Overview
EN ISO 20072:2013 (ISO 20072:2009) specifies requirements and test methods for the design verification of hand‑held aerosol drug delivery devices (ADDDs). It covers 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 focuses on laboratory (in‑vitro) verification that a device consistently meets the manufacturer’s design specification - it is a device design verification standard, not a drug product quality standard.
Key topics and technical requirements
- Device Functionality Profile (DFP): Manufacturers must create a DFP, derived from a risk assessment, which defines performance parameters and tolerance intervals for verification.
- Risk assessment: Use risk analysis to determine critical functions, test scope and acceptance criteria.
- System verification test: Final in‑vitro tests of the assembled ADDD system performed in accordance with the instructions for use to bridge device design to patient interface.
- Test methods and procedures: Standardized laboratory test methods, defined test conditions and evaluation approaches to assess repeatability and reproducibility of device function.
- Uncertainty and conformance: Requirements for dealing with measurement uncertainty and criteria for conformance with specifications.
- Sampling plans: Designed to verify design at a high confidence level; intended for design verification rather than routine lot release.
- Information and labelling: Requirements for marking and instructions for use that support safe and effective device operation.
- Documentation: Test reports and traceable evidence of design verification activities.
Practical applications
- Support for pre‑market design verification and regulatory submissions for inhaler systems and nasal aerosol devices.
- Objective in‑vitro testing during product development, design transfer and post‑approval modifications.
- Independent laboratory testing to confirm device functionality and robustness under expected and extreme use conditions (environmental, electromechanical).
- Use in supplier qualification, verification of refillable vs. pre‑filled configurations, and bridging tests between device design and clinical use.
Who should use this standard
- Medical device manufacturers and design engineers of inhalers, nebulizers and nasal aerosol devices
- Regulatory affairs and quality assurance teams preparing technical documentation or conformity evidence
- Test laboratories and notified bodies performing design verification and conformity assessment
- Product development teams conducting risk‑based verification and validation
Related standards and guidance
- ISO 14971 (risk management for medical devices)
- ISO 13485 (medical device quality management)
- Relevant EU directives/regulations and national medical device legislation
Keywords: aerosol drug delivery device, ADDD, design verification, device functionality profile, in‑vitro testing, system verification test, risk assessment, inhaler standard.
