What is ISO 18113-1:2022-In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements?
ISO 18113-1:2022 specifies the terms, definitions, and general requirements for the labeling of in vitro diagnostic medical devices.
Here are some key aspects covered in ISO 18113-1:2022:
Scope: The standard applies to in vitro diagnostic medical devices, which are used to examine samples from the human body for the purpose of providing information for diagnostic, monitoring, or compatibility purposes.
Terms and definitions: ISO 18113-1 provides a comprehensive list of terms and their definitions related to the labeling of in vitro diagnostic medical devices. These definitions help ensure consistency and clarity in communication.
General requirements: The standard sets out general requirements for the labeling of in vitro diagnostic medical devices. This includes the information that should be provided by the manufacturer on the label, such as the device’s intended purpose, instructions for use, precautions, contraindications, storage conditions, and more. It also covers requirements for symbols, graphical symbols, and colors used in labeling.
Labeling for specific device types: While ISO 18113-1 primarily focuses on general requirements, it also highlights specific labeling considerations for different types of in vitro diagnostic medical devices. This includes information on reagents, calibrators, control materials, instruments, and software.
The purpose of ISO 18113-1 is to ensure that the information supplied by the manufacturer on the labeling of in vitro diagnostic medical devices is accurate, consistent, and easily understandable. Compliance with this standard helps promote patient safety and facilitates proper use of these devices by healthcare professionals.
Requirements of ISO 18113-1:2022-In vitro diagnostic medical devices
Labeling content: The standard requires the manufacturer to provide specific information on the device label. This includes the device’s intended purpose, instructions for use, precautions, contraindications, storage conditions, and any specific warnings or limitations. The labeling should also indicate the device’s performance characteristics, such as analytical sensitivity, analytical specificity, and the clinical performance if relevant.
Clarity and legibility: The labeling must be clear, legible, and prominently displayed on the device or its packaging. The information should be easily visible and readable, even for individuals with visual impairments. The font size, style, and color should be chosen to ensure maximum readability.
Symbols and graphical symbols: If symbols or graphical symbols are used on the label, they should comply with relevant international standards or national requirements. The standard provides guidance on the use of symbols and their meanings to ensure consistent interpretation across different regions.
Multilingual labeling: If the device is intended for distribution in multiple countries or regions with different languages, the labeling should be provided in the languages relevant to those markets. The manufacturer should ensure that the information is accurately translated and appropriately presented in each language.
Packaging information: The standard emphasizes the need for important information to be provided on the device’s packaging, in addition to the device label. This includes the device’s essential characteristics, handling instructions, and any necessary precautions or warnings.
Software and electronic labeling: If the device incorporates software or electronic labeling, the manufacturer should ensure that the information is accessible, visible, and easily navigable to the user. It should also comply with relevant regulatory requirements for electronic labeling.
Labeling for components and accessories: This standard addresses the labeling requirements for components, reagents, calibrators, control materials, and accessories associated with in vitro diagnostic medical devices. The labeling should clearly identify the intended use and any specific instructions or limitations for those components or accessories.
By complying with ISO 18113-1:2022, manufacturers can ensure that the information supplied on the labeling of in vitro diagnostic medical devices meets the necessary requirements for safety, effectiveness, and proper use. It helps promote consistent communication, enhances patient safety, and facilitates regulatory compliance.
Benefits of ISO 18113-1:2022-In vitro diagnostic medical devices
Clarity and consistency: The standard ensures that the information provided on the labeling of in vitro diagnostic medical devices is clear, consistent, and easily understandable. This helps healthcare professionals and users to quickly and accurately interpret the information, reducing the risk of errors and enhancing patient safety.
Regulatory compliance: Compliance with ISO 18113-1 helps manufacturers meet regulatory requirements for labeling of in vitro diagnostic medical devices. Adhering to the standard assists in demonstrating conformity to relevant regulations and directives, facilitating the regulatory approval process and market access.
Improved usability: The standard emphasizes the need for user-friendly labeling, including clear instructions for use and appropriate warnings and precautions. This enhances the usability of the devices, making it easier for healthcare professionals to correctly and safely operate the devices, leading to improved patient care.
Multilingual support: ISO 18113-1:2022 addresses the requirement for multilingual labeling in regions with different languages. By providing information in the languages relevant to the target markets, the standard facilitates the global distribution and use of in vitro diagnostic medical devices.
Enhanced patient safety: Accurate and comprehensive labeling reduces the risk of improper use or misinterpretation of in vitro diagnostic medical devices. This contributes to improved patient safety by minimizing the potential for errors, adverse events, and incorrect diagnoses.
Consistent symbols and graphical symbols: The standard provides guidance on the use of symbols and graphical symbols on the labels of in vitro diagnostic medical devices. This promotes consistent interpretation and understanding of these symbols across different devices and regions, reducing confusion and potential risks.
Accessible electronic labeling: With the increasing use of software and electronic labeling, the standard ensures that the information is accessible, visible, and easily navigable for users. This helps users, including those with visual impairments, to access and understand the labeling information effectively.
Overall, the standard benefits the industry by establishing standardized requirements for labeling, which in turn contributes to improved patient safety, regulatory compliance, and enhanced usability of in vitro diagnostic medical devices.
What is ISO 18113-2:2022-In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use?
ISO 18113-2:2022 standard specifically focuses on the labeling requirements for in vitro diagnostic reagents intended for professional use.
Here are some key aspects covered in ISO 18113-2:2022:
Scope: The standard applies to in vitro diagnostic reagents that are used by healthcare professionals in laboratory or point-of-care settings for diagnostic purposes. It does not cover reagents for self-testing or over-the-counter use.
Labeling content: ISO 18113-2 specifies the specific information that should be provided by the manufacturer on the label of in vitro diagnostic reagents. This includes the name and description of the reagent, its intended use, instructions for use, storage conditions, precautions, and any specific warnings or limitations. The labeling should also provide information on the performance characteristics, such as analytical sensitivity, analytical specificity, and any clinical performance data if relevant.
Clarity and legibility: The standard emphasizes that the labeling should be clear, legible, and prominently displayed on the reagent container or packaging. The font size, style, and color should be chosen to ensure maximum readability, even for individuals with visual impairments.
Symbols and graphical symbols: If symbols or graphical symbols are used on the label, they should comply with relevant international standards or national requirements. The standard provides guidance on the use of symbols and their meanings to ensure consistent interpretation and understanding.
Multilingual labeling: Similar to ISO 18113-1, if the in vitro diagnostic reagents are intended for distribution in multiple countries or regions with different languages, the labeling should be provided in the languages relevant to those markets. The translations should be accurate and appropriately presented in each language.
Packaging information: In addition to the label, the standard emphasizes the need for important information to be provided on the reagent’s packaging. This includes essential characteristics, handling instructions, and any necessary precautions or warnings.
Software and electronic labeling: If the in vitro diagnostic reagents incorporate software or electronic labeling, the manufacturer should ensure that the information is accessible, visible, and easily navigable to the user. It should comply with relevant regulatory requirements for electronic labeling.
Therefore, ISO 18113-2:2022 helps manufacturers ensure that the information supplied on the labeling of in vitro diagnostic reagents for professional use meets the necessary requirements for safety, effectiveness, and proper use. It promotes clear communication, enhances user understanding, and facilitates regulatory compliance for these specific types of in vitro diagnostic products.
Who needs ISO 18113-1:2022-In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling)?
Manufacturers: Manufacturers of in vitro diagnostic medical devices are the primary audience for ISO 18113-1. They need to ensure that the information supplied on the labeling of their devices meets the standard’s requirements. Compliance with the standard helps manufacturers demonstrate conformity to labeling regulations, enhance patient safety, and facilitate regulatory approvals.
Regulatory Authorities: Regulatory authorities responsible for overseeing in vitro diagnostic medical devices can reference the standard as a benchmark for evaluating the labeling of these devices. Compliance with the standard can assist regulatory bodies in assessing the safety, effectiveness, and quality of the devices and ensuring their alignment with applicable regulations and directives.
Healthcare Professionals: This standard is designed to provide clear, comprehensive, and consistent information on the labeling of in vitro diagnostic medical devices. Healthcare professionals, such as doctors, laboratory technicians, and nurses, rely on this labeling information to understand the intended use, instructions for use, precautions, and limitations of the devices. Compliance with the standard improves the usability of the devices and promotes accurate interpretation by healthcare professionals, leading to improved patient care.
Users of In Vitro Diagnostic Devices: Patients and individuals using in vitro diagnostic medical devices, either under the guidance of healthcare professionals or for self-testing, can benefit from the standardized labeling information provided by the standard. The clear and understandable labeling helps users better understand the devices, their purpose, and how to use them correctly and safely.
Standards Organizations: ISO 18113-1 is a globally recognized standard that provides a common framework for labeling in vitro diagnostic medical devices. Other standards organizations and industry bodies can reference ISO 18113-1 to ensure consistency and harmonization in labeling requirements across different jurisdictions and regions.
By adhering to ISO 18113-1:2022, manufacturers and other stakeholders in the in vitro diagnostic medical device industry can promote patient safety, facilitate regulatory compliance, improve usability, and enhance the overall quality of these devices.
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Also read: ISO 23640:2011-In vitro diagnostic medical devices
