SIST EN ISO 20072:2011
(Main)Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
This International Standard applies to the design, labelling, instructions for use and testing requirements for hand-held single- and multi-use aerosol drug delivery devices (ADDDs) intended to deliver a metered or premetered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites). This International Standard applies to both refillable and disposable devices intended for personal use. This International Standard is intended for device design verification and not for drug product quality assessment. The objective of this International Standard is to verify, by laboratory (in-vitro) testing, that the ADDD design consistently meets the manufacturer's design specification by satisfying a device functionality profile and system verification test both of which are determined from a risk assessment and evaluated in accordance with the instructions for use. This International Standard excludes continuous or semi-continuous aerosolization devices covered in ISO 27427, aerosolization devices which do not emit active pharmaceutical ingredient (API), general purpose aerosolization devices (for use with ventilators) and atomizers. This International Standard does not apply to manufacturers of single parts or components of the ADDDs [e.g. (spray) pumps, valves, containers, etc.].
Inhalationsgeräte zur gezielten medizinischen Anwendung - Anforderungen und Prüfverfahren (ISO 20072:2009)
Die vorliegende Internationale Norm gilt für die Anforderungen an Ausführung, Kennzeichnung, Gebrauchsanweisung
und Prüfung von Hand gehaltenen Inhalationsgeräten (ADDD) für den Einmal- und den
Mehrfachgebrauch, die dazu dienen, ein dosiertes oder vordosiertes Arzneimittel in aerosolierter Form in den
Atemtrakt (einschließlich Nase, Mund, Luftröhre, Bronchien und Alveolen) eines Menschen oder über diesen
zu verabreichen. Diese Internationale Norm gilt sowohl für nachfüllbare als auch Einmalgeräte für den
Eigengebrauch.
Diese Internationale Norm ist für die Ausführungsverifizierung der Geräte, nicht jedoch die Qualitätsbeurteilung
von Arzneimittelprodukten vorgesehen. Das Ziel dieser Internationalen Norm besteht darin, durch
Labor-(In-vitro-)prüfung zu verifizieren, dass die Ausführung des Inhalationsgeräts dauerhaft die Ausführungsspezifikation
des Herstellers erfüllt, indem sie sowohl ein Geräte-Funktionsprofil als auch eine Systemverifizierungsprüfung
besteht, die beide auf einer Risikobeurteilung beruhen und in Übereinstimmung mit der
Gebrauchsanweisung bewertet werden.
Die vorliegende Internationale Norm schließt Folgendes aus: Die von ISO 27427 abgedeckten kontinuierlich
und halbkontinuierlich arbeitenden Aerosolvernebler sowie Aerosolvernebler, die keine arzneilich wirksamen
Bestandteile (API, en: active pharmaceutical ingredients) abgeben, Universal-Vernebler (für die Anwendung
mit Gebläsen) und Zerstäuber.
Diese Internationale Norm gilt nicht für die Hersteller von Einzelteilen der Inhalationsgeräte [z. B.
(Sprüh-)Pumpen, Ventile, Behälter usw.].
ANMERKUNG In einigen Fällen fällt ein Gerät möglicherweise in den Anwendungsbereich sowohl dieser
Vérification de la conception d'un dispositif d'administration de médicament sous forme d'aérosol - Exigences et méthodes d'essai (ISO 20072:2009)
L'ISO 20072:2009 s'applique aux exigences de conception, d'étiquetage, de notice d'utilisation et d'essai relatives aux dispositifs d'administration de médicament sous forme d'aérosol ou aérosols-doseurs (ADDD) utilisés une ou plusieurs fois et tenus à la main, destinés à l'administration de médicaments sous forme d'aérosols dosés ou prédosés au système respiratoire humain ou par son intermédiaire (incluant les voies nasale, orale, trachéale, bronchiale et alvéolaire). La présente Norme internationale s'applique aux dispositifs non réutilisables et rechargeables destinés à un usage personnel.
L'ISO 20072:2009 est destinée à la vérification de la conception du dispositif et non pas à l'évaluation de la qualité du médicament. L'objectif de la présente Norme internationale est de vérifier, par des essais (in vitro) de laboratoire, que la conception d'un ADDD satisfait invariablement aux spécifications de conception du fabricant en se conformant au profil de performance et à l'essai de vérification du système, lesquels sont déterminés à partir d'une appréciation du risque et évalués conformément à la notice d'utilisation.
Inhalatorji za namensko uporabo v medicini - Zahteve in preskusne metode (ISO 20072:2009)
Ta mednarodni standard velja za načrtovanje, označevanje, navodila za uporabo in zahteve za preskušanje za ročne inhalatorje za namensko enkratno ali večkratno uporabo (ADDD), namenjene vnosu merjenega ali vnaprej izmerjenega zdravila v obliki aerosola s pomočjo človeške dihalne poti (vključno z nosnim, ustnim, sapniškim, bronhialnim in alveolarnim predelom). Ta mednarodni standard velja za naprave za ponovno polnjenje in naprave za enkratno uporabo, namenjene osebni uporabi. Ta mednarodni standard je namenjen preverjanju načrta naprave in ne ocenjevanju kakovosti zdravil. Cilj tega mednarodnega standarda je z laboratorijskim (in vitro) preskušanjem potrditi, da načrt ADDD dosledno izpolnjuje specifikacijo načrta proizvajalca tako, da se zadosti profilu funkcionalnosti naprave in preskusu preverjanja sistema, pri čemer je oboje navedeno določeno iz ocene tveganja ter ocenjeno v skladu z navodili za uporabo. Ta mednarodni standard izključuje naprave za zvezno in nezvezno razprševanje, zajete v ISO 27478, naprave za razprševanje, ki ne oddajajo aktivne farmacevtske sestavine (API), splošne naprave za razprševanje (za uporabo z ventilatorjem) in atomizatorje. Ta mednarodni standard ne velja za proizvajalce posamičnih delov ali komponent ADDD [npr. (pršilne) pumpice, ventile, posodice itd.].
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20072:2011
01-februar-2011
Inhalatorji za namensko uporabo v medicini - Zahteve in preskusne metode (ISO
20072:2009)
Aerosol drug delivery device design verification - Requirements and test methods (ISO
20072:2009)
Inhalationsgeräte zur gezielten medizinischen Anwendung - Anforderungen und
Prüfverfahren (ISO 20072:2009)
Vérification de la conception d'un dispositif d'administration de médicament sous forme
d'aérosol - Exigences et méthodes d'essai (ISO 20072:2009)
Ta slovenski standard je istoveten z: EN ISO 20072:2010
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 20072:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 20072:2011
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SIST EN ISO 20072:2011
EUROPEAN STANDARD
EN ISO 20072
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2010
ICS 11.040.10
English Version
Aerosol drug delivery device design verification - Requirements
and test methods (ISO 20072:2009)
Vérification de la conception d'un dispositif d'administration Ausführungsverifizierung von Inhalationsgeräten -
de médicament sous forme d'aérosol - Exigences et Anforderungen und Prüfverfahren (ISO 20072:2009)
méthodes d'essai (ISO 20072:2009)
This European Standard was approved by CEN on 2 October 2010.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20072:2010: E
worldwide for CEN national Members.
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SIST EN ISO 20072:2011
EN ISO 20072:2010 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
2
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SIST EN ISO 20072:2011
EN ISO 20072:2010 (E)
Foreword
The text of ISO 20072:2009 has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and intravascular catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 20072:2010 by Technical Committee CEN/TC 205
“Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by April 2011, and conflicting national standards shall be withdrawn at the
latest by April 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 20072:2009 has been approved by CEN as a EN ISO 20072:2010 without any modification.
3
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SIST EN ISO 20072:2011
EN ISO 20072:2010 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on Medical Devices
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
Medical Devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
5 and 8 (all parts) 1, 2 Design verification addresses
user interface, labelling, general
design requirements,
environmental and mechanical
testing
5 (all parts) and 6.4 3
5.6.2 4
5.6.2 through 5.6.7 5
5.2 6 Essential requirement 6.a
relating to the clinical evaluation
is not specifically addressed in
the present standard.
5.1, parts h, i, j, l and 5.2 7
5.1, parts h, i, j, l and 5.2 8
5.1 part d and 5.6 9
5.1, 5.5, 6.4.2, 6.4.3, 6.4.4, 8.2 10
5.1, part k, m, n and 5.6.8 12
8 (all parts) 13 The parts of ER 13.3.a) relating
to the address of manufacturer
and to the authorized
representative are not
addressed.
ERs 13.3.f) and 13.6.h) relating
to single-use are not addressed.
ER 13.6.q) is not addressed.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
4
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SIST EN ISO 20072:2011
INTERNATIONAL ISO
STANDARD 20072
First edition
2009-08-01
Aerosol drug delivery device design
verification — Requirements and test
methods
Vérification de la conception d'un dispositif d'administration de
médicament sous forme d'aérosol — Exigences et méthodes d'essai
Reference number
ISO 20072:2009(E)
©
ISO 2009
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SIST EN ISO 20072:2011
ISO 20072:2009(E)
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ii © ISO 2009 – All rights reserved
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SIST EN ISO 20072:2011
ISO 20072:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Symbols and abbreviated terms .6
5 Requirements.7
5.1 General.7
5.2 Risk assessment requirements.8
5.3 Device functionality profile.8
5.4 System verification test .8
5.5 Uncertainty of measurements and conformance with specification.9
5.6 Test requirements.9
6 Test methods.11
6.1 General.11
6.2 Test procedures.12
6.3 Test conditions .16
6.4 Test evaluations.17
7 Test report .19
8 Information supplied by the manufacturer .19
8.1 General.19
8.2 Marking .19
8.3 Instructions for use .20
Annex A (informative) Rationale for requirements .22
Annex B (informative) Further guidance and clarification of the device functionality profile .24
Annex C (informative) Rationale for test methods.26
Annex D (informative) Two-sided tolerance limit factors (k).29
Annex E (informative) Alternative acceptance criteria for the device functionality profile
evaluation .35
Bibliography .42
© ISO 2009 – All rights reserved iii
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SIST EN ISO 20072:2011
ISO 20072:2009(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 20072 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters.
iv © ISO 2009 – All rights reserved
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SIST EN ISO 20072:2011
ISO 20072:2009(E)
Introduction
This International Standard applies to hand-held aerosol drug delivery devices (ADDD) intended to administer
medication to humans. To avoid unnecessarily restricting innovation, given the broad variation in device
designs, this International Standard addresses the more general design/labelling requirements rather than
specific physical and prescriptive design requirements. However, this International Standard does require the
elaboration of a device functionality profile (DFP) specific to the ADDD in question. This International Standard
also addresses ADDD design requirements from both the user interface and safety perspectives.
An ADDD is used as part of a system consisting of the ADDD, the container, the medication and the labelling,
including the instructions for use. Therefore, design verification of the ADDD includes a final system
verification test conducted in accordance with the instructions for use.
From a regulatory perspective, the ADDD system may be reviewed and approved as part of a drug product
(combination of ADDD and medication) or as a device by itself. For the purposes of this International
Standard, such regulatory distinctions do not alter the intent of the design verification process described
herein. As an example, in the European Union (EU), if an ADDD is placed on the market in such a way that
the ADDD and the medication form a single integral product (i.e. the system) that is intended exclusively for
use in the given combination and which is not refillable, that single product shall be governed by Directive
2001/83/EEC. However, the relevant essential requirements of Annex I of the Medical Device Directive
(93/42/EEC) shall apply as far as safety and performance-related ADDD features are concerned, which is the
specific objective of this design verification standard.
Regardless of the distinctions (“drug” or “device,” pre-filled or refillable), it is recognised that ADDD design
verification is an important component of the overall validation process. Moreover, design verification is
iterative, to be conducted at various phases throughout the ADDD’s development and subsequent ADDD
post-approval modifications. In all instances, design verification is conducted using the phase-appropriate
instructions for use. It is understood that in the early phases of ADDD development an appropriate subset of
the requirements contained herein might apply, but that all of the requirements will be satisfied as part of the
final design verification exercise. Furthermore, design verification should be considered a minimum
requirement for the safe and effective use of the ADDD, and in many instances additional testing may be
appropriate as indicated by a risk assessment that shall also be conducted.
This International Standard introduces the requirement for developers and/or manufacturers to create a device
functionality profile (DFP) for a given ADDD based on the ISO Standard for device risk assessment (as a part
of ISO 14971). The device functionality profile defines the parameters and tolerance intervals used to verify
the ADDD's ability to meet the manufacturer's design specifications during in-use conditions and following
environmental and electromechanical extreme use conditions. This International Standard also includes a
system verification test conducted at standard atmosphere and nominal flow rate as a simple bridge between
the device design and the patient interface.
The purpose of this International Standard is to ensure a method and guide for independent testing of the
repeatability and reproducibility of ADDD functionality that verifies compliance with its design specification.
The design verification process may include use of applicable regulatory agency requirements and/or test
methods. The sampling plans for this International Standard are intended to verify the design at a high
confidence level. They do not replace the more general manufacturing quality systems, including lot release,
which appear in standards on quality systems (e.g. the ISO 9000 series or ISO 13485).
Figure 1 illustrates the process this International Standard advises to use in order to assess and verify
whether a design meets the determined DFP.
© ISO 2009 – All rights reserved v
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SIST EN ISO 20072:2011
ISO 20072:2009(E)
Figure 1 — ADDD design verification process
This International Standard specifically addresses the most basic elements regarding the safe and effective
use of ADDD in humans. It does not define the pharmaceutical or clinical performance of an ADDD. Any
labelling indicating ADDD use to deliver medication to specific regions of the respiratory tract falls under the
authority of national governments or regional agencies regulating the manufacture and marketing of medical
devices and pharmaceutical products. In some countries national regulations exist, and their requirements can
supersede or complement this International Standard.
For a given manufacturer, existing marketed products and those currently under development might not fulfil
some of the requirements. However, manufacturers should comply with this International Standard when
improving the functional design of existing ADDDs or developing new ADDDs to obtain an even higher level of
quality.
Annex A describes the reasoning for establishing the various requirements in this International Standard.
vi © ISO 2009 – All rights reserved
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SIST EN ISO 20072:2011
INTERNATIONAL STANDARD ISO 20072:2009(E)
Aerosol drug delivery device design verification —
Requirements and test methods
1 Scope
This International Standard applies to the design, labelling, instructions for use and testing requirements for
hand-held single- and multi-use aerosol drug delivery devices (ADDDs) intended to deliver a metered or pre-
metered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal,
bronchial and alveolar sites). This International Standard applies to both refillable and disposable devices
intended for personal use.
This International Standard is intended for device design verification and not for drug product quality
assessment. The objective of this International Standard is to verify, by laboratory (in-vitro) testing, that the
ADDD design consistently meets the manufacturer's design specification by satisfying a device functionality
profile and system verification test both of which are determined from a risk assessment and evaluated in
accordance with the instructions for use.
This International Standard excludes continuous or semi-continuous aerosolization devices covered in
ISO 27427, aerosolization devices which do not emit active pharmaceutical ingredient (API), general purpose
aerosolization devices (for use with ventilators) and atomizers.
This International Standard does not apply to manufacturers of single parts or components of the ADDDs [e.g.
(spray) pumps, valves, containers, etc.].
NOTE There might be times when a device falls under the scope of this International Standard and that of
ISO 27427. The committee envisions that the intended use of the product and the risk assessment of the device will derive
which International Standard the manufacturer chooses for design verification of the ADDD. This International Standard
outlines the process by which ADDD design verification is to be performed in conjunction with a risk-based device
functionality profile of the ADDD with either the medication, a placebo or a representative medication. ISO 27427 outlines
the process by which the characterization of the aerodynamic aerosol performance of a nebulizing system for use with a
non-specific class of active pharmaceutical ingredient(s) is made.
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 14971:2007, Medical devices — Application of risk management to medical devices
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
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 (all parts), Sterilization of health care products — Radiation
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
© ISO 2009 – All rights reserved 1
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SIST EN ISO 20072:2011
ISO 20072:2009(E)
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
IEC 60068-2-27, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
IEC 60068-2-30:2005, Environmental testing — Part 2-30: Tests — Test Db: Damp heat, cyclic (12 h + 12 h
cycle)
IEC 60068-2-32, Environmental testing — Part 2: Tests. Test Ed: Free fall
IEC 60068-2-64, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and
guidance
IEC 60601-1, 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 60601-1-8, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential
performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
IEC 60721-3-7, Classification of environmental conditions — Part 3-7: Classification of groups of
environmental parameters and their severities — Portable and non-stationary use
IEC 61000-4-2, Electromagnetic compatibility (EMC) — Part 4-2: Testing and measurement techniques —
Electrostatic discharge immunity test
IEC 61000-4-3, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement techniques —
Radiated, radio-frequency, electromagnetic field immunity test
IEC 62304, Medical device software — Software life-cycle processes
IEC 62366, Medical devices — Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accessory
add-on device (specifically referenced in the ADDD instructions for use) that may be used in conjunction with
an ADDD to enable or enhance its performance
EXAMPLE Spacers, holding chambers, actuation counters, content indicators, etc.
3.2
active pharmaceutical ingredient
API
molecule(s) responsible for producing the intended therapeutic action
3.3
actuation
operation of the ADDD to release medication that will be aerosolized
NOTE The actuation can consist of the loading and release of the medication or only the release of the medication.
2 © ISO 2009 – All rights reserved
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SIST EN ISO 20072:2011
ISO 20072:2009(E)
3.4
actuation counter
dose counter
mechanism numerically counting down the number of actuations
NOTE The actuation counter may either be an accessory or integrated with the ADDD.
3.5
ADDD system
integrated system comprised of the ADDD, patient interface and the medication (i.e. a combination product)
3.6
aerosol
suspension of particles in gas
[ISO 27427:2009, definition 3.1]
NOTE 1 Particles can be liquid and/or solid.
NOTE 2 The gas can be the driving gas or ambient air.
3.7
aerosol drug delivery device
ADDD
device for the delivery of medication in the form of an aerosol
3.8
claimed lifetime
time period, and/or number of actuations, stated by the ADDD manufacturer within which the device
functionality profile of the ADDD will remain within the design specification comprising the timeframe within
which the patient uses the ADDD
NOTE Claimed lifetime is not necessarily the same as the shelf life of the ADDD.
3.9
claimed lifetime testing
performance evaluation simulating the claimed lifetime stated by the ADDD manufacturer within which the
device functionality profile of the ADDD will remain within the design specification
3.10
combination product
ADDD used with a specific medication
3.11
content indicator
visual indicator showing the amount of medication remaining in the ADDD
NOTE A content indicator can be either an accessory or integrated with the ADDD.
3.12
design verification
confirmation by examination and provision of objective evidence that specified design requirements have been
fulfilled
3.13
device functionality profile
DFP
parameters and tolerance intervals used to assess whether the ADDD meets the manufacturer's design
specification
NOTE It must be possible to evaluate the properties using laboratory (in vitro) testing.
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SIST EN ISO 20072:2011
ISO 20072:2009(E)
3.14
dose
mass of API prescribed to elicit a therapeutic response
NOTE 1 More than one actuation of the ADDD may be required to achieve the specified dose.
NOTE 2 For certain APIs, mass can be replaced by the use of biological equivalent units.
3.15
emitted mass
EM
mass of medication per actuation emitted from the ADDD mouthpiece at the patient interface
3.16
excipient
any substance included with the active pharmaceutical ingredient(s) of the medication
3.17
fixed-dose ADDD
ADDD where the amount of medication delivered per actuation (mass or bioequivalent units), either pre-
metered or from a reservoir, is pre-set by the manufacturer
3.18
hand-held
capable of being held in the hand and moved to the patient's mouth or nose for use
3.19
harm
physical injury or damage to the health of people, or damage to property or the environment
[ISO 14971:2007, definition 2.2]
3.20
holding chamber
accessory comprising a volume between the ADDD and the patient's mouth or nose and designed to
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Inhalatorji za namensko uporabo v medicini - Zahteve in preskusne metode (ISO 20072:2009)Inhalationsgeräte zur gezielten medizinischen Anwendung - Anforderungen und Prüfverfahren (ISO 20072:2009)Vérification de la conception d'un dispositif d'administration de médicament sous forme d'aérosol - Exigences et méthodes d'essai (ISO 20072:2009)Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:FprEN ISO 20072kSIST FprEN ISO 20072:2010en,fr,de01-junij-2010kSIST FprEN ISO 20072:2010SLOVENSKI
STANDARD
kSIST FprEN ISO 20072:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 20072
April 2010 ICS 11.040.10 English Version
Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
Vérification de la conception d'un dispositif d'administration de médicament sous forme d'aérosol - Exigences et méthodes d'essai (ISO 20072:2009)
Ausführungsverifizierung von Inhalationsgeräten - Anforderungen und Prüfverfahren (ISO 20072:2009) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 205.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN ISO 20072:2010: EkSIST FprEN ISO 20072:2010
FprEN ISO 20072:2010 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices .4 kSIST FprEN ISO 20072:2010
FprEN ISO 20072:2010 (E) 3 Foreword The text of ISO 20072:2009 has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and intravascular catheters” of the International Organization for Standardization (ISO) and has been taken over as FprEN ISO 20072:2010 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 20072:2009 has been approved by CEN as a FprEN ISO 20072:2010 without any modification. kSIST FprEN ISO 20072:2010
FprEN ISO 20072:2010 (E) 4 Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on Medical Devices
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on Medical Devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 5 and 8 (all parts) 1, 2 Design verification addresses user interface, labelling, general design requirements, environmental and mechanical testing 5 (all parts) and 6.4 3
5.6.2 4
5.6.2 through 5.6.7 5
5.2 6 Essential requirement 6.a relating to the clinical evaluation is not specifically addressed in the present standard. 5.1, parts h, i, j, l and 5.2 7
5.1, parts h, i, j, l and 5.2 8
5.1 part d and 5.6 9
5.1, 5.5, 6.4.2, 6.4.3, 6.4.4, 8.2 10
5.1, part k, m, n and 5.6.8 12
8 (all parts) 13 The parts of ER 13.3.a) relating to the address of manufacturer and to the authorized representative are not addressed. ERs 13.3.f) and 13.6.h) relating to single-use are not addressed. ER 13.6.q) is not addressed. WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. kSIST FprEN ISO 20072:2010
Reference numberISO 20072:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO20072First edition2009-08-01Aerosol drug delivery device design verification — Requirements and test methods Vérification de la conception d'un dispositif d'administration de médicament sous forme d'aérosol — Exigences et méthodes d'essai
kSIST FprEN ISO 20072:2010
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ii © ISO 2009 – All rights reserved
kSIST FprEN ISO 20072:2010
ISO 20072:2009(E) © ISO 2009 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Symbols and abbreviated terms.6 5 Requirements.7 5.1 General.7 5.2 Risk assessment requirements.8 5.3 Device functionality profile.8 5.4 System verification test.8 5.5 Uncertainty of measurements and conformance with specification.9 5.6 Test requirements.9 6 Test methods.11 6.1 General.11 6.2 Test procedures.12 6.3 Test conditions.16 6.4 Test evaluations.17 7 Test report.19 8 Information supplied by the manufacturer.19 8.1 General.19 8.2 Marking.19 8.3 Instructions for use.20 Annex A (informative)
Rationale for requirements.22 Annex B (informative)
Further guidance and clarification of the device functionality profile.24 Annex C (informative)
Rationale for test methods.26 Annex D (informative)
Two-sided tolerance limit factors (k).29 Annex E (informative)
Alternative acceptance criteria for the device functionality profile evaluation.35 Bibliography.42
kSIST FprEN ISO 20072:2010
ISO 20072:2009(E) iv © ISO 2009 – All rights reserved 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 20072 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters. kSIST FprEN ISO 20072:2010
ISO 20072:2009(E) © ISO 2009 – All rights reserved vIntroduction This International Standard applies to hand-held aerosol drug delivery devices (ADDD) intended to administer medication to humans. To avoid unnecessarily restricting innovation, given the broad variation in device designs, this International Standard addresses the more general design/labelling requirements rather than specific physical and prescriptive design requirements. However, this International Standard does require the elaboration of a device functionality profile (DFP) specific to the ADDD in question. This International Standard also addresses ADDD design requirements from both the user interface and safety perspectives. An ADDD is used as part of a system consisting of the ADDD, the container, the medication and the labelling, including the instructions for use. Therefore, design verification of the ADDD includes a final system verification test conducted in accordance with the instructions for use. From a regulatory perspective, the ADDD system may be reviewed and approved as part of a drug product (combination of ADDD and medication) or as a device by itself. For the purposes of this International Standard, such regulatory distinctions do not alter the intent of the design verification process described herein. As an example, in the European Union (EU), if an ADDD is placed on the market in such a way that the ADDD and the medication form a single integral product (i.e. the system) that is intended exclusively for use in the given combination and which is not refillable, that single product shall be governed by Directive 2001/83/EEC. However, the relevant essential requirements of Annex I of the Medical Device Directive (93/42/EEC) shall apply as far as safety and performance-related ADDD features are concerned, which is the specific objective of this design verification standard. Regardless of the distinctions (“drug” or “device,” pre-filled or refillable), it is recognised that ADDD design verification is an important component of the overall validation process. Moreover, design verification is iterative, to be conducted at various phases throughout the ADDD’s development and subsequent ADDD post-approval modifications. In all instances, design verification is conducted using the phase-appropriate instructions for use. It is understood that in the early phases of ADDD development an appropriate subset of the requirements contained herein might apply, but that all of the requirements will be satisfied as part of the final design verification exercise. Furthermore, design verification should be considered a minimum requirement for the safe and effective use of the ADDD, and in many instances additional testing may be appropriate as indicated by a risk assessment that shall also be conducted. This International Standard introduces the requirement for developers and/or manufacturers to create a device functionality profile (DFP) for a given ADDD based on the ISO Standard for device risk assessment (as a part of ISO 14971). The device functionality profile defines the parameters and tolerance intervals used to verify the ADDD's ability to meet the manufacturer's design specifications during in-use conditions and following environmental and electromechanical extreme use conditions. This International Standard also includes a system verification test conducted at standard atmosphere and nominal flow rate as a simple bridge between the device design and the patient interface. The purpose of this International Standard is to ensure a method and guide for independent testing of the repeatability and reproducibility of ADDD functionality that verifies compliance with its design specification. The design verification process may include use of applicable regulatory agency requirements and/or test methods. The sampling plans for this International Standard are intended to verify the design at a high confidence level. They do not replace the more general manufacturing quality systems, including lot release, which appear in standards on quality systems (e.g. the ISO 9000 series or ISO 13485). Figure 1 illustrates the process this International Standard advises to use in order to assess and verify whether a design meets the determined DFP. kSIST FprEN ISO 20072:2010
ISO 20072:2009(E) vi © ISO 2009 – All rights reserved
Figure 1 — ADDD design verification process This International Standard specifically addresses the most basic elements regarding the safe and effective use of ADDD in humans. It does not define the pharmaceutical or clinical performance of an ADDD. Any labelling indicating ADDD use to deliver medication to specific regions of the respiratory tract falls under the authority of national governments or regional agencies regulating the manufacture and marketing of medical devices and pharmaceutical products. In some countries national regulations exist, and their requirements can supersede or complement this International Standard. For a given manufacturer, existing marketed products and those currently under development might not fulfil some of the requirements. However, manufacturers should comply with this International Standard when improving the functional design of existing ADDDs or developing new ADDDs to obtain an even higher level of quality. Annex A describes the reasoning for establishing the various requirements in this International Standard. kSIST FprEN ISO 20072:2010
INTERNATIONAL STANDARD ISO 20072:2009(E) © ISO 2009 – All rights reserved 1Aerosol drug delivery device design verification — Requirements and test methods 1 Scope This International Standard applies to the design, labelling, instructions for use and testing requirements for hand-held single- and multi-use aerosol drug delivery devices (ADDDs) intended to deliver a metered or pre-metered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites). This International Standard applies to both refillable and disposable devices intended for personal use. This International Standard is intended for device design verification and not for drug product quality assessment. The objective of this International Standard is to verify, by laboratory (in-vitro) testing, that the ADDD design consistently meets the manufacturer's design specification by satisfying a device functionality profile and system verification test both of which are determined from a risk assessment and evaluated in accordance with the instructions for use. This International Standard excludes continuous or semi-continuous aerosolization devices covered in ISO 27427, aerosolization devices which do not emit active pharmaceutical ingredient (API), general purpose aerosolization devices (for use with ventilators) and atomizers. This International Standard does not apply to manufacturers of single parts or components of the ADDDs [e.g. (spray) pumps, valves, containers, etc.]. NOTE There might be times when a device falls under the scope of this International Standard and that of ISO 27427. The committee envisions that the intended use of the product and the risk assessment of the device will derive which International Standard the manufacturer chooses for design verification of the ADDD. This International Standard outlines the process by which ADDD design verification is to be performed in conjunction with a risk-based device functionality profile of the ADDD with either the medication, a placebo or a representative medication. ISO 27427 outlines the process by which the characterization of the aerodynamic aerosol performance of a nebulizing system for use with a non-specific class of active pharmaceutical ingredient(s) is made. 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 14971:2007, Medical devices — Application of risk management to medical devices ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing 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 (all parts), Sterilization of health care products — Radiation ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements kSIST FprEN ISO 20072:2010
ISO 20072:2009(E) 2 © ISO 2009 – All rights reserved 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 IEC 60068-2-27, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock IEC 60068-2-30:2005, Environmental testing — Part 2-30: Tests — Test Db: Damp heat, cyclic (12 h + 12 h cycle) IEC 60068-2-32, Environmental testing — Part 2: Tests. Test Ed: Free fall IEC 60068-2-64, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and guidance IEC 60601-1, 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 60601-1-8, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60721-3-7, Classification of environmental conditions — Part 3-7: Classification of groups of environmental parameters and their severities — Portable and non-stationary use IEC 61000-4-2, Electromagnetic compatibility (EMC) — Part 4-2: Testing and measurement techniques — Electrostatic discharge immunity test IEC 61000-4-3, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement techniques — Radiated, radio-frequency, electromagnetic field immunity test IEC 62304, Medical device software — Software life-cycle processes IEC 62366, Medical devices — Application of usability engineering to medical devices 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 accessory add-on device (specifically referenced in the ADDD instructions for use) that may be used in conjunction with an ADDD to enable or enhance its performance EXAMPLE Spacers, holding chambers, actuation counters, content indicators, etc. 3.2 active pharmaceutical ingredient API molecule(s) responsible for producing the intended therapeutic action 3.3 actuation operation of the ADDD to release medication that will be aerosolized NOTE The actuation can consist of the loading and release of the medication or only the release of the medication. kSIST FprEN ISO 20072:2010
ISO 20072:2009(E) © ISO 2009 – All rights reserved 33.4 actuation counter dose counter mechanism numerically counting down the number of actuations NOTE The actuation counter may either be an accessory or integrated with the ADDD. 3.5 ADDD system integrated system comprised of the ADDD, patient interface and the medication (i.e. a combination product) 3.6 aerosol suspension of particles in gas [ISO 27427:2009, definition 3.1] NOTE 1 Particles can be liquid and/or solid. NOTE 2 The gas can be the driving gas or ambient air. 3.7 aerosol drug delivery device ADDD device for the delivery of medication in the form of an aerosol 3.8 claimed lifetime time period, and/or number of actuations, stated by the ADDD manufacturer within which the device functionality profile of the ADDD will remain within the design specification comprising the timeframe within which the patient uses the ADDD NOTE Claimed lifetime is not necessarily the same as the shelf life of the ADDD. 3.9 claimed lifetime testing performance evaluation simulating the claimed lifetime stated by the ADDD manufacturer within which the device functionality profile of the ADDD will remain within the design specification 3.10 combination product ADDD used with a specific medication 3.11 content indicator visual indicator showing the amount of medication remaining in the ADDD NOTE A content indicator can be either an accessory or integrated with the ADDD. 3.12 design verification confirmation by examination and provision of objective evidence that specified design requirements have been fulfilled 3.13 device functionality profile DFP parameters and tolerance intervals used to assess whether the ADDD meets the manufacturer's design specification NOTE It must be possible to evaluate the properties using laboratory (in vitro) testing. kSIST FprEN ISO 20072:2010
ISO 20072:2009(E) 4 © ISO 2009 – All rights reserved 3.14 dose mass of API prescribed to elicit a therapeutic response NOTE 1 More than one actuation of the ADDD may be required to achieve the specified dose.
NOTE 2 For certain APIs, mass can be replaced by the use of biological equivalent units. 3.15 emitted mass EM mass of medication per actuation emitted from the ADDD mouthpiece at the patient interface 3.16 excipient any substance included with the active pharmaceutical ingredient(s) of the medication 3.17 fixed-dose ADDD ADDD where the amount of medication delivered per actuation (mass or bioequivalent units), either pre-metered or from a reservoir, is pre-set by the manufacturer 3.18 hand-held capable of being held in the hand and moved to the patient's mouth or nose for use 3.19 harm physical injury or damage to the health of people, or damage to property or the environment [ISO 14971:2007, definition 2.2] 3.20 holding chamber accessory comprising a volume between the ADDD and the patient's mouth or nose and designed to contain the aerosol following an actuation NOTE A holding chamber has some means for retaining the aerosol after ADDD actuation has occurred and prior to the patient inhaling. 3.21 instructions for use directions provided by the manufacturer for the correct handling and operation of the ADDD 3.22 integral supply of medication manufacturer-sealed supply of medication contained by or provided to an ADDD EXAMPLE Reservoirs or blisters. 3.23 intended use application of the ADDD that is specified by the manufacturer in the instructions for use 3.24 in-use life time specified by the manufacturer that the medicinal product can be used after opening or after first use by the patient kSIST FprEN ISO 20072:2010
ISO 20072:2009(E) © ISO 2009 – All rights reserved 53.25 label text (printed or graphic) affixed to or present (etched) on or accompanying the ADDD 3.26 label claim amount of API (mass) marked on the label of the ADDD NOTE In some countries the label claim is the amount of API that is emitted from the ADDD mouthpiece. In other countries the label claim might be the amount of API that is metered by the ADDD, but not necessarily all emitted from the mouthpiece of the ADDD. 3.27 medication API(s) alone or API(s) formulated with excipients(s) 3.28 medicinal product the medication in the ADDD 3.29 nasal delivery administration of medication to or through the nose 3.30 nominal flow rate volumetric air flow rate through the ADDD which is described by the manufacturer as typical for the intended patient population 3.31 operator person (patient/user) using the ADDD 3.32 oral delivery administration of medication to or through the mouth 3.33 placebo dosage form that does not contain API 3.34 pre-filled ADDD in which the medication is inserted at manufacture and cannot be replenished by the patient 3.35 pre-metered defined amount of medication equal to one actuation placed during its manufacture into a package (blister, capsule) for u
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