BS EN ISO 20417:2021
Medical devices. Information to be supplied by the manufacturer
| Standard number: | BS EN ISO 20417:2021 |
| Pages: | 86 |
| Released: | 2022-05-27 |
| ISBN: | 978 0 539 22260 9 |
| Status: | Standard |
BS EN ISO 20417:2021 - Medical Devices: Information to be Supplied by the Manufacturer
In the ever-evolving world of medical technology, ensuring the safety and efficacy of medical devices is paramount. The BS EN ISO 20417:2021 standard is a comprehensive guide that outlines the essential information that manufacturers must provide for medical devices. This standard is crucial for manufacturers, healthcare professionals, and regulatory bodies to ensure that medical devices are used safely and effectively.
Overview of the Standard
The BS EN ISO 20417:2021 standard, released on May 27, 2022, is a pivotal document that provides detailed guidelines on the information that must be supplied by manufacturers of medical devices. With a total of 86 pages, this standard is a thorough resource that covers various aspects of medical device information, ensuring that all necessary details are communicated clearly and effectively.
Key Features
- Standard Number: BS EN ISO 20417:2021
- Pages: 86
- Release Date: 2022-05-27
- ISBN: 978 0 539 22260 9
- Status: Standard
Importance of the Standard
The BS EN ISO 20417:2021 standard is essential for several reasons:
- Compliance: It helps manufacturers comply with international regulations and standards, ensuring that their products meet the necessary safety and performance criteria.
- Safety: By providing comprehensive information, the standard ensures that healthcare professionals have all the necessary details to use medical devices safely and effectively.
- Transparency: It promotes transparency by requiring manufacturers to disclose critical information about their products, including instructions for use, safety warnings, and performance data.
- Quality Assurance: The standard helps maintain high-quality standards in the production and distribution of medical devices, ultimately benefiting patients and healthcare providers.
Who Should Use This Standard?
The BS EN ISO 20417:2021 standard is designed for a wide range of stakeholders in the medical device industry, including:
- Manufacturers: To ensure their products meet international standards and are safe for use.
- Regulatory Bodies: To assess and approve medical devices for market entry.
- Healthcare Professionals: To understand the proper use and potential risks associated with medical devices.
- Quality Assurance Teams: To implement and maintain high standards in the production and distribution of medical devices.
Detailed Content
The standard covers a wide range of topics, including but not limited to:
- Labeling Requirements: Detailed guidelines on what information must be included on the labels of medical devices.
- Instructions for Use: Comprehensive instructions that ensure the safe and effective use of the device.
- Safety Information: Critical safety warnings and precautions that must be communicated to users.
- Performance Data: Information on the performance characteristics of the device, including any limitations or conditions of use.
- Packaging and Storage: Guidelines on the proper packaging and storage conditions to maintain device integrity.
Conclusion
The BS EN ISO 20417:2021 standard is an indispensable resource for anyone involved in the medical device industry. By adhering to this standard, manufacturers can ensure that their products are safe, effective, and compliant with international regulations. Healthcare professionals and regulatory bodies can rely on the information provided to make informed decisions about the use and approval of medical devices.
With its comprehensive guidelines and detailed requirements, the BS EN ISO 20417:2021 standard is a cornerstone of quality and safety in the medical device industry. Whether you are a manufacturer, a healthcare provider, or a regulatory authority, this standard is an essential tool for ensuring the highest standards of medical device safety and performance.
BS EN ISO 20417:2021
This standard BS EN ISO 20417:2021 Medical devices. Information to be supplied by the manufacturer is classified in these ICS categories:
- 11.040.01 Medical equipment in general
- 11.120.01 Pharmaceutics in general
- 01.110 Technical product documentation
There is guidance or rationale for this Clause contained in Clause A.2.
This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.
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