YY 0648-2008Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (English PDF)

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 increase.

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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.

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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).

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h) biological hazards;

i) Hazardous chemicals.

1.2.2

Contents not included in the scope of this standard increase.

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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.

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3.1 Types of equipment and equipment

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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.

4.4.1 Overview

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a) Equipment and circuit diagrams should be checked to determine what may occur and may occur during normal use and reasonably foreseeable misuse

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Causes dangerous fault conditions.

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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.

5.1.1 Overview

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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.

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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).

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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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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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Effects of solvents and reagents that may be encountered during use, including cleaning agents and disinfectants specified by the manufacturer.

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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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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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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.

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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 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.

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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.

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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.

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.

This chapter in GB 47.93.1 applies.

11.3 spill

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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.

13.1 Toxic and harmful gases

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13.1 Toxic and harmful gases and substances replace.

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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.

14.3 Over-temperature protection device

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In self-testing in vitro diagnostic medical equipment, the over-temperature protection device should not be reset automatically.