EN ISO 20072:2010

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, 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

• Status: Withdrawn
• Publication Date: 26-Oct-2010
• Withdrawal Date: 05-Feb-2013
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• 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 20072:2011 - Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)

Relations

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

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,
...