NF EN ISO 20072

NF EN ISO 20072

January 2011
Standard Cancelled

Aerosol drug delivery device design verification - Requirements and test methods

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.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2011

Number of pages

55 p.

Reference

NF EN ISO 20072

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S93-100

Print number

1 - 28/12/2010

International kinship

ISO 20072:2009

European kinship

EN ISO 20072:2010
Sumary
Aerosol drug delivery device design verification - Requirements and test methods

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.

Standard replaced by (1)
NF EN ISO 20072
August 2013
Standard Current
Aerosol drug delivery device design verification - Requirements and test methods

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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Symboles et abréviations
    7
  • 5 Exigences
    7
  • 5.1 Généralités
    7
  • 5.2 Exigences relatives à l'appréciation du risque
    9
  • 5.3 Profil de performance
    9
  • 5.4 Essai de vérification du système
    9
  • 5.5 Incertitude de mesure et conformité aux spécifications
    9
  • 5.6 Exigences d'essai
    9
  • 6 Méthodes d'essai
    12
  • 6.1 Généralités
    12
  • 6.2 Modes opératoires d'essai
    13
  • 6.3 Conditions d'essai
    18
  • 6.4 Évaluations de l'essai
    19
  • 7 Rapport d'essai
    20
  • 8 Informations fournies par le fabricant
    20
  • 8.1 Généralités
    20
  • 8.2 Marquage
    21
  • 8.3 Notice d'utilisation
    22
  • Annexe A (informative) Justificatif des exigences
    24
  • Annexe B (informative) Directives et explications supplémentaires relatives au profil de performance
    26
  • Annexe C (informative) Justificatif des méthodes d'essai
    28
  • Annexe D (informative) Facteurs de limite de tolérance bilatéraux, k
    31
  • Annexe E (informative) Autres critères d'acceptation concernant l'évaluation du profil de performance
    37
  • Bibliographie
    44
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