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Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
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YY 0648-2008: PDF in English YY 0648-2008
Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101. Particular requirements for in vitro diagnostic (IVD) medical equipment
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
YY 0648-2008/IEC 61010-2-2101..2002
Safety of electrical equipment for measurement, control and laboratory use
Requirements Part 2-101. In Vitro Diagnostics (I 犞 D)
Specific requirements for medical equipment
(IEC 61110-2-2101..2002, IDT)
Published in.2008-04-25
Implemented in.2009-12-12
Published by the State Food and Drug Administration
Foreword
The entire content of this standard is mandatory.
This standard is equivalent to adopting the international standard IEC 6110-2-10..2002 "Safety requirements for electrical equipment for measurement, control and laboratory use.
Part 2-101. Particular Requirements for In Vitro Diagnostic (IVD) Medical Devices (English version), its technical content and structure are in accordance with IEC 6110-2-11
with. GB 47.93.1 "Safety requirements for electrical equipment for measurement, control, and laboratory use-Part 1. General requirements" has been used equivalently
Content of IEC 61110-1..2001 and Technical Corrigendums 1 and 2. Consistent with GB 4973.1-2007, omitting IEC 6110-2-101..2001
Preface and the contents of "Appendix H Definition Index".
This standard modifies 5.4.4b) (see 6.12) of the IEC 61101-2-101..2002 standard to (see 6.11), because IEC 6110-10.
There is no such clause in.2001 and GB 4973.1-2007; this standard should be used in conjunction with GB 4973.1-2007.
The "applicable" part of this standard indicates that the corresponding clauses in GB 4973.1-2007 are applicable to this standard;
The "replacement", "modification" or "deletion" parts are subject to the provisions in this standard; the "addition" part in this standard indicates
In addition to the corresponding provisions in GB 4793.1-2007, it must also meet the provisions added in this standard.
Appendix BB of this standard is a normative appendix, and Appendix AA is an informative appendix.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the Standardization Technical Committee for In vitro Diagnostic Systems.
This standard was drafted. Beijing Medical Device Inspection Institute.
The main drafters of this standard. Zeng Ning, Han Xiaopeng, Zhang Zhaoyuan.
YY 0648-2008/IEC 61010-2-2101..2002
Safety of electrical equipment for measurement, control and laboratory use
Requirements Part 2-101. In Vitro Diagnostics (I 犞 D)
Specific requirements for medical equipment
1 Scope and purpose
Except for the following, this chapter in GB 47.93.1 applies.
1.1 Scope
replace.
This standard applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-testing in vitro diagnostic medical purposes.
In vitro diagnostic medical devices, whether used alone or in combination, are intended to be used by manufacturers for the examination of in vitro samples, including those from humans
Blood and tissue samples from individuals, whose sole or main purpose is to provide information for one or more of the following.
● a physiological or pathological condition; or
● a congenital anomaly;
● determine the safety and compatibility of potential receptors;
● Monitoring of treatment measures.
Self-testing in vitro diagnostic medical devices are intended for use by manufacturers in non-professional home environments.
Note. If all or a part of the equipment belongs to the scope of this standard, and also belongs to the scope of one or several other GB 4793 special standards, this equipment
Equipment also needs to meet the requirements of those other specific standards.
1.1.2 Equipment not covered by this standard
increase.
Add the second paragraph below.
Products used in general laboratories are not in vitro diagnostic medical devices, unless they are specifically expected by the manufacturer based on their characteristics
For in vitro diagnostic tests.
1.2 Purpose
1.2.1 Contents included in the scope of this standard
replace.
Replace the first sentence with the following.
The purpose of this standard is to ensure that the design and construction methods used are at an acceptable level of risk for the operator and the surrounding environment.
Provide a high degree of protection and use risk management where appropriate (see Appendix AA).
increase.
Add two new entries.
h) biological hazards;
i) Hazardous chemicals.
1.2.2 Contents not included in the scope of this standard
increase.
Add a new entry and the following note.
g) Treatment or manipulation of the material being analyzed outside the equipment.
Note. The requirement to cover these disciplines is the responsibility of the committee that develops the appropriate standards.
YY 0648-2008/IEC 61010-2-2101..2002
2 Normative references
Except for the following, this chapter in GB 47.93.1 applies.
increase.
ＹＹ/T 0316-2003 Application of medical device risk management to medical devices
3 Terms and definitions
Except for the following, this chapter in GB 47.93.1 applies.
3.1 Types of equipment and equipment
Added definition.
3.101
Physical harm or violation of human health, or damage to property or the environment.
[ISO /IEC Guide 51..1999, Definition 3.3]
3.102
The combination of the probability of damage and the severity of the damage.
[ISO /IEC Guide 51..1999, Definition 3.2]
3.103
Acceptable risks in a specific context based on current values of society.
[ISO /IEC Guide 51..1999, Definition 3.7]
Note 1. Permissible risk is the ideal of absolute safety, the requirements to be met by a product, process or service, and benefits such as user benefits, suitability of purpose,
Balance of cost efficiency, risk assessment, relevant social habits and technical level.
Note 2. The term "acceptable risk" in Y/T 0316 is used in the same sense as the allowable risk.
3.104
Products, processes, or services are not used in the way the supplier expects, but this can be generated by easily predictable human behavior.
[ISO /IEC Guide 51..1999, Definition 3.14]
3.105
It can only be removed using tools or appropriate force, and can withstand the temperature, friction, common solvents, reagents and
The effect of steam.
3.106
A callout, text or a graphic symbol is permanently attached to the product.
4 Test
Except for the following, this chapter in GB 47.93.1 applies.
4.4.1 Overview
replace.
Replace entry a) in the first paragraph.
a) Equipment and circuit diagrams should be checked to determine what may occur and may occur during normal use and reasonably foreseeable misuse
YY 0648-2008/IEC 61010-2-2101..2002
Causes dangerous fault conditions.
delete.
Remove the first dash.
increase.
Added terms.
4.4.2.1 Wrong 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 Signs and documents
Except for the following, this chapter in GB 47.93.1 applies.
5.1.1 Overview
replace.
Replace the third paragraph with the following.
Quantitative and unit text symbols shall be in accordance with IEC 60027. Wherever possible, internationally recognized symbols including Table 1 should be used
number. If other additional symbols are required, it should not be possible to confuse them with internationally recognized symbols. No pair of symbols
Color requirements, except for the symbol 101 (see Table 1). Graphical symbols should be explained in the document.
Table 1 symbols
increase.
Add the following new symbols.
Number symbol publication description
background color
---yellow;
Symbols and outlines
---black
ISO 7000-0655 Biohazard
102 Lot EN980, Chapter 4 Lot Number
5.1.2 Identification
replace.
Equipment should be marked with at least the following information.
a) Manufacturer's name or trademark, and address. The address should include at least the city and country;
b) model, name, or other method of identifying equipment;
c) the name and address of the manufacturer's authorized representative in accordance with local regulations;
Note. For example, in the European Union this is a natural or legal person as identified within the European Community.
The following additional content should be marked on the equipment or packaging or in the instruction manual.
1) Serial number, such as SN ×××× (serial number) or a batch number that can optionally start with the symbol 102 “LOT” in Table 1;
2) The following.
Ii) clear indication that the device is an in vitro diagnostic medical device;
Ii) if applicable, the device is a clear indication of self-testing in vitro diagnostic medical equipment;
Ⅲ) If there is a potential risk, the detachable device shall be identified by the manufacturer and component identification, and the batch number when appropriate.
Identification
Ⅳ) The expiry date of consumable parts is expressed in the order of year, month and day (if relevant).
YY 0648-2008/IEC 61010-2-2101..2002
increase.
Added terms.
5.1.101 Transport and storage
Packaging should be labelled to indicate any special shipping or storage conditions.
Compliance is checked by inspection.
5.2 Warning signs
replace.
Replace the fifth paragraph with the following four paragraphs.
Potentially infectious equipment due to samples or reagents used shall be marked marked 101 in Table 1.
Equipment that is hazardous due to the use of chemical substances shall be marked with the appropriate symbol, or symbol 14 of Table 1 (if no
symbol).
Containers or bags containing biohazardous waste that can be removed from the equipment during normal use shall be marked with the symbol 101 in Table 1.
Other warning signs are in 5.1.5.1c), 6.1.2b), 6.5.1.2.g), 6.6.2, 7.2c), 7.3, 10.1, 13. Specified in 2.2.
5.3 Mark durability
replace.
Replace the first paragraph with the following new paragraph.
5.1.2 ~ 5.2 required signs should be permanently affixed and kept legible under normal conditions of use, able to resist temperature and friction and normal
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 compliance, which reads as follows.
If it is specified that the solvent or reagent used with the equipment can affect the durability of a particular mark, that mark must also be used.
Wipe each 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 comment in the second paragraph.
increase.
Add a new third paragraph, which reads as follows.
Information should be provided on any risk that cannot be reduced to the level of allowable risk through the protective measures specified in this standard. If needed
Training or the use of additional protective measures or personal protective equipment to reduce the risk to a tolerable level should be specified.
5.4.3 Equipment installation
replace.
Replace the title and original text with the following.
5.4.3 Equipment transportation, installation and assembly instructions
If applicable, the documents provided to those responsible should include the following.
a) instructions for shipping after delivery to the person responsible;
b) ground bearing requirements;
c) the respective weights of the major heavy components;
d) positioning and placement instructions, including space required for ventilation and safe and effective operator maintenance;
e) assembly instructions;
f) instructions for protective earthing;
g) the sound data required in 12.5.1;
h) instructions regarding 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.
YY 0648-2008/IEC 61010-2-2101..2002
ｊ) details on protective measures for hazardous radiation (see Chapter 12);
k) connection to the power source;
l) Only applicable to 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 or circuit breakers (see 6.11.2.1) and external overcurrent protection devices (see 9.5.1), and
A suggestion that a switch or circuit breaker should be close to the equipment if this is necessary for safety.
m) Special maintenance requirements (eg air, coolant), including pressure limits.
Compliance is checked by checking the files.
5.4.4 Operation of equipment
replace.
If applicable, the instructions for use should include.
a) details of operating controls and their use in all modes of operation; and sequence of operations;
Note 1. IEC 60073 gives guidance on 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 the use of the symbols in each special case where danger is involved.
f) a description of the actions that any operator can take if a failure occurs;
g) instructions and recommendations for cleaning and disinfection, and recommended materials (see 11.2);
h) instructions for waste disposal;
i) if normal use involves handling of hazardous substances, instructions for proper use and the need for 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, use protective gloves or
Other protective measures;
k) instructions for protection of the mouth, nose or eyes if the equipment may release dangerous aerosol vapors during normal use;
l) instructions and requirements for protective equipment, such as protection, if potentially hazardous visible or invisible radiation may be released
glasses;
m) The instructions should state that if the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired.
damage.
Note 2. Manufacturers should have knowledge of the Laboratory Biosafety Manual published by the internationally recognized World Health Organization. It provides information about disinfectants, they
Information on use, dilutions and potential applications. There are also national regulations 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. The manufacturer should
Provides a way for those responsible to confirm that equipment that has been maintained, repaired, or moved has been treated as such.
Compliance is checked by checking the files.
increase.
Added subclauses.
5.4.4.1 Self-test in vitro diagnostic medical equipment
The instructions for use of the self-testing in vitro diagnostic medical device are given in Appendix BB.
Compliance is checked by checking the files.
5.4.101 Discontinuation of equipment due to maintenance or disposal
Responsible persons should be provided with instructions to eliminate or reduce the hazards involved in discontinuing use, transport or handling. These instructions should include
Requirements to minimize biohazards.
Compliance is checked by checking the files.
YY 0648-2008/IEC 61010-2-2101..2002
5.4.102 Transport and storage
The manufacturer shall specify the transport and storage conditions. Documents should include provisions for permitted environmental conditions for transport and storage, which should
Reappear on the outside of the device packaging (see 5.1).
Compliance is checked by inspection.
6 Protection against electric shock
This chapter in GB 47.93.1 applies.
7 Protection against mechanical hazards
This chapter in GB 47.93.1 applies.
8 Resistance to mechanical shock and impact
Except for the following, this chapter in GB 47.93.1 applies.
increase.
Added subclauses.
8.101 Transport and storage
When packed in the manufacturer's packaging, the device should not pose a hazard during normal use after transportation or storage under the conditions specified by the manufacturer
(See 5.1.101 and 5.4.110).
Compliance is checked by checking the manufacturer's test records.
Note. Test instructions are given in the publications of ASTM D4169 and the International Transport Safety Association.
九 Prevent the spread of flame
This chapter in GB 47.93.1 applies.
10 Device temperature limits and heat resistance
This chapter in GB 47.93.1 applies.
11 Protection against liquid danger
Except for the following, this chapter in GB 47.93.1 applies.
11.3 spill
replace.
If liquid may spill into the device during normal use, the device should be designed to be insulated or dangerously charged internal uninsulated parts
Wet, or potentially aggressive substances (such as corrosives, toxic or flammable liquids) do not cause danger as a result of contact with equipment components.
Compliance is checked by inspection. If in doubt, use 0.2L of water to steadily pour from a height of 0.1m for 15s.
The operator must pour or handle the liquid and every part where the liquid may touch the electrical components.
After this treatment, the equipment shall be able to pass the voltage test of 6.8 immediately (without wet pretreatment), and accessible parts shall not
Exceeding the limit of 6.3.1.
Where appropriate, compliance can also be checked 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
This chapter in GB 47.93.1 applies.
13 Protection against released gases, explosions and implosions
Except for the following, this chapter in GB 47.93.1 applies.
YY 0648-2008/IEC 61010-2-2101..2002
modify.
Amend the title of this clause to read 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
replace.
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 hazardous substances are used in the equipment, the operator should not get wet or inhale potentially dangerous amounts. Device contains
Areas of this substance should be equipped with protective covers or similar protective measures.
14 Components
Except for the following, this chapter in GB 47.93.1 applies.
14.3 Over-temperature protection device
increase.
Add a new third paragraph, which reads as follows.
In self-testing in vitro diagnostic medical equipment, the over-temperature protection device should not be reset automatically.
15 Protection by Interlocking Device
This chapter in GB 47.93.1 applies.
16 measuring circuit
This chapter in GB 47.93.1 applies.
YY 0648-2008/IEC 61010-2-2101..2002
appendix
In addition to the following, the appendix in GB 47.93.1 applies.
increase.
Add the following two new appendices, Appendix AA and Appendix BB, as follows.
YY 0648-2008/IEC 61010-2-2101..2002
Appendix AA
(Informative appendix)
Risk Management
The risk analysis and risk assessment shall be carried out in accordance with the provisions of ＹＹ/T 0316, and if necessary, continue to reduce the risk to achieve an acceptable
Level of risk.
Note 1. ＹＹ/T 0316 specifically includes in vitro diagnostic medical equipment within its scope. There is also an informative appendix on in vitro diagnostic medical equipment.
Compliance is assessed by evaluating risk management documents.
Achieving a satisfactory level of safety through risk reduction in order to achieve at least the allowable risks. Risk assessments are performed and documented to
At least the permissible risks are reached by repeating the process with the following.
a) Risk analysis
Risk analysis is the process of determining hazards and estimating risks based on the use of available information.
b) Risk assessment
Each risk analysis is based on the calculated severity and probability of the estimated risk level and the determined risk level
The degree of acceptance of this scheme is determined by the following method (see Figure AA.1).
1) Widely acceptable area
In some cases, the risk is so low that it is compared with other risks and from the use of this in vitro diagnostic medical
From a device benefit perspective, it is negligible. In this case, the risk is acceptable and does not need to be
Actively take risk control. This level meets the requirements for allowable risk.
2) Reasonable and feasible area (ALARP)
This level is not a requirement to automatically reach the allowable risk. Reasonable areas are always needed as a result of risk analysis
A reason why the risk cannot be further reduced with feasible methods.
3) Inadmissible area
This level contains non-permissible risks.
c) Risk reduction
If the initial risks are unacceptable, precautions should be identified and implemented. The process of risk analysis and risk assessment is then
No new risks were introduced, including inspection and precautions.
Figure AA. 1 Acceptance of risk
YY 0648-2008/IEC 61010-2-2101..2002
Appendix BB
(Normative appendix)
Instruction manual for self-testing in vitro diagnostic medical equipment
As a permanent part, the instruction manual should include at least Article BB. Chapter 1 to Chapter BB. Items applicable in Chapter 3.
BB. １ Warning instructions
BB. 1.1 Location and structure
General warning instructions should be placed in front of the operation and maintenance instructions, at or near the beginning of the instructions. Other specific warnings say
The instructions can be inserted where the special danger occurs in the instructions. Warning instructions should be clearer than others (examples include different colors
Paper, red font, bold type, large type).
BB. 1.2 Content
BB. 1.2.1 Overview
Warning instructions should include BB. For all relevant entries in 1.2.2, the use of the following terms or use is equally clear to non-professionals and
Clear language.
Note 1. The term "this equipment" may be replaced by the actual name of the equipment and "manufacturer" may be replaced by the actual manufacturer or supplier name.
Note 2. It is recommended to use simple illustrations to explain and support the warning instructions.
Note 3. The numbering of warnings is optional.
BB. 1.2.2 List of warning instructions
The order of the list below takes into account the importance of warnings and the order in which users may be exposed to the dangers involved. If the design under consideration is
The relative importance or exposure order is different, and this order can be modified. Other necessary warnings should be added and placed
Based on the same considerations.
Important safety instructions
DANGER --- Misuse of electrical equipment can cause electric shock to death, burns, fire and other hazards.
Basic security precautions should always be implemented, including all those listed below.
When the device is used by or in the vicinity of children, persons with disabilities or patients, close monitoring is necessary.
Read the following before using the device
1) The setting of the inspection voltage matches the supply voltage.
2) Connected to grid power.
a) Only applicable to plug-connected equipment. Where the protective grounding is required, plug the equipment into a grounded power outlet;
b) Only applicable to permanently connected equipment. The equipment must not be installed before it is installed by a qualified electrician or authorized service engineer.
To use the device.
Note 1. Taking into account national regulations, this statement may need to be changed.
Note 2. For permanently connected equipment, replace the “unplug” in warnings 3), 4) and 5) with “off the grid power switch”.
3) Unplug immediately after using the device.
YY 0648-2008/IEC 61010-2-2101..2002
4) Disconnect the plug before filling the equipment.
5) Do not put the device in liquid, and do not put it in a place where it may fall into the liquid. If the device gets wet,
Before unplugging.
6) When the device is plugged in, do not leave the device unattended.
7) Use the equipment only for the purpose described in the instruction manual.
8) Do not use accessories that are not provided or recommended by the manufacturer.
9) If the equipment is not working properly or damaged, do not use the equipment.
Note. Examples of typical defects include.
a) damage to the power cord or its plug;
b) damage caused by dropping the equipment;
c) Damage caused by dropping the equipment into water or spilling water on the equipment.
10) Do not allow the device or its cord to come into contact with surfaces that are too hot to reach.
11) Do not block the vents or place the device on a soft surface that may block the vents. Keep the vents away from soft cloth,
Hair, fluff, etc.
12) Do not place anything on top of the device.
13) Unless specifically required to do so in the instruction manual, do not drop or put anything into the openings, pipes or seams of the equipment.
14) Do not use the equipment where aerosol droplets are used or where oxygen is regulated.
15) Do not use the equipment outdoors.
Save these instructions
BB. 2 Operating instructions before first use
Instructions for performing operations only once before first use in any particular location should follow the warning instructions, and if applicable,
It should include at least the following.
a) assembly instructions;
b) any necessary protective earthing instructions;
c) requirements for plug-connected equipment and power supply;
d) permanently connected equipment.
1) Details of grid power requirements and connections, including the rated temperature requirements of the cable;
2) Requirements for any external switches or circuit breakers (see 6.11.2.1) or external overcurrent protection devices (see 9.5.1). Should also include
Include suggestions that switches or circuit breakers should be close to the equipment;
e) For equipment using batteries, battery types and installation methods;
f) instructions for ......
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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