BS EN ISO 18113-2:2024
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use
| Standard number: | BS EN ISO 18113-2:2024 |
| Pages: | 26 |
| Released: | 2024-06-12 |
| ISBN: | 978 0 539 13479 7 |
| Status: | Standard |
BS EN ISO 18113-2:2024 - In vitro Diagnostic Medical Devices
Information Supplied by the Manufacturer (Labelling) In vitro Diagnostic Reagents for Professional Use
Standard Number: BS EN ISO 18113-2:2024
Pages: 26
Released: 2024-06-12
ISBN: 978 0 539 13479 7
Status: Standard
Overview
The BS EN ISO 18113-2:2024 standard is an essential document for professionals in the field of in vitro diagnostic medical devices. This standard provides comprehensive guidelines on the information that must be supplied by the manufacturer, specifically focusing on the labelling of in vitro diagnostic reagents intended for professional use. Released on June 12, 2024, this 26-page document is a critical resource for ensuring compliance with international regulations and maintaining the highest standards of safety and efficacy in the medical diagnostics industry.
Key Features
- Comprehensive Guidelines: This standard offers detailed instructions on the labelling requirements for in vitro diagnostic reagents, ensuring that all necessary information is clearly communicated to healthcare professionals.
- International Compliance: Adhering to the BS EN ISO 18113-2:2024 standard ensures that your products meet international regulatory requirements, facilitating global distribution and acceptance.
- Enhanced Safety: Proper labelling as per this standard helps in minimizing the risk of errors in the use of diagnostic reagents, thereby enhancing patient safety and the reliability of diagnostic results.
- Professional Use: The standard is specifically tailored for reagents intended for professional use, addressing the unique needs and challenges faced by healthcare providers and laboratory technicians.
Why This Standard is Important
In the rapidly evolving field of medical diagnostics, accurate and reliable information is paramount. The BS EN ISO 18113-2:2024 standard ensures that manufacturers provide all necessary details about their in vitro diagnostic reagents, including usage instructions, safety warnings, and performance characteristics. This not only aids in the correct and effective use of these products but also helps in maintaining high standards of patient care.
By adhering to this standard, manufacturers can demonstrate their commitment to quality and regulatory compliance, which is crucial for building trust with healthcare providers and regulatory bodies. Moreover, it helps in reducing the risk of product recalls and legal issues, thereby safeguarding the manufacturer's reputation and financial stability.
Detailed Content
The BS EN ISO 18113-2:2024 standard covers a wide range of topics related to the labelling of in vitro diagnostic reagents. Some of the key areas include:
- Identification of the Product: Clear and unambiguous identification of the reagent, including its name, batch number, and expiry date.
- Intended Use: Detailed information on the intended use of the reagent, including the specific diagnostic tests it is designed for.
- Instructions for Use: Comprehensive instructions on how to use the reagent, including preparation, handling, and storage requirements.
- Safety Information: Important safety warnings and precautions to ensure the safe handling and use of the reagent.
- Performance Characteristics: Information on the performance characteristics of the reagent, including sensitivity, specificity, and accuracy.
Who Should Use This Standard?
The BS EN ISO 18113-2:2024 standard is designed for a wide range of stakeholders in the medical diagnostics industry, including:
- Manufacturers: To ensure that their products meet international labelling requirements and are safe for use by healthcare professionals.
- Regulatory Bodies: To assess the compliance of in vitro diagnostic reagents with international standards.
- Healthcare Providers: To understand the labelling information provided by manufacturers and ensure the correct use of diagnostic reagents.
- Laboratory Technicians: To follow the instructions and safety guidelines provided on the reagent labels, ensuring accurate and reliable diagnostic results.
Conclusion
The BS EN ISO 18113-2:2024 standard is an indispensable resource for anyone involved in the manufacture, regulation, or use of in vitro diagnostic reagents. By providing clear and comprehensive guidelines on labelling, this standard helps in ensuring the safe and effective use of diagnostic reagents, thereby contributing to better patient outcomes and higher standards of healthcare.
With its focus on professional use, the BS EN ISO 18113-2:2024 standard addresses the specific needs of healthcare providers and laboratory technicians, making it a valuable tool for enhancing the quality and reliability of medical diagnostics.
BS EN ISO 18113-2:2024
This standard BS EN ISO 18113-2:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) is classified in these ICS categories:
- 11.100.10 In vitro diagnostic test systems