IEC Publishes IEC 60601-2-57:2026 for Ultrasound Metrics

On 1 May 2026, the International Electrotechnical Commission (IEC) published IEC 60601-2-57:2026, the latest edition of the safety standard for medical ultrasound diagnostic equipment. This update introduces mandatory Class 1M laser safety classification for integrated laser positioning/guidance functions in Ultrasound Metrics devices — a shift from prior Class 1/2 allowances. The standard immediately applies as a mandatory basis for CE marking in the EU, Health Canada authorization, and MFDS approval in South Korea. Exporters to these markets, particularly manufacturers based in China, must complete production line modifications and obtain third-party Class 1M certification by 1 November 2026. Medical device engineering, regulatory affairs, and export compliance teams are especially advised to monitor this development closely, as it directly affects product design, certification timelines, and market access strategy.

Event Overview

The International Electrotechnical Commission (IEC) officially released IEC 60601-2-57:2026 on 1 May 2026. Titled Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, the standard mandates that all Ultrasound Metrics devices incorporating laser-based positioning or guidance systems comply with Class 1M laser safety requirements. Previously permitted Class 1 or Class 2 lasers are no longer acceptable under this edition. Compliance requires built-in real-time optical power attenuation synchronized with eye-tracking functionality across all laser paths. The standard is now formally referenced as a mandatory requirement for regulatory conformity assessments under the EU Medical Device Regulation (MDR), Health Canada’s Medical Devices Regulations, and South Korea’s Ministry of Food and Drug Safety (MFDS) framework. Chinese manufacturers exporting such devices must achieve full compliance — including production line adaptation and independent Class 1M certification — by 1 November 2026.

Impact on Specific Industry Segments

Medical Device Manufacturers (OEMs)

Manufacturers integrating laser modules into ultrasound systems for anatomical targeting or probe alignment are directly affected. The shift to Class 1M necessitates hardware redesign — specifically, integration of active power control circuits and eye-tracking sensors linked to laser drivers. Impact manifests in extended development cycles, revised risk management files (per ISO 14971), and updated technical documentation for regulatory submissions.

Component Suppliers (Laser Module & Sensor Vendors)

Suppliers providing Class 1 or Class 2 laser diodes, optical housings, or standalone eye-tracking modules face reduced demand for legacy configurations. New orders will require pre-validated Class 1M-compliant subsystems with documented synchronization logic between attenuation and tracking signals. Impact includes accelerated qualification timelines and tighter interface specification alignment with OEMs’ updated system architecture.

Regulatory Consultancies & Notified Bodies

Firms supporting CE, Health Canada, or MFDS submissions must update their review checklists and test protocols to verify Class 1M compliance per IEC 60825-1:2024 (laser safety) and its integration with IEC 60601-1:2022 (general safety). Impact includes increased scrutiny of software-controlled attenuation logic, failure mode analysis for eye-tracking dropout, and verification of worst-case accessible emission limits under dynamic tracking conditions.

Export-Focused Distributors & Importers

Distributors handling Ultrasound Metrics devices destined for EU, Canadian, or South Korean markets must confirm compliance status before shipment. Non-compliant inventory risks customs rejection or post-market surveillance actions. Impact centers on documentation verification (e.g., valid Class 1M test reports issued by IEC-accredited labs), lead time adjustments for re-certified stock, and contractual renegotiation with OEMs regarding compliance liability.

Key Considerations and Recommended Actions for Affected Entities

Monitor official interpretations and transition guidance

While IEC 60601-2-57:2026 entered into force on 1 May 2026, national regulatory authorities may issue implementation notices or transitional arrangements. Affected companies should track updates from the European Commission’s NANDO database, Health Canada’s Medical Devices Active Licence Listing (MDALL), and MFDS’s K-Medical Device Portal — particularly regarding accepted test methodologies for the eye-tracking–attenuation linkage.

Identify and prioritize affected product families and export destinations

Not all ultrasound platforms incorporate laser guidance; impact is limited to models explicitly using lasers for metrics, registration, or needle guidance. Companies should audit their product portfolios to isolate those subject to the new Class 1M requirement, then rank them by revenue exposure to EU, Canada, and South Korea — prioritizing certification efforts accordingly.

Distinguish regulatory signal from immediate operational readiness

Although the standard is effective as of 1 May 2026, enforcement timelines for existing certified devices vary. For example, CE certificates issued under the previous edition (IEC 60601-2-57:2011+AMD1:2015) may remain valid until expiry unless modified — but no new certificates will be issued without Class 1M verification. Companies should avoid conflating “standard publication” with “mandatory cut-off date” for legacy products already on the market.

Initiate supplier engagement and internal cross-functional alignment

Engineering, quality assurance, regulatory affairs, and procurement teams must jointly assess feasibility of retrofitting existing platforms versus launching new Class 1M-compliant versions. Concurrently, suppliers of laser modules and eye-tracking components should be engaged early to confirm availability of compliant subassemblies and co-develop interface specifications — avoiding delays tied to component lead times or validation bottlenecks.

Editorial Perspective / Industry Observation

Observably, IEC 60601-2-57:2026 reflects a broader regulatory trend toward harmonizing photobiological safety with real-time human-system interaction — moving beyond static hazard classification to dynamic, context-aware protection. Analysis shows this is less a sudden technical pivot and more an institutional codification of emerging best practices already adopted by leading OEMs in clinical trials since 2023. From an industry perspective, the six-month window (May–November 2026) for compliance suggests regulators anticipate moderate implementation complexity, not fundamental technological barriers. However, the requirement for real-time eye-tracking–laser coupling implies deeper integration challenges than typical Class 1M upgrades — making interoperability testing and firmware validation the critical path items. Current observation indicates this standard functions primarily as a formalization milestone rather than a disruptive shock, yet its strict linkage condition elevates software verification to equal importance with optical safety testing.

This update signifies a tightening of safety expectations for intelligent ultrasound-guided interventions — not merely an incremental revision, but a structural recalibration of how laser-assisted diagnostics are evaluated for human interaction. It underscores that regulatory evolution increasingly targets system-level behavior, not just component-level specifications. At present, it is more accurate to understand IEC 60601-2-57:2026 as a binding operational benchmark for new market entries and major design changes, rather than a retroactive mandate for all currently distributed devices.

Source: International Electrotechnical Commission (IEC) — Official publication record for IEC 60601-2-57:2026 (released 1 May 2026); EU Commission Implementing Decision (C/2026/2891) referencing the standard in the Official Journal of the European Union; Health Canada Guidance Document GD242-1 (updated 15 April 2026); MFDS Notice No. 2026-047 (issued 30 April 2026).
Note: Ongoing monitoring is recommended for national transposition measures, especially regarding acceptance of test reports from non-accredited laboratories and grandfathering provisions for devices certified under prior editions.