GB 4793.8-2008 English PDFUS$879.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 4793.8-2008: Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes Status: Obsolete
Basic dataStandard ID: GB 4793.8-2008 (GB4793.8-2008)Description (Translated English): Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes Sector / Industry: National Standard Classification of Chinese Standard: C47 Classification of International Standard: 11.080.10 Word Count Estimation: 22,228 Date of Issue: 2008-03-24 Date of Implementation: 2009-01-01 Quoted Standard: IEC 60079; ISO 6718-1991 Adopted Standard: IEC 61010-2-042-1997, IDT Regulation (derived from): Announcement of Newly Approved National Standards No. 5, 2008 (No. 118 overall) 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 applies to include with automatic loading and unloading systems for autoclaves and sterilizers using toxic gas they have a sterilization chamber for treatment of medical materials, and for laboratory processing uses, such as for sterilization. If the pressure sterilizer is installed in the same apparatus for humidifying steam generator, this standard applicable safety requirements also apply to steam generators. GB 4793.8-2008: Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes---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. Safety requirements for electrical equipment for measurement, control, and laboratory use.Part 2-042. Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes ICS 11.080.10 C47 National Standards of People's Republic of China GB 4793.8-2008/IEC 61010-2-042.1997 Measurement, control and laboratory use electrical equipment safety Requirements - Part 2-042. toxic gas treatment Autoclaves for laboratory and medical materials, and Requirements for sterilizer (IEC 61010-2-042.1997, IDT) Published 2008-03-24 2009-01-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China issued Table of ContentsIntroduction Ⅲ Introduction Ⅳ And a range of object 1 2 Normative references 2 Definition 2 3 4 Test 3 5 Mark and File 3 6 6 against electric shock 7 7 against mechanical hazard Resistance to mechanical shock and impact 8 9 9 the device temperature limit and prevent spread of flame 9 10 Temperature 9 11 10 Anti-liquid hazardous Anti source 12 includes a laser radiation, including acoustic and ultrasonic pressure 11 13 anti-gas releases, explosions and burst 11 14 14 Components 15 with a protective interlock 16 16 measuring circuit 16 Appendix 17 GB 4793.8-2008/IEC 61010-2-042.1997ForewordAll technical contents of this standard is mandatory. This standard is based on the International Electrotechnical Commission IEC 66 measurement, control and safety technology committee established by laboratory equipment IEC 61010-2-042 "measurement, control and laboratory safety requirements for electrical equipment with Part 2-042. toxic gases are used for medical treatment Particular requirements for autoclaves and sterilizers materials, and for laboratory use "established. This is equivalent to using standard IEC 61010-2-042.1997. Measurement, control and safety standards for electrical equipment with the laboratory consists of two parts. General Requirements - Part 1, Part 2 for the production Requirements for the safety of the product. This part is necessary because toxic gases are used for device function requires special considerations given of the device described in Laid Sex. The structure of these devices, there are many potentially dangerous components, have different security requirements, to increase or modify the standard Part 1 Content. It should be noted, there are standards and regulations in other countries or international organizations. As it may be to increase the standard should be noted. This standard states that "suitable" partial, GB 4793.1 indicate corresponding provision in the standard applicable to the present; this standard states that "substitution" Or "Edit" section, the present subject to standard provisions; this standard states "addition" part, showing in addition to comply with the GB 4793.1 Should be outside the provisions of this standard must be met in increased provisions. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee sterilization equipment and technology. This standard was drafted. Hangzhou power of sterilization plant, the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection center. The main drafters. Chen Yuen, Zhou Qingqing, Huang Xiulian, Zhong Kui St., GAO Li. GB 4793.8-2008/IEC 61010-2-042.1997IntroductionIn the sterilizer chamber above or below the sterilization apparatus using toxic gases at atmospheric pressure, some portions of its structure potentially dangerous. They shall comply with the safety requirements specified in GB 4793.1, it must also meet a number of other security requirements. In particular, these include security requirements The protection of the operator and the surrounding environment, to protect yourself from accidental escape of toxic gases. Other existing national and international standards and norms, should also be considered, so that they can complement this standard. GB 4793.8-2008/IEC 61010-2-042.1997 Measurement, control and laboratory use electrical equipment safety Requirements - Part 2-042. toxic gas treatment Autoclaves for laboratory and medical materials, and Requirements for sterilizer1 Scope and PurposeExcept as follows, GB 4793.1 chapter apply. 1.1 Scope Alternative. This standard is applicable to a system with automatic loading and unloading autoclaves and sterilizers, they have a toxic gas in killing Bacteria chamber for treatment of medical materials and process for laboratory use, such as for sterilization. Note 1. The automatic loading system security using the national safety regulations or other safety regulations. Note 2. generally believed that automatic control of the sterilization cycle for the safe operation of equipment using toxic gas is very important because the manual control system might be Serious harm to the operator (see 1.2). Note 3. a primary gas sterilizing agent used is ethylene oxide and formaldehyde. NOTE 4. For some applications, a sterilization chamber to be carried out above or below atmospheric pressure. Note 5. All the pressure refer to absolute pressure. Atmospheric pressure (1bar) ≥100kPa. Note 6. Unless otherwise specified, "autoclaves" refers to include various sterilizer account. If the pressure sterilizer is mounted for humidifying steam generator in the same apparatus, the predetermined standard is applicable safety requirements, but also with the Apply equally to the steam generator. 1.1.2 within the scope of this standard does not include modify. Add the following words after the last dash. Autoclaves itself generates free gaseous environment (see 13.2.103.1). increase. Add a new dash and notes the following. --- environment cabinet Note 1. Since the second part of the covered autoclaves are all toxic gases are used, only using steam or dry heat sterilization of other types of devices not included; Note 2. The standard does not discuss the special requirements of the washing disinfection, not discuss a great risk of microbial load associated hazards, nor discuss pressure vessel Own design requirements. 1.2 Purpose modify. Following text is inserted after the word sixth dash "gas". (Including accidental escape of toxic gases) 1.4 Environmental conditions Alternative. The first dash replaced by the following. --- indoor use, otherwise if the manufacturer can be used outdoors (see GB 4793.1-2007 11.6). GB 4793.8-2008/IEC 61010-2-042.19972 Normative referencesTerms of the following documents constitute provisions of this section by reference in this section. For dated reference documents, all later Amendments (not including errata content) or revisions do not apply to this section, however, encourage the parties to agreements based on research of Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this section. Except as follows, GB 4793.1 (including amendments 1.1992 and amendments 2.1995) chapter apply. increase. 2.1 IEC standard IEC 60079 Determination of the electrical apparatus for Explosive Gas Atmospheres 2.2 ISO standard ISO 6718.1991 explosion proof and explosion-proof safety disc means a disc Definition 3 Except as follows, GB 4793.1 chapter apply. 3.1 Equipment and device status Increase definitions. 3.1.101 The load handling apparatus for a certain condition to the next (for example, sterilization) is attached to the pressure vessel or vacuum container. 3.1.102 A complete process operation, the process is typically adjusted by an automatic control, performed in a predetermined sequence. 3.2 Increase definitions. 3.2.101 The pressure sterilizer apparatus operation cycle can be completed in a predetermined time, temperature, pressure and concentration conditions such as gas sterilization. 3.2.102 Load portion is placed within the sterilization autoclaves. 3.2.103 Material handling equipment and placed in operation by a pressure cycle of sterilization. 3.2.104 A sterilization chamber, a jacket (if installed with), and all the doors open member permanently connect the pressure-sterilized chamber consisting of means. Note. the pressure vessel does not include those that separate individually isolated components, such as steam generator tubing, and other accessories. 3.2.105 This is part of the operating cycle. Meanwhile, toxic gases or reaction products thereof, and both of them, desorption from the load out, until Reaches a predetermined level. NOTE. ventilation pressure may be within or outside the sterilizer. GB 4793.8-2008/IEC 61010-2-042.1997 3.2.106 Sterilizer for sterilizing an article loading apparatus part, which comprises the sterilization chamber. Note. In fact, you can not reach an absolute condition, therefore, sterility expressed in probability.4 TestExcept as follows, GB 4793.1 chapter apply. 4.3.5 cover and removable parts Alternative. The second sentence with the following alternatives. When the movable lid without tools, and having locking means to automatically stop member, when the cover is opened become dangerous (see 1.2), The lid can not be opened. 4.4.2.4 Motor increase. Add the following new second paragraph. If you can not quickly let the motor stops, the same shall be individually tested another motor. 4.4.2.10 heating means increase. Add the following two new dash. --- pressure controller should be invalidated (except those that meet the requirements 11.7.4 overpressure safety device), so that the heating system or a continuous work circuit. --- loss of feedwater to be simulated. 4.4.2.12 interlocks increase. At the end of the first paragraph, add the following sentence. Mechanical interlock device should be turned off sequentially. Insert the following new paragraph after the first paragraph. If the interlock to prevent accidental contact with the gas sterilant, the application as a non-toxic gas such as nitrogen to the test. Add the following provisions. 4.4.2.101 network power failure or partial failure First, should the mains power input to the device supply voltage falls below 89% of rated voltage, 5min, and then turned off. Then, connect 90% of the rated voltage, a predetermined rate down slowly press down the manufacturer, until the pressure stopped until the sterilizer. 4.4.2.102 other supply failure Each non-electric supply or service, such as sterilant gas, air, liquid, vapor, drainage system and an exhaust system, depending on the less favorable case Conditions should turn interrupted or partially interrupted.5 Mark and fileExcept as follows, GB 4793.1 chapter apply. 5.1.1 Overview increase. Insert a new Note 1 below the original comment re renumbered Note 2. Note 1. Guidance on the indicator color and non-illuminated pushbutton, see IEC 60073. 5.1.2 logo increase. GB 4793.8-2008/IEC 61010-2-042.1997 Add the following new dash and two new paragraphs. --- Pressure Vessels mark (see 5.1.102). Jacketed pressure vessel, if the pressure which the jacket and the sterilization chamber pressure different from the sterilization chamber and the jacket should be indicated 5.1.102 Seeking relevant information. The consolidated information should be marked on the outside of the pressure vessel. For the product of pressure and volume is less than 5000kPa · L (50bar · litres) a pressure container, the marker may be permanently Posts prison anywhere in the device. 5.1.3 Network Power Alternative. The following alternatives to the original text content in d). d) If the apparatus can be provided different nominal supply voltage, the equipment should provide a means to show its set voltage. Portable equipment should It can be seen from the outside of the display. If the structure of the device can without tools to change the power voltage setting, it is also the practice You should be able to change the display. 5.1.6 terminals and operating means increase. After item e) adding a new entry aa) the following. aa) change the controller during normal use of the set value become dangerous (see 1.2), then the controller should be configured associated A display device, such as gauges, dials, light emitting diode (LED) and the like. Note. functions associated therewith individual controllers, indicators and instruments, the group should be woven together. Add the following provisions. 5.1.101 overpressure safety device Means (see 11.7.4) should be labeled with a type, name, or other means, and it should be marked with the set pressure. If sterilization A disc disposed between the chamber and the explosion-proof safety overpressure mounting means, the disc burst pressure shall be marked and their associated predetermined temperature. 5.1.102 pressure vessel marker Marking pressure vessels shall comply with the applicable regulations of the country of use. If there are no national regulations, the manufacturer shall it require the buyer to the provisions applicable Labeling regulations require the use of. In any case, labeling should include the following. a) name of the manufacturer of the pressure vessel; b) serial number of the pressure vessel; c) the same gate identification number (this number may be the serial number of the pressure vessel); d) maximum working pressure; e) maximum operating temperature; f) the minimum operating pressure (if it is lower than the atmospheric pressure); g) the test pressure; h) producing the pressure vessel based on criteria; i) sterilization chamber volume (liters). 5.2 Warning Flag increase. The new increase in the following three paragraphs. If the pressure sterilizer is mounted lockable by 7.103 preventing door closure means, the operator notices the warning mark should enter the sterilization chamber Before the device you want to lock and key save during the sterilization chamber itself, as well as other methods of locking device. Permanent firmly affixed and clearly legible mark should be provided on a place easily visible to the operator device, the marking should indicate the gas Hazardous nature of sterilization agent, such as flammability and toxicity. If the marked position allows, but also to prevent the danger should take note of precaution Shi (see 1.2). To learn more information, the operator can refer to the manual. GB 4793.8-2008/IEC 61010-2-042.1997 When the pressure sterilizer using a non-use design load, may result in dangerous (see 1.2), should be appropriate warning mark, Indicate the type of load may be employed. If the equipment is not enough position marked warning mark may be marked with the symbol 1 in Table 14. 5.4.1 Overview increase. Add the following three new dash. --- statement shall comply with the requirements of 14.101 pressure vessel; --- sterilant container, such as a case of leaks due to a fire, the sterilant contacts the skin and people's eyes, or by inhalation to the respiratory Emergency road and so on, should follow the guidelines; NOTE. This should be indicated on the guide autoclaves or apparent position of the next. Description --- warning labels shall comply with the applicable regulations of the country of use. 5.4.2 Equipment nominal operating conditions increase. Add a new dash below. --- air enters the apparatus and equipment rated operation at a pressure above atmospheric pressure the maximum leak rate of air or gas sterilant Escaping maximum leakage rate of the equipment rated. 5.4.3 Equipment Installation Alternative. File should include the requirements specified in 5.4.3.1,5.4.3.2 and 5.4.3.3. Assembly and installation instructions 5.4.3.1 The description shall include the following details. a) position, a fixed installation instructions, comprising a safe and effective maintenance of the required service space; Piece weight b) and the main weight of the total weight of the components; c) floor load requirements; d) assembling method; e) network connection and power requirements; f) the protective earthing instructions; g) sound power and data requirements (see 12.5.1); h) the surrounding environment and hazardous gas related requirements (see 13.2.103.1). 5.4.3.2 requires special facilities Installation instructions shall include the following requirements for special facilities. a) the desired properties acyclic mounting apparatus ventilation system (see 13.1.106); NOTE. The ventilation ventilation system at least 10 times per hour, but if a large device, the ventilation frequency should be increased. b) the pressure sterilizer separate sensors for monitoring the ventilation system of unknown fault workplace (see 13.1.106); c) non-recycled local exhaust system, for eliminating escape thereof (see 13.1.109); d) the drainage system; e) a drain passage of the exhaust system (see 13.1.108); f) an exhaust system sterilization chamber; g) steam supply and exhaust system (if needed). 5.4.3.3 permanently connected equipment Requirements for external switch or circuit breaker (see 6.12.2.1) and an external overcurrent protection devices (see 9.6), and these switches or Circuit breaker device disposed in the vicinity of the recommendation. Compliance can be verified by inspection. 5.4.4 Equipment operation Alternative. GB 4793.8-2008/IEC 61010-2-042.1997 5.4.4 Equipment operation 5.4.4.1 Manual Instruction should contain. a) Under all operating conditions, the control operation of the device; b) if appropriate, the positioning device is given the description should not be difficult to disconnect device operation (see 6.12); c) a description of other devices and accessories, including the identification of suitable accessories, detachable parts and any special materials; Predetermined value d) of the intermittent operation (when applicable); e) GB 4793.1 symbols on a predetermined interpretation device for; f) cleaning instructions (see 11.2); g) for sterilization before entering the room, the door of the operating instructions (see 7.103), and pointed out that the operator must be saved at any time during the sterilization chamber Good key, or other methods to lock the device, which is very important; h) in the event of a failure, responsible for the safety of using a turnkey or other equivalent means to enter the sterilization chamber in contact with said load Ming (see 13.102); i) the measures taken in the event of a failure. Note. The above description should be construed operation cycles comprising various special methods of the recorded data. For example, fault monitoring or monitoring a chart recorder may lead to Trend failure. 5.4.4.2 consumable material It should provide inspection of the consumable material, and replace the stored instructions, including sterilant source-related member (grooves, brackets, connectors Wait). It further includes a specification in order to minimize the risk (see 1.2) and the protective means and program details. See also 5.2. 5.4.4.3 Operator Training To ensure that properly trained operator, and can monitor the use of toxic gases autoclaves safe use, with the manufacturer's It should be noted SHEET respons......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 4793.8-2008_English be delivered?Answer: Upon your order, we will start to translate GB 4793.8-2008_English as soon as possible, and keep you informed of the progress. 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