BS EN ISO 18113-1:2024
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions, and general requirements
| Standard number: | BS EN ISO 18113-1:2024 |
| Pages: | 68 |
| Released: | 2024-06-12 |
| ISBN: | 978 0 539 13478 0 |
| Status: | Standard |
BS EN ISO 18113-1:2024 - In vitro Diagnostic Medical Devices
Information Supplied by the Manufacturer (Labelling) Terms, Definitions, and General Requirements
Standard Number: BS EN ISO 18113-1:2024
Pages: 68
Released: 2024-06-12
ISBN: 978 0 539 13478 0
Status: Standard
Overview
The BS EN ISO 18113-1:2024 standard is an essential document for manufacturers, suppliers, and users of in vitro diagnostic (IVD) medical devices. This comprehensive standard provides detailed guidelines on the information that must be supplied by the manufacturer, focusing on labelling, terms, definitions, and general requirements. Released on June 12, 2024, this 68-page document is a critical resource for ensuring compliance with international regulations and enhancing the safety and efficacy of IVD medical devices.
Key Features
- Comprehensive Guidelines: Offers detailed instructions on the information that must be provided by manufacturers, ensuring clarity and consistency in labelling.
- Standardized Terms and Definitions: Provides a standardized set of terms and definitions to ensure uniform understanding and communication across the industry.
- General Requirements: Outlines the general requirements for labelling, helping manufacturers meet regulatory standards and improve product safety.
- International Compliance: Aligns with global standards, making it easier for manufacturers to comply with international regulations and market their products worldwide.
Why This Standard is Important
In vitro diagnostic medical devices play a crucial role in healthcare, providing essential information for the diagnosis, treatment, and monitoring of diseases. Accurate and clear labelling is vital to ensure that these devices are used correctly and safely. The BS EN ISO 18113-1:2024 standard helps manufacturers provide the necessary information in a consistent and understandable manner, reducing the risk of errors and enhancing patient safety.
Who Should Use This Standard?
This standard is designed for a wide range of stakeholders in the IVD medical device industry, including:
- Manufacturers: To ensure their products meet regulatory requirements and are labelled correctly.
- Regulatory Authorities: To verify that products comply with international standards.
- Healthcare Providers: To understand the information provided by manufacturers and use IVD devices safely and effectively.
- Quality Assurance Professionals: To implement and maintain compliance with labelling standards.
Detailed Content
The BS EN ISO 18113-1:2024 standard covers a wide range of topics, including:
- Scope and Field of Application: Defines the scope of the standard and its applicability to various types of IVD medical devices.
- Normative References: Lists the normative references that are essential for the application of the standard.
- Terms and Definitions: Provides a comprehensive list of terms and definitions used in the standard, ensuring a common understanding across the industry.
- General Requirements: Outlines the general requirements for labelling, including the information that must be provided and the format in which it should be presented.
- Specific Labelling Requirements: Details the specific labelling requirements for different types of IVD medical devices, ensuring that all necessary information is included.
- Annexes: Includes informative and normative annexes that provide additional guidance and examples to help manufacturers comply with the standard.
Benefits of Compliance
Compliance with the BS EN ISO 18113-1:2024 standard offers numerous benefits, including:
- Enhanced Safety: Ensures that IVD medical devices are labelled with accurate and clear information, reducing the risk of misuse and enhancing patient safety.
- Regulatory Compliance: Helps manufacturers meet international regulatory requirements, facilitating market access and reducing the risk of non-compliance penalties.
- Improved Quality: Promotes high-quality labelling practices, contributing to the overall quality and reliability of IVD medical devices.
- Increased Trust: Builds trust with healthcare providers and patients by demonstrating a commitment to safety and quality.
Conclusion
The BS EN ISO 18113-1:2024 standard is an indispensable resource for anyone involved in the manufacture, regulation, or use of in vitro diagnostic medical devices. By providing clear and comprehensive guidelines on labelling, terms, definitions, and general requirements, this standard helps ensure that IVD devices are used safely and effectively, ultimately contributing to better healthcare outcomes.
BS EN ISO 18113-1:2024
This standard BS EN ISO 18113-1:2024 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