YY 1621-2018 PDF EnglishUS$235.00 · In stock · Download in 9 seconds
YY 1621-2018: [YY/T 1621-2018] Medical carbon dioxide incubator Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Obsolete YY 1621: Historical versions
YY 1621-2018: [YY/T 1621-2018] Medical carbon dioxide incubator---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY1621-2018PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100 C 44 Medical carbon dioxide incubator ISSUED ON: SEPTEMBER 28, 2018 IMPLEMENTED ON: APRIL 01, 2020 Issued by: National Medical Products Administration Table of ContentsForeword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Terms and definitions... 4 4 Requirements ... 5 5 Test methods ... 8 6 Labels, packaging identification, instructions for use ... 10 7 Packaging, transportation, storage ... 12 Appendix A (Normative) Test method for temperature control performance ... 13 Appendix B (Normative) Test method for carbon dioxide's concentration control performance ... 18 Medical carbon dioxide incubator1 ScopeThis standard specifies the terms and definitions, requirements, test methods, labels, packaging identification and instructions for use, packaging, transportation, storage of medical carbon dioxide incubators (hereinafter referred to as incubators). This standard is applicable to medical carbon dioxide incubators, for culturing biological cells, tissues, bacteria and other human-derived samples, in clinical tests. The upper limit of the incubation temperature of the incubator, to which this standard applies, is 55 °C; the lower limit of the temperature is 3 °C ~ 5 °C higher than the ambient temperature; the control range of carbon dioxide concentration is 0% ~ 20%; the internal volume is 100 L ~ 300 L.2 Normative referencesThe following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 Packaging - Pictorial marking for handling of goods GB 4793.1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements GB 4793.6 Safety requirements for electrical for measurement control and laboratory use - Part 6: Particular requirements for laboratory equipment for the heating of materials GB/T 14710 Environmental requirement and test methods for medical electrical equipment GB/T 18268.1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Temperature control range The temperature range, within which the incubator can be effectively controlled, when operating under specified environmental conditions. 3.2 Working space The space area within the working room, where the specified technical conditions are met. 3.3 Chamber temperature The temperature of the geometric center of the workspace.4 Requirements4.1 Working environment conditions If the manufacturer has no special working environment requirements, the working environment of the incubator shall meet the following requirements: a) Ambient temperature: 18 °C ~ 30 °C; b) Relative humidity: ≤ 80%; c) Atmospheric pressure: 86 kPa ~ 106 kPa; d) There is no strong vibration and corrosive gas around; e) The influence of direct sunlight or other cold and heat sources shall be avoided; f) Power supply voltage: 220 V ± 22 V; g) Voltage frequency: 50 Hz ± 1 Hz. 4.2 Appearance and structure 4.2.1 The surface of the incubator shall be clean and flat, without obvious scratches, burrs and unevenness; the characters and symbols shall be clearly marked. 4.2.2 The internal accessories (such as shelves and supports) of the incubator's working room shall be easily disassembled and assembled, without tools. 4.7 Alarm The incubator shall be able to set the temperature and carbon dioxide concentration. It shall have the following alarm functions: a) The alarm for the temperature exceeding the upper limit; b) The alarm for the temperature exceeding the lower limit; c) The alarm for carbon dioxide concentration exceeding the upper limit; d) The alarm for carbon dioxide concentration exceeding the lower limit; e) The alarm for the door opening time exceeding the limit. 4.8 Door open recovery time 4.8.1 Temperature recovery time The temperature recovery time of the incubator shall be ≤ 10 min. 4.8.2 Carbon dioxide's concentration recovery time The recovery time of carbon dioxide concentration in the incubator shall be ≤ 10 min. 4.9 Thermal insulation performance The incubator shall have good thermal insulation performance. The secondary temperature difference shall be ≤ 8.0 °C. 4.10 Prevention of condensation The incubator shall control the generation of condensed water. There shall be no condensed water, on the inside of the inner door, the top, side walls and upper half of the rear wall of the working room. Note: The inner door generally refers to the sealed glass door of the incubator. 4.11 Over-temperature protection In order to prevent the damage to the cultured samples, which are caused by excessive temperature, the incubator shall have an over-temperature protection function. When the temperature control device fails, it shall be able to ensure that the temperature of the incubator does not exceed the set temperature by 1.5 °C. 4.12 Safety 4.12.1 The general requirements for electrical safety of the incubator shall comply with the provisions of GB 4793.1. 4.12.2 The special requirements for electrical safety of the incubator shall comply with the provisions of GB 4793.6. 4.12.3 The electromagnetic compatibility requirements of the incubator shall comply with the provisions of GB/T 18268.1. 4.13 Environmental test The environmental test of the incubator shall be carried out, in accordance with the provisions of GB/T 14710.5 Test methods5.1 Appearance and structure Visual observation and actual operation inspection shall meet the requirements of 4.2. 5.2 Temperature display and control performance 5.2.1 Check the technical information provided by the manufacturer, which shall meet the requirements of 4.3.1. 5.2.2 Visual inspection shall meet the requirements of 4.3.2. 5.2.3 Carry out testing, according to the method in Appendix A; the results shall meet the requirements of 4.3.3, 4.3.4, 4.3.5, 4.3.6. 5.3 Carbon dioxide's concentration display and control performance 5.3.1 Check the technical information, as provided by the manufacturer, which shall meet the requirements of 4.4.1. 5.3.2 Visual inspection shall meet the requirements of 4.4.2. 5.3.3 Carry out testing, according to the method in Appendix B; the results shall meet the requirements of 4.4.3 and 4.4.4. 5.4 Relative humidity control performance According to the test conditions specified in A.1, the incubator is in normal working mode: the temperature is set to 37.0 °C, the carbon dioxide's concentration is set to 0.0%. When the humidity detection equipment is placed in the center of the incubator, its resolution is 0.1% or better. When the device shows that the temperature reaches the set temperature and waits for 2 h, the humidity, which is measured at the center position, shall meet the requirements of 4.5. 5.5 Noise 5.9 Prevention of condensation According to the test conditions specified in A.1, in the normal working mode of the incubator, set the temperature to 37.0 °C; set the carbon dioxide's concentration to 0.0%. Wait 24 h, after the equipment display temperature reaches the set temperature. Carry out the visual inspection, which shall meet the requirements of 4.10. 5.10 Over-temperature protection According to the test conditions specified in A.1, the temperature is set to 37.0 °C; the carbon dioxide's concentration is set to 0.0%. When the simulated temperature control device fails, the measurement chamber's temperature shall meet the requirements of 4.11. 5.11 Safety 5.11.1 The general requirements for electrical safety shall be tested, according to the methods specified in GB 4793.1. 5.11.2 The special requirements for electrical safety shall be tested, according to the method specified in GB 4793.6. 5.11.3 Electromagnetic compatibility requirements shall be tested, according to the method specified in GB/T 18268.1. 5.12 Environmental test Carry out test, according to the provisions of GB/T 14710.6 Labels, packaging identification, instructions for use6.1 General The text content of labels, packaging identifications, instructions for use shall be in Chinese; other languages may be added. The use of Chinese shall comply with the national language norm. The words, symbols, graphics, tables, pictures, etc. of labels, packaging identifications, instructions for use shall be accurate, clear, standardized. The symbols, which are used in labels and instructions for use, shall comply with the requirements of YY/T 0466.1. 6.2 Labels Incubator labels shall contain at least the following: a) Product name, model or specification; b) The name and address of the manufacturer; c) The rated power; d) The power supply voltage and frequency; e) The date of manufacture and service life. 6.3 Packaging identification The packing box shall have the following contents: a) The product model and name; b) The name of the manufacturer; c) The net weight and gross weight; d) The product number and date of manufacture; e) The overall dimensions; f) The storage and transportation conditions; g) The words, diagrams or signs, such as "handle with care", "upward", "afraid of moisture", "fragile", which are specified in GB/T 191. 6.4 Instructions for use Instructions for use shall comply with the relevant requirements of national standards or industry standards. It generally shall include the following contents: a) The product name, model, specification; b) The name, registered address, production address, contact information, after-sales service organization of the manufacturer; c) The product performance, main structure, scope of application, working space; d) Precautions and other contents, that need to be warned or prompted; e) Explanation of graphics, symbols, abbreviations, etc., which are used in medical device labels; f) The installation and use instructions or illustrations; g) The product maintenance and service methods, special storage conditions, methods; h) Other contents, which are specified in the product technical requirements, that shall be indicated in the manual.Appendix A(Normative) Test method for temperature control performance A.1 Test conditions The temperature of the test environment shall be within the range of 22 °C ± 3 °C. It shall avoid the influence of heat sources and strong air flow. The interior of the incubator is in an empty state, BUT includes internal accessories (such as shelves and supports). A.2 Test equipment The equipment used for temperature detection is generally composed of a temperature sensor, a temperature recorder or a temperature indicator. The resolution of the temperature detection equipment shall be better than that of the tested equipment; the maximum response time of its temperature detection is τ0.9 ≤ 5 s. A.3 Arrangement of temperature detection points The distance, between the temperature detection point and the inside of the workspace, is about 1/10 of the width, height or depth of the workspace. This distance determines the position of the detection plane. The temperature detection points are evenly distributed, on the three horizontal detection planes (see Figure A.1). There are 9 detection points, on each detection plane (see Figure A.2), that is, a total of 27 detection points. The sensor probe of the temperature detection point, on each detection plane, shall be more than 15 mm away from the shelf, to ensure that the sensor probe does not come into contact with metal materials, such as the shelf or inner wall. points of "low, medium, high" are detected, meanwhile one temperature point of "low, medium, high" is replaced by 37.0 °C. Example: If the temperature control range of a certain type of incubator is (ambient temperature + 5.0 °C) - 55.0 °C, the current test environment temperature is 22.0 °C, THEN, the minimum control temperature is 22.0 °C + 5.0 °C = 27.0 °C, the maximum control temperature is 55.0 °C, the low-point temperature detection point is 27.0 °C + (55 °C - 27 °C)/5 = 32.6 °C; the mid- point temperature detection point is 27.0 °C + (55 °C - 27 °C)/2 = 41.0 °C; high-point temperature detection point 55.0 °C - (55.0 °C - 27.0 °C)/5 = 49.4 °C. A.5 Inspection of temperature control performance The incubator is operating in normal user usage mode, where the carbon dioxide's concentration is set to 0.0%. After the device shows that the temperature reaches the set temperature, wait for 2 hours, before starting recording the data. Take records at the interval of 10 s, for a duration of 1 h. Pay attention to observe the change of temperature display value. Record 10 display readings randomly. A.6 Evaluation of temperature performance According to the temperature data, which is recorded in A.5 "Inspection of temperature control performance", analyze the temperature data AND evaluate the temperature control performance. A.6.1 Calculation of temperature display error Calculate T display error, according to formula (A.1): T display error = ±| display - T setting| ………………………… (A.1) Where: T display error - The temperature display error; display - The "arithmetic mean" of the temperature display values, which is recorded in A.5; T setting - The temperature set point. A.6.2 Calculation of temperature control error Calculate T control error, according to formula (A.2):Appendix B(Normative) Test method for carbon dioxide's concentration control performance B.1 Test conditions The temperature of the test environment shall be within the range of 22 °C ± 3 °C, to avoid the influence of heat sources and strong air flow. The interior of the incubator is in an empty state, BUT accessories, such as shelves, are included. The set temperature of the incubator is the common temperature point 37.0 °C. B.2 Test equipment Carbon dioxide tester is divided into "pump type" and "probe type". The range of carbon dioxide concentration is 0% ~ 20%; the response time is less than 20 s. The resolution of the carbon dioxide tester shall be better than that of the tested equipment; the standard gas shall be used for calibration, before use. Other carbon dioxide concentration measurement methods can be used, as long as they produce equivalent measurements. B.3 Arrangement of carbon dioxide detection points For the "probe type" tester, the sensor shall be placed in the center of the incubator AND not in direct contact with the shelf. For the "pump type" tester, the sampling tube shall take sample, from the center of the incubator. B.4 Setting of test points of carbon dioxide control range It shall be carried out, under the following concentration detection control points: a) Detection point for low-point carbon dioxide concentration: In the lower 1/5 position, within the gas concentration range; b) Detection point for mid-point carbon dioxide concentration: In the middle 1/2 position, within the gas concentration range; c) Detection point for high-point carbon dioxide concentration: In the high 1/5 position, within the gas concentration range; d) Detection point for common carbon dioxide concentration: The 5.0% is the concentration point, which must be tested. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY 1621-2018 be delivered?Answer: The full copy PDF of English version of YY 1621-2018 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY 1621-2018_English with my colleagues?Answer: Yes. The purchased PDF of YY 1621-2018_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY 1621-2018 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds.Question 5: Should I purchase the latest version YY 1621-2018?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 1621-2018 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.How to buy and download a true PDF of English version of YY 1621-2018?A step-by-step guide to download PDF of YY 1621-2018_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).Step 2: Search keyword "YY 1621-2018". Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart. Step 4: Select payment option (Via payment agents Stripe or PayPal). Step 5: Customize Tax Invoice -- Fill up your email etc. Step 6: Click "Checkout". Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively. Step 8: Optional -- Go to download PDF. Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice. See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9 |
