Robotics and autonomous systems

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IEC 80601-2-78 ED2 Medical electrical equipment - Part 2-78

IEC 80601-2-78 ED2 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation. 

In the medium term, IEC 80601‑2‑78 Ed.2 will serve as the basis for a corresponding European standard that can be harmonised under the MDR. This will support European SMEs by providing a recognised and authoritative framework for demonstrating conformity. As a result, companies can reduce the time and cost associated with regulatory approval, improve the quality and consistency of their technical documentation, and accelerate their access to the European market

 

Burkhard Zimmermann

Description of Activities

Leading IEC SC62 D JWG 36 and support IEC SC62A JWG 9 as an expert

Country
Switzerland
Fellow's country
Open Call
Organisation type
Organization
Congenius AG
Portrait Picture
Burkhard
Proposal Title
Leading IEC SC62 D JWG 36 and support IEC SC62A JWG 9 as an expert
Role in SDO
Standards Development Organisation
Topic
Robotics
StandICT.eu Year
2029
Year

Jan Veneman

Country
Switzerland
Impact on SMEs (8th Open Call)
Europe hosts a vibrant ecosystem of start-ups and SMEs developing rehabilitation robots - systems that support relearning functional movement after neurological injury or disease. Under the EU Medical Device Regulation (MDR), manufacturers must demonstrate compliance with the state of the art for safety and performance. For devices within scope, IEC 80601-2-78 has become the key benchmark for basic safety and essential performance of rehabilitation robots. Following publication of the first edition (2019), the joint working group initiated a second edition revision to incorporate early implementation feedback and advances in technology. As this revision progresses toward Committee Draft closure, small manufacturers can expect clearer, more practicable requirements, reducing ambiguity in design inputs, verification planning, and conformity assessment. In parallel, IEC 60601-4-1 (Technical Report) provides a shared framework to characterize and manage degrees of autonomy in medical electrical equipment and systems. current development practices with where general safety requirements are heading.
Overall, these initiatives close critical gaps for European SMEs by clarifying expectations around robotic and AI-enabled rehabilitation devices, helping them accelerate safe market access, contain compliance costs, and remain competitive across EU and global markets.
Impact on society (8th Open Call)
Rehabilitation robotics are among the earliest real-world uses of medical robots and have paved the way for broader adoption of robotics and AI in healthcare and daily living environments with vulnerable users. Clear, harmonised safety requirements and reproducible test methods
are essential - not only to protect patients and clinicians, but also to give manufacturers and providers the confidence to deploy these technologies responsibly. By codifying “state-of the-art” expectations, the standards framework enables innovation while safeguarding users.
Societal benefits enabled by robust standards include:
Patient safety and dignity: Defined limits, fail-safe behaviours, and human–robot interaction requirements reduce the risk of harm and ensure predictable performance in rehabilitation settings.
Healthcare access: Standardised safety/performance criteria help scale high-quality therapy beyond specialised centres, supporting adoption in regional hospitals and community care.
Clinician support and quality of care: Reliable, well-tested systems can deliver high-dose, repeatable training while reducing therapist physical strain, freeing time for complex clinical tasks.
Public trust and uptake: Transparent, consensus-based requirements underpin procurement, reimbursement, and clinical guidelines—building societal confidence in robotic care.
Innovation with accountability: Clear targets shorten development cycles, lower compliance ambiguity for SMEs, and focus competition on outcomes and usability rather than ad-hoc safety interpretations.
The degree-of-autonomy guidance further generalises these protections to any medical product using robotic or AI technologies. By providing a common language for autonomy levels and the associated safety controls and human oversight, it supports ethically aligned, trustworthy deployment of AI-enabled medical devices across care pathways, from clinics to homes.
Open Call
Organisation type
Organization
Hocoma Medical GmbH
Portrait Picture
Jan Veneman
Proposal Title (8th Open Call)
Participation in IEC TC 62/SC 62D/JWG 35/36 and TC 62/SC 62A/JWG 9 (Medical Robots and Medical AI)
Standards Development Organisation
StandICT.eu Year
2029
Year
Topic (8th Open Call)

Morten Kühnrich

Country
Denmark
Open Call
Organization
4XRobots
Portrait Picture
Morten Kühnrich
Proposal Title (8th Open Call)
Robotics — Electrical interfaces — Connectivity interoperability for End-effectors
Standards Development Organisation
Topic (8th Open Call)

Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance

IEC 60068-2-64:2008+A1:2019 demonstrates the adequacy of specimens to resist dynamic loads without unacceptable degradation of its functional and/or structural integrity when subjected to the specified random vibration test requirements. Broadband random vibration may be used to identify accumulated stress effects and the resulting mechanical weakness and degradation in the specified performance. This information, in conjunction with the relevant specification, may be used to assess the acceptability of specimens. This standard is applicable to specimens which may be subjected to vibration of a stochastic nature resulting from transportation or operational environments, for example in aircraft, space vehicles and land vehicles. It is primarily intended for unpackaged specimens, and for items in their transportation container when the latter may be considered as part of the specimen itself. However, if the item is packaged, then the item itself is referred to as a product and the item and its packaging together are referred to as a test specimen. This standard may be used in conjunction with IEC 60068-2-47:2005, for testing packaged products. If the specimens are subjected to vibration of a combination of random and deterministic nature resulting from transportation or real life environments, for example in aircraft, space vehicles and for items in their transportation container, testing with pure random may not be sufficient. See IEC 60068-3-8:2003 for estimating the dynamic vibration environment of the specimen and based on that, selecting the appropriate test method. The major changes with regard to the previous edition concern the removal of Method 1 and Method 2, replaced by a single method, and replacement of Annex A with suggested test spectra and removal of Annex C. Also included in this revision is the testing of soft packed specimens.

IEC 60068-2-64:2008+A1:2019

German Standardization Roadmap Industrie 4.0, Version 4

A Strategic and technically oriented document in which describes the current development status of Industrie 4.0, outlines the requirements for standards, specifications and industry standards, and provides impetus for successful implementation.

Digital Enhanced Cordless Telecommunications (DECT); Study on URLLC use cases of vertical industries for DECT evolution and DECT-2020

Presents a study of use cases and vertical scenarios for Ultra-Reliable Low-Latency Communications (URLLC) intended to be used as base requirements for evolving DECT. Applications / Use Cases include Home and Building Automation, including Smart Living; Industry automation - Factories of the Future, Industry 4.0; Mobile robots

ETSI TR 103 515

ETSI Technology Radar

The document provides an overview of ETSI activities linked to StandardizationNeeds in the area of "Robotics and Autonomous Systems" (RAS), referred to as a “multidisciplinary scientific and technological domain for implementing complex systems with cognitive capabilities” (see the EU ICT Standardization Rolling Plan)

ETSI White Paper No. 45

IoT LSP use cases and standards gaps

Contains Gap analysis in the context of Smart Manufacturing with respect to Standards Gaps. Proposes some recommendations to overcome potential gaps. Particular attention will be paid on horizontal application layer standardization and to assure an interworking framework among different vertical industrial segments

ETSI TR 103 376