GB 4793.4-2019 English PDFUS$564.00 ยท In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 4793.4-2019: Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 4: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials Status: Valid GB 4793.4: Historical versions
Basic dataStandard ID: GB 4793.4-2019 (GB4793.4-2019)Description (Translated English): Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 4: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials Sector / Industry: National Standard Classification of Chinese Standard: C47 Classification of International Standard: 11.080.10 Word Count Estimation: 30,316 Date of Issue: 2019-12-17 Date of Implementation: 2021-01-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB 4793.4-2019: Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 4: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials---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 4. Particular requirements for sterilizers and washer-disinfectors for handling medical materials) ICS 11.080.10 C47 National Standards of People's Republic of China Replaces GB 4793.4-2001, GB 4793.8-2008 Safety of electrical equipment for measurement, control and laboratory use Requirements Part 4. Special requirements for sterilizers and washer-disinfectors controlandlaboratoryuse-Part 4. Particularrequirementsfor (IEC 61010-2-040..2005, Safety requirements for electricalequipment for measurement, controlandlaboratoryuse-Part 2-040. Particularrequirementsfor (sterilizersandwasher-disinfectorsusedtotreatmedicalmaterials, IDT) 2019-12-17 Release 2021-01-01 Implementation State Administration of Market Supervision Published by the National Standardization Management Committee ContentsForeword III 1 Scope and purpose 1 2 Normative references 2 3 Terms and definitions 2 4 Test 3 5 Logos and documents 4 6 Protection against electric shock 7 7 Protection against mechanical hazards and hazards related to mechanical functions 8 8 Resistance to mechanical shock and impact 11 9 Preventing the spread of flames 11 10 Temperature limits and heat resistance of the device 11 11 Protection against liquid hazards 12 12 Radiation protection (including laser source), acoustic pressure and ultrasonic pressure 14 13 Protection against released gases, pathogenic substances, explosions and implosions 14 14 Components 19 15 Protection with interlocks 20 16 Test and measurement equipment 20 Appendix G (informative) Leaks and ruptures due to liquid pressure 21 References 22ForewordAll technical contents of this standard are mandatory. GB 4793 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory is currently divided into 9 parts. --- Part 1. General requirements (IEC 61010-1); --- Part 2. Particular requirements for handheld and hand-operated current sensors for electrical measurement and testing (IEC 61010-2-032); --- Part 3. Special requirements for laboratory mixing and stirring equipment (IEC 61010-2-051); --- Part 4. Special requirements for sterilizers and washer-disinfectors for handling medical materials (IEC 61010-2-040); --- Part 5. Safety requirements for handheld probe assemblies for electrical measurement and testing (IEC 61010-031); --- Part 6. Particular requirements for laboratory heating equipment (IEC 61010-2-010); --- Part 7. special requirements for laboratory centrifuges (IEC 61010-2-020); --- Part 9. Particular requirements for automatic and semi-automatic equipment for analytical and other purposes in laboratories (IEC 61010-2-081); --- Part 10. Special requirements for test and measurement circuits (IEC 61010-2-030). This part is Part 4 of GB 4793. This section is drafted in accordance with the rules given in GB/T 1.1-2009. This section replaces GB 4793.4-2001 "Measurement, control and laboratory electrical equipment for safety laboratory processing of medical materials Special requirements for autoclaves "and GB 4793.8-2008" Safety requirements for electrical equipment for measurement, control and laboratory use-Part 2-042. Specific requirements for the use of toxic gases for the treatment of medical materials and for autoclaves and sterilizers for laboratory use. This section starts with GB 4793.4- Mainly.2001, integrated the content of GB 4793.8-2008. Compared with GB 4793.4-2001, the main technical changes in this section are as follows. --- Amended the scope of application (see Chapter 1, Chapter 1 of GB 4793.4-2001); --- Added terms and definitions of "dangerous" (see 3.5.2); --- Deleted the term and definition of "autoclave" (see 3.1.101 of GB 4793.4-2001); --- Modified the terms and definitions of "cavity" and "operation cycle" (see 3.2.101, 3.2.105, 3.2.101 of GB 4793.4-2001, 3.1.102); --- Added requirements for covers and removable parts (see 4.3.2.3); --- Increased work cycle requirements (see 4.3.2.11); --- Removed the requirements for pressure vessel marking (see 5.1.2 of GB 4793.4-2001); --- Removed the requirement of voltage indication mark (see 5.1.3 of GB 4793.4-2001); --- Delete the requirement to change the control indicating device (see 5.1.6 in GB 4793.4-2001); --- Removed the requirements for pressure vessels (see 5.1.102 in GB 4793.4-2001); --- Increased the requirements for the non-electrical supply in the instructions for the rated range of pressure and flow (see 5.4.2); --- Increased the installation instructions for special systems in the manual (see 5.4.3.101); --- Increased the requirements for operator training in the instructions (see 5.4.101); --- Increased the requirement for anti-shock by adding 13.0 regarding electrical in hazardous gas environments generated by potentially flammable and explosive sterilants Requirements (see 6.1.1); --- Increased the test requirements when checking the bottom of accessible parts (see 6.2.1); --- Added requirements for installation instructions for special systems (see 5.4.3.101); --- Removed the requirements for bell-shaped pressure vessels (see 7.2.102 of GB 4793.4-2001); --- Increased the stability requirements of the door (see 7.3); --- Increased the requirements and test methods of the handle or handle in the lifting and handling device (see 7.4); --- Removed the requirements for resistance to mechanical shock and collision (see Chapter 8 of GB 4793.4-2001); --- Removed the requirements for over-temperature protection devices (see GB 4793.4-2001 9.5); --- Increased equipment temperature limits and heat resistance requirements (see Chapter 10); --- Increased the requirement to prevent liquid overflow (see 11.4); --- Increased requirements for safe emissions (see 11.101); --- Increased overview of released gases, pathogenic substances, explosion and implosion protection (see 13.0); --- Increased requirements for toxic and harmful gases (see 13.1); --- Added requirements for explosions and implosions (see 13.2); --- Added requirements for other hazards caused by the use of toxic sterilants (see 13.101); --- Added requirements for stoichiometric systems (see 13.102); --- Removed the requirement to approach the port (see 14.103 in GB 4793.4-2001); --- Increased the requirement to prevent opening of access (see 14.102). Compared with GB 4793.8-2008, the main technical changes in this section are as follows. --- Amended the scope of application (see Chapter 1, Chapter 1 of GB 4793.8-2008); --- Added terms and definitions of "dangerous" (see 3.5.2); --- Deleted the term and definition of "pressure sterilizer" (see 3.1.101 of GB 4793.8-2008); --- Deleted the term and definition of "automatic controller" (see 3.2.101 in GB 4793.8-2008); --- Deleted the term and definition of "ventilation" (see 3.2.105 in GB 4793.8-2008); --- Modified the terms and definitions of "cavity" and "running cycle" (see 3.2.101, 3.2.105, 3.2.102 of GB 4793.8-2008, 3.1.102); --- Added requirements for covers and removable parts (see 4.3.2.3); --- Increased work cycle requirements (see 4.3.2.11); --- Removed the requirement for pressure vessel marking (see 5.1.2 of GB 4793.8-2008); --- Removed the requirement of network power (see 5.1.3 of GB 4793.8-2008); --- Removed the requirements for terminals and operating devices (see 5.1.6 in GB 4793.8-2008); --- Removed the requirements for pressure vessels (see 5.1.102 of GB 4793.8-2008); --- Increased the requirements for the non-electrical supply in the instructions for the rated range of pressure and flow (see 5.4.2); --- Increased the installation instructions for special systems in the manual (see 5.4.3.101); --- Increased the requirements for operator training in the instructions (see 5.4.101); --- Increased the requirement for anti-shock by adding 13.0 regarding electrical in hazardous gas environments generated by potentially flammable and explosive sterilants Requirements (see 6.1.1); --- Increased the test requirements when checking the bottom of accessible parts (see 6.2.1); --- Added requirements for installation instructions for special systems (see 5.4.3.101); --- Increased the stability requirements of the door (see 7.3); --- Increased the requirements and test methods of the handle or handle in the lifting and handling device (see 7.4); --- Removed the requirements for resistance to mechanical shock and collision (see Chapter 8 of GB 4793.8-2008); --- Removed the requirements for over-temperature protection devices (see GB 4793.8-2008 9.5); --- Increased equipment temperature limits and heat resistance requirements (see Chapter 10); --- Increased the requirement to prevent liquid overflow (see 11.4); --- Increased requirements for safe emissions (see 11.101); --- Increased overview of released gases, pathogenic substances, explosion and implosion protection (see 13.0); --- Added requirements for other hazards caused by the use of toxic sterilants (see 13.101); --- Added requirements for stoichiometric systems (see 13.102); --- Increased the requirement to prevent opening of access (see 14.102). This section uses the translation method equivalent to IEC 61010-2-040..2005, Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-040. Particular requirements for sterilizers and washer-disinfectors for handling medical materials. The Chinese documents that have a consistent correspondence with the international documents referenced normatively in this section are as follows. --- GB 3836 (all parts) Electrical equipment for explosive gas environments [IEC 60079 (all parts)]; --- GB/T 23127-2008 Electric appliances connected to water source to avoid siphon and hose assembly failure IDT); --- HG/T 3115-1998 Borosilicate glass 3.3 performance (ISO 3585..1991, IDT). For ease of use, the following editorial changes have been made in this section. --- In order to be consistent with the existing series of standards, the standard name was changed to `` Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 4. Particular requirements for sterilizers and washer-disinfectors for the treatment of medical materials ''; --- Added an introduction to the special case description in the normative references; --- Omit the content of "Appendix H (informative appendix) Definition Index"; --- Fixed typographical errors in the original English standard. Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents. This section is proposed and managed by the State Drug Administration. This section was drafted by. Guangdong Medical Device Quality Supervision and Inspection Institute, Shandong Xinhua Medical Devices Co., Ltd., Kunshan Ultrasound Instrument Co., Ltd., Hangzhou Younik Disinfection Equipment Co., Ltd. The main drafters of this section. Feng Danqian, Fu Jilin, Hu Changming, Liu Xiaolin, Xu Hongquan, Zhou Qingqing. The previous versions of the standards replaced by this section are. --- GB 4793.4-2001; --- GB 4793.8-2008.IntroductionThis section is a special safety standard for sterilizers and washer-disinfectors used to process medical materials. GB 4793.1- 2007 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Part 1. General Requirements (IEC 61010-1..2001, IDT) content. For the definition of sterilizer, see 3.2.103.The washer-disinfector is intended for cleaning and disinfecting medical devices and other medical devices, Equipment for medicine and veterinary goods. This section is used in conjunction with GB 4793.1-2007. Provisions not mentioned in this section or provisions that indicate "applicable" indicate that The corresponding provisions in GB 4793.1-2007/IEC 61010-1..2001 are applicable to this section; this section states "addition", "replacement", "modification" Or "deleted" provisions, which means that the corresponding provisions of GB 4793.1-2007/IEC 61010-1..2001 have been changed. Due to the original ISO 61010-2-040..2005 normative reference document ISO 6718 "Explosion-proof partitions and explosion-proof partition devices" has been obsolete Has been approved by ISO 4126-2 "Overvoltage protection safety devices Part 2. Explosion-proof component safety devices", ISO 4126-3 "Overvoltage protection safety devices Installation Part 3. Explosion-proof component safety device and safety valve combination, ISO 4126-4 "Overpressure protection safety device Part 4. Hydraulic control Safety valve, ISO 4126-5 "Overpressure protection safety devices-Part 5. Controllable safety decompression system", ISO 4126-6 "Overpressure protection safety equipment Part 6. Application, selection and installation of safety devices for explosion-proof components '' has been replaced by 5 standards, so this section uses these 5 standards to replace Replace the content of ISO 6718 in the original standard. Safety of electrical equipment for measurement, control and laboratory use Requirements Part 4. Special requirements for sterilizers and washer-disinfectors1 Scope and purposeExcept for the following, this chapter of GB 4793.1 applies. 1.1.1 Applicable equipment Instead. This section applies to the use of medical materials in the medical environment, veterinary, pharmaceutical and laboratory fields under the environmental conditions of 1.4. Safety requirements for electrical equipment for sterilization, cleaning, and disinfection. E.g. a) steam sterilizers and sterilizers; b) Sterilizers and sterilizers that use chemical disinfection (toxic gases, toxic aerosols, or toxic vapors); c) sterilizers and sterilizers using hot air or hot inert gas; d) Clean the sterilizer. 1.1.2 Equipment not covered by this section Add the following note to 1.1.2d). Note. The definition of 2.2.15 "medical electrical equipment" in GB 9706.1-2007 is as follows. Have no more than one connection to a special power supply network for the diagnosis, treatment or monitoring of patients under medical supervision, physical or electrical with the patient Electrical equipment that contacts, and/or transmits or receives energy to and from patients, and/or detects these transmitted or acquired energy. Add the following second paragraph to 1.1.2. This section also does not apply to the following types of equipment. aa) Equipment used in a hazardous gas environment (see IEC 60079), except for the use of flammable sterilants to create the environment inside the equipment Equipment (see 13.0); bb) environmental box (see GB 4793.1); cc) laboratory equipment that heats materials for other purposes than sterilizers or sterilizers (see GB 4793.6); dd) laundry equipment (see GB 4706.26, GB 4706.24, GB 4706.20 and ISO 10472), unless designed for use in medical materials Poisonous ee) dishwasher (see GB 4706.25 and GB 4706.50). 1.2.1 All aspects included in the scope of this section Instead. The following content and notes replace the 1.2.1g) and notes in GB 4793.1. g) released gases (including accidentally escaping toxic gases), pathogenic substances, explosions and implosions (see Chapter 13). Note. Pay attention to laws, administrative regulations and other requirements of the State Council's health administrative department and work safety supervision and management department on protecting workers' health and safety. special Do not pay attention to the safety requirements of the equipment equipped with an automatic loading and unloading system. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 4793.4-2019_English be delivered?Answer: Upon your order, we will start to translate GB 4793.4-2019_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB 4793.4-2019_English with my colleagues?Answer: Yes. The purchased PDF of GB 4793.4-2019_English will be deemed to be sold to your employer/organization who actually pays 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. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version GB 4793.4-2019?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB 4793.4-2019 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. |
