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Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 0600.5-2011: Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 5: Gas-powered emergency resuscitators Status: Valid
Basic dataStandard ID: YY 0600.5-2011 (YY0600.5-2011)Description (Translated English): Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 5: Gas-powered emergency resuscitators Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C46 Classification of International Standard: 11.040.10 Word Count Estimation: 43,494 Date of Issue: 2011-12-31 Date of Implementation: 2013-06-01 Quoted Standard: GB 3100; GB 3102.1; GB 3102.2; GB 3102.3; GB 3102.4; GB 3102.5; GB 3102.6; GB 3102.7; GB 3102.8; GB 3102.9; GB 3102.10; GB 3102.11; GB 3102.12; GB 3102.13; GB 4208-2008; GB/T 4999-2003; GB 7144-1999; GB 9706.1-2007; GB 15382-2009; GB 19633; YY/T 0316-2008; YY 0461; YY 0466.1-2009; YY/T 0753.1-2009; YY/T 0753.2-2009; YY/T 0799; YY 0801.1; YY/T 0802-2010; YY 1040.1; YY 1040.2; ISO 10524-1; ISO 10524-3 Adopted Standard: ISO 10651-1-2006, IDT Regulation (derived from): State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the use of first responders who left with a pneumatic resuscitation for the basic safety and essential performance requirements. The device for emergency spaces, in normal use, continuous monitoring by the operator. YY 0600 This part also provides for recovery of component (3. 22) requirements. YY 0600 This part does not apply to electric resuscitators. YY 0600.5-2011: Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 5: Gas-powered emergency resuscitators---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 5. Gas-powered emergency resuscitators ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standard YY 0600.5-2011/ISO 10651-5..2006 Dedicated to basic safety and main performance of medical ventilator Requirements Part 5. Pneumatic First Aid Resuscitator (ISO 10651-5..2006, IDT) 2011-12-31 release 2013-06-01 Implementation Published by the State Food and Drug Administration ContentsForeword I Introduction Ⅱ 1 * range 1 2 Normative references 1 3 Terms and definitions 2 4 General requirements 4 4.1 Overview 4 4.2 Other test methods 5 4.3 Acceptance Criteria 5 5 Structural requirements 5 5.1 Overview 5 5.2 Connector 6 6 Operating requirements 7 6.1 Overview 7 6.2 Environmental resistance 8 6.3 Resistance to typical use 8 6.4 Dimensions and quality 9 6.5 Air source 9 7 Performance 10 7.1 Ventilation requirements 10 7.2 * Ventilation performance 11 8 Identification, marking and documentation 14 8.1 Overview 14 8.2 Mark 14 8.3 Operation and maintenance information provided by the manufacturer 16 Appendix A (Informative) Basic Principles 19 Appendix B (Normative) Test Method 24 Appendix C (informative) Relationship between this part of YY 0600 and CPR guidelines 33 Appendix D (informative) Clause 34 of this part of YY 0600 that discusses basic principles Appendix E (Informative) Terminology-Index of Defined Terms 36 References 38 YY 0600.5-2011/ISO 10651-5..2006ForewordYY 0600 `` Special Requirements for Basic Safety and Main Performance of Medical Ventilators '' is divided into five parts. --- Part 1. Household respiratory support equipment; --- Part 2. Home ventilator for ventilator dependent patients; --- Part 3. Ventilator for emergency and transport; --- Part 4. artificial resuscitator; --- Part 5. Pneumatic emergency resuscitator. This section is Part 5 of YY 0600. This section is drafted in accordance with the rules given in GB/T 1.1-2009. This part is equivalent to ISO 10651-5..2006 "Special requirements for basic safety and main performance of medical ventilators. Part 5. Pneumatics First Aid Resuscitator. Compared with ISO 10651-5..2006, this section has the following editorial changes. --- The introduction of ISO 10651-5..2006 was modified into the introduction of this part; --- The international standards quoted in ISO 10651-5..2006 are correspondingly adopted as national standards and industry standards. Use these national standards and industry standards as the normative use; if there is no corresponding adoption as national standards and industry standards, the The cited ISO international standards are used as norms. Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents. This part is proposed and managed by the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116). This section was drafted. Shanghai Medical Equipment Testing Institute. The main drafters of this section. Wang Wei and Fu Guoqing. YY 0600.5-2011/ISO 10651-5..2006IntroductionResuscitation committees and associations point out that for patients at risk of life Perform on-site cardiopulmonary resuscitation and start a series of continuous ambulances until the patient can get professional medical care and will get the most effective Ambulance results. To improve possible ambulances at an early stage, experts and organizations train non-professionals in key locations, such as Where they gather or where danger arises, they can provide a higher level of ambulance in the shortest possible time. There is increasing awareness that the use of basic equipment can greatly improve efficiency, such as avoiding mouth-to-mouth contact while providing ventilation device of. Simply put, pneumatic rescue resuscitators can deliver controlled ventilation, and this section specifies the standard indicators required to achieve safety. The clauses marked with an asterisk (*) in this part of YY 0600 have basic principles in Appendix A. YY 0600.5-2011/ISO 10651-5..2006 Dedicated to basic safety and main performance of medical ventilator Requirements Part 5. Pneumatic First Aid Resuscitator1 ScopeThis part of YY 0600 specifies the basic safety and main performance requirements of human emergency rescue resuscitators used by first responders. This device is used in emergency places and is continuously monitored by the operator during normal use. This part of YY 0600 also specifies requirements for resuscitator components (3.22). This part of YY 0600 does not apply to electric resuscitators. Note. YY 0600.3 contains the contents of ventilator for emergency and transportation.2 Normative referencesThe following documents are essential for the application of this document. For dated references, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB 3100 international unit system and its application (ISO 1000) GB 3102 (all parts) Quantities and units [ISO 31 (all parts)] GB 4208-2008 enclosure protection level (IP code) (IEC 60529..2001, IDT) GB/T 4999-2003 Anesthesia breathing equipment term (ISO 4135..2001, IDT) GB 7144-1999 cylinder color code GB 9706.1-2007 Medical electrical equipment Part 1. General requirements for safety (IEC 60601-1. 1988 A1..1991 A2. (1995, IDT) GB 15382-2009 General technical requirements for gas cylinder valves GB 19633 Packaging for final sterilized medical devices (GB/T 19633-2005, ISO 11607..2003, IDT) YY/T 0316-2008 Application of medical device risk management to medical devices (ISO 14971..2007, IDT) YY 0461 Breathing circuit for anesthesia machine and ventilator (YY 0461-2003, ISO 5367..2000, IDT) YY 0466.1-2009 Medical devices. Symbols for labelling, marking and providing information of medical devices. Part 1. General requirements (ISO 15223-1..2007, IDT) YY/T 0753.1-2009 Respiratory filters for anesthesia and breathing. Part 1. Salt test method for evaluating filtration performance (ISO 23328-1..2003, IDT) YY/T 0753.2-2009 Respiratory filters for anesthesia and breathing Part 2. Non-filtering aspects (ISO 23328-2. (2002, IDT) YY/T 0799 Medical Gas Low Pressure Hose Assembly (YY/T 0799-2010, ISO 5359..2008, MOD) YY 0801.1 Terminals for medical gas piping systems-Part 1. Terminals for compressed medical gases and vacuum (YY 0801.1- (2010, ISO 9170-1..2008, MOD) YY/T 0802-2010 Information provided by sterilization manufacturers of medical devices for handling re-sterilizable medical devices (ISO 17664. (2004, IDT) YY 1040.1 Conical joints for anesthesia and breathing equipment-Part 1. Taper heads and sleeves 1..1996, IDT) YY 1040.2 Conical joints for anesthesia and breathing equipment-Part 2. Threaded load-bearing joints YY 0600.5-2011/ISO 10651-5..2006 (2006, IDT) ISO 10524-1 Pressure regulators for medical gases. Part 1. Pressure regulators and pressure regulators with flow meter (Pressureregulatorsforusewithmedicalgases-Part 1. Pressureregulatorsandpressureregulators withflow-meteringdevices) ISO 10524-3 Pressure Regulators for Medical Gases Part 3. Pressure Regulators with Gas Cylinder Valves (Pressureregulators forusewithmedicalgases-Part 3. Pressureregulatorsintegratedwithcylindervalves)3 terms and definitionsGB/T 4999-2003, GB 9706.1-2007 and the following terms and definitions apply to this document. Appendix E gives Source of all terms in this section. 3.1 Random filesaccompanyingdocuments Documents included with the resuscitator or resuscitator assembly, including information for the user, operator, installer or assembler It is all important information, especially information about security. Note. Rewrite GB 9706.1-2007, definition 2.1.4. 3.2 Automatic pressure-cycle resuscitator After the pressure set by the control device is reached, the resuscitator is switched from inspiratory phase to expiratory phase. 3.3 Automatictime-cycledresuscitator A resuscitator that automatically controls the cycle between inspiratory and expiratory phases at time intervals set by the control device. 3.4 Automatic volume-cycle resuscitator After the delivery capacity set by the control device is reached, the resuscitator is switched from inspiratory phase to expiratory phase. 3.5 Cardiopulmonary resuscitation cardiopulmonaryresuscitation A combination of breathing assistance and chest compressions for patients who are judged to be cardiac arrest. [AHA CPR and First Aid Guide] 3.6 Clearly legible Can make the operator or related personnel with normal vision see clearly. Note. See 8.2.1. 3.7 * Delivered volume delivered volume Vdel The volume of gas delivered through the patient connection during the inspiratory phase. 3.8 On-demand valve A component of the resuscitator that delivers the pressure-related airflow caused by the patient at the patient connection. 3.9 First responder Trained personnel to provide initial response to respiratory emergencies. YY 0600.5-2011/ISO 10651-5..2006 Example 1. firefighter Example 2. First responder 3.10 Gas-poweredemergencyresuscitator Resuscitator Portable type that uses compressed gas as the power source and is expected to be used urgently to provide lung ventilation for resuscitated persons device. 3.11 Unexpected positive end-expiratory pressure inadvertentpositiveend-expiratory pressure Unexpected PEEP inadvertentPEEP Unexpected positive pressure at the connection port of the end-expiratory patient. 3.12 Intermediatehose A pipeline that transfers gas between resuscitator components. 3.13 Manual-cycledresuscitator The inspiratory phase and the expiratory phase are controlled by the operator by repeatedly operating the resuscitator. Note. In this document, on-demand valves that can be controlled by manual triggers are classified as "manual circulation resuscitators containing on-demand valves", rather than These countries commonly define "on-demand valves." 3.14 Minutevolume Volume of gas inhaled or exhaled by the patient's lungs per minute. 3.15 Operator Man operating a resuscitator. Note. GB 9706.1-2007 was rewritten to define 2.12.17. 3.16 Patient-triggeredresuscitator The cycle from expiration to inspiration is a resuscitator triggered by the patient's inspiration. 3.17 Patient-triggering At the patient connection port, a pressure drop generated by the patient initiates a set inspiratory operation mode. 3.18 Patient valve A valve in the breathing system of a resuscitator directs gas into the lungs during inhalation and directs gas from the lungs into the atmosphere during expiration. 3.19 Pressure-limiting device A device that defines the maximum pressure in the respirator's respiratory system. 3.20 Resuscitator breathing system Respiratory system bounded by low-pressure gas inlet, gas inlet and patient connection port, if provided, plus fresh gas inlet and The exhaust is bounded by the respiratory system. YY 0600.5-2011/ISO 10651-5..2006 3.21 Resuscitator dead space The volume of gas that was previously exhaled in the respirator's respiratory system and delivered to the patient during the subsequent inspiratory phase. 3.22 Resuscitatorset All necessary components to enable the resuscitator to be transported to an emergency ambulance and ready for immediate use. 3.23 Safety hazard Potentially harmful effects directly on the patient, other people, animals, or the environment caused by the resuscitator. Note. Rewrite GB 9706.1-2007, definition 2.12.18. 3.24 Single fault condition In the resuscitator, only one safety-related dangerous protective measure fails, or only one external abnormality occurs. Note. Rewrite GB 9706.1-2007, definition 2.10.11.4 General requirements4.1 Overview Transport, storage, installation, normal use and maintenance according to random documents.Under normal conditions and single failure conditions, the resuscitator should not Causes reasonably foreseeable hazards, and does not cause safety hazards that are not related to the intended application purpose. A risk management process in accordance with YY/T 0316 shall be implemented. When implementing YY/T 0316. a) The term "medical equipment" should be considered equivalent to a resuscitator. b) The term "fault state" referred to in YY/T 0316 shall include, but shall not be limited to, a single fault as defined in this part of YY 0600 status. c) Where YY 0600 specifies the measurable requirements for specific risks and meets these requirements, the requirements of these requirements Residual risk should be considered acceptable unless there is objective evidence to the contrary. This part of YY 0600 specifies requirements that can generally be applied to risks related to resuscitators and is expected to be used as a tool in the risk management process. Hazards, and their associated risks and risk control measures. Conditions or faults that can cause dangerous risks in safety have been pointed out in the clauses of YY 0600. In these cases, it is often necessary A risk management process is performed to determine what the actual safety hazard is and testing is required to show the known safety hazards Does not appear under specified conditions. For each constituent component of a resuscitator, such as patented components, non-medical subsystems and legacy components, the manufacturer may not be able to Conforms to all procedures indicated in this part of YY 0600. In this case, the manufacturer should specifically consider whether additional risk control is needed 制 Measures. The requirements in this part of YY 0600 involve that if there is no unacceptable risk, the manufacturer decides the risk according to its acceptable risk regulations. Acceptability or unacceptability of risks. Compliance is checked by inspection of risk management documents. If the manufacturer. --- A risk management process has been established, --- an acceptable level of risk has been established, and --- It has been proven that the residual risk is acceptable (according to the regulations that determine acceptable risk). Then the requirements of this chapter and all requirements related to risk management documents in this part of YY 0600 are considered to be in compliance. YY 0600.5-2011/ISO 10651-5..2006 4.2 Other test methods If the same level of safety is available, the manufacturer may use a different type test method than detailed in this part of YY 0600. however In case of dispute, the methods specified in this section should be used as a reference method. 4.3 Acceptance criteria Many of the test clauses in this part of YY 0600 set acceptance criteria for performance. These acceptance criteria should always be met. When the performance level specified by the manufacturer in the random file is higher than the performance level specified in this part of YY 0600, the manufacturer specifies The level is the acceptance level and should be met.5 Structural requirements5.1 Overview 5.1.1 Structural materials When selecting the constituent materials of all gas transmission components, consideration should be given to what is mentioned in the random file. --- Can be managed by a resuscitator, and --- Chemical and physical characteristics of any substance that can be used to clean, disinfect or sterilize the resuscitator. Compliance is checked by examining risk management documents. 5.1.2 Faces, corners and edges Damaged rough surfaces, sharp corners, open ends and sharp edges of tubular components should be avoided or covered. Special attention should be paid to hair Clearance of thorns. Compliance is checked by inspection. 5.1.3 Material filtration Resuscitators and components should be designed and manufactured in such a way as to pose the greatest health risks in use as a result of leaching from substances in the resuscitator or its components small. Particular attention should be paid to the toxicity of materials and the compatibility of materials and substances in contact with gases during normal use. Compliance is checked by examining risk management documents. 5.1.4 Breathing circuit Breathing tubes used for the respirator breathing system with an internal diameter greater than 18mm should meet the requirements of YY 0461. Compliance is checked according to the requirements of YY 0461. 5.1.5 Supply of sterile components If the product is declared to be sterile on the label, it should be in accordance with GB 18278, GB 18279, GB 18280, GB 18281 or GB/T.19974 Sterilize by an appropriate and validated method specified in. The packaging of aseptically supplied resuscitators or components should meet the requirements of GB 19633. Such packages should not be sealed once opened, Otherwise it should be clearly stated that the packaging has been opened. Non-sterile packaging systems should be designed to maintain sterilized products at the expected cleanliness level before use, and should be designed to keep microorganisms Harm caused by pollution is minimal. Compliance is checked by examining the methods of sterilization and disinfection in the random documentation and by examining the relevant verification reports. YY 0600.5-2011/ISO 10651-5..2006 5.1.6 * Respiratory filter Any respiratory system filter, whether integrated with the resuscitator or specified in the accompanying documentation for the resuscitator, shall meet Applicable parts in YY/T 0753.1 and YY/T 0753.2. Compliance is checked according to the requirements of YY/T 0753.1 and YY/T 0753.2. 5.1.7 Function Arrangement Any single fault condition shall not cause any monitoring or alarm system function and related ventilation control specified in this part of YY 0600 Control function is a failure in which the monitoring or alarm system function fails at the same time, and thus the function of the monitored resuscitator cannot be checked. Failure. Compliance is checked by simulating a single fault condition and visual inspection. 5.1.8 Protection against accidental adjustment Means should be provided to prevent accidental changes to control settings including on-off switches, such as locks, guards, damping and braking And other mechanical technologies. Compliance is checked by visual inspection according to the instruction manual. 5.1.9 Selector switch/control For non-continuous adjustment control, measures should be provided to prevent the selector from staying in the middle position. Example 1. "On-Off" switch. Example 2. Oxygen concentration selector. Example 3. Preset selector, discrete value of transmission capacity or frequency. Compliance is checked by inspection. 5.1.10 Accuracy of working data When the resuscitator is used normally, the gas should be delivered with the accuracy indicated in the instruction manual. See 8.3.2.2. Compliance is checked by the appropriate test methods in this part of YY 0600. 5.1.11 * Resuscitator assembly The resuscitator should be provided with the resuscitator assembly, or the resuscitator assembly should be recommended in the accompanying documents, including compliance with this part of YY 0600 Medical gas supply system in accordance with relevant requirements. 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