๐ฌ ๐๐๐ฐ ๐๐ฎ๐ซ๐จ๐ฉ๐๐๐ง ๐๐ญ๐๐ง๐๐๐ซ๐ ๐๐ง๐ก๐๐ง๐๐๐ฌ ๐๐๐๐๐ญ๐ฒ ๐๐จ๐ซ ๐๐๐๐ข๐๐๐ฅ & ๐๐๐ฌ๐ญ๐ก๐๐ญ๐ข๐ ๐๐ข๐ ๐ก๐ญ-๐๐จ๐ฎ๐ซ๐๐ ๐๐๐ฏ๐ข๐๐๐ฌ. EN IEC 60601-2-57:2026 - the European standard specifying essential safety and performance requirements for non-laser light source equipment used in medical, diagnostic, therapeutic, monitoring and cosmetic/aesthetic applications - has been published! This standard adopts the latest international text and adds European-specific annexes to align it with the EU Medical Device Regulation (MDR), providing a clear pathway for manufacturers to demonstrate conformity in the EU market. ๐ Why it matters: โข Sets up-to-date safety and performance requirements for devices using non-laser optical radiation (e.g., LED and other light sources). โข Improves risk classification and hazard communication to protect patients and operators. โข Harmonises European and international regulatory expectations, supporting wider market access. ๐๐ก๐ข๐ฌ ๐ข๐ฌ ๐๐ง ๐ข๐ฆ๐ฉ๐จ๐ซ๐ญ๐๐ง๐ญ ๐ฌ๐ญ๐๐ฉ ๐ข๐ง ๐๐ง๐ฌ๐ฎ๐ซ๐ข๐ง๐ ๐ญ๐ก๐๐ญ ๐ฅ๐ข๐ ๐ก๐ญ-๐๐๐ฌ๐๐ ๐ฆ๐๐๐ข๐๐๐ฅ ๐๐ง๐ ๐๐๐ฌ๐ญ๐ก๐๐ญ๐ข๐ ๐ญ๐๐๐ก๐ง๐จ๐ฅ๐จ๐ ๐ข๐๐ฌ ๐ซ๐๐ฆ๐๐ข๐ง ๐ฌ๐๐๐, ๐๐๐๐๐๐ญ๐ข๐ฏ๐ ๐๐ง๐ ๐ญ๐ซ๐ฎ๐ฌ๐ญ๐ฐ๐จ๐ซ๐ญ๐ก๐ฒ ๐๐จ๐ซ ๐๐ฅ๐ข๐ง๐ข๐๐ข๐๐ง๐ฌ ๐๐ง๐ ๐ฎ๐ฌ๐๐ซ๐ฌ ๐๐ฅ๐ข๐ค๐. Read more: https://lnkd.in/ecMihNvU hashtag#TrustStandards hashtag#ENinthespotlight
New EN IEC 60601-2-57!๐ฌ
The new European standard sets updated safety & performance requirements for non-laser light source equipment used in medical & aesthetic applications, aligning with EU MDR.
Read more: lnkd.in/ecMihNvU
#TrustStandards #ENinthespotlight