🌐 Understanding Standards 🌐

Thu, 20 Jun 2024 17:56:43 GMT

What is the difference between a 'TR', 'TS', 'IS' and 'EN? ��

As a member of ISO and IEC, I often encounter questions about the differences between an International Standard (IS), Technical Report (TR), Technical Specification (TS), and European Standard (EN). Understanding the difference between these types of documents and their compliance levels is crucial for medical device manufacturers and often misunderstood, both by newcomers to the industry, as well as seasoned regulatory affairs professionals. Here’s a quick guide:

�� Technical Report (TR)
TR documents, such as ISO/TR 24971 , provide guidance and information rather than mandatory requirements. They are designed to support manufacturers in understanding and implementing best practices related to, for example, risk management, usability engineering, and other aspects of medical device development. While not compulsory, adhering to the recommendations in a TR can enhance the robustness of a manufacturer’s processes and align them with industry expectations, potentially facilitating regulatory approval.

�� Technical Specification (TS)
A TS provides requirements and recommendations based on the latest technical advancements and market needs. It’s a more flexible document compared to an IS and can be used when there is a need for a fast-track solution or when the subject matter is still under development. TS serves as a stepping stone towards a full International Standard, allowing industry feedback and refinement.

�� International Standard (IS)
IS documents, such as ISO 13485 for quality management systems in the medical device industry, are formal requirements that must be implemented to achieve compliance. These standards are often mandated by regulatory bodies and need to be integrated into a company’s Quality Management System (QMS) and product development processes. Compliance with these standards ensures that products meet safety, efficacy, and regulatory requirements.

�� European Standard (EN)
An EN is a standard developed by CEN (European Committee for Standardization) or CENELEC (European Committee for Electrotechnical Standardization) that applies across Europe. While not inherently legally mandatory, EN standards often become de facto mandatory when referenced by European regulations or directives, facilitating trade and ensuring safety and interoperability within the European Single Market.

�� Being a visual learner but terrible at drawing, I tried to depict this relationship in the diagram provided above.

�� Sources :

ISO Standards
IEC Standards
EN Standards

Update on ISO/IEC Standards in MedTech

Thu, 20 Jun 2024 16:57:16 GMT

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Amidst the wave of standards in the AI domain and the intense focus on AI regulation, key developments specific to the MedTech sector may have slipped under the radar.

Here are is a distilled overview of five work items in the domain of medical devices that warrant your attention! ��

�� IEC 62304: This cornerstone standard for Medical Device Software (MDSW) has been approved for revision by a newly formed IEC Maintenance Group (MT). Considered long-overdue by some, this should be on the radar of anyone working with MDSW.

�� ISO/TS 24971-2: Offering guidance on the application of Risk Management (i.e., ISO 14971) to AI-enabled medical devices, this new Technical Specification (TS) is based on previous guidance developed in collaboration between AAMI and BSI and is developed in a Joint Working Group (JWG) between ISO and IEC.

�� IEC/TS 62366-2: Recognized as a guidance in the application of Usability Engineering to Medical Devices, this document—presently a Technical Report (TR)—was recently approved for revision which includes the conversion into a Technical Specification (TS).

�� ISO/AWI 18969: Currently being developed in a Working Group (WG) under ISO, this standard is aimed to be the first covering the highly complex domain of Clinical Evaluation within the MedTech industry, making it one of the more anticipated work items on the list.

�� ISO/IEC AWI TR 18988: The scope of this new Technical Report (TR) includes the identification of processes, factors, concepts, and terms related to AI in health informatics.

The prevalent use of abbreviations in standardisation may serve expert members but can make the work surrounding standardization seem like a 'black box' to people outside the committees. If this post has sparked your curiosity, you might wonder:

��What is the difference between a Technical Specification (TS), Technical Report (TR) and a International Standard (IS) and how does it affect compliance?
��Where is this work undertaken and how does one get involved?
��What is the difference between a Maintenance Group (MT), Joint Working Group (JWG) a regular Working Group (WG)?

In a hope to lessen the ambiguity surrounding this work and promote broader understanding, I plan to address these questions and others in upcoming posts - some of which will be in collaboration with Danish Standard and other industry stakeholders. I hope to see you contribute in the comments and join the forthcoming discussions! ��️

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🌐 Understanding Standards 🌐

What is the difference between a 'TR', 'TS', 'IS' and 'EN? ��

Update on ISO/IEC Standards in MedTech

This is a subtitle for your new post