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YY 0600.1-2007: Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 1: Home-care ventilatory support devices
YY 0600.1-2007
Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 1. Home-care ventilatory support devices
ICS 11.040.10
C46
People's Republic of China pharmaceutical industry standards
Medical ventilator
Basic safety and key performance specific requirements
Part 1. Household respiratory support equipment
(ISO 10651-6..2004, MOD)
Posted on.2007-01-31
2008-02-01 implementation
State Food and Drug Administration released
Directory
Foreword Ⅲ
Introduction IV
1 range 1
2 Terms and definitions 1
3 General requirements 2
4 General requirements for testing 3
5 Categories 3
6 identify, mark and file 3
7 input power 5
8 basic safety types 6
9 removable protective device 6
10 environmental conditions 6
11 does not use 6
12 Do not use 6
13 Overview 6
14 Requirements for classification 6
15 Voltage and/or energy limits 6
16 shell and protective cover 7
17 isolation 7
18 Protective earthing, functional grounding and potential equalization 7
19 Continuous leakage current and patient auxiliary current 7
20 Dielectric strength 7
21 mechanical strength 7
22 moving parts 7
23 face, corner and edge 7
24 Certainty in normal use 7
25 splashes 7
26 Vibration and noise 7
27 Pneumatic and hydraulic power 7
28 Suspension 7
29 X-ray radiation 8
30 α, β, γ, neutron radiation and other particle radiation 8
31 Microwave radiation 8
32 light radiation (including laser) 8
Infrared radiation 8
34 UV radiation 8
35 sound energy (including ultrasound) 8
36 Electromagnetic compatibility 8
37 Location and basic requirements 8
38 logo, random file 8
Common requirements for AP and APG type devices
40 Requirements and tests on AP type equipment, components and components thereof
41 Requirements and tests on APG type equipment, parts and components thereof
42 over-temperature 8
43 fire 9
44 Overflow, Spillage, Leakage, Moisture, Intake, Cleaning, Disinfection, Sterilization and Compatibility 9
Pressure vessels and pressure parts
46 human error 10
47 static charge 10
48 Biocompatibility
49 Power supply interrupt 10
50 Work Data Accuracy 10
51 to prevent dangerous output 10
52 Abnormal operation and fault status 12
53 Environmental Testing 12
54 Overview 12
Housing and cover
56 components and components 12
57 network power part, components and wiring 14
Protective Grounding - Terminals and Connections
Structure and Routing 14
101 alarm system 14
102 General Standard Appendix 14
Appendix AA (informative) Fundamentals 15
References 18
Figure 101 Measurement of Exhalation Pressure and Ventilation Instrument Configuration 11
Table 101 expiratory pressure and ventilation measurement conditions 12
Foreword
YY 0600 "Medical ventilator basic safety and main performance requirements", consists of the following components.
--- Part 1. Household respiratory support equipment;
--- Part 2. home ventilator relying on ventilator patients;
--- Part 3. Respirators for first aid and transfer.
Other parts of YY 0600 will be formulated.
--- Part 4. artificial respiration equipment;
--- Part 5. Pneumatic emergency resuscitation equipment.
This part of YY 0600 Part 1, modify the use of international standards ISO 10651-6..2004 "medical ventilator --- Basic Safety
And main performance specific requirements - Part 6. Household respiratory support equipment "(in English). This part of ISO 10651-6..2004 master
The differences are as follows.
--- This part of ISO 10651-6..2004 Chapter 2 "Normative references" adjusted to 1.101; Chapter 3 "Terms and Definitions"
Adjusted to Chapter 2, consistent with the universal standard number;
--- Chapter 46 revised as "do not adopt";
--- 56.3bb) high pressure input port connector to comply with the provisions of Table 2 and Figure 3 in ISO 5359;
--- Removed Appendix BB;
--- The units in this section "hPa" are converted to "kPa."
This section is based on GB 9706.1-2007 (IEC 60601-1. 1988 + Amd1..1991 + Amd2..1995, IDT) "medical electrical
Equipment Part 1. General requirements for safety "of the special standards, and GB 9706.1 supporting the use of, and with GB 9706.1-2007
(IEC 60601-1. 1988 + Amd1..1991 + Amd2..1995, IDT).
This section thirty-sixth chapter EMC and YY 0505-2005 "Medical electrical equipment Part 1-2. General requirements for safety Parallel
Quasi. EMC requirements and testing "the same period.
Appendix AA of this section is an informative annex.
This part of the National Anesthetic and Breathing Equipment Standardization Technical Committee proposed and centralized.
This section is drafted. Shanghai Draeger Medical Devices Co., Ltd.
The main drafters of this section. Ding Deping, Li Li.
introduction
This section YY 0600 specifies the respiratory support equipment requirements, the device is mainly used in home care, but can also be elsewhere
Used (in the healthcare sector or elsewhere), the patient used does not (totally) rely on the ventilator's support, which means that such ventilator is not
Think of life support equipment. The power sources for their often used locations are often unreliable; and are often trained to varying degrees
Health care staff to use under control.
This part of YY 0600 is based on GB 9706.1 "Medical electrical equipment Part 1. General requirements for safety," the special standards,
GB 9706.1 is called "Common Criteria" here. Common standards are all used or monitored by qualified personnel in general medical and patient settings
Medical electrical equipment safety standards, it also includes some of the requirements for reliable operation to ensure safety.
Common standards and parallel standards and special standards combined use. Collateral standards include special technical and/or hazardous requirements and apply to them
There are applications such as medical systems, EMC, ray protection for diagnostic X-ray equipment, software and more. Special standards apply to special equipment types, for example
Such as medical electron accelerator, high-frequency knife, bed and so on.
Note. parallel standard and specific standard instructions, respectively, see GB 9706.1-2007 in 1.5 and the first. 2 chapters.
YY 0600 this part of the article, chapter and article number and common standards. Changes to the common standard texts and supplements to the parallel standards
Charge, by using the following words.
--- "Replace" means that the chapter or section of the common standard is completely replaced by the text of this part.
--- "Increasing" means that the relevant text in this section is new content (eg, bars, columns, notes, tables, diagrams) attached to common standards.
--- "Modify" means that the existing content of the common standard is partially modified.
In order to avoid confusion with the modified version of the common standard itself, the added chapters, bars, tables and figures in this part of YY 0600 are numbered starting from 101;
Fill the entry with the letters aa), bb) number; Supplementary appendix to AA, BB and other numbers.
The clauses marked with an asterisk () in this section have the basic principle of speed drawing in Appendix AA.
Requirements for anesthesia ventilator see ISO 8835-5.
Sleep apnea respiratory treatment equipment requirements see ISO 17510-1.
Medical ventilator
Basic safety and key performance specific requirements
Part 1. Household respiratory support equipment
1 range
In addition to the following sections, GB 9706.1-2007 Chapter 1 applies.
modify.
This section YY 0600 specifies the basic safety of household respiratory support equipment and the main performance requirements, the device is suitable for not having to
With YY 0600.2 home ventilator patients, mainly used in home care can also be used elsewhere (such as the health care sector).
If the requirements of this part of YY 0600 supersede or modify the part of the general standards requirements, then the requirements take precedence over the corresponding generic
Claim.
1.101 Normative references
The terms in the following documents become provisions of this section by reference to this part of YY 0600. For dated references,
Its subsequent Amendments (not including errata content) or revisions do not apply to this section, however, to encourage the agreement reached under this section
Of the parties to study whether the latest version of these documents can be used. For undated references, the latest version applies to this section.
GB/T 4999-2003 anesthesia breathing apparatus terminology (ISO 4135..2001, IDT)
GB/T 5332-1985 Flammable liquids and gases ignition temperature test method (eqv IEC 60079-4. 1975)
GB 7144-1999 cylinder color logo
GB 9706.1 Medical electrical equipment Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988+
Amd1..1991 + Amd2..1995, IDT)
GB/T.19974-2005 Sterilization and sterilization of medical products, sterilization factor characteristics and medical equipment sterilization process set, confirm and day
Common control requirements (ISO 14937..2000, IDT)
YY/T 0316-2003 Medical Device Risk Management for Medical Devices (ISO 14971..2000, IDT)
YY 0461-2003 Anesthesia Machines and Breathing Machines Breathing Lines (ISO 5367..2000, IDT)
YY 0466-2003 Medical Devices Labeling, Marking and Notification of Use for Medical Devices (ISO 15223..2000, IDT)
YY 0505-2005 Medical electrical equipment Part 1-2. General requirements for safety Collateral standard. EMC requirements and tests
(IEC 60601-1-2..2001, IDT)
YY 1040.1-2003 Anesthetic and respiratory equipment - Conical connectors - Part 1. Cones and taper sleeves (ISO 5356-1..1996, IDT)
ISO 5356-2 Anesthetic breathing apparatus --- Conical joints --- Part 2. threaded load-bearing joints
ISO 5359 Low-pressure hose assemblies for medical gas systems
ISO 5362 anesthetic gas storage bags
ISO 7396-1 medical gas pipeline system --- Part 1. compressed medical gases and vacuum pipes
ISO 15001 anesthetic and respiratory equipment --- oxygen compatibility
IEC 60601-1-8..2003 Medical electrical equipment --- Part 1-8. General requirements for safety --- Collateral standard. alarm system ---
Requirements, Testing, and Guidance --- Medical Electrical Equipment General Alarm System Requirements and Guidelines for Medical Electrical Systems
2 Terms and definitions
GB/T 4999-2003, GB 9706.1 established in the following terms and definitions apply to this section YY 0600.
increase.
2.101
Pressure at patient connection port.
2.102
Part of the equipment, under normal use
--- Functional realization of the patient must be in direct contact with the part, or
--- Make contact with patients, or
--- Need to be touched by the patient, or
--- All parts that can be connected to the breathing system.
Note. According to GB 9706.1-2007 in 2.1.5 rewrite.
2.103
Normal visual acuity of the operator or other relevant personnel readable.
2.104
Ventilator, suitable for home use, without the need for continuous professional monitoring, to augment or provide pulmonary ventilation to the patient on which the patient depends.
Note. Because the ventilator is used in ventilation-dependent patients, it is considered a life support device.
2.105
Ventilator for home use without continuous professional monitoring to increase or provide pulmonary ventilation in patients that patients do not rely on
Ventilation.
NOTE 1 This ventilator is intended for patients who are ventilatory-free, supportive of respiratory support and have no significant decline in their health.
Note 2. This term is hereinafter referred to as "ventilator".
2.106
The total amount of gas that enters or leaves the patient's lungs every minute.
2.107
The operator's position when using the device normally.
3 General requirements
In addition to the following sections, GB 9706.1-2007 Chapter 3 applies.
3.1
Amendment (added at the end of this article).
This shall include all display values and calibration controls that exceed the environmental limits specified in 10.2.1 and shall be connected to the manufacturer's instruction manual
In the provisions of all attachments.
This can result in a hazard and can not be detected by any intrinsic fault (internal procedure) or cycle (eg oxidizer
Leaks, software damage) should be considered as a normal condition and not as a single fault condition.
3.4
Amendment (added at the end of this article).
The same degree of safety can be proved by YY/T 0316-2003 risk analysis.
4 test of the general requirements
GB 9706.1-2007 Chapter 4 applies.
5 categories
In addition to the following sections, Chapter 5 of GB 9706.1-2007 applies.
5.2
Increase (added at the end of this article).
Note. A ventilator can have different types of application parts.
6 identify, mark and file
In addition to the following sections, GB 6706.1-2007 Chapter 6 applies.
6.1 External marking of equipment or equipment components
replace.
e) Origin instructions
Where applicable, name and address of manufacturer and authorized representative.
Modify [add j)].
j) Input power
The rated input power markings shall include the maximum rated power output of the Aux network power supply socket on the ventilator.
Modify [add after q]].
q) Physiological effects
If applicable, use "rubber" warnings.
increase.
aa) Any high pressure input port shall be marked with gas name or symbol in accordance with the provisions of GB 7144-1999, gas pressure range and maximum
The traffic requirements. If the flow control or hose using a dedicated gas color scale, should be consistent with the requirements of GB 7144-1999.
bb) Operable port should be marked. If symbols are used, there should be a description of the symbols in the instruction manual.
cc) Any special storage and shipping instructions.
dd)  Any special warnings and/or precautions for immediate use with ventilators.
For example. after storage and transport outside the environmental conditions specified for use.
ee) When applicable, the first time after use, ventilator or accessories safe to use time, expre...