinuation of use, transportation or disposal. If any, these
The description should include requirements to minimize biohazards.
Compliance is checked by visual inspection of the documents.
6 Protection against electric shock
Chapter 6 of GB 4793.1-2007 is applicable.
7 Protection against mechanical hazards
Except for the following, Chapter 7 of GB 4793.1-2007 is applicable.
7.2 Sports parts
delete.
Delete the second and third paragraphs.
increase.
Added bars.
7.2.101 Accessibility during normal use
As an exception, if exposure of moving parts during normal use is unavoidable, it should be determined through risk management (see Appendix AA)
Whether moving parts can cause injury to the operator. Follow these priorities in order to make these
The risk is minimized.
a) protective devices (interlocking systems or other methods that can only be removed using tools);
b) protective cover;
c) mechanical baffle;
d) there is sufficient distance between the safe area and the moving parts;
e) warning signals (audible or visual);
f) Warning signs (see 5.2).
The measures in b) to d) shall be combined with warnings on hazardous areas (see 5.4.1).
If exposure of moving parts during normal use is unavoidable, the instructions should describe procedures that can cause injury, only to the operator
Be warned of potential dangers and have received sufficient training to operate the procedures in the safest way possible to operate this
Process.
Compliance is checked by visual inspection and by the methods specified in Appendix AA.
7.2.102 Accessibility beyond normal use
In addition to normal use, during routine maintenance, if technically unavoidable reasons, the operator has to contact
Dangerous moving parts can only complete certain procedures, such as adjustment, if all the following measures are taken, contact the moving parts
Is allowed.
a) For moving parts protected by the device in 7.2.101a), it is impossible to reach without using tools;
b) The responsible person's statement should include a statement that operators should be trained to allow hazardous operations;
c) Any lid or component that should be removed before touching moving parts should have a warning sign (see 5.2) indicating the operator
Personnel are prohibited from contact without training. As an option, the symbol 14 of Table 1 should be marked on the cover or parts, and be documented
Includes warning instructions.
Compliance is checked by visual inspection and by the methods specified in Appendix AA.
8 Resistance to mechanical shock and impact
Except for the following, Chapter 8 of GB 4793.1-2007 is applicable.
8.2.1 Devices other than handheld devices and in-line devices
instead.
Replace the original c) with the following.
c) For fixed equipment, equipment with a mass greater than 100kg, its size and weight (weight) make it impossible to move unintentionally and normally
This test is not required for equipment that does not move during use.
9 Preventing the spread of fire
Chapter 9 of GB 4793.1-2007 is applicable.
10 Equipment temperature limits and heat resistance
Chapter 10 of GB 4793.1-2007 is applicable.
11 Protection against liquid hazards
Except for the following, Chapter 11 of GB 4793.1-2007 applies.
11.3 Spill
instead.
Under normal use, liquid may spill into the equipment.The equipment should be designed as a dangerously charged part that is insulated or internally uninsulated.
Moisture, or potentially corrosive substances (such as corrosive, toxic or flammable liquids) will not cause danger after contact with equipment parts.
Compliance is checked by visual inspection. If in doubt, use 0.2L of water to level off from a height of 0.1m for 15s.
Stably fall on the part where the operator should pour or handle the liquid, and every part where the liquid may touch the electrical parts.
In the area where the automatic sample loading process is performed, it is also necessary to use 5 times the maximum amount of liquid spilled by the device during normal use.
The volume of liquid completes the above test.
After this treatment, the equipment shall be able to pass the voltage test of 6.8 immediately (without moisture pretreatment), and accessible parts shall not
Exceeded the limit of 6.3.1.
Compliance can also be checked, where appropriate, by checking the compatibility of potentially aggressive substances with the parts of the equipment they are in contact with.
12 Radiation protection (including laser source), acoustic pressure and ultrasonic pressure
Chapter 12 of GB 4793.1-2007 is applicable.
13 Protection against released gases, explosions and implosions
Except for the following, Chapter 13 of GB 4793.1-2007 applies.
modify.
Modify the title of this chapter as follows.
13 Protection against released gases and substances, explosions and implosions
13.1 Toxic and harmful gases
modify.
Modify the title as follows.
13.1 Toxic and harmful gases and substances
instead.
Replace the first paragraph with the following two new paragraphs.
Under normal conditions or single fault conditions, the equipment should not release toxic or harmful gases or substances reaching dangerous doses.
If potentially dangerous substances are released from the equipment, operators should not be wetted or inhale potentially dangerous doses. Equipment package
Areas containing such substances should be equipped with protective covers or similar protection methods.
14 components
Chapter 14 of GB 4793.1-2007 is applicable.
15 Protection with interlock
Chapter 15 of GB 4793.1-2007 is applicable.
16 Test and measurement equipment
Chapter 16 of GB 4793.1-2007 is applicable.
appendix
In addition to the following, the GB 4793.1-2007 appendixes are applicable.
Added new appendix AA.
Appendix AA
(Normative appendix)
Risk Management
In order to comply with the requirements of 7.2.101, at least the permissible risks are achieved through risk reduction measures to obtain a satisfactory level of safety. Should perform wind
Risk management, and documented, to achieve at least the allowable risk by repeating the process including the following.
a) Risk analysis
Risk analysis is the process of identifying hazards and estimating risks based on available information.
b) Risk assessment
Each risk analysis requires a plan to calculate the severity and probability of the evaluated risk level and the judged risk
The acceptable level of risk level is determined according to the following methods (see Figure AA.1).
1) Widely acceptable area
In some cases, the risks are so low that they are compared to other risks and from the perspective of benefiting from using the device
Look, it is negligible. In this case, the risk is acceptable and no proactive risk control is required
system. This level meets the requirements for allowing risk.
2) Reasonable and feasible area (ALARP)
This level does not automatically meet the requirements for allowing risk. A reasonably feasible area as a result of a risk analysis always requires a
Reasons why the risk cannot be further reduced with feasible methods.
3) Inadmissible zone
This level includes non-permissible risks.
c) Risk reduction
If the initial risks are unacceptable, precautions should be identified and implemented. Then the process of risk analysis and risk assessment
It should be repeated, including checking that precautions do not introduce new risks.
Note 1. For in vitro diagnostic medical equipment within the scope of YY0648, the risk management process specified in this standard is used. For other equipment, the following standards give risk
Management guide. GB/T 0316 and ISO 14121.
Note 2. ISO 14121 is required to comply with the contents of ISO /T R12100-2 recommendation. This recommendation is replaced by the relevant requirements of GB 4793.
Figure AA.1 Acceptance of risks
references
Add the following publications.
[1] GB/T 16273.1-1996 general symbols for graphical symbols for equipment (ISO 7000. 1989, IDT).
[2] YY/T 0316-2003 Application of medical device risk management to medical devices (ISO 14971..2000, IDT).
[3] GB/T 4025-2003 Basic and safety rules for human-machine interface logos and indicators and coding rules for operating devices
(IEC 60073..1996, IDT).
[4] ISO /IEC Guide51..1999, Safetyaspects-Guidelinesfortheirinclusionsinstandards.
[5] ISO /T R12100-2..1992, Safetyofmachines-Basicconcepts, generalprinciplesfordesign-
Part 2. Technicalprinciplesandspecifications.
[6] ISO 14121..1999, Safetyofmachinery-Principlesofriskassessment.
[7] LaboratoryBiosafetyManual, WorldHealthOrganization, 1984.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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