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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
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
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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
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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
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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
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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
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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.
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Remove the first dash.
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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
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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
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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
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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
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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
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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
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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
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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
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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...