BS EN ISO 18113-3:2024
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use
| Standard number: | BS EN ISO 18113-3:2024 |
| Pages: | 26 |
| Released: | 2024-06-12 |
| ISBN: | 978 0 539 13480 3 |
| Status: | Standard |
BS EN ISO 18113-3:2024 - In vitro Diagnostic Medical Devices
Standard Number: BS EN ISO 18113-3:2024
Pages: 26
Released: 2024-06-12
ISBN: 978 0 539 13480 3
Name: In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use
Status: Standard
Overview
The BS EN ISO 18113-3:2024 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 instruments intended for professional use.
Key Features
- Comprehensive Guidelines: This standard offers detailed instructions on the labelling requirements for in vitro diagnostic instruments, ensuring that all necessary information is clearly communicated to the end-users.
- Professional Use: Tailored specifically for instruments used by healthcare professionals, this standard ensures that the labelling meets the high standards required in professional medical environments.
- Up-to-Date Information: Released on June 12, 2024, this standard reflects the latest advancements and regulatory requirements in the field of in vitro diagnostics.
- International Compliance: As an ISO standard, it is recognized and respected globally, facilitating international trade and compliance with regulatory requirements across different countries.
Why This Standard is Important
In the rapidly evolving field of in vitro diagnostics, accurate and clear labelling is crucial for ensuring the correct use of diagnostic instruments. The BS EN ISO 18113-3:2024 standard helps manufacturers provide essential information that can prevent misuse, enhance safety, and improve the overall quality of diagnostic results. By adhering to this standard, manufacturers can ensure that their products are reliable, safe, and effective, thereby gaining the trust of healthcare professionals and regulatory bodies alike.
Who Should Use This Standard?
This standard is indispensable for:
- Manufacturers of In Vitro Diagnostic Instruments: Ensuring that their products meet the required labelling standards.
- Regulatory Bodies: Verifying that in vitro diagnostic instruments comply with international labelling requirements.
- Healthcare Professionals: Understanding the information provided on diagnostic instruments to ensure proper usage.
- Quality Assurance Teams: Implementing and maintaining compliance with labelling standards.
Detailed Content
The BS EN ISO 18113-3:2024 standard spans 26 pages and covers a wide range of topics related to the labelling of in vitro diagnostic instruments. Key sections include:
- General Requirements: Overview of the basic labelling requirements for in vitro diagnostic instruments.
- Specific Labelling Requirements: Detailed instructions on the specific information that must be included on the labels, such as product name, intended use, and manufacturer details.
- Symbols and Pictograms: Guidelines on the use of standardized symbols and pictograms to convey important information clearly and concisely.
- Instructions for Use: Requirements for the accompanying instructions that must be provided with the diagnostic instruments.
- Compliance and Verification: Procedures for ensuring that the labelling meets the required standards and how to verify compliance.
Benefits of Compliance
Adhering to the BS EN ISO 18113-3:2024 standard offers numerous benefits, including:
- Enhanced Safety: Clear and accurate labelling helps prevent misuse and reduces the risk of errors, thereby enhancing patient safety.
- Regulatory Approval: Compliance with international standards facilitates regulatory approval and market access in different countries.
- Improved Trust: Meeting high labelling standards builds trust with healthcare professionals and end-users, leading to increased adoption and usage of the diagnostic instruments.
- Quality Assurance: Ensures that the products meet the highest quality standards, contributing to better diagnostic outcomes.
Conclusion
The BS EN ISO 18113-3:2024 standard is a vital resource for anyone involved in the manufacturing, regulation, or use of in vitro diagnostic instruments. By providing clear and comprehensive guidelines on labelling, this standard helps ensure that diagnostic instruments are used correctly and safely, ultimately contributing to better healthcare outcomes. Whether you are a manufacturer looking to comply with international standards, a regulatory body verifying product compliance, or a healthcare professional using these instruments, this standard is an invaluable tool for ensuring the highest levels of quality and safety in in vitro diagnostics.
BS EN ISO 18113-3:2024
This standard BS EN ISO 18113-3:2024 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