ISO 20417: What You Need to Know

This article is an introduction to ISO 20417 and details about the standards that make up the document itself.

a medical device properly labeled to conform to the ISO 20417 standard

What is ISO 20417?

ISO 20417:2021 is an international standard that defines requirements and gives information for medical devices throughout their life cycle. ISO 20417 caters to all types and all classes of medical devices and labeling. The standard applies to any organization involved in the life cycle of medical devices, including designers, manufacturers, distributors, service providers, and users.

According to ISO, ISO 20417  provides information for the requirements of medical device or a medical accessory supplied by the manufacturer. It includes the needed requirements for labels and identification on a medical device or accessory which include its packaging and any accompanying information.

Why is it Essential?

The purpose of this standard is to ensure that medical materials and devices are safe and effective for their intended use. It also aims to ensure that these products are properly labeled so that consumers can make informed decisions about which products to use. 

ISO 20417 is an essential standard for the medical industry and consumers of medical products. It will help improve the quality of health care and make it more accessible to people worldwide.

What are the Benefits of Using ISO 20417?

ISO 20417 is a quality management standard developed specifically for the healthcare industry. It helps organizations establish and maintain a quality management system and can be used to assess the overall quality of an organization’s healthcare services.

There are many benefits of using ISO 20417, including:

  • Improved patient safety
  • Increased efficiency
  • Reduced medical costs
  • Enhanced inventory management
  • Increased trust in the medical product
  • Stronger product information expertise
  • Smoother trade with other manufacturers

By implementing this standard, healthcare organizations can strengthen their quality management systems and improve the quality of their services.

What Does ISO 20417:2021 Cover?

ISO 20417 covers the requirements applicable for identification and labels on a medical device or accessory, including: 

  • The name and/or trade name and address of the manufacturer
  • The identification number of the device
  • The CE mark, if applicable, and
  • Any other relevant information

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Applications in the Industry

ISO 20417 can be applied in many following ways in the medical field such as the following:

Electronic Records (E-records) Storage

In keeping with the trend of storing medical records electronically, ISO 20417 can be used as a specification for the structuring and formatting of e-records. For example, the requirement for a name field in case history could be that it should never be an empty field. However, it does not restrict to the container format like XML or PDF, where you may store this information. 

Report Templates

Reports need to be structured in line with the Digital Imaging and Communications in Medicine (DICOM) standards for transmission and reading by Picture Archiving and Communication System (PACS). 

For example, an image report needs to consist of the following components: 

  • Patient information 
  • Study identifier 
  • Accession number 
  • Procedure description

Medical Image Archiving

Images acquired through medical devices need to follow specifications while they are archived. This helps doctors read and analyze the image without any trouble using different reader devices.

FAQs for ISO 20417

BS EN ISO stands for the British document of an EN ISO standard. This means that the document is a British Standard, a European Standard, as well as an ISO standard that has the same content. 

An ISO is a standard that is recognized internationally. Meanwhile, an EN ISO is the standard’s localized counterpart in the European Union, hence why it becomes an EN ISO. 

EN 1041 was made to support and guide medical device companies to comply with the requirements of the European Medical Device Directives (MDD). Meanwhile, ISO 20417 is the updated regulation applicable to all medical device manufacturers. Since the MDD was replaced with the Medical Device Regulation (MDR), a new standard was needed. 

ISO 20417 is used by medical device companies and manufacturers. It serves as a detailed guide for the requirements for the identification and labels on a medical device or accessory they produce.

SafetyCulture Content Team
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SafetyCulture Content Team
The SafetyCulture content team is dedicated to providing high-quality, easy-to-understand information to help readers understand complex topics and improve workplace safety and quality. Our team of writers have extensive experience at producing articles for different fields such as safety, quality, health, and compliance.