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Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 0600.3-2007: Lung ventilators for medical use. Particular requirements for basic safety and essential performance -- Part 3: Emergency and transport ventilators Status: Valid
Basic dataStandard ID: YY 0600.3-2007 (YY0600.3-2007)Description (Translated English): Lung ventilators for medical use. Particular requirements for basic safety and essential performance -- Part 3: Emergency and transport ventilators Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C46 Classification of International Standard: 11.040.10 Word Count Estimation: 27,280 Date of Issue: 2007-01-31 Date of Implementation: 2008-02-01 Quoted Standard: GB/T 2423.6-1995; GB/T 2423.8-1995; GB/T 2423.10-1995; GB/T 4999-2003; GB/T 5332-1985; GB 7144-1999; GB 9706.1; GB 9706.28-2006; YY 0461-2003; YY 0505-2005; YY 0574.1-2005; YY 0574.2-2005; YY 1040.1-2003; ISO 5356-2-1987; ISO 5359-1989; ISO 5362-1986; ISO 9170-1990; IEC 68-8-36 Adopted Standard: ISO 10651-3-1997, MOD Regulation (derived from): Chinese industry standards for record 2007 of 4 (total of 88) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies in case of emergency and patient transport used when the portable ventilator requirements. This section is based on GB 9706. 1 "Medical electrical equipment Part 1: General requirements for safety, " the specific standard. As the 1. 3 GB 9706. 1 expressed, the requirements of this than the relevant requirements of GB 9706. 1 more effective. If this part of the statement of GB 9706. 1 certain conditions apply, it refers only to the terms of the demands made by the considered first aid and the use of ventilator-associated transfer when applicable. This section and GB 9706. 28 "Medical electrical equipment Part 2: Safety requirements for treatment of ventilator ventilator" There is a common requirement. GB 9706. 1-2007 given in Chapter 1 Scope and purpose are applicable. First aid and transferred using a portable ventilator (hereinafter referred to as "breathing machine") is often installed in ambulances or other emergency vehicles, but also outside of the vehicle must be used by the operator or other personnel onboard the occasion. These devices are often highly trained personnel to varying degrees outside the hospital or home use. This section also applies to be permanently installed in the ambulance or aircraft ventilator. This section does not apply artificial respiration (such as artificial resuscitator). YY 0600.3-2007: Lung ventilators for medical use. Particular requirements for basic safety and essential performance -- Part 3: Emergency and transport ventilators---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. Lung ventilators for medical use.Particular requirements for basic safety and essential performance.Part 3. Emergency and transport ventilators ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standard YY 060.3-2007 Medical ventilator Specific requirements for basic safety and main performance Part 3. Respirators for emergency and transport (ISO 10551-3..1997, MOD) 2007-01-31 released 2008-02-01 implementation Published by the State Food and Drug Administration ContentsForeword III Introduction IV First article overview 1 1 Scope 1 2 Terms and definitions 2 3 General requirements 3 4 General requirements for testing 3 5 Classification 3 6 Identification, marking and documentation 3 7 Input power 6 Part II Environmental Conditions 6 8 Basic safety type 6 9 Removable protective device 6 10 Environmental Conditions 6 11 Not used 6 12 Not used 6 Chapter III Protection against electric shock hazards 7 13 Overview 7 14 Requirements for classification 7 15 Limitation of Voltage and/or Energy 7 16 Housing and protective cover 7 17 Isolation 7 18 Protective earth, functional earth and potential equalization 7 19 Continuous leakage current and patient auxiliary current 7 20 Dielectric strength 7 Chapter 4 Protection against Mechanical Hazards 7 21 Mechanical strength 7 222 Moving parts 8 23 Faces, corners and edges 8 24 Stability during normal use 8 25 Splash 8 26 Vibration and noise 8 27 Pneumatic and Hydraulic Power 8 28 Hanging objects 8 Chapter 5 Protection against Unwanted or Excessive Radiation Hazards 8 29 X-Ray Radiation 8 30 α, β, γ, neutron radiation and other particle radiation 9 31 microwave radiation 9 YY 060.3-2007 32 Light radiation (including laser radiation) 9 33 Infrared radiation 9 34 ultraviolet radiation 9 35 sound energy (including ultrasound) 9 36 Electromagnetic Compatibility 9 Chapter 6 Protection against the danger of ignition of flammable anesthetic mixtures 9 37 Location and basic requirements 9 38 mark, random file 9 39 Common requirements for AP and APG equipment 9 40 Requirements and tests for AP-type equipment and its parts and components 41 Requirements and tests for APG-type equipment and its parts and components Chapter 7 Protection against overtemperature and other dangers 10 42 over temperature 10 43 fire protection 10 44 Overflow, liquid spill, leak, dampness, ingress of liquid, cleaning, disinfection and sterilization 45 Pressure vessels and pressure parts 10 46 Human error 10 47 electrostatic charge 11 48 Materials for application parts in contact with the patient's body 11 49 Power supply interruption 11 Chapter 8 Accuracy of Work Data and Prevention of Dangerous Outputs 11 50 Accuracy of working data 11 51 Prevention of Dangerous Outputs 11 Chapter IX Abnormal Operation and Failure State; Environmental Test 13 52 Abnormal operation and fault status 13 53 Environmental Test 13 Chapter 10 Structural Requirements 13 54 Overview 13 55 Housing and cover 14 56 Components and Assemblies 14 57 network power supply parts, components and wiring 15 58 Protective Earth --- Terminals and Connections 15 59 Structure and wiring 15 Appendix 16 Appendix AA (Informative) Basic Principles 16 Appendix BB (informative) Reference 19 Appendix CC (informative appendix) The chapter number in this part is compared with ISO 10651-3..1997 chapter number YY 060.3-2007ForewordThe general title of Y600 is "Special Requirements for Basic Safety and Main Performance of Medical Ventilators", which consists of the following parts. --- Part 1. Household respiratory support equipment; --- Part 2. Home ventilator for ventilator dependent patients; --- Part 3. Respirators for emergency and transport. Other parts of Y600 will be formulated one after another. --- Part 4. artificial breathing equipment; --- Part 5. Pneumatic first aid resuscitation equipment. This part is the third part of Y0600. It is modified to adopt the international standard ISO 10651-3..1997 "Medical ventilator --- Part 3. Specific requirements for ventilator for emergency and transfer ", the main differences between this part and ISO 10651-3..1997 are as follows. --- This section adjusts ISO 10651-2..2004 Chapter 2 "Normative Reference Documents" to 1.101; Chapter 3 "Terms and Definitions" Adjusted to Chapter 2, consistent with the general standard number; --- Article 10.2.1a) The ambient temperature range is modified to "unless stated otherwise by the manufacturer, the ambient temperature range is -18 ° C to + 50 ° C". The main reason for revising this article is that it is difficult to implement this article at the current domestic level, but it is not appropriate to modify the original standard technology. Technical parameters, so be sure to add "unless otherwise specified by the manufacturer" in this clause; --- Article 36.202.2.1 was amended to "Unless the manufacturer indicates otherwise, the level will be changed from 3V/m to 30V/m". This article is amended The main reason is that the original standard requires an order of magnitude greater than general medical device products, making it difficult to achieve at the current domestic level. Large, but it is not appropriate to modify the technical parameters of the original standard, so it is determined to add "unless stated otherwise by the manufacturer" in this clause Expression. This section is based on GB 9706.1-2007 (IEC 60601-1. 1988 + Amd1..1991 + Amd2..1995, IDT) "Medical Electrical Equipment Part 1. Special requirements for general safety requirements (common standards), used in conjunction with GB 97.16.1, and with GB 976.1- 2007 (IEC 60601-1. 1988 + Amd1..1991 + Amd2..1995, IDT) was implemented in the same period. Chapter 36 of this part is juxtaposed with Z05505-2005 "Medical Electrical Equipment Part 1-2. General Safety Requirements Standard. Electromagnetic Compatibility-Requirements and Tests "implemented concurrently. Appendix AA, Appendix BB, and Appendix CC of this section are informative appendices. This part is proposed and managed by the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment. This section was drafted. Beijing Yi'an Meida Technology Development Co., Ltd., Shanghai Dräger Medical Devices Co., Ltd. The main drafters of this section. Li Yunfei, Ding Deping, Deng Yongru, Li Li. YY 060.3-2007IntroductionThis part of the Q600 is specific requirements for portable ventilator for emergency and transport. These devices must meet breathing Machine definitions (automatically augmenting or providing ventilation to a patient's lungs), but they are more often medically trained by people with varying degrees of training Out-of-hospital or home use. This part of Y600 is a special standard based on GB 9701.1 "Medical Electrical Equipment Part 1. General Safety Requirements." GB 970.1 is referred to herein as the "common standard." Common standards are all used or monitored by qualified personnel in general medical and patient environments The basic standard for the safety of medical electrical equipment, it also includes some requirements for reliable operation to ensure safety. Common standards are used in combination with side-by-side and proprietary standards. Tiered standards include special technical and/or hazardous requirements and apply to all There are application equipment, such as medical systems, EMC, radiation protection for diagnostic X-ray equipment, software, etc. Specific standards apply to special equipment types, such as Such as medical electron accelerator, high frequency electric knife, hospital bed and so on. For a description of the parallel and special standards, see GB 9.76.1-2007 in Chapter 1.5 and Chapter A2, respectively. The numbering of chapters, chapters, and articles in this part of Y0600 is consistent with the general standards. Changes to the text of the General Standard and supplements to the Parallel Standard Charge, specified by using the following words. --- "Replace" means that the chapter or section of the general standard is completely replaced by the text of this section. --- "Additional" means that the relevant text in this section is new content (for example, bar, column item, note, table, figure) attached to the general standard. --- "Modified" means that the existing content of the general standard has been partially modified. In order to avoid confusion with the revised version of the General Standard itself, the chapters, bars, tables and figures added to this part of Q6000 are numbered starting from 101; The supplementary columns are numbered by the letters aa) and bb); the supplementary appendixes are numbered by AA, BB, etc. The clauses marked with an asterisk () in this section are described in Appendix AA. YY 060.3-2007 Medical ventilator Specific requirements for basic safety and main performance Part 3. Respirators for emergency and transport First overview1 ScopeNote. See instructions in Appendix AA. This section is a special standard based on GB 97.16.1 "Medical Electrical Equipment-Part 1. General Safety Requirements". As in GB 970.1 As stated in 1.3, the requirements of this section are more effective than the relevant requirements of GB 9706.1. If GB 97016.1 is declared in this section The application of a provision means that the provision applies only if the request made is relevant to the ventilator for emergency and transport in question. This section has common features with GB 9706.28 "Medical Electrical Equipment Part 2. Ventilator Safety Specific Requirements Treatment Ventilator" Claim. The scope and purpose given in Chapter 1 of GB 970.1-2007 are applicable, but 1.1 shall be modified as follows. This section specifies requirements for portable ventilators used in emergency situations and when transporting patients. Emergency breathing and transport portable breathing (Hereinafter referred to as "ventilator") is often installed in ambulances or other rescue vehicles, but it is also often used outside the vehicle and must be operated by Occasions where personnel or other persons carry them. These devices are often used outside the hospital or at home by trained personnel. this Some also apply to ventilators that are fixedly mounted on ambulances or aircraft. This section does not apply to artificial respirators (such as artificial resuscitators). 1.101 Normative references The following documents contain provisions which, through reference in this text, constitute provisions of this section. For dated references, All subsequent amendments (excluding errata) or revisions are not applicable to this standard, however, it is encouraged to reach agreement in accordance with this section The parties studied whether the latest versions of these documents could be used. For undated references, the latest edition applies to this section. GB/T 243.6-1995 Environmental test for electric and electronic products Part 2. Test method Test Eb and guidelines Collision (IEC 68-2-29. 1987, IDT) GB/T 243.8-1995 Environmental test for electric and electronic products Part 2. Test method test Ed Free fall (IEC 68-2-2..1990, IDT) GB/T 2423.10-1995 Environmental test for electric and electronic products Part 2. Test method Test Fc and guideline vibration (Sine) (IEC 68-2-6. 1982, IDT) GB/T.1999-2003 Terms for Anesthesia and Respiratory Equipment (ISO 4135..2001, IDT) GB/T 5332-1985 Test method for ignition temperature of flammable liquids and gases (IEC 61979-4. 1975, EZV) GB 7144-1999 cylinder color code GB 97016.1 Medical electrical equipment Part 1. General safety requirements (GB 9706.1-2007, IEC 60601-1. 1988+ Amd1..1991 + Amd2..1995, IDT) GB 9706.28-2006 Medical electrical equipment. Part 2. Special requirements for ventilator safety. Therapeutic ventilator (IEC 60601- 2- 12..2001, MOD) ＹＹ0461-2003 Breathing circuit for anesthesia machine and ventilator (ISO 5367..2000, IDT) ＹＹ0555-2005 Medical electrical equipment Part 1-2. General requirements for safety and safety Standards EMC requirements and tests Inspection (IEC 60601-1-2..2001, IDT) YY 060.3-2007 ＹＹ0574.1-2005 Alarm signals for anesthesia and respiratory care Part 1. Visual alarm signals (ISO 9703-1..1992, IDT) ＹＹ 054.2-2005 Alarm signals for anesthesia and respiratory care Part 2. Audible alarm signals (ISO 9703-2..1992, IDT) ＹＹ1040.1-2003 Conical joints for anesthesia and breathing equipment-Part 1. Taper head and sleeve (ISO 5356-1..1996, IDT) ISO 5356-2. 1987 Conical connection devices for anesthesia and breathing equipment. Part 2. Load-bearing threaded connection devices ISO 5359. 1989 Low-pressure flexible connecting parts for medical gas systems ISO 5362. 1986 Anesthesia Airbag ISO 9170..1990 Terminal devices for medical gas piping systems IEC 68-2-2-36 Environmental test for electric and electronic products --- Part 2. Test method --- Test Fdb. Broadband random vibration --- Medium reproducibility2 Terms and definitionsExcept for the following definitions, 1.3 of GB 9706.28-2006 and Chapter 2 of GB 9706.1-2007 apply. The definition in 2.1.5 of GB 970.1 should be modified as follows. 2.1.5 The breathing apparatus is connected to the patient or any part of the respiratory system. Part of the equipment, during normal use. --- The part in which the function must be in direct contact with the patient, or --- the part that may be used to contact the patient; or --- need to be touched by the patient, or --- All parts that can be connected to the respiratory ventilation system. Note. See instructions in Appendix AA. The definition in GB 9.706.28-2007, 1.19 should be amended to. 1.3.19 Gas inlet with a pressure greater than 500kPa. Note. Please pay attention to the definition in GB/T 4999. The following definitions also apply. 2.101 It is mainly used for portable ventilator for respiratory rescue outside the hospital. 2.102 Equipment for reducing bacteria and particles in gas systems. 2.103 Related to infants weighing less than 5kg. 2.104 Passive portable medical equipment that provides breathing for patients with impaired breathing in emergency situations. 2.105 It is related to children weighing between 5kg and 40kg. YY 060.3-2007 2.106 A ventilator for transporting to and from a hospital and between patients.3 General requirementsGB 970.1-2007 Chapter 3 applies and adds the following. All parts of the ventilator should be designed and manufactured in such a way that substances filtered out or leaked from the device bring health to the patient when the device is in use The risk is minimized. increase. 3.6 犪 犪) The applicable single fault conditions include. a) Open or short circuits or circuits that cause temperature rise (see Chapter 7). b) Output errors caused by software errors. Note. See also 54.1. 3.6 犫 犫) Illumination of 215 lx shall be provided. The measurement of environmental illuminance should be completed by the control board facing the measuring subject. Inspector The visual acuity (or corrected visual acuity) of the operator reached 5.0.4 General requirements for testingGB 9706.1-2007 Chapter 4 applies.5 classificationChapter 9 of GB 970.1-2007 is applicable. Note. A ventilator may have different types of application parts. 6 Identification, marking and documentation Chapter 9 of GB 970.1-2007 is applicable, and the following contents are added and modified. If applicable, the address of the manufacturer and/or authorized representative should also be marked. Add the following clause after 6.1 (i). 6.1)) Any element that is sensitive to the direction of the airflow (except that the direction of flow can be exchanged) shall be accessible to The pieces are marked with clear, easy-to-read and permanently attached arrows indicating the direction of the airflow. 6.1 犫 犫) All high-pressure gas input ports shall be marked with the gas name or gas symbol and pressure range of the gas in accordance with GB 7144. And maximum flow requirements. 6.1 犮 犮) If there is an interface accessible to the operator, the interface shall be marked. The following terms should be at least Chinese or operator Marked in mother tongue. In addition, the symbols listed and explained in the instruction manual can also be used. 1) Drive gas input port. marked with the text "drive gas input". 2) Fresh gas suction port. marked with the text "Fresh gas suction". 3) Emergency air intake. marked with the text "Warning. Emergency air intake-blocking is strictly prohibited". 4) Manual ventilation port. marked with the text "airbag". 5) Air outlet. marked with the text "Air Out". 6) Air return port. marked with the text "Air Return". 7) Exhaust port. marked with the text "Exhaust". 8) Pressure measurement port. marked with the text "pressure measurement" and marked with easy-to-read arrows. YY 060.3-2007 Electronic display such as CRT. 1) Special storage and/or operation instructions; 2) Special instructions for use; 3) any special warnings and/or warnings related to the direct operation of the ventilator; 4) The specified weight range of the ventilator is applicable. 1) Description of contents; 2) "SINGLE USE ONLY", "NO USE USE", or The symbol 3.2 in Y0466-2003; 3) If applicable, "Sterile" or any of the symbols 3.20 to 3.24 in Y0466-2003; 4) the names or trademarks and addresses of manufacturers, suppliers and authorized representatives; 5) Recommended cleaning, disinfection and sterilization methods; 6) Type identification, or symbol 3.15 in Z046.6-2003; 7) batch or serial number identification, or the symbol 3.14 or 3.16 in Z046.6-2003; 8) The weight of the ventilator and any accompanying equipment (such as cylinders, batteries, regulators, packing boxes, etc.). Note. The recommended use of some breathing accessories can be included in the instruction manual. Period of use. 6.8.2 i) Add the following. The instruction manual should be attached as follows. 1) Expected working hours and working environment a) If the ventilator is equipped with an internal power supply, the ventilator shall meet the requirements specified by the manufacturer under normal conditions of use. Minimum working hours of the indicator; b) in the case of a pneumatic ventilator, the range of air pressure to be supplied (see 10.2); c) If the ventilator is equipped with a backup power source, the function of the ventilator after the switch to the backup power source should be described. 2) Unless the introduction of air can be prevented, the use of a ventilator in a hazardous or explosive atmosphere should be given. Methods, including warning users that if the ventilator is not tightly sealed, it is dangerous to use it in a contaminated air environment of. If available, the manufacturer should explain how to avoid mixing in or inhaling air, such as using a filter. 3) Before connecting the respiratory system to the patient, test the following alarms. a) high voltage alarm; b) breathing circuit integrity alarm (if provided); c) power failure alarm; d) High and low oxygen alarms (if provided). 4) Applicable scope of ventilator (for example, adult, newborn, weight range); 5) If the ventilator is equipped with a gas mixing system, the manufacturer should provide the necessary information for safe operation; 6) Recommendations on the use of alternative br...... |
