BS EN ISO 20072:2013 - Aerosol Drug Delivery Device Design Verification

In the rapidly evolving field of medical technology, ensuring the safety and efficacy of devices is paramount. The BS EN ISO 20072:2013 standard is a comprehensive guide that provides essential requirements and test methods for the design verification of aerosol drug delivery devices. This standard is a critical resource for manufacturers, designers, and quality assurance professionals involved in the development and production of these devices.

Overview of BS EN ISO 20072:2013

Released on February 28, 2013, this standard is a part of the ISO (International Organization for Standardization) series, which is recognized globally for its rigorous and detailed guidelines. The document spans 54 pages and is identified by the ISBN 978 0 580 82254 4. As a standard, it holds a significant status in the industry, ensuring that all aerosol drug delivery devices meet the necessary safety and performance criteria before reaching the market.

Key Features and Benefits

• Comprehensive Guidelines: The standard provides a detailed framework for the design verification process, ensuring that all aspects of the device's performance are thoroughly evaluated.
• Global Recognition: As part of the ISO series, this standard is recognized and respected worldwide, facilitating international trade and compliance.
• Enhanced Safety: By adhering to the requirements outlined in this standard, manufacturers can ensure that their devices are safe for use, reducing the risk of adverse effects on patients.
• Improved Efficacy: The test methods included in the standard help verify that the devices deliver the intended dosage accurately and consistently, enhancing treatment outcomes.

Who Should Use This Standard?

The BS EN ISO 20072:2013 standard is indispensable for a variety of professionals in the medical device industry, including:

• Manufacturers: To ensure that their products meet international safety and performance standards.
• Design Engineers: To guide the design process and ensure compliance with regulatory requirements.
• Quality Assurance Teams: To develop robust testing protocols and verify device performance.
• Regulatory Bodies: To assess compliance and approve devices for market entry.

Detailed Content

The standard covers a wide range of topics essential for the design verification of aerosol drug delivery devices, including:

• Design Requirements: Specifications that the device must meet to ensure safety and efficacy.
• Test Methods: Detailed procedures for evaluating the performance of the device under various conditions.
• Performance Criteria: Benchmarks that the device must achieve to be considered compliant with the standard.
• Documentation: Guidelines for maintaining comprehensive records of the design and testing process.

Why Compliance Matters

Compliance with the BS EN ISO 20072:2013 standard is not just a regulatory requirement; it is a commitment to quality and patient safety. By following the guidelines set forth in this standard, manufacturers can demonstrate their dedication to producing reliable and effective medical devices. This not only enhances the reputation of the company but also builds trust with healthcare providers and patients.

Conclusion

The BS EN ISO 20072:2013 standard is an essential tool for anyone involved in the design, production, and regulation of aerosol drug delivery devices. Its comprehensive guidelines and test methods ensure that these devices are safe, effective, and ready for use in the healthcare industry. By adhering to this standard, manufacturers can achieve compliance, improve product quality, and ultimately contribute to better patient outcomes.

BS EN ISO 20072:2013

This standard BS EN ISO 20072:2013 Aerosol drug delivery device design verification. Requirements and test methods is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment
• 11.140 Hospital equipment
• 13.340.99 Other protective equipment
• 31.260 Optoelectronics. Laser equipment

This International Standard 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.

This International Standard 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.

This International Standard excludes continuous or semi-continuous aerosolization devices covered in ISO 27427, aerosolization devices which do not emit active pharmaceutical ingredient (API), general purpose aerosolization devices (for use with ventilators) and atomizers.

This International Standard does not apply to manufacturers of single parts or components of the ADDDs [e.g. (spray) pumps, valves, containers, etc.].

NOTE There might be times when a device falls under the scope of this International Standard and that of ISO 27427. The committee envisions that the intended use of the product and the risk assessment of the device will derive which International Standard the manufacturer chooses for design verification of the ADDD. This International Standard outlines the process by which ADDD design verification is to be performed in conjunction with a risk-based device functionality profile of the ADDD with either the medication, a placebo or a representative medication. ISO 27427 outlines the process by which the characterization of the aerodynamic aerosol performance of a nebulizing system for use with a non-specific class of active pharmaceutical ingredient(s) is made.