BS EN ISO 18113-4:2024
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing
| Standard number: | BS EN ISO 18113-4:2024 |
| Pages: | 26 |
| Released: | 2024-06-12 |
| ISBN: | 978 0 539 13481 0 |
| Status: | Standard |
BS EN ISO 18113-4:2024 - In vitro Diagnostic Medical Devices
Information Supplied by the Manufacturer (Labelling) for In Vitro Diagnostic Reagents for Self-Testing
Introducing the latest standard in the realm of in vitro diagnostic medical devices, the BS EN ISO 18113-4:2024. This comprehensive document is an essential resource for manufacturers, healthcare professionals, and regulatory bodies involved in the production and use of in vitro diagnostic reagents for self-testing. Released on June 12, 2024, this standard sets the benchmark for the information that must be supplied by manufacturers, ensuring clarity, safety, and efficacy in self-testing diagnostics.
Key Features and Benefits
- Standard Number: BS EN ISO 18113-4:2024
- Pages: 26
- Release Date: 2024-06-12
- ISBN: 978 0 539 13481 0
- Status: Standard
This standard is meticulously crafted to provide detailed guidelines on the labelling requirements for in vitro diagnostic reagents intended for self-testing. It ensures that all necessary information is clearly communicated to the end-users, thereby enhancing the reliability and accuracy of self-administered diagnostic tests.
Comprehensive Labelling Requirements
The BS EN ISO 18113-4:2024 standard outlines the essential information that must be included on the labels of in vitro diagnostic reagents. This includes:
- Product name and description
- Intended use and target population
- Instructions for use
- Storage and handling requirements
- Warnings and precautions
- Manufacturer's details
- Batch number and expiry date
By adhering to these guidelines, manufacturers can ensure that their products are user-friendly and meet the highest standards of safety and effectiveness.
Ensuring User Safety and Confidence
One of the primary goals of the BS EN ISO 18113-4:2024 standard is to enhance user safety and confidence. By providing clear and comprehensive information, this standard helps users to correctly perform self-tests, interpret results accurately, and take appropriate actions based on those results. This is particularly crucial in the context of self-testing, where users may not have immediate access to professional medical advice.
Global Relevance and Compliance
The BS EN ISO 18113-4:2024 standard is aligned with international best practices and regulatory requirements. This ensures that products labelled in accordance with this standard are compliant with global regulations, facilitating their acceptance and use in multiple markets. For manufacturers, this means a streamlined process for bringing products to market and a broader reach for their diagnostic solutions.
Supporting Innovation in Self-Testing
As the field of in vitro diagnostics continues to evolve, the BS EN ISO 18113-4:2024 standard supports innovation by providing a clear framework for the development and labelling of new self-testing reagents. This encourages the creation of more advanced, user-friendly diagnostic tools that can empower individuals to take control of their health and well-being.
Why Choose BS EN ISO 18113-4:2024?
Choosing the BS EN ISO 18113-4:2024 standard means choosing a commitment to quality, safety, and user satisfaction. This standard is an invaluable resource for ensuring that in vitro diagnostic reagents for self-testing are labelled with the utmost precision and clarity, providing users with the information they need to use these products effectively and safely.
Conclusion
The BS EN ISO 18113-4:2024 standard is a critical tool for anyone involved in the manufacture, regulation, or use of in vitro diagnostic reagents for self-testing. With its detailed guidelines and comprehensive requirements, this standard ensures that these products are labelled in a way that promotes safety, accuracy, and user confidence. Embrace the future of self-testing diagnostics with the BS EN ISO 18113-4:2024 standard and ensure that your products meet the highest standards of quality and compliance.
BS EN ISO 18113-4:2024
This standard BS EN ISO 18113-4:2024 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