Anaesthetic and respiratory equipment — Nebulizing systems and components

ISO 27427:2010 specifies requirements for the safety, performance and testing for general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in an aerosol form, to humans through the respiratory system. ISO 27427:2010 includes gas-powered nebulizers which can be powered by, for example, compressors, pipeline systems, cylinders, etc., and electrically-powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive) and capillary devices] or manually-powered nebulizers. ISO 27427:2010 does not apply to devices intended for nasal deposition. ISO 27427:2010 does not apply to devices intended solely to provide humidification or hydration by providing water in aerosol form. ISO 27427:2010 does not apply to drug-specific nebulizers (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers and their components).

Matériel d'anesthésie et de réanimation respiratoire — Systèmes de nébulisation et ses composants

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Status
Withdrawn
Publication Date
02-Mar-2010
Withdrawal Date
02-Mar-2010
Current Stage
9599 - Withdrawal of International Standard
Start Date
11-Dec-2013
Completion Date
11-Dec-2013
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INTERNATIONAL ISO
STANDARD 27427
Second edition
2010-03-15
Anaesthetic and respiratory equipment —
Nebulizing systems and components
Matériel d'anesthésie et de réanimation respiratoire — Systèmes de
nébulisation et ses composants
Reference number
ISO 27427:2010(E)
ISO 2010
---------------------- Page: 1 ----------------------
ISO 27427:2010(E)
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ii © ISO 2010 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 27427:2010(E)
Contents Page

Foreword ............................................................................................................................................................iv

Introduction.........................................................................................................................................................v

1 *Scope.....................................................................................................................................................1

2 Normative references............................................................................................................................1

3 Terms and definitions ...........................................................................................................................3

4 General requirements and requirements for test...............................................................................4

4.1 Risk management..................................................................................................................................4

4.2 *Test methods and alternatives ...........................................................................................................4

4.3 Electrical safety .....................................................................................................................................5

4.4 Mechanical safety..................................................................................................................................5

4.5 Pneumatic safety ...................................................................................................................................5

4.6 Protection against inadvertent adjustments ......................................................................................5

4.7 Protection against infection .................................................................................................................5

4.8 Usability..................................................................................................................................................5

5 Marking and instructions for use.........................................................................................................6

5.1 Marking...................................................................................................................................................6

5.2 Symbols..................................................................................................................................................7

5.3 Instructions for use ...............................................................................................................................7

6 Construction requirements ..................................................................................................................9

6.1 Materials .................................................................................................................................................9

6.2 Connectors...........................................................................................................................................10

6.3 Rotary controls ....................................................................................................................................13

7 Cleaning, sterilization and disinfection.............................................................................................13

8 Biocompatibility...................................................................................................................................13

Annex A (informative) Rationale......................................................................................................................14

Annex B (normative) Diameters of respirable fraction particles .................................................................16

Annex C (normative) Test methods for aerosol output and aerosol output rate.......................................17

Annex D (normative) Test methods for particle sizing .................................................................................21

Annex E (informative) Test apparatus for leak test .......................................................................................27

Annex F (informative) Hazard identification for risk assessment................................................................28

Annex G (informative) Taxonomy of general purpose nebulizers ...............................................................35

Annex H (informative) Environmental aspects ..............................................................................................37

Annex AA (informative) Conformance to essential principles.....................................................................38

Bibliography......................................................................................................................................................42

© ISO 2010 – All rights reserved iii
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ISO 27427:2010(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

(ISO member bodies). The work of preparing International Standards is normally carried out through ISO

technical committees. Each member body interested in a subject for which a technical committee has been

established has the right to be represented on that committee. International organizations, governmental and

non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the

International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 27427 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,

Subcommittee SC 2, Airways and related equipment.

This second edition cancels and replaces the first edition (ISO 27427:2009), of which it constitutes a minor

revision.
The following changes were made:
⎯ a new subclause 4.1.2 (Clinical evaluation) was added;

⎯ a new subclause 4.8 (Usability) was added and, as a result, two new references were added in Clause 2;

⎯ 5.1.2 a) was updated;
⎯ a new item 5.1.2 d) was added and the subsequent items were renumbered;
⎯ in 5.1.2, a new item (o) was added;
⎯ in 5.3.2, two new items (u and v) were added;
⎯ a note was added to 6.1.2.
In addition, several minor editorial changes were made.
iv © ISO 2010 – All rights reserved
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ISO 27427:2010(E)
Introduction

Nebulizers are widely used to deliver drugs, in an aerosol form, to humans through the respiratory system.

These drugs may be in the form of a solution, suspension or emulsion. Aerosol inhalation is the preferred

route of administration of some drugs. Some drugs are intended for treatment of systemic disease and other

drugs are intended to treat respiratory diseases. To achieve the intended treatment, aerosol particles may

need to be deposited in specific parts of the respiratory tract. Different size particles tend to deposit in different

parts of the respiratory system; therefore, the performance profile and the intended use of the nebulizer must

be defined by the manufacturer and specified in the accompanying documentation. Nebulizers are also used

for diagnostic purposes using radioisotopes, and for lung challenge tests and the delivery of vaccines.

This International Standard is based on the European Standard EN 13544-1:2007. This International Standard

was developed to cover “general purpose” nebulizers. It was specifically written to ensure that the results of

the various tests declared by the manufacturer were meaningful to the users and buyers of nebulizers.

The objectives of this International Standard are to ensure:

⎯ the suitability of the nebulizers for the intended use as disclosed by the manufacturer;

⎯ safety, particularly for electrically-powered nebulizers;

⎯ compatibility between the materials of the components and the dispensed liquid;

⎯ biocompatibility of the materials of the components that come into contact with the human body.

Important changes were made to the original EN standard in recognition of the advances in test devices such

as lasers and low-flow impactors that allow manufacturers to use different test methods, provided these

alternate methods are validated against the methods specified in this International Standard.

Terms defined in this document are set in bold type.

Throughout this International Standard, text for which a rationale is provided in Annex A is indicated by an

asterisk (*).
© ISO 2010 – All rights reserved v
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INTERNATIONAL STANDARD ISO 27427:2010(E)
Anaesthetic and respiratory equipment — Nebulizing systems
and components
1 *Scope

This International Standard specifies requirements for the safety, performance and testing for general purpose

nebulizing systems intended for continuous or breath-actuated delivery of liquids, in an aerosol form, to

humans through the respiratory system.

This International Standard includes gas-powered nebulizers which can be powered by, for example,

compressors, pipeline systems, cylinders, etc., and electrically-powered nebulizers [e.g. spinning disc,

ultrasonic, vibrating mesh (active and passive) and capillary devices] or manually-powered nebulizers.

*This International Standard does not apply to devices intended for nasal deposition.

This International Standard does not apply to devices intended solely to provide humidification or hydration by

providing water in aerosol form.

*This International Standard does not apply to drug-specific nebulizers (e.g. metered dose inhalers, metered

liquid inhalers, dry powder inhalers and their components).
2 Normative references

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.

ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical

equipment — Part 1: General requirements

ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —

Part 2: Lock fittings

ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded

weight-bearing connectors
ISO 5359, Low-pressure hose assemblies for use with medical gases
ISO 5361-1, Tracheal tubes — Part 1: General requirements
ISO 7000, Graphical symbols for use on equipment — Index and synopsis

ISO 7396-1, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and

vacuum

ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with

compressed medical gases and vacuum
© ISO 2010 – All rights reserved 1
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ISO 27427:2010(E)

ISO 9276-2, Representation of results of particle size analysis — Part 2: Calculation of average particle

sizes/diameters and moments from particle size distributions

ISO 10524-1, Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure

regulators with flow-metering devices

ISO 10524-3, Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with

cylinder valves

ISO 10524-4, Pressure regulators for use with medical gases — Part 4: Low-pressure regulators

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices

ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices

ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects

ISO 14971:2007, Medical devices — Application of risk management to medical devices

ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen

ISO 15002, Flow-metering devices for connection to terminal units of medical gas pipeline systems

ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be

supplied

ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO 23328-1, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to

assess filtration performance

IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and

essential performance

IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential

performance — Collateral standard: Electromagnetic compatibility — Requirements and tests

IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential

performance — Collateral standard: Usability

IEC 62366, Medical devices — Application of usability engineering to medical devices

EN 556-1, Sterilization of medical devices — Requirements for medical devices to be designated

“STERILE” — Part 1: Requirements for terminally sterilized medical devices

ENV 737-6, Medical gas pipeline systems — Part 6: Dimensions and allocation of probes for terminal units for

compressed medical gases and vacuum
EN 13544-2, Respiratory therapy equipment — Part 2: Tubing and connectors

CGA V-5-2005, Diameter Index Safety System — Noninterchangeable Low Pressure Connections for Medical

Gas Applications
2 © ISO 2010 – All rights reserved
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ISO 27427:2010(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aerosol
suspension of particles in gas
NOTE 1 Particles can be liquid or solid.
NOTE 2 The gas can be the driving gas or ambient air.
3.2
aerosol output

amount of aerosol delivered to the patient by the nebulizing system for the given fill volume

3.3
aerosol output rate

amount of aerosol delivered to the patient by the nebulizing system per unit of time

3.4
breath-actuated nebulizing system
nebulizer triggered by a respiratory parameter
NOTE Examples of this classification are to be found in Annex G.
3.5
continuous nebulizing system

nebulizer in which aerosol is delivered continuously over multiple inhalation/exhalation breathing cycles or

over long periods
3.6
electrically-powered nebulizer
nebulizer that operates by means of electrical power

NOTE Electrically-powered nebulizer includes ultrasonic, vibrating mesh and capillary-type devices

3.7
gas-powered nebulizer
nebulizer in which the aerosol is generated by compressed gas
3.8
liquid container
part of the nebulizer that contains the liquid for nebulization
3.9
manually-powered nebulizer
nebulizer that operates by means of human power
3.10
mass median aerodynamic diameter
MMAD

maximum particle size at which 50 % of the aerosol output is delivered to the respiratory tract

3.11
maximum fill volume

maximum volume of liquid, expressed in millilitres, in the liquid container when the nebulizer is filled to its

maximum filling level
© ISO 2010 – All rights reserved 3
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ISO 27427:2010(E)
3.12
nebulizer

device that converts a liquid to an aerosol of a controlled particulate size range

3.13
nebulizing system

device, including the nebulizer and all other components, required to make the aerosol available for

inhalation
3.14
respirable fraction
amount of drug (in micrograms) contained in particles with sizes less than 5 µm
3.15
respirable range
aerosol particle sizes from 0,5 µm to 5,0 µm
3.16
validation

confirmation through the provision of objective evidence that the requirements for a specific intended use or

application have been fulfilled
NOTE 1 The term “validated” is used to designate the corresponding status.
NOTE 2 The use conditions for validation can be real or simulated.
4 General requirements and requirements for test
4.1 Risk management
4.1.1 General

Nebulizing systems and nebulizers shall, when transported, stored, installed, operated in normal use and

maintained according to the instructions of the manufacturer, cause no safety hazard which could be

reasonably foreseen using risk management procedures in accordance with ISO 14971 and which is

connected with their intended application, in normal and in single fault condition.

NOTE A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous

situations might remain undetected over a period of time and, as a consequence, might lead to an unacceptable risk. In

that case, a subsequent detected fault condition needs to be considered as a single fault condition. Specific risk control

measures need to be determined within the risk management process to deal with such situations.

4.1.2 Clinical evaluation

If applicable, a clinical evaluation shall be performed and documented in the risk management file.

Check compliance by inspection of the risk management file.
4.2 *Test methods and alternatives
4.2.1 Test methods for aerosol output, aerosol output rate and particle sizing

The type-test methods for aerosol output, aerosol output rate and particle sizing are specified in Annexes C

and D.
4 © ISO 2010 – All rights reserved
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ISO 27427:2010(E)
4.2.2 Alternative test methods

The manufacturer may use type-test methods for aerosol output, aerosol output rate and particle sizing

different from those specified in Annexes C and D.

Alternative test methods shall be validated against the test methods in Annexes C and D to demonstrate

equivalency.

Demonstration of equivalency shall be included in the technical documentation of the manufacturer.

Evidence shall be provided upon request, e.g. to regulatory authorities.
4.3 Electrical safety

A nebulizing system that utilizes electrical power shall meet the requirements given in IEC 60601-1, in

addition to the requirements given in this International Standard.
Check compliance by application of the tests of IEC 60601-1.
4.4 Mechanical safety
Nebulizing systems shall comply with Clause 9 of IEC 60601-1:2005.
Check compliance by inspection.
4.5 Pneumatic safety

If it is declared by the manufacturer that a nebulizer is intended to be connected directly to a pipeline system

complying with ISO 7396-1 or a pressure regulator complying with ISO 10524-1 or ISO 10524-3, the

nebulizer shall meet the requirements of this International Standard for a pneumatic power supply having a

range of 280 kPa (2,8 bar) to 600 kPa (6 bar) and shall not cause a safety hazard under single fault conditions

of the medical gas supply, i.e. up to 1 MPa (10 bar) inlet pressure.
4.6 Protection against inadvertent adjustments

Means of protection against inadvertent adjustment of controls which can create a hazardous output shall be

provided.

NOTE Mechanical control techniques, such as locks, shielding, friction-loading and detents, are considered suitable.

Pressure-sensitive finger pads, capacitive finger switches and microprocessor-oriented “soft” controls or a specific

sequence of key or switch operations are also considered suitable.
Check compliance by visual inspection following the instructions for use.
4.7 Protection against infection

All parts of the nebulizing system subject to contamination by exhaled gases and intended to be reused by

different patients shall be disinfectable or sterilizable.
4.8 Usability

The manufacturer shall address, in a usability engineering process, the risk resulting from poor usability

according to IEC 60601-1-6 and IEC 62366.
Check compliance by inspection of the usability engineering file.
© ISO 2010 – All rights reserved 5
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ISO 27427:2010(E)
5 Marking and instructions for use
5.1 Marking
5.1.1 General

a) All flow-direction-sensitive components, breathing attachments or parts (e.g. facemask or mouthpiece

one-way valve, etc.) shall be either clearly and durably marked with an arrow showing the direction of gas

flow if operator-detachable, manufactured to prevent incorrect assembly or permanently attached.

b) If gas-specific, the inlet and outlet shall be identified by clear and durable marking.

5.1.2 Marking of devices, labels and packaging
Devices, labels and/or packaging shall contain the following:

a) the name or trademark and address of the manufacturer; for devices imported into the European Union,

the following applies: the name and address of the person responsible and of the authorized

representative of the manufacturer established within the European Community shall be provided with the

device or with the accompanying document;
b) device identification and content information;
c) an indication that the device is sterile, if appropriate;

d) for single-use devices, the manufacturer shall disclose the risks associated with reusing in the instructions

for use or upon request;

NOTE The manufacturer's attention is drawn to the regulatory provision requiring that the indication of single use

must be consistent across the Community.

e) device packaging and/or labelling to differentiate between the same or similar products, both sterile and

non-sterile, placed on the market by the same manufacturer;
f) the batch code, if appropriate;
g) the expiry date, if the device is sensitive to storage or shelf-life;
h) an indication that the device is for single use, if appropriate;
i) any special storage and/or handling conditions;

j) any warning and/or precaution to take, e.g. compatibility with the use of oxygen mixtures and compatibility

between oxygen and administered drugs;
k) the year of manufacture, except for those covered by f);

l) the recommended method(s) of cleaning and disinfection or sterilization, if appropriate;

m) for packages containing parts made of antistatic or conductive material, the word “ANTISTATIC” or

“CONDUCTIVE”, if appropriate;

n) the liquid container of the nebulizer shall be marked at the maximum fill volume level; this shall be

defined in the instruction for use [see 5.3.2 a) i)];

o) if phthalates are incorporated in parts of the medical devices coming directly or indirectly into contact with

the patient, the device shall be labelled accordingly. If such devices are used for the treatment of children

or of pregnant or nursing women, the residual risk has to be identified and stated in the instructions for

use.
6 © ISO 2010 – All rights reserved
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ISO 27427:2010(E)
5.1.3 Marking of controls and instruments
a) Gas supply pressures shall be displayed in kilopascals.
b) Pressures in breathing systems shall be displayed in pascals ×100.
c) Flows shall be displayed in litres per minute.

d) If supplied, air entrainment/oxygen dilution valves shall be marked in % O (oxygen).

5.2 Symbols
ISO 7000, ISO 15223 and Clause 6.4 of IEC 60601-1:2005 apply.
5.3 Instructions for use
5.3.1 *General

Nebulizers, nebulizing systems and parts thereof shall be accompanied by instructions for use which shall

include the information given in 5.3.2.
5.3.2 Disclosures

a) The purpose and the intended use of the device and parts thereof, including the power and/or control

devices.

b) The types of liquid (e.g. solution and/or suspension and/or emulsion) the device is designed to nebulize.

c) The distribution of particles, in terms of mass, within each of the following size ranges: % > 5 µm, % 2 µm

to 5 µm, % < 2 µm.

d) The mass median aerodynamic diameter (MMAD) as derived from the particle size distribution curve

(see Figure D.2).
e) The respirable fraction performance of the nebulizer.

f) The aerosol output and aerosol output rate at the maximum fill volume under test conditions defined

in C.1.1. In addition, for gas-powered nebulizers, the aerosol output and aerosol output rate at the

minimum and maximum driving gas flows with the corresponding pressures under test conditions defined

in C.1 and C.2.

g) Disclosure of the residual volume (in millilitres), when tested in accordance with the test method

described in Annex C.
h) For a breath-actuated nebulizer, the method and relevant sensitivity.

i) A statement that using a solution, suspension or emulsion different from that recommended by the

manufacturer, in particular for a suspension and/or high-viscosity solution, may alter the particle size

distribution curve, the mass median aerodynamic diameter, aerosol output and/or aerosol output

rate, which may be different from those disclosed by the manufacturer.
j) The recommended maximum fill volume.

k) The maximum A-weighted sound pressure level, as derived from the test method in 9.6.2.1 of

IEC 60601-1:2005.

l) If hand-held, an indication of the spatial orientation (e.g. vertical, horizontal, inverted) at which the

nebulizer continues to function as intended.
© ISO 2010 – All rights reserved 7
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ISO 27427:2010(E)

m) Whether the nebulizer is suitable for use in anaesthetic breathing systems or lung ventilator breathing

systems.

n) If applicable, the maximum temperature above ambient reached in the nebulizing chamber in all operating

conditions.
o) Interdependence of controls, if applicable.

p) The pressure and flow characteristics of any gas power outlet under the worst-case conditions stated by

the manufacturer.
q) The specified range of flows required from any gas source, if applicable.

r) A statement of the composition and dryness specification for all gases to be supplied to the nebulizer, if

relevant.

s) Details of non-return valves and pressure-relief valves and their characteristics, if fitted.

t) The lifetime of the reusable parts.

u) If the device is used in the treatment of children or pregnant or nursing women, the residual risk of using

phthalates incorporated into the devices that come directly or indirectly into contact with the patient has to

be identified and stated in the instructions for use.

v) The instructions for use shall contain the date of issue or the latest revision.

Check compliance by inspection.
5.3.3 Materials compatibility

a) A statement that the materials used for the components may not be compatible with solutions,

suspensions or emulsions different from those recommended by the manufacturer, in particular for

suspensions and high-viscosity solutio
...

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