This article is an introduction to ISO 20417 and details about the standards that make up the document itself.
Published 22 Nov 2022
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.
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.
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:
By implementing this standard, healthcare organizations can strengthen their quality management systems and improve the quality of their services.
ISO 20417 covers the requirements applicable for identification and labels on a medical device or accessory, including:
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ISO 20417 can be applied in many following ways in the medical field such as the following:
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.
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:
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.
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.
Implementing ISO 20417 can be a daunting task, but with SafetyCulture (formerly iAuditor), you can be sure that you’re on the right track. SafetyCulture is the perfect tool for helping you effectively implement ISO 20417. With SafetyCulture, you can easily create, edit, and share digital checklists, conduct audits remotely, and generate reports with detailed findings.
With SafetyCulture, you can do the following:
Shella Marie Ang
Shella Marie Ang is a content contributor for SafetyCulture. Cultivating her experience in social media marketing, virtual assistance, and SEO has helped her create compelling content for websites and blogs. Her medical background also has given her an edge when it comes to writing medical and health-related content. She loves reading in her free time and being around other creatives.
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