1、INTERNATIONAL STANDARD IS0 10651-3 First edition 1997-01-15 Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators Ven tila teurs pulmonaires 2 usage m6dical - Partie 3: Exigences particuh this type of International Standard is referred to as a “Pa
2、rticular Standard”. As stated in 1.3 of IEC 601-1:1988, the requirements of this part of IS0 10651 take precedence over those of IEC 601-I :1988. Where this part of IS0 10651 specifies that a clause of IEC 601-I applies, it means that the clause applies only if the requirement is relevant to the ven
3、tilator under consideration. This part of IS0 10651 has common requirements with IEC 601-2-12. It also includes requirements from IS0 10651-I :I 993. The scope and object given in clause 1 of IEC 601-I :I 988 apply, except that 1 .I shall be replaced by the following: This part of IS0 10651 specifie
4、s requirements for portable lung ventilators designed for use in emergency situations and transport. Emergency and transport ventilators, called hereafter “ventilator”, are often installed in ambulances or other types of rescue vehicles, but are often used outside this environment, where they have t
5、o be carried by the operator or other persons. These devices will frequently be used outside the hospital or home by personnel with different levels of training. This part of IS0 10651 is also applicable to devices permanently mounted in ambulances or aircraft. This part of IS0 10651 does not cover
6、operator-powered ventilators (i.e. manual resuscitators). 1.2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 10651. At the time of publication, the editions indicated were valid. All standards are subje
7、ct to revision, and parties to agreements based on this part of IS0 10651 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 32: 1977, Gas cylin
8、ders for medical use - Marking for identification of con tent. IS0 1065%3:1997(E) 0 KG IS0 5356-l :I 996, Anaesthetic and respiratory equipment - Conical connectors - Part I: Cones and sockets. IS0 5356-2:1987, Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weigh
9、t- bearing connectors. IS0 5358:1992, Anaesthetic machines for use with humans. IS0 5359: 1989, Low-pressure flexible connecting assemblies for use with medical gas systems. I SO 5362: 1986, Anaes the tic reservoir bags. IS0 5367: 1991, Breathing tubes intended for use with anaesthetic apparatus and
10、 ventilators. IS0 7767:- 1), Oxygen monitors for monitoring patient breathing mixtures - Safety requirements. IS0 9170: I 990, Terminal units for use in medical gas pipeline systems. IS0 9703-I : 1992, Anaesthesia and respiratory care alarm signals - Part 1: Visual alarm signals. IS0 9703-2: 1994, A
11、naesthesia and respiratory care alarm signals - Part 2: Auditory alarm signals. IS0 10651-I :I 993, Lung ventilators for medical use - Part 1: Requirements. IEC 68-2-6: 1982, Environmental testing - Part 2: Tests - Test Fc: Vibration (sinusoidal). IEC 68-2-29:1987, Environmental testing - Part 2: Te
12、sts - Test Eb and Guidance: Bump. IEC 68-2-32:1990, Environmental testing - Part 2: Tests - Test Ed: Free fall. I EC 68-2-36: 1983, Environmental testing - Part 2: Tests - Test Fdb: Random vibration wide band - Reproducibility medium. IEC 79-4:1975, Electrical apparatus for explosive gas atmospheres
13、 - Part 4: Method of test for ignition temperature. I EC 601-I : 1988, Medica/ electrical equipment - Part 1: General requirements for safety. I EC 601-I -2: 1993, Medical electrical equipment - Part I: General requirements for safety - Electromagnetic compatibility - Requirements and tests. I .3 De
14、finitions For the purposes of this part of IS0 10651, the definitions given in IS0 10651-I :I 993, I .3, and in clause 2 of I EC 601-I : 1988 apply, with the following exceptions. The definition given in IEC 601-I :I 988, 2.1.5, shall be replaced by the following: 2.1.5 applied part: All parts of th
15、e ventilator intended to be connected to the patient or to the breathing system. NOTE - See also the rationale in annex M. 1) To be published. 2 0 IS0 IS0 10651=3:1997(E) The definition given in IS0 10651-I :I 993, I .3.19, shall be replaced by the following: 1.3.19 high-pressure gas input part: Gas
16、 input port to which gas is supplied at a pressure greater than 500 kPa. NOTE - Attention is drawn to the definitions given in IS0 4135. The following definitions also apply: 1.3.1 emergency ventilator: Portable lung ventilator intended for emergency ventilation and resuscitation use primarily outsi
17、de hospital facilities. 1.3.2 microbial bacterial particulate filter: Device intended to reduce bacteria content and particulate matter content of the gas stream. 1.3.3 neonatal: Pertaining to an individual weighing less than 5 kg. 1.3.4 operator-powered resuscitator: Portable non-active medical dev
18、ice used in emergency situation to provide lung ventilation to individual whose breathing is inadequate. 1.3.5 paediatric: Pertaining to an individual weighing between 5 kg and 40 kg. 1.3.6 transport ventilator: Lung ventilator intended for use during transport to, between, or within hospital facili
19、ties. 1.4 General requirements The general requirements given in clause 3 of IEC 601-I :I 988 apply, with the following addition: NOTE - All parts of the ventilator should be designed and manufactured to minimize health risks due to substances leached or leaking from the device during use. 3.6 k) Ap
20、plicable single-fault conditions are a) short- and open-circuits of components or wiring which can increase temperature (see clause 7); b) incorrect output resulting from software error(s). 3.6 k R) An oxidant leak which is not detected by e.g. an alarm or periodic inspection shall be considered a n
21、ormal condition and not a single-fault condition. NOTE - See also 54.1. 3.6 I) Illumination of 215 lux shall be provided. Measurement of ambient illumination shall be made from the control panel toward the test subject. Test operator shall have vision of 1, corrected if necessary. 1.5 General requir
22、ements for tests The requirements given in clause 4 of IEC 601-I :I 988 apply. 1.6 Classification The classification given in clause 5 of IEC 601-I : 1988 applies. NOTE - A ventilator may have applied parts of different types. 3 IS0 10651=3:1997(E) 0 IS0 1.7 Identification, marking and documents The
23、 requirements given in clause 6 of IEC 601-I :I 988 apply with the following additions and modifications: 6.1 e) Amend existing IEC 601-I :I 988 text to read: The address of the manufacturer and/or authorized representative, as applicable, shall also be marked. After 6.1 z) add the following items:
24、6.1 aa) All operator-accessible flow-direction-sensitive components, unless non-interchangeable, shall be permanently marked with a clearly legible arrow indicating the direction of flow. 6.1 ab) Any high-pressure gas input port shall be marked with the name or symbol of the intended gas in accordan
25、ce with IS0 5359, the range of supply pressures and the maximum flow requirement. 6.1 ac) If operator-accessible ports are provided, they shall be marked. The following terms shall be used at least in the national language or English. Alternatively, symbols may be used and explained in the instructi
26、ons for use. Driving gas input port: the words “DRIVING GAS INPUT”; fresh gas intake port: the words “FRESH GAS INTAKE”; emergency air intake port: the words “WARNING: EMERGENCY AIR INTAKE - DO NOT OBSTRUCT”; manual ventilation port: the word “BAG”; 5) gas output port: the words “GAS OUTPUT”; 6) gas
27、 return port: the words “GAS RETURN”; 7) gas exhaust port: the word “EXHAUST”; 8) pressure gauge port: the words “PRESSURE GAUGE” marked with a clearly legible arrow. 6.1 ad) Each ventilator assembly shall be provided with a permanently attached checklist which summarizes the test procedures recomme
28、nded by the manufacturer which have to be performed prior to use. The use of electronic displays, e.g. a CRT, is permitted. 6.1 ae) The ventilator shall be durably and legibly marked with the following as far as applicable: 1) any particular storage and/or handling instructions; 2) any particular in
29、structions for use; 3) 4) any particular warnings and/or precautions relevant to the immediate operation of the ventilator; the range of body mass for which use of the ventilator is specified. 6.1 af) Packages containing breathing attachments intended for single-patient use shall be clearly marked w
30、ith the following: 1) a description of the contents; 2) the words “SINGLE PATIENT USE”; NOTE - Symbol No. 1051 given in IS0 7000 may additionally be used. 3) the word “STERILE” or “NON-STERILE”, as applicable; 4) the name and/or trademark or the manufacturer and/or supplier; 4 IS0 IS0 10651=3:1997(E
31、) 5) recommended methods of cleaning, disinfection and sterilization; 6) an identification reference to the type, batch or serial number; 7) the mass of the ventilator and any associated equipment (e.g. cylinder, batteries, regulators, carrying cases, etc.); NOTE - Some breathing attachments may con
32、tain these recommended methods in the instructions for use. 6.1 ag Packages containing breathing attachments made of conductive materials shall be clearly r the word “CONDUCTIVE” or “ANTISTATIC”. 6.1 ah) Packages containing breathing attachments for single-patient use or which are disposab clearly m
33、arked with the recommended duration of use. 6.1 ai) If gas-specific colour coding of flow controls and flexible hoses is provided, it shall be in a with IS0 32. 6.8.2 a) Add the following text: arked with e shall be accordance The instructions for use shall additionally include the following: I) Exp
34、ected operating time and conditions therefor. a) If the ventilator has an internal power source, a specification of the minimum operating time during which the ventilator meets the specifications under normal use as stated by the manufacturer shall be given. b) If the ventilator is pneumatically pow
35、ered, the range of supply pressures shall be stated (see 10.2). d If the ventilat or is provided with reserve powe r SUPPlY shal be descr ibed. a reserve power supply, the functioning after a switchover to the 2) Unless entrainment of air is prevented, recommendation for use in hazardous or explosiv
36、e atmospheres, including a warning that if the ventilator will entrain or permit the patient to inhale gas from the atmosphere, its use in contaminated environments may be hazardous. If applicable, the manufacturer shall describe how to prevent such entrainment or inhalation, for example, by the use
37、 of a filter. 3) 4) A method of testing the following alarms prior to connection of the breathing system to the patient: a) high-pressure alarm; b) breathing circuit integrity alarm, if provided; d power failure alarm; d) high and low oxygen concentration alarms, if provided. The intended use of the
38、 ventilator (e.g. adult, neonatal, range of body mass). 5) If the ventilator is fitted with a gas mixing system, the manufacturer shall disclose the information necessary for safe operation. 6) A recommendation that an alternative means of ventilation be available. 6.8.2 d) Add the following text: T
39、he instructions for use shall contain information about cleanliness and sterility upon delivery for parts in contact with the patient or the respiratory gases. 6.8.3 a) Add the following text: The requirement given applies with the following addition: 5 IS0 10651=3:1997(E) 0 IS0 Unless otherwise spe
40、cified, parameters shall be assumed to be expressed under ATPD (atmospheric temperature and pressure, dry) conditions. The technical description shall additionally include the following information, as far as applicable. 1) The following pressure information: maximum limited pressure (Prim max.); mi
41、nimum (subatmospheric) limited pressure (prim min.); range of values to which the maximum working pressure can be set and the means by which the maximum is assured (e.g. pressure cycling, pressure-limiting pressure generation); a statement whether negative pressure (subatmospheric) is available in t
42、he expiratory phase. if there is a facility for negative pressure in the expiratory phase, the limiting pressure and generated pressure, if applicable, shall be listed for the expiratory phase and the inspiratory phase; range of values to which the minimum (subatmospheric) working pressure can be se
43、t and the means by which the minimum is assured. 2) Ranges of the following parameters, if preset or settabie to values above ambient: - cycling pressure; - end-expiratory pressure; - delivered concentration of oxygen. 3) Description of the means of triggering. 4) The purpose, type, range and sensin
44、g position of all measuring a nd display devices the ventilator or recommended by the manufac turer for use wit h the ventilator. either incorporated into 5) Conditions under which any measured or displayed flow, volume or ventilation (t) are to be expressed (e.g. ATPD, BTPS) and the condition and c
45、omposition of gas in the corresponding sensor complies with the accuracy requirements specified in 51.9. so that the display 6) For alarms used with the emergency ventilator, a statement of their type, capabilities, principle of the alarm detection and, if appropriate, suppression or delay of annunc
46、iation, estimated battery life and suitable replacement batteries. Size and type of battery, criteria for the need for replacement and any special precautions. Internal volume of any breathing attachments or other components or subassemblies recommended by the manufacturer to be placed between the p
47、atient connection port and the patient. The manufacturer of these components shall disclose the test method on request. The instructions for use shall include disclosure of the resistance, compliance, internal volume and other functional characteristics of the complete ventilator breathing system, i
48、ncluding any breathing attachment or other components or subassemblies, e.g. humidifier or microbial filter, recommended by the manufacturer, and identification of any operator-detachable breathing system components. Inspiratory and expiratory resistances shall be disclosed for flowrates of 60 l/min
49、 for adult use, 30 I/min for paediatric use and 5 I/min for neonatal use. A statement that the operator will have to ensure (in accordance with 56.16) that these values are not exceeded when adding attachments or other components or subassemblies to the breathing system. IO) Disclosure of the characteristics or the microbial filter, if fitted. 11 12 ) Pneumatic diagram of the ventilato recommended by th e man ufacturer r and a diagram for each ventilator breathing sys tern either supplied or ) Details of any restrictions on th
