ISO 20072:2009

Overview

ISO 20072:2009 - Aerosol drug delivery device design verification - Requirements and test methods - is an ISO standard for the design verification of hand‑held aerosol drug delivery devices (ADDDs). It applies to single‑ and multi‑use, refillable and disposable devices intended to deliver metered or pre‑metered aerosolized medication to the human respiratory tract (nasal, oral, tracheal, bronchial and alveolar sites). The standard is focused on device design verification by laboratory (in‑vitro) testing, not on drug product quality.

Key topics and requirements

• Device Functionality Profile (DFP): Manufacturers must define a DFP based on a risk assessment (ISO 14971), specifying performance parameters and tolerance intervals used for verification.
• System Verification Test: In‑vitro testing of the ADDD as a system (device + container + medication or representative formulation) performed according to the instructions for use to bridge device design and patient interface.
• Risk‑based approach: Design verification scope and test selection are driven by device risk assessment; verification is iterative across development phases.
• Test methods and conditions: The standard provides guidance on test procedures, test conditions, evaluation criteria, measurement uncertainty and sampling intended to demonstrate repeatability and reproducibility of device functionality.
• Information requirements: Marking, labelling and instructions for use must support the verification testing and reflect real‑world operation.
• Documentation: Requirements for test reports and traceable evidence that the design consistently meets the manufacturer’s specification.
• Scope limits: Excludes continuous or semi‑continuous nebulizing systems covered by ISO 27427 and does not apply to individual parts/components manufacturers.

Applications

ISO 20072:2009 is intended for practical use by:

• Device designers and R&D teams validating ADDD concepts during development.
• Quality assurance and regulatory affairs groups preparing design verification evidence for submissions.
• Third‑party testing laboratories performing independent in‑vitro verification.
• Notified bodies and regulators reviewing device safety/performance claims. Practical uses include final design verification before market approval, verification after design changes, and establishing objective acceptance criteria for device function under simulated use.

Related standards

Relevant reference standards cited within ISO 20072:2009 include:

• ISO 14971 (risk management for medical devices) - used to create the DFP
• Standards on sterilization and biocompatibility (ISO 10993‑1, ISO 11135‑1, ISO 11137, ISO 17665‑1)
• EMC and environmental testing standards (IEC 61000‑4‑2, IEC 60068 series)
• Usability and software lifecycle standards (IEC 62366, IEC 62304)

By integrating ISO 20072:2009 into product development, manufacturers can demonstrate a risk‑based, repeatable process to verify that aerosol drug delivery devices meet their intended design specifications and user instructions.