Microsoft Word C035973e doc Reference number ISO 10651 2 2004(E) © ISO 2004 INTERNATIONAL STANDARD ISO 10651 2 Second edition 2004 07 01 Lung ventilators for medical use — Particular requirements for[.]
Marking on the outside of equipment or equipment parts
The name and address of the manufacturer and authorized representative, if applicable
Amendment (add at the end of the list item): j) Power input
The rated power input marking shall include the maximum rated power output available to the auxiliary mains socket-outlets with which the ventilator is equipped
Amendment (add at the end of the list item): q) Physiological effects
If applicable, a warning that latex is used
Addition: aa) Any high-pressure input port shall be marked with the name or symbol of gas in accordance with
The article emphasizes that flow control and flexible hoses should adhere to ISO 5359 standards, including supply pressure range and maximum flow requirements When gas-specific color-coding is used for hoses, it must comply with ISO 32 Operator-accessible ports should be clearly marked, with symbols explained in the instructions for use and validated according to IEC 60601-1-6 Additionally, it is important to include specific storage and transport instructions, as well as any warnings or precautions relevant to the immediate use of the ventilator.
EXAMPLE Those relevant after storage or transport outside the environmental conditions specified for use
Ensure clear labeling by indicating the date when the ventilator or accessory’s safe operation cannot be guaranteed, using the year and month, with Symbol 3.12 from ISO 15223:2000 if applicable Packaging for single-use breathing attachments must be clearly marked to prevent reuse, ensuring patient safety and compliance with ISO 2004 standards.
2) an identification reference to the type, or Symbol 3.13 from ISO 15223:2000;
3) an identification reference to the batch or serial number, or Symbol 3.14 or 3.16 from ISO 15223:2000;
4) the name or trademark and the address of the manufacturer, supplier and authorized representative;
5) packages containing latex shall be clearly marked with the word “LATEX”;
6) the word “STERILE”, or Symbols 3.20 to 3.24 from ISO 15223:2000;
Manufacturers must clearly mark single-use devices with labels such as “SINGLE USE ONLY,” “DO NOT REUSE,” or the applicable ISO 15223:2000 Symbol 3.2 to ensure proper usage and prevent reuse All flow-direction-sensitive components that can be removed without tools must be durably and legibly marked with arrows indicating the flow direction, ensuring correct installation and function Additionally, device packaging and labeling should clearly differentiate between sterile and non-sterile versions of similar products from the same manufacturer to avoid confusion and ensure patient safety.
Marking of controls and instruments
Amendment (add at the end of the list item):
Airway pressures shall be marked in both SI units and centimetres water column (cmH 2 O)
Addition: aa) Visual displays shall be visible and clearly legible
Amendment (add at the end of the compliance test): and the legibility test of 6.101.
Identification of medical gas cylinders and connections
Instructions for use
Amendment (add at the end of the list item): d) Cleaning, disinfection and sterilization of parts in contact with the patient
If applicable, the instructions for use shall contain
information about cleaning and sterilization prior to first use,
information about cleaning, disinfection and sterilization and any restriction concerning re-use,
Instructions specify the maximum number of reprocessing cycles—covering cleaning, disinfection, and sterilization—before a component becomes unusable They also provide visual or functional pass/fail criteria to determine when a component should no longer be used after reprocessing.
Addition: aa) Additional general information
The instructions for use shall include the following:
1) the intended use of the ventilator;
2) description of operator-accessible ports See also 6.1 bb) and 56.3 dd);
3) the rated supply range and consumption that is required for normal use of the ventilator (see also
4) information necessary to ensure that the ventilator is installed correctly and is in safe and correct working order;
5) a method for testing the function of the alarm system for each possible alarm condition and a recommendation for the interval of testing;
6) if the ventilator is provided with a reserve power supply:
how to determine the status of the reserve power source;
how the reserve power source can be tested; and
the functioning after a switchover to the reserve power supply
7) * the ampere-hour rating of the internal electrical power source, and the operational time after it has become fully charged;
8) if the ventilator has provision for an external reserve electrical power source (see 49.101 and
the rated voltage range requirement;
the nominal voltage range; and
9) for each control and measured variable provided on the ventilator, a listing of the applicable range, resolution and accuracy (see also Clause 51);
The accuracy should be expressed in the form of maximum zero error, expressed in appropriate units, plus a sensitivity error, expressed, e.g as a percentage of reading
If the ventilator is intended for use in environmental conditions that exceed the specified limits outlined in section 10.2.1, it is essential to disclose these extended environmental parameters Additionally, manufacturers should clearly explain how operating beyond the standard conditions may impact the ventilator's performance This transparency ensures users are informed about potential performance variations when deploying the ventilator in harsher environments.
11) the inspiratory and expiratory pressures measured at the patient connection port at 60 l/min for ventilators intended for providing tidal volumes greater than 300 ml, or at 30 l/min for tidal volumes between 300 ml and 30 ml, or at 5 l/min for tidal volumes less than 30 ml, when the recommended ventilator breathing system is in use and normal ventilation is compromised by the total or partial loss of power supply (see 49.102);
12) a statement as to whether any portion of the gas supplied to a high-pressure input port is used as fresh gas;
13) * a statement to the effect that antistatic or electrically conductive hoses or tubing shall not be used;
14) warning statement to the effect that the ventilator shall not be covered or positioned in such a way that the operation or performance of the ventilator is adversely affected (e.g positioned next to a curtain that blocks the flow of cooling air, thereby causing the ventilator to overheat);
15) a statement to the effect that adding attachments or other components or sub-assemblies to the ventilator breathing system can cause the pressure during expiration at the patient connection port to increase;
16) a statement to the effect that, while the ventilator is in use, an alternative means of ventilation should always be available;
17) a statement to the effect that it is of vital importance to provide supervision of ventilation In addition, it should be assured that the person taking care of the patient is capable of taking the necessary corrective actions in the event of a ventilator alarm condition or a malfunction of the ventilator;
18) specifications about the nature and frequency of maintenance operations necessary to ensure continuing safe and correct operation This information also applies to accessory components.
Technical description
Addition: aa) Additional general information
The technical description shall include
the conditions under which any measured or displayed flow, volume or ventilation is to be expressed, e.g ambient temperature and pressure dry (ATPD) or body temperature and pressure saturated (BTPS), etc,
the principle, including a summary of algorithms, by which each alarm condition is detected,
The performance characteristics of a ventilator depend on its associated breathing system, including recommended attachments and components such as breathing tubes, humidifiers, filters, and other sub-assemblies specified by the manufacturer.
a pneumatic diagram of the ventilator, including each ventilator breathing system either supplied or recommended by the manufacturer,
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any restrictions on the sequence and directions of components intended to be placed within the ventilator breathing system, e.g where such components are flow-direction-sensitive,
the means by which the continuing pressure alarm condition is detected and the structure of the detection algorithm,
a listing of the following pressures:
maximum steady limiting pressure (p LSmax );
minimum steady limiting pressure (p LSmin );
range of values to which the maximum working pressure (p Wmax ) can be set, and the means by which the maximum is limited (e.g pressure cycling, pressure limiting, pressure generation);
range of values to which the minimum working pressure (p Wmin ) can be set, and the means by which the minimum is achieved
The technical description shall include, if applicable, the following:
for all variables displayed or used for control, the filtering and/or smoothing techniques applied;
if sub-atmospheric pressure can be used, the limiting pressure for the inspiratory and expiratory phases;
the characteristics of the breathing system filter, e.g connector size, dead space, compliance and flow resistance
Clear and legible indications are accurately perceived by an operator with 20/20 vision (corrected if necessary) or a visual acuity of 0 on the log MAR scale from a distance of approximately 1 meter (±10%) under lighting conditions of 215 ± 65 lux The operator views information and markings positioned perpendicular to and within 15° above, below, and to the sides of their line of sight, ensuring optimal visibility and safety.
IEC 60601-1:1988, Clause 7 applies, except as follows
Maintaining the rated supply pressure range is essential to ensure proper ventilator performance The maximum flow requirement, as measured at the ventilator's high-pressure input port, must not be exceeded for more than 0.25 seconds Adhering to these parameters guarantees the ventilator operates within its designated specifications and ensures patient safety.
Compliance is checked by inspection
IEC 60601-1:1988, Clause 8 applies © ISO 2004 – All rights reserved 9
IEC 60601-1:1988, Clause 10 applies, except as follows:
Environment
The replacement specifications include an ambient temperature range of +5 °C to +40 °C, ensuring optimal operation within these temperatures The device is designed to function effectively within an ambient relative humidity range of 10% to 95%, accommodating various environmental conditions It can withstand atmospheric pressures from 600 hPa to 1100 hPa, guaranteeing reliability across different altitudes Additionally, it is capable of operating under a combination of +45 °C temperature with 75% relative humidity, ensuring performance in high-temperature and high-humidity environments.
Any extension (widening) of these conditions, as specified by the manufacturer, shall be disclosed in the accompanying documents See also 6.8.2 aa) 10).
Power supply
Replacement (third dashed list item):
a voltage fluctuation not exceeding − 20 % to + 10 % of the nominal voltage;
For ventilators connected to a medical gas pipeline system compliant with ISO 7396-1, they must operate safely and meet ISO 10651 standards across inlet pressures ranging from 280 kPa to 600 kPa, with no safety hazards up to 1,000 kPa The maximum gas flow rate at the ventilator's high-pressure input port should not exceed 60 l/min (measured over 10 seconds) at 280 kPa under normal conditions Additionally, transient flow rates must not surpass 200 l/min for more than 3 seconds, ensuring safe and reliable ventilator operation within specified pressure and flow parameters.
NOTE Flowrate values are expressed under ATPD conditions
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IEC 60601-1:1988, Clause 14 applies, except as follows
15 Limitation of voltage and/or energy
18 Protective earthing, functional earthing and potential equalization
19 Continuous leakage currents and patient auxiliary currents
IEC 60601-1:1988, Clause 19 applies, except as follows:
19.4 * Tests h) Measurement of the patient leakage current
Patient leakage current must be measured from all designated applied parts, ensuring that all parts of the same type are electrically connected Parts connected to the protective earth terminal should be tested separately from those not connected to the earth, to ensure accurate and compliant leakage current assessments.
30 Alpha, beta, gamma, neutron radiation and other particle radiation
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IEC 60601-1:1988, Clause 36 applies except as follows
Amendment (add at the end of the clause):
The ventilator shall meet the appropriate requirements of IEC 60601-1-2 The ventilator shall be Class B and shall be considered life-supporting equipment
39 Common requirements for category AP and category APG equipment
40 Requirements and tests for category AP equipment, parts and components thereof
41 Requirements and tests for category APG equipment, parts and components thereof
IEC 60601-1:1988, Clause 42 applies © ISO 2004 – All rights reserved 13
IEC 60601-1:1988, Clause 43 applies, except as follows:
To minimize the risk to patients, others, and the environment from fire hazards, ignitable materials must not be simultaneously exposed to multiple hazardous conditions under normal or single fault scenarios.
the temperature of the material is raised to its minimum ignition temperature, and
NOTE An air mixture with a volume fraction of less than 25 % oxygen is not considered to be an oxidizer
The minimum ignition temperature is determined in accordance with IEC 60079-4 using the oxidizing conditions present under normal and single fault conditions
If sparking can occur under normal or single fault condition, the material subjected to the energy dissipation of the spark shall not ignite under the oxidizing conditions present
determining the temperature to which the material is raised under the normal and single fault conditions,
observing if ignition occurs under the most unfavourable combination of normal conditions with a single fault condition
Components of the ventilator system that come into contact with oxygen under normal or single fault conditions at pressures exceeding 50 kPa must comply with ISO 15001 standards, ensuring safety and reliability in oxygen-rich environments.
Compliance is checked by inspection
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
IEC 60601-1:1988, Clause 44 applies, except as follows.
Spillage
Amendment (add at the end of the subclause):
The ventilator shall be so constructed that the spillage does not cause a safety hazard.
Cleaning, sterilization and disinfection
Amendment (add at the end of second sentence):
, or be provided with a breathing system filter
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Amendment (add before the compliance test):
Ventilators or accessories labelled sterile shall have been sterilized using an appropriate, validated method as described in ISO 14937
Non-sterile device packaging systems must be designed to preserve the cleanliness of products intended for sterilization before use, ensuring they remain sterile at their required level Additionally, these packaging systems should be engineered to minimize the risk of contamination, safeguarding product integrity throughout storage and handling Proper design and adherence to sterilization standards are essential to maintain product safety and regulatory compliance.
Amendment (add at the end of the compliance test):
If a sterility claim is made, review of the accompanying documents for methods of sterilization and disinfection and comparison to the relevant validation reports.
Compatibility with substances used with the equipment
The ventilator and parts thereof shall be designed and manufactured to minimize health risks due to substances leached from the ventilator or its components during use
Particular attention should be paid to the toxicity of materials and their compatibility with substances and gases with which they enter into contact during normal use
Compliance is checked by inspection of the information provided by the manufacturer
45 Pressure vessels and parts subject to pressure
IEC 60601-1:1988, Clause 45 applies, except as follows
Amendment (add as an additional sentence):
These requirements shall not apply to the ventilator breathing system
IEC 60601-1:1988, Clause 46 applies, except as follows
49 Interruption of the power supply
IEC 60601-1:1988, Clause 49 applies, except as follows
The ventilator must be equipped with an internal electrical power source capable of powering the device for at least 1 hour It should include a mechanism to monitor and indicate the current status of this power source, ensuring reliable operation during power interruptions.
NOTE Ways to evaluate the state include, for example, determination of the time remaining, the percent charged, or via a fuel gauge
The ventilator must be equipped with a detection system that alerts users to an impending internal electrical power supply failure before complete power loss This alarm should initially be of at least medium priority and can escalate to high priority as the power source depletes Additionally, the device's instructions should specify the time interval between complete power loss and the activation of the impending supply failure alarm, ensuring users are informed and prepared for potential power issues.
The operator needs sufficient time “prior to the loss of all power” to take action to ensure that alternative arrangements can be made to continue the life-supporting function
Compliance is checked by reducing the power source(s) to values below the minimum value(s) specified by the manufacturer as required for the intended use
49.102 Additional external backup power source
The ventilator shall have a means of connection to an additional external backup power source A description of the means of connection shall be given in the instructions for use
NOTE A means of connection to an automotive vehicle power source can be provided
Compliance is checked by inspection and inspection of the instructions for use
49.103 Spontaneous breathing during power failure
The ventilator should be capable of supporting spontaneous breathing when normal ventilation is impaired due to electrical or pneumatic power supply issues outside the manufacturer's specified parameters Additionally, resistance values during single fault conditions must be disclosed in the accompanying documentation to ensure safety and compliance.
NOTE The purpose of this requirement is to allow the patient to breathe spontaneously during “power failure conditions” of the ventilator
Compliance is verified by simulating supply power conditions outside of normal parameters and measuring flow rate, pressure, and resistance at the patient connection port These measurements are then compared to the values specified in the accompanying documents to ensure adherence to safety and performance standards.
49.104 Accidental operation of the on/off-switch
Means shall be provided to prevent accidental operation of the on/off-switch
NOTE This can be accomplished by means of hardware or software
Compliance is checked by inspection
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IEC 60601-1:1988, Clause 51 applies, except as follows
51.101 Failure of air and oxygen supply systems
The ventilator must be equipped with a gas failure alarm to promptly detect issues with the air or oxygen supply systems In the event of oxygen supply loss, the device should automatically switch to ventilation using only ambient air, ensuring continuous patient support This feature enhances patient safety by providing reliable alerts and uninterrupted ventilation during supply failures.
Not delivering the set gas mixture within the manufacturer's tolerance for the composition of the mixture is considered a failure
Compliance is checked by inspection and functional testing
51.102 Adjustable ventilator breathing system pressure limitation
A means shall be provided to prevent pressure in the ventilator breathing system in excess of the active limit value(s)
Different types of ventilator breaths, such as SIMV, volume control, and pressure support, can have multiple active pressure limits, each with its own high-pressure threshold This is because these ventilation modes may operate simultaneously, requiring independent pressure limit controls to ensure patient safety and effective ventilation Understanding these varying pressure limits is essential for proper ventilator management and avoiding complications like barotrauma.
Pressure limits must be either adjustable by the operator or defined within an active breathing algorithm, or a combination of both If operators cannot directly modify these limits, the corresponding algorithms responsible for determining them must be clearly described in the instructions for use.
When an active limit value is reached, the ventilator automatically reduces the pressure in the breathing system to ensure patient safety The time from reaching the limit pressure until the pressure begins to decrease must not exceed 200 milliseconds This rapid response is crucial for maintaining optimal ventilation and preventing potential harm.
Compliance is checked by inspection and functional testing
51.103 Maximum ventilator breathing system pressure limitation
The pressure at the patient connection port shall not exceed 60 hPa (60 cmH 2 O) in normal condition and single fault condition
Compliance is evaluated through controlled ventilation of a test lung, simulating both normal and single fault conditions, including occlusion of the patient connection port During testing, the pressure at the patient connection port is meticulously measured to assess device performance.
The airway pressure shall be indicated The displayed value shall be accurate within ± (2 % of the full-scale reading + 8 % of the actual reading)
Compliance is checked by visual inspection and verification of accuracy
51.105 * High-inspiratory pressure alarm condition
The ventilator must feature a reliable mechanism to detect high-inspiratory pressure alarms To ensure patient safety, the device should trigger the alarm after a maximum delay of three consecutive breaths under high-inspiratory pressure conditions Implementing this prompt alert system is essential for timely intervention and optimal respiratory support.
If this alarm condition exists for longer than ten consecutive breaths, the priority of this alarm condition shall escalate See also Clause 101
Patient-generated transient pressures (e.g a cough) should not cause the alarm condition
Means shall be provided to prevent the alarm limit from being set above the maximum steady limiting pressure as described in 51.103
Compliance is assessed during controlled ventilation of a test lung by simulating both normal and fault conditions, such as occlusion of the patient connection port The measurement of pressure at the patient connection port is essential to evaluate the ventilator's compliance performance in these scenarios, ensuring accurate and reliable operation under various conditions.
2 volume measurement device (part of ventilator) to be tested
6 recorder (pressure as a function of time) with an accuracy ± 2 % of actual reading for verification of accuracy of volume measurement device
7 ventilator breathing system (part of ventilator)
NOTE The volume measurement device (2) can be located elsewhere in the ventilator breathing system (7)
Figure 101 — Configuration of test apparatus for measurement of expiratory pressure and volume
The ventilator must be equipped with a reliable method for expiratory monitoring, which includes features to detect and alert for abnormal expiratory parameters Specifically, it should monitor expiratory tidal volume, with alarms for both low and high tidal volume conditions of at least medium priority Alternatively, it can monitor expiratory minute volume, providing alarms for deviations beyond preset limits Additionally, the device should measure expiratory end-tidal CO₂ levels, with alarms for both low and high end-tidal CO₂ gas levels of at least medium priority, in accordance with regulation 56.103.
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The accuracy of the measurement for tidal volumes greater than 100 ml or minute volumes greater than
3 l/min shall be ± 20 % of the actual value
Compliance is checked by visual inspection and verification of accuracy using the apparatus shown in
Figure 101 and described in Table 101
Table 101 — Conditions for expiratory pressure and volume measurements
Test conditions for ventilators intended to deliver tidal volumes Adjustable parameter
V T > 300 ml V T u 300 ml Tidal volume V T (ml) as measured by means of pressure sensor on test lung (V T = C × p max )
NOTE The accuracy for C and R applies over the ranges of the measured parameters
The ventilator shall be equipped with a means to detect a hypoventilation alarm condition
NOTE The hypoventilation alarm condition can be determined by the measurement of the variables specified in
51.104 or 51.106 but possibly requires additional detection means The hypoventilation alarm condition can also be determined by an intelligent alarm system utilizing one or more variables
Compliance is checked by inspection
The ventilator shall be equipped with a means to detect a continuing positive-pressure alarm condition The maximum alarm signal generation delay shall be 17 s
Compliance is checked by using the method described in the technical description
Ventilators must include detection capabilities for respiratory frequency alarm conditions, specifically for low-level respiratory rates Additionally, they may be equipped to identify high respiratory frequency alarms, ensuring comprehensive monitoring of patient respiratory status.
Compliance is checked by inspection
52 Abnormal operation and fault conditions
IEC 60601-1:1988, Clause 52 applies, except as follows © ISO 2004 – All rights reserved 19
Amendment (add following the existing paragraph):
A single fault should not compromise the monitoring or alarm system or the associated ventilation control function The system must remain capable of detecting any loss of the monitored ventilator control function, ensuring reliable safety and operational integrity.
IEC 60601-1:1988, Clause 54 applies, except as follows.
Protection against inadvertent adjustments
A means of protection against accidental adjustments of controls that can create a hazardous output shall be provided
Mechanical control techniques, including locks, shielding, friction-loading, and detents, are considered suitable for ensuring secure operation For pressure-sensitive finger pads, capacitive finger switches, and microprocessor-oriented "soft" controls, implementing a specific sequence of keys or switch operations enhances security and usability These control methods are essential for protecting sensitive systems and ensuring reliable user interactions.
Compliance is tested by visual inspection following the instructions for use
IEC 60601-1:1988, Clause 56 applies, except as follows.
Connections — General
Additions: aa) * Gas leakage from gas supply connections
1) Reverse gas flowrate from all gas input ports into the supply system of the same gas shall not exceed 100 ml/min under normal conditions
The cross-flow rate of gas between high-pressure input ports should not exceed 100 ml/h during normal operation If, under single fault conditions, the flow surpasses this limit, the ventilator must trigger an auditory alarm Additionally, the maximum allowable cross-flow rate between gases under fault conditions is 100 ml/min to ensure safety and prevent hazardous cross-contamination.
Compliance is checked by inspection of the information provided by the manufacturer
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````,`-`-`,,`,,`,`,,` - bb) High-pressure input ports
High-pressure input port connectors shall be the body of an NIST fitting complying with the requirements of
ISO 5359, the male part of a quick connection complying with the requirements of ISO 5359, or a proprietary connector incompatible with the fittings and connectors specified in ISO 5359
Compliance is checked by inspection cc) Connection to the medical gas supply system
If an operator-detachable hose assembly is provided for connection between the ventilator and the medical gas supply system, it shall comply with ISO 5359
Compliance is checked by inspection dd) Statements specific to named ports
A fresh-gas intake port, if provided, shall not be compatible with connectors complying with
2) gas output, gas return port, and patient connection port connectors
The gas output, gas return port, and patient connection port shall, if conical [see also 6.1 bb)], be one of the following:
a 22 mm conical connector complying with ISO 5356-1 or ISO 5356-2;
a 15 mm conical connector complying with ISO 5356-1;
a coaxial 15 mm/22 mm conical connector complying with ISO 5356-1 or ISO 5356-2
Non-conical connectors shall not engage with conical connectors complying with ISO 5356-1 unless they comply with the engagement, disengagement and leakage requirements of that standard
An emergency air intake port shall be provided It shall not accept any connector complying with ISO 5356-1 or ISO 5356-2
The emergency air intake port should be designed to prevent obstruction when the ventilator is in use
4) Flow-direction-sensitive component connectors
Any operator-detachable flow-direction-sensitive component of the ventilator breathing system shall be so designed that it cannot be fitted in such a way that it presents a hazard to the patient
If an accessory port is provided, it shall not be compatible with connectors specified in ISO 5356-1 or ISO 5356-2 and shall be provided with a means to secure engagement and closure
NOTE This port is commonly used for sampling of gases or for introduction of therapeutic aerosols © ISO 2004 – All rights reserved 21
When designing a port for introducing a monitoring probe, it must be incompatible with connectors as specified in ISO 5356-1 and ISO 5356-2 The port should include a securement mechanism to hold the probe in position and a closure method to seal the port after the probe’s removal.
The ventilator shall not be equipped with a manual ventilation port
Compliance is checked by inspection
56.101 Reservoir bags and breathing tubes a) Any reservoir bags intended for use in the ventilator breathing system shall comply with ISO 5362 b) Breathing tubes intended for use in the ventilator breathing system shall comply with ISO 5367
Compliance is checked by inspection
56.102 Humidifiers and heat and moisture exchangers
Any humidifier or heat and moisture exchanger, either incorporated into the ventilator or recommended for use with the ventilator, shall comply with ISO 8185, ISO 9360-1 or ISO 9360-2 respectively
Compliance is checked by inspection
Any pulse oximeter or capnometer, either incorporated into the ventilator or recommended for use with the ventilator, shall comply with ISO 9919 or ISO 21647, respectively
Compliance is checked by inspection
56.104 Oxygen monitor and alarm condition
If the ventilator is intended for use with a fractionally inspired oxygen concentration greater than ambient, then the ventilator shall be provided with an oxygen monitor for the measurement of inspired oxygen concentration, e.g in the inspiratory limb or at the patient connection port The oxygen monitor shall comply with ISO 21647 and shall, in addition, be provided with a means to detect a high-oxygen-concentration alarm condition The high-oxygen-concentration alarm condition shall be at least medium priority
Alarm limits can be manually set by the operator or calculated automatically based on the configured oxygen concentration, ensuring flexible monitoring If these limit values are not directly adjustable, the underlying algorithm used to determine alarm thresholds must be clearly outlined in the device’s technical documentation Proper configuration of alarm limits is essential for accurate oxygen level monitoring and safety compliance.
Compliance is checked by inspection
Any monitoring equipment integrated into the ventilator that is not referenced in this part of ISO 10651 shall comply with the relevant Particular Standard for that monitoring equipment
Compliance is checked by inspection
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57 Mains parts, components and layout
IEC 60601-1:1988, Clause 57 applies, except as follows
Amendment (add an additional dashed list item):
Any detachable power supply cord of an electrically powered ventilator shall be protected against accidental disconnection from the ventilator under a force of 100 N
Replacement (replace the compliance test):
Compliance is checked by inspection and, for a ventilator when provided with an appliance coupler, by the following test:
Subject the detachable power supply cord for 1 min to an axial pull of force of 100 N
During the test, the mains connector becoming disconnected from the appliance inlet of the ventilator is considered a failure
58 Protective earthing — Terminals and connections
IEC 60601-1-8:2003, Clause 201 applies, except as follows
Amendment: (add at the end of the third paragraph)
The maximum duration of the alarm paused interval for any alarm condition required by this part of ISO 10651 shall not exceed 120 s
Amendment (replace the first sentence with the following):
The ventilator alarm system shall be provided with:
````,`-`-`,,`,,`,`,,` - © ISO 2004 – All rights reserved 23 a) the alarm system shall log the occurrence, identity and alarm limits of all high priority alarm conditions;
The alarm system should log
technical alarm conditions b) the contents of the log
shall be stored for a specified period of time not less than 72 h or until deleted by user action,
shall not be lost by losses of power of less than 72 h,
shall not be erasable by the operator, and
The manufacturer must ensure that the alarm system log is accessible for review by the operator at all times Additionally, the manufacturer is required to disclose in the instructions for use what happens to the contents of the log if the alarm system experiences a total power loss—whether from the mains or internal power sources—for more than 72 hours.
The Appendices of IEC 60601-1:1988 apply
Addition: The subsequent annexes form an additional element of this part of ISO 10651
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This annex offers a clear rationale for certain requirements outlined in ISO 10651, aimed at readers familiar with this standard but not involved in its development It provides essential insights into the reasoning behind specific provisions, ensuring a better understanding of the standard's application and importance.
Understanding the rationale behind these requirements is essential for their correct application As clinical practices and technologies evolve, this rationale will support necessary revisions to ISO 10651 to accommodate these advancements, ensuring continued relevance and effectiveness.
The numbering of the following rationale corresponds to the numbering of the clauses in this part of ISO 10651 The numbering is, therefore, not consecutive
The definition of applied part in this part of ISO 10651 is the basis for clarification of requirements for, and measurement of, patient leakage current
It is possible that antistatic tubing or other tubing that is conductive could be used in the ventilator breathing system in error
ISO 10651 does not specify requirements for leakage currents from electrically operated attachments like humidifiers and heating elements connected to ventilator breathing systems This is because the types of attachments used in clinical settings cannot be anticipated by manufacturers or testing laboratories, making standardized regulation infeasible.
Parts integrated with ventilators, such as temperature and carbon dioxide sensors that contact the patient and connect to the ventilator, are classified as applied parts These components are subject to specific leakage current requirements outlined in ISO 10651 to ensure patient safety.
Software errors, should they occur, should not cause a safety hazard to the patient, operator, or the user
This requirement, however, is equivalent to that of IEC 60601-1:1988, 3.1 that effectively states that all devices shall cause no safety hazard under normal conditions and a single fault condition
Treating an undetected software defect that results in hazardous conditions as a normal part of operation is a prudent approach This strategy ensures safe integration of software-controlled medical devices within the IEC 60601-1 and IEC 60601-1-4 standards, enhancing overall device safety and compliance.
This approach is advisable, especially with respect to a failure mode effect analysis, to prove compliance with IEC 60601-1:1988, 3.1
Undetected faults can remain unnoticed for an extended period, leading to potential issues It is crucial to recognize that a subsequent fault should not be dismissed as inconsequential if it occurs in the presence of an existing undetected fault Such a first fault is often considered a normal condition, emphasizing the importance of thorough fault detection and analysis for optimal system reliability and maintenance.
An undetected oxygen leak can be a significant safety concern that is often overlooked It should only be regarded as a normal condition if it goes unnoticed by alarm systems and routine inspections, assuming the system is not infallible Regular monitoring and maintenance are essential to ensure such leaks are promptly identified and addressed, preventing potential hazards.
Immediate implies the ability to be used quickly enough to prevent serious patient injury © ISO 2004 – All rights reserved 25
The operating time can vary considerably and be affected by temperature and both the charge and the discharge rate of the battery
IEC 60601-1 defines specific ambient conditions such as temperature, relative humidity, barometric pressure, and power supply for medical equipment to meet the General Standard requirements These conditions reflect the typical environment found in healthcare facilities Manufacturers have the flexibility to specify extended ambient conditions beyond those outlined in the standard to accommodate different operational settings.