の上 27 February 2026, CENELEC published a new European safety standard covering non-laser light source equipment used in medical and aesthetic applications. The standard aligns safety and performance requirements with EU Medical Device Regulation (MDR 2017/745) 適用範囲は 1 January 2026. It affects manufacturers of professional-use devices emitting ultraviolet (UV), visible, or infrared (IR) radiation from sources such as LEDs and lamps, excluding lasers.
アップデートの詳細
The standard establishes essential safety and performance requirements for optical radiation devices used in therapeutic, diagnostic, monitoring, and aesthetic procedures. It introduces enhanced risk group classification, hazard labeling, そして operator instructions to mitigate risks including skin burns and eye damage.
Manufacturers must document risk group classification for all covered optical radiation sources and ensure uniform light output verification. High-risk devices are required to carry durable hazard labeling with exposure information and include clear instructions on protective measures for operators.
The scope is limited to professional-use equipment and explicitly excludes home-use appliances and sunbeds.
Alignment with EU MDR
Devices compliant with the standard benefit from presumption of conformity to EU MDR requirements starting in January 2026. Manufacturers of clinical phototherapy systems, diagnostic imaging devices, monitoring equipment, and aesthetic devices using non-laser optical radiation must align technical documentation and labeling practices to maintain EU market access.
発効日
The standard EN IEC 60601-2-57:2026 enters into force on 1 January 2026, establishing formal compliance requirements for non-laser light source medical and aesthetic equipment in the European Union.
なぜそれが重要なのか
This update provides regulatory clarity by harmonizing safety expectations for non-laser optical radiation devices under the EU MDR framework. It supports technical and digital alignment through standardized verification and documentation requirements, enhances operational efficiency, and maintains a neutral regulatory burden for manufacturers already operating under MDR obligations.
誰に関係があるか
このアップデートは、 Regulatory Affairs, Quality Assurance, R&D, Engineering, and IT teams responsible for product design, risk management, technical documentation, and MDR compliance of optical radiation-based medical and aesthetic devices.
次のステップ
Regulatory teams should assess current product portfolios against the new standard, review risk classification and labeling practices, そして coordinate with R&D and quality teams to ensure technical documentation and instructions for use support MDR presumption of conformity.
As organizations prepare for the application of this new CENELEC standard, RegASK helps teams stay ahead of evolving EU safety requirements. RegASK は、消費財やライフサイエンスなどの規制の厳しい分野のグローバル組織が複雑な規制環境に積極的に対応できるようにする、主要なエージェント AI 規制インテリジェンスおよびワークフロー オーケストレーション プラットフォームです。. 高度なエージェントAIと専門家の協力を組み合わせることで、, RegASK タイムリーな予測的かつ実用的な洞察とエンドツーエンドの自動化を提供し、コンプライアンス プロセスを合理化し、リスクを軽減し、160 か国以上で市場アクセスを加速します。. もっと詳しく知る または 今すぐデモを予約してください。
よくある質問
What is the new CENELEC standard for non-laser light source medical equipment?
It is a European safety standard published on 27 February 2026 that defines safety and performance requirements for professional-use medical and aesthetic devices emitting UV, visible, or IR radiation from non-laser sources.
When does EN IEC 60601-2-57:2026 take effect?
The standard takes effect on 1 January 2026.
Which devices fall under the scope of this standard?
It applies to professional-use medical and aesthetic equipment used in therapy, diagnostics, monitoring, and cosmetic procedures, excluding home-use devices and sunbeds.
How can RegASK support compliance with this standard?
RegASK チームは track applicable standards, assess MDR impact, and align documentation workflows, supporting efficient compliance with new EU safety and performance requirements.
