BS EN ISO 18113-5:2024
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing
| Standard number: | BS EN ISO 18113-5:2024 |
| Pages: | 24 |
| Released: | 2024-07-31 |
| ISBN: | 978 0 539 13482 7 |
| Status: | Standard |
BS EN ISO 18113-5:2024 - In vitro Diagnostic Medical Devices
Standard Number: BS EN ISO 18113-5:2024
Pages: 24
Released: 2024-06-12
ISBN: 978 0 539 13482 7
Status: Standard
Overview
The BS EN ISO 18113-5:2024 standard is an essential document for manufacturers of in vitro diagnostic (IVD) medical devices, specifically focusing on the information supplied by the manufacturer for self-testing instruments. This standard ensures that all necessary information is clearly and accurately provided, enhancing the safety and effectiveness of IVD devices used by non-professional users.
Key Features
- Comprehensive Guidelines: This standard provides detailed guidelines on the labelling requirements for IVD instruments intended for self-testing, ensuring that users receive all the necessary information to use the devices safely and effectively.
- Enhanced Safety: By adhering to this standard, manufacturers can significantly reduce the risk of misuse and potential harm, thereby enhancing the overall safety of their products.
- Regulatory Compliance: Compliance with BS EN ISO 18113-5:2024 helps manufacturers meet regulatory requirements, facilitating market access and acceptance of their products.
- Clear Instructions: The standard emphasizes the importance of clear and understandable instructions, which are crucial for non-professional users to operate the devices correctly.
Why This Standard is Important
In vitro diagnostic devices play a critical role in modern healthcare, enabling individuals to monitor and manage their health conditions effectively. However, the effectiveness of these devices largely depends on the quality and clarity of the information provided by the manufacturer. The BS EN ISO 18113-5:2024 standard addresses this need by setting out comprehensive requirements for labelling and information supplied with IVD instruments for self-testing.
This standard is particularly important for ensuring that non-professional users can understand and follow the instructions, thereby minimizing the risk of errors and enhancing the reliability of test results. By providing clear and concise information, manufacturers can help users achieve accurate and reliable results, which is essential for effective health management.
Who Should Use This Standard?
The BS EN ISO 18113-5:2024 standard is designed for manufacturers of in vitro diagnostic medical devices, particularly those producing instruments intended for self-testing. It is also relevant for regulatory bodies, healthcare professionals, and other stakeholders involved in the development, approval, and use of IVD devices.
By following the guidelines set out in this standard, manufacturers can ensure that their products meet the highest standards of safety and quality, thereby gaining the trust and confidence of users and regulatory authorities alike.
Detailed Content
The standard covers a wide range of topics related to the labelling and information supplied with IVD instruments for self-testing, including:
- General Requirements: Basic principles and general requirements for labelling and information supplied by the manufacturer.
- Specific Labelling Requirements: Detailed requirements for the content and format of labels, including symbols, warnings, and instructions for use.
- User Instructions: Guidelines for creating clear and understandable user instructions, including step-by-step procedures and troubleshooting tips.
- Performance Characteristics: Information on the performance characteristics of the device, including accuracy, precision, and limitations.
- Safety Information: Essential safety information, including potential risks and how to mitigate them.
Benefits of Compliance
Compliance with the BS EN ISO 18113-5:2024 standard offers numerous benefits for manufacturers, users, and regulatory bodies, including:
- Improved User Safety: Clear and accurate information helps users operate the devices safely, reducing the risk of errors and potential harm.
- Enhanced Product Quality: Adhering to the standard ensures that products meet high-quality standards, enhancing their reliability and effectiveness.
- Regulatory Approval: Compliance with the standard facilitates regulatory approval, enabling manufacturers to bring their products to market more quickly and efficiently.
- Increased User Confidence: Providing clear and comprehensive information helps build user confidence in the product, leading to higher satisfaction and trust.
Conclusion
The BS EN ISO 18113-5:2024 standard is a vital resource for manufacturers of in vitro diagnostic medical devices, particularly those intended for self-testing. By providing comprehensive guidelines on labelling and information supplied by the manufacturer, this standard helps ensure that users receive all the necessary information to use the devices safely and effectively. Compliance with this standard not only enhances product quality and safety but also facilitates regulatory approval and market acceptance.
Investing in the BS EN ISO 18113-5:2024 standard is an investment in the safety, quality, and success of your in vitro diagnostic medical devices. Ensure that your products meet the highest standards and gain the trust and confidence of users and regulatory authorities alike.
BS EN ISO 18113-5:2024
This standard BS EN ISO 18113-5:2024 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