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GB 11243-2008 English PDF

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GB 11243-2008: Medical electrical equipment -- Part 2: Particular requirements for safety of baby incubators
Status: Obsolete

GB 11243: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB 11243-2008	English	914	Add to Cart	4 days [Need to translate]	Medical electrical equipment -- Part 2: Particular requirements for safety of baby incubators	Obsolete	GB 11243-2008
GB 11243-2000	English	RFQ	ASK	4 days [Need to translate]	Medical electrical equipment Particular requirements for safety of baby incubators	Obsolete	GB 11243-2000
GB 11243-1989	English	RFQ	ASK	3 days [Need to translate]	Particular requirements for the safety of baby incubator	Obsolete	GB 11243-1989

PDF similar to GB 11243-2008

Standard similar to GB 11243-2008

YY/T 1933 YY/T 1712 GB 9706.227 GB 9706.204 GB 9706.225 GB 9706.219

Basic data

Standard ID	GB 11243-2008 (GB11243-2008)
Description (Translated English)	Medical electrical equipment -- Part 2: Particular requirements for safety of baby incubators
Sector / Industry	National Standard
Classification of Chinese Standard	C39
Classification of International Standard	11.040.55
Word Count Estimation	23,287
Date of Issue	2008-12-30
Date of Implementation	2010-03-01
Older Standard (superseded by this standard)	GB 11243-2000
Regulation (derived from)	Announcement of Newly Approved National Standards No. 26 of 2008 (total 139)
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This Chinese standard relates to incubator safety requirements. This standard does not apply to the carriage for transport baby incubator.

GB 11243-2008: Medical electrical equipment -- Part 2: Particular requirements for safety of baby incubators

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical electrical equipment.Part 2. Particular requirements for safety of baby incubators ICS 11.040.55 C39 National Standards of People's Republic of China GB 11243-2008/IEC 60601-2-19.1990 Replacing GB 11243-2000 Medical electrical equipment - Part 2. Particular requirements for safety of baby incubators (IEC 60601-2-19.1990, A1.1996, IDT) Posted 2008-12-30 2010-03-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Preface Ⅰ Introduction Ⅱ The first chapter Overview 1 1. Scope and purpose 1 2 Terms and definitions 1 3 2 General requirements 4 General test requirements 3 6 Identification, marking and documents 3 The second environmental conditions 4 10 4 environmental conditions Third of the risk of electric shock protection 4 20 Dielectric strength 4 Title IV of the mechanical hazards Protection 4 21 Mechanical strength 4 22 moving parts 5 Stability of 524 normal use Title VII of the ultra-mild additional safety hazard protection 6 42 Overtemperature 6 43 Fire 6 44 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection, sterilization and compatibility 7 7 46 Human Error 49 interrupt the power supply 7

8 output accuracy and prevent the risk of the eighth chapter of the job data

8 50 Operating data accuracy Tenth Canto structural requirements 9 54 Overview 9 55 housings and covers 9 56 10 components and subassemblies Chapter 11. Additional requirements 11 101 ALARM 11 102 SPL 12 103 humidifying device 12 104 air within the tank cover maximum rate of 12 105 dioxide (CO2) concentration 12 Annex L (normative) References --- 15 publications mentioned standards Annex AA (informative) Guidelines and Rationale 16 Fig. 10113 Fig. 10213 Figure 103 illustrates the main requirements of the standard 14 GB 11243-2008/IEC 60601-2-19.1990

Foreword

All the technical contents of this standard is mandatory. This standard is identical with IEC 60601-2-19.1990 "Medical electrical equipment - Part 2. Particular requirements for safety of baby incubators" and repair Change member 1 (1996). The standard IEC 60601-2-19.1990 made the following editorial changes. --- For the international standard quoted in the standard, if it has converted to our standards, this standard will replace the standard number of international and domestic standards number; --- Remove the IEC 60601-2-19 standard cover, foreword and introduction; The term --- IEC 60601-2-19 standard in capital letters, this standard are shown in bold font. This standard should be GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" used in conjunction. This standard It takes precedence over the corresponding requirements of the standard. This standard replaces GB 11243-2000 "Medical electrical equipment - Part 2. Particular requirements for safety of baby incubators." This standard and GB 11243-2000 main technical content differences are as follows. --- Remove the GB 11243-2000 and GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" repeat Part (General Standard Rev. 2); --- GB 11243-2000 adds something missing in IEC 60601-2-19; --- GB 11243-2000 corrected some clerical error. --- EMC requirements the original reference IEC 60601-1-2.1993 was replaced by a reference (YY0505-2005) IEC 60601-1-2.2001 Appendix L of this standard is a normative appendix, Appendix AA informative appendices. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Medical Electrical Medical Electronic Instrument Standardization Technical Committee Technical Committee (SAC/TC10/SC5) Centralized. This standard was drafted. Shanghai Medical Device detection. The main drafters of this standard. excellence, and Yu. This standard replaces the standard for the previous editions. --- GB 11243-1989, GB 11242-1989; --- GB 11243-2000. GB 11243-2008/IEC 60601-2-19.1990

Introduction

This standard relates to specific safety requirements for infant incubator. The amendments and additions to the standard GB 9706.1-2007 "Medical electrical equipment Preparation Part 1. General requirements for safety ", hereinafter referred to as" common standards. " The specific requirements of the standard takes precedence over generic standards. The special mark Consistent with the quasi-title "Common Criteria." Articles of this chapter, or not mentioned specific standard, "General Standard" or tied for specific criteria such Articles, chapters or shall apply without modification. "General Standard" does not apply in all content and is indicated by the results of this specific standard. The standard Chapter, Article numbers correspond to "General requirements" chapter, article number. Additional terms or FIG starting from 101; additional appendix AA, BB, etc. Added items to aa), bb) and the like. Followed by corresponding test requirements specified. The basic principle for some very important requirements to adapt, given in Annex AA. Consideration of these requirements is to understand the causes, not only Promote the application of standards, and within a certain time can be modified by factors accelerating change clinical practice or technology development being carried out, but Appendix AA is not part of this standard requirements. There are basic principles of the provisions in Annex AA, made after the article number symbol "". GB 11243-2008/IEC 60601-2-19.1990 Medical electrical equipment - Part 2. Particular requirements for safety of baby incubators The first chapter outlines Except the following clauses of the General Standard of the articles apply.

1 Scope and purpose

In addition to these provisions, the General Standard applicable. 1.1 Scope supplement. This standard specifies the safety requirements of this standard as defined in 2.1.101 incubator. This standard does not apply to transport for transport baby incubator 1). 1.2 Purpose supplement. This standard is intended for the incubator shall specify the requirements for patients and users to minimize harm, and whether the provisions of the differential operator Meets the requirement of the test. 1.3 Specific Standard Add the following new text. Infant incubator dedicated revision of the standard to be considered the following documents. GB 9706.1 Medical Electrical Equipment Part 1. General requirements for safety Specific standard take precedence over the Revised Standard Version, referring to the rest of the General Standard. supplement. 1.5 Collateral Standard GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety Collateral standard. Safety requirements for medical electrical systems GB 9706.12-1997 Medical electrical equipment Part 1. General requirements for safety 3. Collateral Standard. diagnostic X-ray radiation device General requirements for radioactive protection YY0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety - Collateral standard. Electromagnetic compatibility requirements and tests IEC 60601-1-4.1996, Medical electrical equipment - Part 1. General requirements for safety 4. Collateral standard. a programmable electrical medical Gas system

2 Terms and definitions

In addition to these provisions, the General Standard applicable. 2.1.101 An apparatus having a baby cabin that has been heated by the baby cabin air to control the infant specific environment. 2.1.102 An environmentally controlled housing for receiving a baby, and having observed part of the baby. 1) See IEC 60601-2-20 for the transport incubator. GB 11243-2008/IEC 60601-2-19.1990 2.1.103 Incubator air temperature is automatically controlled by the air temperature sensor to a value close to the set by the user. 2.1.104 An air temperature-controlled incubator, it has an additional feature that can automatically control the incubator air temperature, so that the baby's skin temperature Biography Sensors measured temperature, close to the user set temperature. 2.9 control means and restricting means Additional definitions. 2.9.101 Measuring a baby's skin temperature sensor means for. 2.9.102 Baby skin is placed on the skin temperature at the temperature sensor. 2.9.103 instead. In the steady state temperature, any provision of uniformly spaced points babies cabin average temperature reading. 2.9.104 On the temperature controller selected temperature. 2.9.105 10cm above the air temperature at the center of the surface of the mat the infant compartment (see FIG. 102, point A). 2.9.106 In the steady state temperature, evenly spaced read the average temperature of the incubator (see Figure 101). 2.10 running equipment Additional definitions. 2.10.101 At 1h interval, the incubator temperature does not exceed 1 ℃ when the state (see FIG. 101).

3 General requirements

In addition to these provisions, the General Standard applicable. 3.6 supplement. Single fault condition refers to the applicable components or wiring short circuit and open circuit will --- Sparks, or --- Increased spark energy, or --- Elevated temperature. supplement. GB 11243-2008/IEC 60601-2-19.1990 3.101 for binding of an alternative heat source device, such as an incubator with a radiant heater, heated mattresses, etc., should be consistent with these alternative Heat requirements for the safety. The requirements for the safety standards should not be because of these additional heat source specified by the manufacturer is changed, the details of which Instructions are provided. Meets requirements by examining the first 42 chapters 56.6 to verify.

4 General requirements for tests

In addition to these provisions, the General Standard applicable. 4.5 ambient temperature, humidity and atmospheric pressure replace. a)  this specific standard if not otherwise specified, all tests should be carried out at an ambient temperature of 21 ℃ ~ 26 ℃. 4.6 Other conditions supplement. aa) If not otherwise specified, the control temperature should be 34 ℃ ± 1 ℃, and should always be at least higher than the ambient temperature of 3 ℃. 6 Identification, marking and documentation In addition to these provisions, the General Standard applicable. 6.1 added. 6.1.101 only oxygen input device, but anaerobic analyzer incubator should be prominently marked "when using an oxygen monitor output oxygen" Text description. 6.1.102 If you do not use tools to be able to touch the heater should be given clear notice near heaters or mark the high surface temperature caveat. 6.3 added. b)  on the controller should be clearly marked at or near the setpoint temperature of each controller. Incubator air temperature control mark The interval should be less than 0.5 ℃, temperature-controlled incubator baby mark spacing should be less than 0.25 ℃. The controller on the gear and/or indicated value, the controls and indicators of the maximum and minimum marks should not cause confusion. 6.7 lights and buttons supplement a) if applicable, the incubator should be equipped with a yellow LED in line with the requirements of 54.101. 6.8 random file 6.8.2 User's Guide supplement. aa) the instructions for use should also include. --- Detailed description of the requirements to ensure that products meet the recommended maintenance methods and maintenance cycle. 1 Description incubator only be performed by staff specially trained in the use of familiar incubator commonly known risks and Benefits under the guidance of qualified medical personnel. 2 direct sunlight or other radiant heat source causes the incubator temperature to a dangerous level warning. 3 instructions using oxygen increases the risk of fire, sparking and auxiliary equipment shall not be placed in the incubator. 4 warning when oxygen is turned on, even small amounts of flammable agents, such as ether and alcohol left in the incubator can cause a fire. 5 according to the provisions of 50.108 measured incubator warm-up time indicator. 6 if applicable, recommend the use of skin temperature sensor placement and use, but also do not include it as anal Warning temperature sensor. Control temperature range and relative humidity range of information 7 incubator. If the incubator does not provide humidity control device, It should be indicated in the instructions for use. GB 11243-2008/IEC 60601-2-19.1990 8 recommended method to establish compliance with the requirements of 44.7. 9 if applicable, instructions can be placed in the incubator and connected auxiliary equipment rack maximum allowable weight. --- For Part B applications may no insulation shall be between the baby and the warning to pay special attention to ensure that connected with the baby Additional equipment is electrically safe. --- Where applicable, shall, visual alarm information on how to test hearing. --- WARNING When using the increased noise level inside the incubator Infant oxygen will. --- Incubator provides simultaneous use of supplementary oxygen equipment operating instructions or as specified in the accompanying documents. --- Description when providing oxygen to the baby, you should use an oxygen analyzer. 10 The manufacturer shall provide a detailed description and specific equipment associated supplies (see 3.101). 11 The manufacturer shall specify the maximum CO2 at 105.1 test requirements. The second environmental conditions Except the following clauses of the General Standard of the articles apply. 10 environmental conditions 10.2.1 Environment instead. a) at ambient temperature + 20 ℃ ~ + 30 ℃. supplement. aa) ambient air flow rate is lower than 0.3m/s. Third of the risk of electric shock protection Except the following clauses of the General Standard of the articles apply. 20 Dielectric strength In addition to these provisions, the General Standard applicable. 20.2 pairs have the application requirements of the equipment part B-b modify. Does not apply to the incubator. 20.3 test voltage supplement. B-d of the insulation should be at least a reference voltage is 250V. Of B-e insulation test voltage shall be at least 1500V. Title IV of the mechanical hazards Protection Except the following clauses of the General Standard of the articles apply. 21 Mechanical strength In addition to these provisions, the General Standard applicable. 21.6 supplement. b) through the above test, should be able to work properly, you should ensure that the mechanical and structural integrity of the incubator; such as latches and the door remains tight GB 11243-2008/IEC 60601-2-19.1990 Closed, provided by the manufacturer or can be obtained from the manufacturer of auxiliary equipment should be kept secure. supplement. 21.101 using walls, siding and other gear compartment, so that the baby should be securely retained in the infant compartment. Such as doors, entrances and other files can be opened or separated Removed in order to contact the baby, they are under the test conditions specified below, shall be closed and will not be opened. When performance is fastened, should not be Close gear compartment is not tight or locked unsound situation can occur under the following test conditions, the incubator should be closed to ensure its mechanical properties. Through inspection and test shall verify compliance with the following requirements. Do not use any tools, willfully causing all entrance doors, seems to have shut up, do not be secured as much as possible, a horizontal force In the center of the entrance door. The force should be within 5s ~ 10s time gradually increased from zero to 20N, and keep 5s at maximum. 21.102 accessories, brackets and bracket should be appropriate, in accordance with its use of adequate strength. Compliance shall be verified by inspection and the following test. With a gradually increasing force perpendicular to the central role of the bracket and the bracket. For example, in the extended position of the attachment manufacturer's recommended shelf placement load. Within 5s ~ 10s, scratch force equal to three times the recommended value, and keep 1min. There should be no signs of damage to the test component. 22 moving parts In addition to these provisions, the General Standard applicable. 22.2 Review. b) If no air circulation fan only when the baby in an incubator and to dismantle parts of the corresponding device can be connected to clean Touch, which requirement does not apply. 24 Stability in normal use In addition to these provisions, the General Standard applicable. 24.1 Replacement. In normal use inclined by 5 ° and at 10 ° tilted transport, the incubator should remain stable. 24.3 Replacement. b) the device in any possible position of normal use, and on the horizontal 0.09rad (5 °) angle of the slope. If installed Wheels, the wheels should be temporarily fixed in the most unfavorable position. Most doors, drawers and the like should be placed in normal use Unfavorable position. Mattress tray should extend outside the box cover. The test should be repeated at an angle 0.18rad (10 °), the mattress tray should not protrude outside the case cover. Doors, drawers and the like should be placed In the most unfavorable position. 24.102 make incubator overturned lateral force, should be greater than 100N. Compliance shall be verified by the following test. The infant incubator wheels locked, parts and accessories and equipment, a combination of the most adverse condition, plus a lateral force, and by measurement Force measurements, the point of force should be the highest point in the body of the device, when the force is less than equal to 100N, the incubator should not be overturned. 24.103 If the mattress tray can be extended to cover outside the box, this should be limited to ensure the tray and remain attached to the incubator, and get support, And in the weight of the baby will not fall over. Compliance shall be verified by the following test. In the case of the mattress tray is fully extended, the central edge of the mattress tray exert a downward force is gradually increasing, in 5s ~ The 10s to force 100N, and keep 1min. Incubator tray on the horizontal axis tilt shall not exceed 5 °, the support structure should not have Visible signs of damage. 24.104 If the device is mounted on wheels, the manufacturer shall provide the device can be prevented in the upper level of at least 10 ° of slope movement occurs Means. Compliance is verified by inspection and the following test. The wheels fall upon the location of the device is placed in the device and all accessories installed on the inclined surface of the horizontal 10 °, the recording equipment GB 11243-2008/IEC 60601-2-19.1990 It is in a stable state. Title VII of the ultra-mild other security risk protection Except the following clauses of the General Standard of the articles apply. 42 Overtemperature In addition to these provisions, the General Standard applicable. 42.1 Review. By deleting the table "piece of equipment in normal use, may be short-term contact with the patient" 10a) in the last line of the first column and the second column "50" (℃). 42.3 1) Replacement. 1) is used as the surface temperature of the contact with the baby should not exceed 40 ℃, may be exposed to the other surface temperature of the baby, the metal surface should be Not more than 40 ℃, other materials should not exceed 43 ℃. These requirements apply to normal and single fault condition. include. --- Air circulation failure occurs; --- Thermostat failure occurs; --- Skin temperature sensor is disconnected. Compliance shall be verified by the following test. Used as infant contact and maximum surface temperature may be in contact with the baby should be the requirements of the General Standard 42.4 was measured, and According to the specific standard of 101.1 and 56.6aa) compliance tests specified test conditions. 43 fire In addition to these provisions, the General Standard applicable. supplement. 43.101 order to eliminate the oxygen system equipment have enclosed cabin oxygen may become a fire hazard electrical components caused at least a source of ignition Shall meet one of the following requirements. --- Application meets the requirements of 43.102 electrical gear spacer element may accumulate oxygen compartment separated. Equipment section --- containing electrical components shall 43.103 ventilation requirements. --- Under normal use and single fault condition, the electrical components may become a source of ignition shall meet the requirements of 43.104. Any profile 43.102 43.101 spacers according to the requirements established in the hole should be sealed at all connection points and cable apertures or other purposes. Compliance shall be verified by checking, if possible, by the provisions of the General Standard 40.5 limited ventilation casing Conformance testing for verification. 43.103 43.101 ventilation requirements so that the oxygen concentration in the cabin is equipped with electrical components shall not exceed ambient levels of 4% volume concentration. Such as If using forced air to meet this requirement, the alarm device shall be equipped with a fault condition. Compliance shall be verified by the following test. Should be at the highest possible concentration of oxygen appears to measure oxygen concentration under the following conditions. --- Including possible oxygen leakage single fault condition; --- Choose the most unfavorable control settings; --- Supply voltage deviation ± 10% when. After the test in the case of power cut should 4h, that is, the power supply and cut off the oxygen supply to maintain repeated. Air exchange per hour of the test chamber should be 3 to 10 times the volume. 43.104 may produce sparks or cause surface temperature rises to become a source of ignition circuit should be designed to ignite does not occur in the positive Under a normal state and a single fault condition, at least to meet the following two requirements. --- RMS load voltage and short circuit current rms product should not exceed 10VA; GB 11243-2008/IEC 60601-2-19.1990 --- Element surface temperature should not exceed 300 ℃. Compliance shall be verified by the following test. Should be measured under normal conditions and single fault conditions or calculate the voltage and current, and measure the surface temperature. 44 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection, sterilization and compatibility In addition to these provisions, the General Standard applicable. 44.3 spilled liquid instead.  incubator should not be made into a wet parts that produce hazardous safety once wet liquid spills. Such liquid spills are considered a single fault condition. Compliance can be verified by the following test. Normal use position the device, its canopy in the normal position; the uniform 200mL water poured on the top surface of the device at any point, After this test, the equipment shall comply with the requirements of this standard. 44.4 Leak supplement. When  incubator should be made into the cabin, even in infants surfaces, including the infant carrier liquid polyethylene Shen, will not reduce the safety of the incubator Full sex. 200mL leak is considered normal. Compliance can be verified by the following test. In infants cabin all internal surfaces should be sprayed on the amount of water to flow down along the wall and cohesion, should be uniform and then 200mL of water poured in infants Child tray. After this test, the device shall comply with all the requirements of this standard. 44.7 cleaning, disinfection and sterilization supplement.  If you have a humidifier, it should be designed to use the interval between to clear microorganisms. 46 human error In addition to these provisions, the General Standard applicable. supplement. 46.101 all temperature sensors (including skin temperature sensor) should be clearly identified their intended function. The sensor shall not be possible Connection on the device is not suitable outlet. The method checks to verify compliance. When the baby 46.102 temperature-controlled incubator run as air temperature control the incubator, the indication should be clearly pointed out that the use of Operating mode. Verified by inspection. 46.103 Each rotary temperature control, should be designed to rotate in a clockwise direction when the temperature rises. Compliance shall be verified by inspection. Interrupt the power supply 49 In addition to these provisions, the General Standard applicable. 49.2...

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