ISO 10651 – Managing Compliance of Lung Ventilators for Medical Use(2960)

ISO 10651- Managing Compliance of Lung Ventilators for Medical Use

It is prepared by ISO’s Technical Committee ISO/TC 121. ISO 10651 deals with the managing compliance of lung ventilators for medical use. These ventilators assist those at the risk of cardiac failure, particularly during a cardiac arrest event. These lung ventilators fulfill the purpose of the essential equipment used by a normal bystander who finds himself in this emergency. With the use of these devices, mouth-to-mouth contact can be avoided while performing any resuscitation activity.

Scope of ISO 10651

ISO 10651 defines basic safety and essential performance requirements needed for gas-powered emergency ventilators. These ventilators are intended to be used for human beings by first responders. This equipment is intended to be used in the emergency field, and continuously operator attended in regular use.

Terms & Definitions

The following terms and definitions are part of ISO 10651’s document:

Accompanying Documents

Accompanying documents are those that attend resuscitator or resuscitator sets. They contain all vital information for

  • User
  • Operator
  • Resuscitator’s installer or assembler.
Automatic Pressured-Cycled Resuscitator

A resuscitator that attains a control-setting determined pressure during the cycling of inspiratory phase to expiratory phase.

Automatic Time-Cycled Cylinder

A resuscitator in which cycling from the inspiratory to the expiratory phase is done through an automated process.

Automatic Volume-Cycled Resuscitator

A resuscitator in which cycling from inspiratory phase to expiratory phase occurs after delivery of delivered volume.

Cardiopulmonary Resuscitation

It is a combination of chest compressions and rescues breathing for the victims of cardiac arrest.

Clearly Legible

The one which can be read by an operator or a person with a normal vision.

Delivered Volume

Delivered volume is the gas volume delivered to the patient through the patient connection port.

Demand Valve

It is a part of the resuscitator that delivers gas flow related to the patient’s pressure reduction at the patient connection port.

First Responder

A trained individual who can provide a primary response in a respiratory emergency. (e.g., firefighter, emergency medical technician).

Gas-Powered Emergency Resuscitator

Gas-powered portable equipment intended for immediate use in providing lung resuscitation to individuals having sudden breathing difficulties.

Inadvertent Positive-End Expiratory Pressure

An unintended positive pressure at the patient connection port at the end of the expiratory phase.

Intermediated Host

Host conducting gas between resuscitator’s parts.

Manually-Cycled Resuscitator

A resuscitator in which a repeated manual action of the operator controls the inspiratory and expiratory phase.

Minute Volume

The volume of gas that enters or leaves a patient’s lungs every minute.

Operator

The person who handles the resuscitator.

Patient-Triggered Resuscitator

In this resuscitator, the patient’s inspiratory effort helps in cycling from the expiratory to the inspiratory phase.

Patient-Triggering

An operation mode in which the patient generates a reduced pressure at the patient connection port’s end to initiate the inspiratory phase.

Patient Valve

A valve in the resuscitator breathing system directing gas into the lungs during the inspiratory phase and directing it into the atmosphere from the lungs during the expiratory phase.

Pressure-limiting Device

Limits the maximum pressure within the resuscitator breathing system.

Resuscitator Dead Space

Previously exhaled gas present in the resuscitator breathing system, which is delivered to the patient in the succeeding inspiratory phase.

Resuscitator Set

A pack of all necessary components enabling the resuscitator to be carried to the emergency site and enabling it to be ready for immediate use.

Safety Hazard

Potential detrimental effects arising from the resuscitator can affect the patient, other persons, animals, or surroundings.

Single Fault Condition

A condition in which a single mean for protection against resuscitator’s safety hazard is defective, OR there is the presence of a single external abnormal condition.

General Requirements-Clause 4

General-4.1

  • During transportation, the resuscitator shall be transported, stored, installed, and operated in normal use
  • Its Maintenance will be according to the accompanying documents
  • It will not cause any reasonably foreseeable safety hazard
  • It will not cause any hazard connected with its intended application either in normal or in a single fault condition.

In compliance with ISO 14971, a risk management system will be applied in which:

  • The term “medical device” will have the same meaning as a resuscitator
  • The term “fault conditions” shall include single fault conditions, but it shall not be limited to it only
  • Unless there is a piece of contrary objective evidence, residual risks of measurable requirements specifying and complying with particular risks mentioned in ISO 10651 shall be considered acceptable.

Other Test Methods-4.2

If an equivalent safety degree is obtained, the manufacturer can use different type tests from ISO 10651. But in the event of a dispute, methods specified within ISO 10651 will be used as reference methods.

Acceptance Criteria-4.3

The test clauses of ISO 10651 establish acceptance criteria for performance aspects that will always be met.

Constructional Requirements-Clause 5

General-5.1

Materials of Construction-5.1.1

Accompanying documents will indicate the chemical and physical properties of the materials that will be used for constructing all gas conducting parts. These parts can be:

  • administered through the resuscitator
  • used in cleaning, disinfecting, or sterilizing the resuscitator.

Surfaces, Corners, and Edges-5.1.2

Edges and components of the resuscitator which can cause injury or damage, such as

  • Rough surfaces
  • Sharp corners
  • Open ends of tubular components shall either be avoided or covered. Removing burrs requires special attention in this regard.

Leaching of Substances-5.1.3

The resuscitator and its parts shall be designed. Any health risk posed by its leached substances and components can be minimized during its use. Special attention is required for materials’ toxicity and compatibility with substances and gases. These materials enter into contact during normal use.

Breathing Tubes-5.1.4

Breathing tubes have an internal diameter of 18 mm. Their intended use is in the resuscitator breathing system, and they shall comply with ISO 5367.

Supply of Sterile Compounds-5.1.5

If a product is claimed to be sterile, it must have used an appropriate and validated sterilization method described in ISO 11134, ISO 11135, ISO 11137, ISO 11138, or ISO 14937. It is necessary for resuscitators’ parts or packaging (supplied sterile) to comply with ISO 11607. This packaging will not be capable of re-closure provided the declaration that it has been opened.

For Non-Sterile Packaging Systems

They shall be designed to:

  • Maintain products intended to be sterilized before their use at the intended level of cleanliness
  • Lessen the risk of microbial contamination.

Breathing System Filter-5.1.6

The breathing system filter shall comply with applicable parts of ISO 23328-1 and ISO 23328-2 whether incorporated into the resuscitator or is intended to be used with it.

Arrangement of Functions-5.1.7

For any single fault condition:

  • Any monitoring or alarm system function shall not be used
  • The single fault condition shall not fail the corresponding ventilation control function by making the monitoring or alarm system ineffective
  • It will not fail in detecting the loss of monitored resuscitator function.

Protection against Accidental Adjustments-5.1.8

Any means that can provide protection (e.g., an “on-off” switch) against accidental alteration of control settings shall be provided. Other mechanical techniques can also be used, such as:

  • Locks
  • Shielding
  • Friction-loading
  • Detents.

Selector Switches/Controls-5.1.9

Means that prevent selectors from remaining in an intermediate position shall be provided for controls that are not continuously variable.

Example 1

An “on-off” switch

Example 2

An oxygen concentration selector.

Example 3

A selector for preset and discrete values of delivered volume.

Accuracy of Operating Data-5.1.10

The resuscitator shall deliver ventilation accuracy as indicated in instructions for use during its normal use.

Resuscitator Set-5.1.11

The resuscitator shall be supplied with a resuscitator set. This will include a medical gas supply system complying with relevant requirements of ISO 10651.

Connectors-Clause 5.2

Connectors to the Medical Gas Supply System-5.2.1

A detachable hose assembly connecting the resuscitator and medical gas supply system shall comply with ISO 5359. If this hose assembly system is connected permanently to the resuscitator, the connection will be utilizing either

  • A probe complying with ISO 9170-1 or
  • A permanent connector.

Note: A permanent connector can only be separated using a tool.

Connection to the High-Pressure Gas Input Port-5.2.2

The connection of the hose to the high-pressure gas port of the resuscitator shall be by

  • A non-interchangeable, screw-threaded connector sowing compliance to ISO 5359
  • A probe showing compliance to ISO 9170-1, or
  • A permanent connector.

Patient Connection Port Connector-5.2.3

Resuscitator’s patient connection port connector shall be a coaxial 15mm/22mm connector showing compliance to ISO 5356-1.

Facemask Connector-5.2.4

Facemasks shall either have a 15 mm male connector or a 22mm female connector. They shall mate with the corresponding connectors specified in ISO 5356-1.

Gas Exhaust Port Connector-5.2.5

A gas exhaust port connector shall either be

  • A male conical connector of 30 mm showing compliance to ISO 5356-1 shall be provided, or
  • A proprietary connector that is incompatible with ISO 5356-1 and ISO 9170-1 will have means of preventing the connection of any breathing attachment that conforms to ISO 5356-1 or ISO 5356-2 and ISO 9170-1.

Resuscitator Inspiratory Limb Connectors-5.2.6

If the connectors present in the resuscitator’s respiratory limb are conical, they shall comply with ISO 5356-1 and ISO 5356-2.

For Non-Conical Connectors

Unless they comply with engagement, disengagement, and leakage requirements of ISO 5356-1 or ISO 5356-2, they shall not engage with conical connectors showing compliance to these standards.

Emergency Air Intake Port-5.2.7

It shall

  • Be provided
  • Show compliance to the requirements of 7.1.2.2 and 7.1.2.3
  • Reject any connector complying with ISO 5356-1 or ISO 5356-2.

Operational Requirements-Clause 6

General-6.1

Patient Valve Function after Contamination with Vomitus-6.1.1

During resuscitator’s testing as per Annex B.3.1, the cleaning and restoration to normal function shall not take more than 20 seconds. This process shall then meet Clause 7’s requirements. The valve housing should be constructed to achieve the mechanism operation (e.g., through transparent housing).

Note: Observing the patient valve’s functioning mechanism can help the operator in detecting abnormal operations.

Cleaning, and Sterilization or Disinfection-6.1.2

Those parts and accessories indicated in accompanying documents for reuse shall be cleaned, and sterilized, or disinfected if:

  • They can be contaminated by exhaled patient gas during normal use
  • During single fault condition denoted in Annex B.3.10.

Function Test after Reassembly-6.1.3

Reassembly-6.1.3.1

If a resuscitator is intended to be dismantled by the operator (e.g., for cleaning), then it shall be designed to minimize the risk of incorrect assembly. This will be applied only with the use of items supplied with the resuscitator set.

Functional Test-6.1.3.2

A functional test procedure shall be indicated in the accompanying documents, which the operator will perform after reassembly. He will only use items supplied with the resuscitator set and will demonstrate the resuscitator’s appropriate assembly.

Flow-Direction-Sensitive Component Connectors-6.1.4

A flow-direction-sensitive component that is operator-detachable shall be designed such that it cannot present a safety hazard to the patient upon fitting.

Resistance to Environmental Influences-6.2

Storage and Operating Conditions-6.2.1

Storage-6.2.1.1

The resuscitator set shall comply with requirements given in 5.1.10, 7.2.2, 7.2.4, and 7.2.6. once it gets stored at

  • The temperature between -40ᵒC and +60ᵒC
  • The relative humidity of 40% and 90%, the resuscitator.
Operating Conditions-6.2.1.2

Throughout the range of relative humidity from 5% to 95%, the resuscitator and resuscitator set shall comply with requirements of 5.1.10, 7.2.2, 7.2.4, and 7.2.6 either

  • Through the temperature range from -18ᵒC to +50ᵒC, or
  • Through the temperature range indicated in accompanying documents (in case an operating range is given).

Resistance to Typical Use-6.3

Mechanical Shock-6.3.1

Drop Test-6.3.1.1

The functional continuity of the resuscitator shall be as per the tolerances indicted for normal use. This will be done after the drop test is performed for the resuscitator set and removable parts.

Splash Proof-6.3.2

The resuscitator shall be splash-proof and will be classified as IPX4 in IEC 60529. During and after the test specified in IEC 60529, the resuscitator will work according to accompanying documents under minor favorable working conditions. It will continue to function under the tolerances indicated for normal use and will not cause a safety hazard.

Immersion in Water-6.3.3

The resuscitator shall continue to function within the tolerances indicated for normal use once it has been immersed into water, according to Annex B.3.5.

Size and Mass-6.4

Size-6.4.1

The resuscitator set (either provided or recommended in accompanying documents) must pass through a rectangular opening of 300mmx600mm.

Mass-6.4.2

  • The resuscitator set’s mass (including all recommended contents and full gas cylinders) shall not exceed 5 Kg
  • The resuscitator’s part incorporating the patient connection’s port shall weigh under 0.3 Kg.

Gas Supply-6.5

Gas Cylinders and Cylinder Valve-6.5.1

  • All the gas cylinder’s contents either supplied or recommended by accompanying documents shall be under ISO 32
  • The gas cylinder valve fitted into the gas cylinder and either supplied or recommended by accompanying documents shall be following ISO 10297
  • During special situations, small cylinders with special fittings can be used.

Captive Cylinder Valve Key-6.5.2

If manufactured detachable, the part for opening the cylinder valve (such as the hand-wheel or key) shall be made captive. This will be done by attaching a retaining chain pr something similar that can withstand a static load of at least 200N (20 Kg) without breaking.

Cylinder Regulator-6.5.3

As part of the resuscitator set medical gas supply system, the pressure cylinder either supplied or recommended by accompanying documents will comply with the requirements of ISO 10524-1 or ISO 10524-3.

External Supply-6.5.4

Suppose the operator provides a probe for the resuscitator to connect it with the medical gas supply system. In that case, it shall operate and meet the requirements of ISO 10651’s clause 6.5. The pneumatic power supply will be in the range of 280kPa to 600kPa. This power will not cause any safety if supplied under the single fault condition of medical gas supply up to 1000kPa inlet pressure.

Permanently Connected Resuscitator-6.5.5

If the operator does not supply the resuscitator with a probe to connect it with a medical gas supply system, it shall comply with Claus 6 of ISO 10651. This shall be done throughout the rated range of gas cylinder contents indicated in the accompanying documents. Under the single fault condition (for cylinder pressure regulator supplying up to 1000kPa inlet pressure), this will not cause any safety hazard.

Intermediate Hose-6.5.6

  • Any intermediate hose that can be operator-connected between the resuscitator’s parts will not be fitted with interchangeable connectors on the connectors of hoses complying with ISO 5359
  • The intermediate hose shall also not allow the resuscitator’s parts to connect incorrectly.

Gas Container Capacity-6.5.7

  • Any resuscitator either supplied or recommended by accompanying documents shall accommodate one or more gas cylinders. These gas cylinders shall provide the gas source in the medical gas supply system
  • Resuscitator set shall contain enough gas that will enable it to deliver the patient with at least 100L of oxygen concentration >85% volume fraction.

Performance-Clause 7

Ventilatory Requirements-7.1

Delivered Oxygen Concentration-7.1.1

The resuscitator shall deliver at least 85% volume fraction concentrated oxygen.

Resistance to Spontaneous Breathing-7.1.2

General-7.1.2.1
  • Attachable accessories or selectable functions indicated as a warning in accompanying documents increase the inspiratory and expiratory resistance during the use
  • They are provided for temporary use for specific purposes
  • They are not used during the tests for compliance with these given requirements.
Inspiratory Resistance during the Resuscitator Expiratory Phase-7.1.2.2

For Patients having a Body Mass Greater than 10 Kg

Pressure at the patient connection port shall not exceed 6hPa (6cm H2O) during the expiratory phase below atmospheric pressure, with an inspiratory airflow of 60l/min.

For Patients with a Body Mass Greater up to 10 Kg

Pressure at the patient connection port shall not exceed 6hPa (6cm H2O) during the expiratory phase below atmospheric pressure, with an inspiratory airflow of 6 l/min.

Spontaneous Breathing with the Gas Input Pressure Outside the Rated Range-7.1.2.3

The resuscitator shall either allow spontaneous breathing or operate with the gas input pressure outside the rated range.

When operating outside the rated range and during the inspiratory phase, it shall generate a delivered volume and inspiratory time within +- 25% of that achieved during normal use.

Expiratory Resistance-7.1.2.4

If

  • a removable positive end-expiratory pressure valve (PEEP) is not present, or
  • the integral positive end-expiratory pressure function is set at its minimum value then.

Inadvertent PEEP-7.1.3

At the end of the expiratory phase, the positive expiratory pressure shall not exceed 2hPa (2cm H2O).

Inadvertent Continuing Expiratory Pressure-7.1.4

To prevent the build-up of continuing positive pressure from exceeding 2hPa. Appropriate means shall be provided.

Resuscitator Dead Space and Dead Space of Airway Accessories-7.1.5

The resuscitator dead space shall not exceed 5.5% of the minimum delivered volume from the resuscitator.

Ventilation Performance-Clause 7.2

General-7.2.1

The tests given in ISO 10651 shall be performed when the operator uses the resuscitator.

Classification of Resuscitators
Manually-Cycled Resuscitator-7.2.1.1

It shall meet the requirements given in 7.2.2 to 7.2.8.

Automatic Pressured-Cycled Resuscitator-7.2.1.2

It shall meet the requirements given in 7.2.2 to 7.2.7.

Automatic Time-Cycled or Volume-Cycled Resuscitator-7.2.1.3

It shall meet the requirements given in 7.2.2 to 7.2.7.

Resuscitator with Patient Triggering-7.2.1.4

It shall meet requirements given in

  • 7.2.10
  • The requirements for associated automatic resuscitator function.
Resuscitator with Demand Valve as an Integral Part-7.2.1.5

It shall meet requirements given in

  • 7.2.9
  • The requirements for associated resuscitator function.

Delivered Volume-7.2.2

A resuscitator with operator-adjustable delivered volume shall use the values specified for the limits of their body’s mass range.

Delivered Volume Requirements & Test Conditions

The parameter for delivered volume is:

  • Compliance (I/hPa)
  • Resistance [hPa(I/s)]
  • Inspiration/Expiration Time Ratio ± 20%
  • Frequency (breaths/minute).

Consistency of Delivered Volume-7.2.3

The delivered volume to a test lung shall not deviate ± 150 ml if

  • The resuscitator is used for patients with body mass >40 Kg
  • It delivers >85% volume fraction of O2 for each cycle
  • Its compliance and resistance are changed as specified in Annex B.3.12.

Pressure Limitation under Normal Use-7.2.4

During normal use, the pressure at the patient connection port shall not exceed 60hPa. However, upon the availability of a medical device, the setting pressure-limiting device can be set higher than 60hPa for certain patients.

Pressure Limitations under Single-Fault Conditions-7.2.5

Under the single-fault condition, the pressure at the patient connection port shall not exceed 80hPa.

Pressure-Limitation Activation Alarm Signal-7.2.6

For detecting pressure-limiting device’s operation, means shall be provided. This will activate an auditory signal for:

  • indicating loss of delivered volume because of the pressure-limiting device’s action or
  • when the limitation for set inspiratory pressure is reached.

Note: Any patient-generated pressure (e.g., cough) should not activate the alarm.

Inspiratory Flow-7.2.7

For use in patients with body mass >40 Kg, the resuscitator will deliver:

  • >85% O2
  • Inspiratory flows between 25l/min and 40l/min.
    These will be provided on both free flow to the atmosphere and against a back pressure of 20 hPa.

Operation of Manual Trigger on a Manually-Cycled Resuscitator -7.2.8

As per International Resuscitation guidelines, the operator shall:

  • operate the function with one finger
  • maintaining a mask seal using a two-handed head-tilt, chin-lift method on a manually-cycled resuscitator simultaneously.

Demand Valve-7.2.9

General-7.2.9.1

For demand valve working as resuscitator’s integral part, requirements in 7.2.9.2 to 7.2.9.4 shall be provided.

Threshold Pressure for Initiation of Flow-7.2.9.2

To initiate gas flow from the demand valve at the patient connection port, the pressure shall not exceed 2hPa below atmospheric pressure.

Peak Inspiratory Flow-7.2.9.3

The pressure at peak respiratory flow at the patient connection port shall be 100l/mi. for at least 2 seconds, and

  • It shall not exceed the pressure of 8 hPa below atmospheric pressure
  • The flow will be attained within 250 ms.
Termination Pressure-7.2.9.4

If the pressure at the patient connection port equals atmospheric pressure or equals positive pressure mentioned in accompanying documents, then the demand flow shall be terminated.

Patient-Triggered Resuscitator-7.2.10

If the resuscitator or any of its functions can be patient-triggered according to the accompanying documents, the trigger shall operate within 250 ms. This applies when the patient connection port’s pressure is reduced to greater than 2,5 hPa below atmospheric pressure.

Identification, Marking & Documents-Clause 8

Marking on Resuscitator Set-8.2

Operation & Maintenance Information Provided by Manufacturer-8.3

General Implications-8.3.1

The manufacturer shall provide accompanying documents enclosed with or attached to the resuscitator set’s container. These will include:

  • Instructions for:
    • Use and Maintenance of the resuscitator
    • Recommended accessories.

Contents of Accompanying Documents-8.3.2

Annex A

Annex A discusses the Rationale, which provides help to those who have not participated in ISO 10651.

Annex B

Annex B proposes test methods that can be used in testing the functionality of the resuscitator.

Annex c

It is an informative annex that explains the relationship between ISO 10651 and cardiopulmonary resuscitation Guidelines.

Annex D

It is also an informative annex that supports essential principles of ISO/TR 16142.

Annex E

Annex E is the index of ISO 10651 and contains terminologies of defined terms.

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About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.