EN ISO 20072:2013

Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)

ISO 20072:2009 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.
ISO 20072:2009 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.

Ausführungsverifizierung von Inhalationsgeräten - Anforderungen und Prüfverfahren (ISO 20072:2009)

Die vorliegende Internationale Norm gilt für die Anforderungen an Ausführung, Kennzeichnung, Gebrauchs-anweisung 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 Qualitäts-beurteilung von Arzneimittelprodukten vorgesehen. Das Ziel dieser Internationalen Norm besteht darin, durch Labor (In vitro )prüfung zu verifizieren, dass die Ausführung des Inhalationsgeräts dauerhaft die Ausführungs-spezifikation des Herstellers erfüllt, indem sie sowohl ein Geräte Funktionsprofil als auch eine System-verifizierungsprüfung 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 Internationalen Norm als auch von ISO 27427. Der Ausschuss geht davon aus, dass der Hersteller auf der Grundlage der bestimmungsgemäßen Anwendung des Produkts und der Risikobeurteilung des Gerätes ableiten kann, welche der Internationalen Normen für die Ausführungsverifizierung des Inhalationsgeräts anzuwenden ist. In dieser Internationalen Norm wird der Prozess beschrieben, nach dem die Ausführungsverifizierung des Inhalationsgeräts durchzuführen ist, verbunden mit einem risikobasierten Geräte Funktionsprofil des Inhalationsgeräts, bei dem entweder das Arzneimittel, ein Placebo oder ein repräsentatives Arzneimittel zum Einsatz kommt. In ISO 27427 wird der Prozess beschrieben, nach dem die Charakterisierung der aerodynamischen Aerosolleistung eines Verneblersystems zur Anwendung mit einer unspezifischen Klasse arzneilich wirksamer Bestandteile durchgeführt wird.

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 se uporablja za zasnovo, označevanje, navodila za uporabo in preskusne zahteve za ročne inhalatorje (ADDD) za enkratno ali večkratno uporabo, ki so namenjeni za dostavo odmerjenega ali predhodno odmerjenega zdravila v obliki aerosola v dihalni trakt človeka ali čez dihalni trakt človeka (vključno z nazalnimi, oralnimi, trahealnimi, bronhialnimi in alveolarnimi mesti). Ta mednarodni standard se uporablja za pripomočke za osebno uporabo, ki jih je mogoče ponovno napolniti, in za pripomočke, ki se po uporabi zavržejo. Ta mednarodni standard je namenjen za preverjanje zasnove pripomočka in ne za oceno kakovosti zdravila. Cilj tega mednarodnega standarda je z laboratorijskimi (in-vitro) preskusi preveriti, da je zasnova inhalatorjev dosledno v skladu s specifikacijo proizvajalca,tako da upošteva profil funkcionalnosti pripomočka in preskus preverjanja sistema, pri čemer se oboje določi na podlagi ocene tveganja in oceni v skladu z navodili za uporabo. Ta mednarodni standard izključuje kontinuirane ali polkontinuirane pripomočke za aerosolizacijo, ki so zajeti v standardu ISO 27427, pripomočke za aerosolizacijo, ki ne oddajajo aktivne farmacevtske sestavine (API), pripomočke za aerosolizacijo za splošne namene (za uporabo z respiratornimi pripomočki) in razprševalce. Ta mednarodni standard se ne uporablja za proizvajalce posameznih delov ali sestavnih delov inhalatorjev [npr. (pršilnih) črpalk, valjev, posod itd.].

General Information

• Status: Published
• Publication Date: 05-Feb-2013
• Withdrawal Date: 30-Aug-2013
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 06-Feb-2013
• Completion Date: 06-Feb-2013
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 20072:2013 - Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)

Relations

• Replaces: EN ISO 20072:2010 - Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
• Effective Date: 13-Feb-2013

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2013
1DGRPHãþD
SIST EN ISO 20072:2011
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)
Ausführungsverifizierung von Inhalationsgeräten - 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 20072:2013
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 20072
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2013
ICS 11.040.10 Supersedes EN ISO 20072:2010
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 8 January 2013.

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-CENELEC 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-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20072:2013: E
worldwide for CEN national Members.

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

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 20072:2013 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 August 2013, and conflicting national standards shall be withdrawn at
the latest by August 2013.
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 supersedes EN ISO 20072:2010.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 20072:2009 has been approved by CEN as EN ISO 20072:2013 without any modification.
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)/subclause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
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, parts 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.
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
ISO 20072:2009(E)
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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 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 sub
...