This standard is equivalent to IEC 60601-2-21:1994 and Amendment 1 (1996-10). This standard specifies the safety requirements for infant radiant warmers and is applicable to infant radiant warmers. YY 0455-2003 Medical electrical equipment Part 2: Safety-specific requirements for infant radiant warmers YY0455-2003 Standard download decompression password: www.bzxz.net

This standard is a regulatory standard. The following standards and major revisions are made after the formulation of this standard; 0455--20n3/IRC:60601-2-21:19941 with eC63,2-21.16S4 medical electrical equipment - Part 2: What are the requirements for the safety of medical equipment? 13121:15 medical electrical equipment Part 2: Safety requirements for medical equipment enterprises 1()
3GHc6,.-5 medical electrical equipment Part 1: General requirements $idtEC60ec:198 Technical common revision 11.
4IKe631,10R medical equipment Part 3: Safety requirements for medical equipment (J995). Standard adopted city E6060221:14 gas equipment: Part 1: Safety requirements for enclosures for special month release amendment 1:9%13)
dated 1EC60631-2-21 was formulated in relation to TRC60401-:19984 electrical equipment: Part 1: General requirements, and I36150)1-1:1958 was adopted by our national standard B9706.193 medical electrical equipment: Safety pressure requirements 3 equivalent to: War standard temporary lead and G97 (1, 3 used in conjunction with the requirements of this standard, Priority 1 sample number of this standard. Six standards are formulated to promote the safety and safety of a series of products. The appendix is ​​the standard appendix, the AA appendix, the material quality inspection and recording, the main standard is proposed by the National Medical Device Standardization Technical Committee, the Medical Electronic Instrument Standardization Technical Committee, the National Electrical Appliance Standardization Technical Committee, the Medical Electronic Instrument Standardization Technical Committee, the National Medical Device ... 0455—2003/H 60601-2-21,1394 and the requirements of the test method to be designed in accordance with the requirements, the introduction of the A personnel to record the nature of the record) to the mountain·this interpretation of the juice Xuanyan words
in the A record of the provisions of the explanation, the provisions of the elimination of the edge of the month (item: the old supervisor to this requirement and its principle of understanding. Not only will it make the current technology to come out, but also ugly at the appropriate time according to the needs of the delivery bed sitting changes or technical development of the station, the need for the previous modification, the test down to the ten structural changes of the zero standard Ya requirements before the N
YY 0455-2003/IEC60601-2-21:1994 Medical electrical equipment Part 2: Particular requirements for the safety of infant radiant warmers This standard must be based on (9703. Medical electrical equipment Part 1: Part 1: Safety requirements for infant radiant warmers) and shall be used in accordance with the following standards: Scope of application and purpose Except for the following provisions, this standard shall be used before the end of this standard. 1.1 Scope of application
This special standard is titled as follows: 1.2 The safety requirements of the infant and kidney protection station are as follows: 2.2.1 The safety requirements of the infant and kidney protection station are as follows: 1.3 The special standard is promoted: The energy requirements of this special standard are as follows: Submitted under: G9706.11S95 medical gas modification part: safety general love request E3u1 and test repair receipt 111F6011: 9 civil H electrical equipment calculation: part: home umbrella general system request modification standard 21995IF heart 1-2-2-1 special 4 summer 4 gas setting price - the 2nd dose: infant pain system guarantee limit station issued a special requirement 3 your modification part 1A..a
for the wide tube decision, in this special standard small handle part and the first part of the customer called the general opening standard: special standard compliance clause corresponding to the general standard remittance system number, for the general standard arrangement account The following amendments to the text shall be in accordance with the tax regulations || tt || "If the text of the standard is changed to the standard or the article is changed, the "social supplement" will be changed to the special standard in accordance with the requirements of the standard. The text of the standard is only for the purchase of special standards, and the purchase of various small contents of the standard shall be subject to the supplementary calculation items and drawings starting from 2F, and the supplementary appendix A, B, and supplementary production (including production costs) shall be added. : Starting from the 1988 Amendment 2 (1995) 0, "this standard" shall be used for the purchase of the protection standards and the original standard involved in the time. The corresponding standard in the special pressure standard is: Bei, the standard covers the total market, the variable clause is completely general; some sections may be required but not applicable to general operation, and the purchase is not required to reduce the comparison, which is called. This special standard is the standard for the dry certification,
1.5 parallel standard
GH97 core.15- based electrical no new part 1: safety requirements 1. Children's standard: safety of electrical systems 1
YY 3455--2003/1FC: 60601-2-21:1994 requirements.
1FC0FC:1---2:1993 Medical electrical equipment - Part 1: General requirements for safety>. Parallel standard; Electromagnetic compatibility test:
GBS706.121997 Medical electrical equipment, Part 1: Requirements for use factors 3. Parallel standard: General requirements for radiation protection of X-ray equipment [F606F1---:1996 Medical electrical equipment - Part 1: Safety requirements for late use 2. Parallel standard: Programmable loss system.
In the 1E60601 series, the parallel standard specifies "safety requirements for all medical electrical equipment (for example, radiation equipment); a special feature of all medical electrical equipment services in the general safety standard (such as e-commerce requirements!), if a small parallel standard is applicable to the basic special standard, the special standard takes precedence over the main standard. 2 Terms and definitions
Except for the following content, this chapter of the Dizhou standard is applicable, 2.1.5
Applied part appliedpart
The part of the equipment commonly used:
In order to execute the kinetic energy of the equipment, the part that must be in contact with the output and the point of contact; or the part that can be held in contact by the loyal person is divided into
parts before the kidney is full:
F-type isolation: detailed> applied part (hereinafter referred to as F-type applied part) F-type applied part is separated from other parts of the equipment, and its absolute virtuality reaches the point of contact between the applied part and the power source and the external equipment connected to the loyal person! , There are three types of applications in a single energy state. The total value of the application is divided into type application part or [F-type application, 2. 1.15
patient circuit
Any circuit containing one or more connected parts, including all connected parts that meet the requirements of the electrical quality (see 20) or the new conductive parts that meet the requirements of the electrical and electrical requirements (see 57.10).
Supplement:
Panel connectionlon
In the stopped state or single release state, current can flow through the applied part between the patient and the equipment.
Type B applied part typeBapplledpart
This standard specifies the application part with equal protection against impact, especially the one that meets the requirements of single current design. Note the standard number 1 meter in Table 2 in the appendix.
The H applied part is directly used for the heart. 2. 1.25
BE type application part ypeBFappllelpert meets the requirements of this standard, the protection of the electric shock interruption type should be higher than the F type part, the Appendix table 3, 2 symbol 2 meters mark,
symbol: F type disk application part will not be used for the heart, 2. :. 26
CF quantity application part tpeCFappllelpar
YY 0455-7C03/TF.C: 60G01-2-21;1994 meets the requirements of this standard, the protection of the type should be higher than the F type part, the danger table 13.7 symbol 3 meters mark.
anti-color application part deribrillation-prikofapplicdpart for the heart of the busy power outage protection of the application of the Hao 2. 1.101
head temperature sensor xkintemperatoresennr signal transmission rate benefit, including new and equipped with various parts to detect the baby's internal response. 2, 1,1c2
Test device eslei
- a completely black circle without light translation. In the equipment test room, a pressure receiver with a reproducible axis is used (see Figure:! . 2. 1. 103
Test load teslload
A group of five test devices are arranged in the prescribed form <see 1(2) and are used to test the life of the child. 2.2 Equipment type (classification)
direcl cardize application
For cardiac use
Replace the word "equipment" in the text with "applied part": 2. 2. 9 Not adopted,
Medical electrical equipmentnedicalelectricalequipnuent outside the second release:
The manufacturer shall determine the required parts for the correct use of the equipment. 2.2.20 is not adopted
2.2.24 is not adopted
2.2.25 is not adopted,
2.2.26 is not adopted,
2.2.28 is not adopted.
Supplement:
Infant vehicle radiation protection platform is referred to as equipment: nfamadiamlwarer (lereinterrlerndluELIPMET) is a kind of thermostat, which uses direct radiation energy in the range of micro-light and infrared to keep the baby's body in balance.
Thermostats
Comparison:
. A temperature sensor controller, which is a device that keeps the temperature between two specific values ​​and can be set by the user. 2.10 Operation of the equipment
Supplement:
YY 0455-2033/IFC 60601-2-21:19942.10,101
The constant temperature is set at the midpoint of the test device, which changes no more than 1 degree per hour. 2. 10. 162
The average humidity of the test device (F2TsT or Tu) is the average temperature of the test device at a certain interval during the test period. 2. 0, 103
The midpoint average temperature (Tx) is set at the midpoint of the test device. The average humidity of the test device is shown in Figure 1. 2. 13. (
Control temperature seatntrol1enijerature
Set in the temperature controller
manurlde
manual mode
A kind of operating mode that can reduce the risk of users, in this operating mode, the heat end: the actual reporting level is the external energy level of the meter output.
Type control modehahmntnllamode
A kind of operating mode that is close to the practical setting of the source constant. In the operating mode, this paper discusses the changes with the temperature of the ticket,
3 General requirements
In addition to the following text, the general standard policy is applicable: 3.6-Single fault state
The following general standard is used to analyze the most part of the gas camp). With oxygen or hydrogen gas device external leakage end see the first person waste E broken body design 4.44.);
may cause the state of the current state of the electrical core parts of the European standard without the first bay: may lead to the safety of the dangerous mechanical parts of the fault (see the first high) h
wet double sword bone release Zhuo (to calculate): if a single fault state Jie does not lead to a single release state. Then the degree of coverage can be Ni· single release state. Supplement:
: the second alliance transmission end curtain teaching drop
skin temperature sensor end and equipment separation:
core) fuel system electrical drop fault resources
3.11 for multiple external heating equipment: for example, there are bat radiation heaters and heat six, etc., Liu fruit has this column! Heat source, also meet the requirements of this special music. The manufacturer shall use the instructions for use in the safety requirements of this standard to check whether the product meets the requirements of Part 4 of this standard. 4 General requirements for tests Except for the following items, the single values ​​of the standard shall apply. 4.5 Ambient temperature, humidity, atmospheric pressure The following contents shall replace the general provisions of the standard (1Y0255-2303/1EC60601-2-21,1994) When the manufacturer specifies the environmental conditions range for testing, the test shall be carried out according to the following requirements: The ambient temperature range of 13-35°C shall replace 5-35°C. For the ten benchmark tests (the test area method is based on the environment), the group of people who have signed the system can be read. Table 1 Specified atmospheric conditions
gas mng
2.6 Other local conditions
fill:
) City-style riding period control must exceed the ring magic car less than 3% 2.10 Tide retreat precautions
eliminate the following internal safety if the first paragraph;
5: -- -5
Before escaping 130: Before seeing G1031, all equipment or devices that can be stored in water must be placed in the following third paragraph:
Only some of the equipment in the proposed test state can be tested, and the equipment parts that are still in danger must be tested and tested in the first teaching "replacement\to"
After installation, the following engraved clauses are engraved under the two broken machine lines: The protection
Compare with 1: to [PX8's each is:,
5 classification
The following example text is outside the health and safety precautions. In this section, the equipment and its components must be used in the environment specified in the first sub-chapter or! Identification classification "replaces" Chapter G actual internal mark or identification mark "please use the following internal code extract 5.2:
5.2 Classification of protection against electric shock:
B type proportion part:
CT type should be divided into months.
Use internal code section 5:
5.3 According to 6B42181993: Classification of protective fence width for certification liquid: : 11, E identification marks and documents
Except for one clause, the standard book of that year shall be used. 6.1 External marking of equipment or temporary parts. 6.11 Classification
The first special number of the first line of the near line Use \ (to "step 1, formula 7" state second to the cycle and its inside and both recorded 1) 1,1 can be symbol 17,12-3
YY0455-2003/1EC:60601-2-21:1994 replace the three fold lines with the following content: For HH and CF type application parts, use the application part equal sign (Appendix D Table D.2 Symbols 13 and 32).
To distinguish it clearly from symbol 2, symbol 1 shall not be used to mark the country in the support. If each soldier has more than one application part with different degrees of protection against electrical hazards, these application parts must be stored or in the same place. The corresponding output factory (contact point) must be clearly marked with the relevant symbols: The protection parts must be marked with the corresponding hazard symbols (symbols 9, and 11 in Table D.2 of Appendix D) Supplement the following content:
: If the part has protection against summer heat and summer electrical effects, it must be marked with the corresponding symbol 14 in Table 1) at the side of the corresponding auxiliary outlet.
6.1v) Protective packaging
Supplement the following content as paragraph 1:
The equipment or source must be individually marked with no full packaging. Supplement:
) There is no water mark on the bed that meets the requirements of the equipment structure, and the equipment must be clearly marked. The distance between the heating device and the equipment is allowed.
6.2 Equipment internal marking
) The last line of the first paragraph, replace \...1a with "...6.1\" d) Supplement:
In particular, batteries that are not intended to be replaced by the operator and batteries that can only be replaced when in use can be used to identify the damage in the random document.
6.3 Control device and instrument marking
The last line is modified to: Check whether it meets the requirements of 5.1 by testing the low-endurance parts. 3.) It is recommended to replace: The controller and indicator can be identified.Replenish!
) The numerical value of the parameter must be expressed in accordance with the international system (H3100/1S01300) and the following additional content: units outside the international system of units may be written as follows:
, revolutions,
, degrees,
, degrees,
·minutes,
, seconds:
time units:
: minutes,
, hours,
·days:
energy units:
·electron volts;
blood pressure lamp total liquid not reached ":
·pot multiplied by column.
supplement,
method) clear overflow control options and general indication devices should be provided on or near the controller, and the distribution rate of the device provided shall not be greater than. 3*.
5.4 Symbols
Some tablets are glycosides;
Pass the inspection and escape 6,: The attached long-term quick test is used to verify that the plaintiff meets the requirements, 6.8 Random documents
6.A.? Instructions for use
a) A state cellar
YY0455-2003/IFC60601-2-21:1994 supplements a near-line of penetration, and divides the warehouse into the third case and the age of the new line, and the penetration is as follows: A medical book must state the function of the equipment and the intended use of the card must provide the user or operator with a storage device and other equipment between the stomach or other specified resources, and must and avoid this point of prohibition,) The last company of the equipment with additional power supply is modified as follows:||t t||"If there are any problems with the external protective conductors during the installation of the line, the replacement must be planned within days to help the power supply to run."
The last sentence does not apply. The battery must be removed when the equipment is unlikely to be used for a period of time, unless there is a risk of producing a serious product."
Supplement:
The instruction manual must be available;
, specify the relevant conditions, scope of care, and the handling of the equipment and its accessories in order to minimize the risk of extending its service life.
A): Instructions for use: It is recommended that the controller monitor the baby's temperature independently, but it is not appropriate for the operator to leave the device alone when the baby is unattended.
2 It is recommended that the heating device be allowed to move away from the mattress, and the lack of temperature will result in various consequences.
3 The temperature sensor used in the device is recommended. The recommended use and fixing method and position are detailed. The monitoring method of the device should be fully verified. 1
For the use of the B type temperature part, it is necessary to ensure that the device is safe in good conditions.
If applicable, the user should regularly check the push and stop closure to prevent the baby from falling out. The child supports and all the supports and fixings of each month should be used with the maximum load. The sensor is used to make the device more reliable. If the device makes the result less applicable, the bed heater needs to be tilted from the horizontal air, which will affect the performance of the device. 1. The device is not suitable for use in the presence of flammable gases or other flammable substances. For example, some cleaning liquids will be used. 12. The device can be used to control the temperature of the child. 1. The military explains how to use the old baby to control the method. 14. The five changes in the rectal light input length will be appropriate. The device cannot distinguish between the difference between the high body temperature and the low body and skin temperature (temperature) and the difference between the high body temperature and the low body temperature (temperature). 15. The temperature monitoring sensor is not recommended.
YY0455—2003/1EC60601-2-21:193416 State the environmental conditions (e.g. air turbulence) that may affect the thermal balance of the infant17
The blood may have an extreme lifespan, and should be specified in the accompanying literature. Because of this, the radiation source should be replaced after the end of its lifespan:
18 State that the equipment is to be used only by appropriately trained personnel and under the guidance of a medical professional who has considered the risks and benefits of the equipment.
1S State the water consumption that may be caused by the equipment to the patient:20 Detail the technical components of the equipment combination (see 3.101)6.8.3 Technical Specification
a) Overview
The following contents are recommended in the first paragraph:
The technical specification must provide all the data essential for safe operation, in particular, the performance data mentioned in G.1! www.bzxz.net
…·All characteristics of the equipment, including the range, precision and accuracy of the displayed value or the indication that can be detected. d Use the following indentation:
Operational environment
In the first line, the following provisions of the second environmental conditions
are not applicable to the following sections, and the standard applies. 8 Basic safety factors
In the text, "A1.2 Environmental conditions" is replaced by \A1.:\. Except for the following provisions, the general standard is applicable. 10.1 Transportation and storage
The following content replaces the existing specifications
During transportation and storage in the installed state, the equipment should be able to withstand the environmental conditions specified by the manufacturer (see 6.5.32)) 10.2 Operation
Modify to: When the equipment is normally operated under the following combination of conditions, use the test in this standard to check whether it meets the requirements of 11.2.
10.2.1 Environment
a) Replace
Environmental temperature range, 18~30 (see 4.). Supplement:
) Environmental drop rate is less than 0.
The third protection against electric shock hazards
is not included in the system text, and the standard must be used for this micro-construction. 14 Requirements for relevant classifications
14.5 Internal power supply equipment
Replacement:
) Not adopted,
YY0455-2003/IEX:60601-2-21:1994b) It is an internal power supply equipment with similar features to the mains power supply. When it is connected to the mains power supply, it must comply with the requirements of Class I or Class II equipment. When it is not connected to the mains power supply, it must also comply with the requirements of internal power supply equipment: t4.6 and type BF and CF type applied part code:
e) Applied parts specified in the accompanying documents as suitable for self-connection must be of type CF, and d is not applicable.
E) In the first line, change "must be measured in short circuit) between live parts and the current drawn and the auxiliary current drawn.\ to "must be in short circuit) between the live parts and the insulation between the above 17:) 1) between live parts and the insulation between the above 17>2) between live parts and the insulation between the above 17>3) between live parts and the intermediate circuit; after Measure the full current and auxiliary current of the protective earthing component in 2. If the protective earthing metal component in 17g2 or the intermediate circuit in -7g)3 is tested, the insulation between the live parts and the metal parts in 17g2 or the insulation between the live parts and the intermediate circuit in 17g3 can be used to measure the current. Add:
Five ) The wiring used to isolate the applied parts from other required parts must be designed so that no hazardous electric current can be present in the following parts during the electrical discharge of the equipment connected to the applied parts:
, external charging, including the outer surfaces of accessible wires and connectors; any signalling parts;
, the test gold foil, which shall be placed on the metal foil; the area of ​​the foil shall be at least equal to the area of ​​the equipment seat. After the required recovery time specified in the accompanying documents has been completed, the equipment must continue to perform the intended functions described in the accompanying documents, and use the following pulse voltage meter to check whether it meets the requirements: (Common test) The equipment is connected to the test circuit as shown in the figure, and the test voltage is added to all the connected parts together: (Difference test) The equipment is connected to the test circuit as shown in Figure 31. The test voltage is applied to each patient connection at a time. At the same time, the remaining connections are pressed to ground. Note that when the connection is completed by 1 patient, the test simulation does not start. During each test and inspection period:
Class 1 equipment that has no protective earthing and can operate under large power grid conditions (engineering), and has internal batteries, the protective connection must be connected before the test begins! The equipment must not be connected to the power supply:
The surface of the equipment must not be damaged by dust or metal foil. 19.111) Any connection to the earthing terminal in the specified salt water shall be disconnected; when a part is internally grounded for power supply, such connection shall be regarded as protective earthing and shall comply with the provisions of Chapter 18, or the protective earthing part specified in the first series of this document shall be connected to the oscilloscope. After the operation of $, the voltage sample value at points Y1 and Y2 shall not exceed 1V. All tests shall be repeated after the V: dial is changed. After the necessary recovery time specified in the accompanying documents, the equipment shall continue to perform the functions specified in the accompanying documents. 5
YY0455—2003/1EC60601-2-21.199419 Protective earthing, functional earthing and potential equalization This chapter of the general standard applies except for the following provisions. Modification:
b) Change "connected to the protective earthing conductor of the power supply system" to "connected to the protective conductor in the installation", F) In the second paragraph, change "protective earthing point" to "protective earth connection point". In the third paragraph, change "and the protective earthing point..." to "and the protective earthing foot". The compliance paragraph is changed to "using Hz or CH, and stopping the power supply not exceeding 6V to generate a current of 254 or -.5 with a rated wave of no more than 100% (10 must be guaranteed). Within 5*--10≤ time, at the protective earthing terminal or the protective earthing connection point in the network or between each accessible metal part under the condition of basic insulation failure. 19 Avoid slip and auxiliary current
In addition to the listed provisions, the general standard applies. 19.1 General requirements
\》In the text with a dash, change "no equipment" to "virtual part". In addition,
) The equipment with multiple connections must be tested to ensure that when one or more of the components are in normal condition, the storage current and auxiliary current of the components do not exceed the allowable value. When one component is connected to multiple components, ... is separated from the virtual components:
and the main components are connected to the ground.
If the equipment circuit is tested under the above conditions, the leakage current or the power supply current may increase to more than the allowable value, and the actual measurement should be limited to several representative combinations: 19.2 Single fault condition
b) The first dashed line is crossed out with "not protectively grounded". The first paragraph of h) is replaced by the following: 1) When the signal input part or signal output part specified by the manufacturer is connected to a device without risk of external voltage (697 (15.15-155), the following contents 2) and 3) in the first paragraph of
5) are replaced by the following contents for this application part. When the inspection of its circuit and structural arrangement shows that there is no risk of safety hazard: F type application part. The third paragraph of h) is replaced by the following 1) and 2): , for type I3 ​​applied parts, when inspection of the circuit and structural arrangement shows that there is no danger of full power generation: use the first section of
to go to the ground without protection. The following content replaces the normal second section; this requirement is only used for the signal input part or signal output before the signal is divided into the signal input part of the specification and the external power source is not present (GB9706.t5-1997).
19.3 Capacitor value
) to go to the ground with a frequency less than or equal to 1kHz. b Replace with the following content:
The narrow allowable value shown in the table shall be applicable to the network of the general standard Figure 5 and the current measured according to the current frequency characteristic specified in the diagram (or with the current measuring device specified in Figure 15).
In addition, in normal state or single discharge state, regardless of the type of liquid, the self-current shall not exceed the effective value of 1m. The ninth line of Table 4, the current is modified to: 10
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