Medical electrical equipment - Basic requirements for cybersecurity
Industry standard on basic cybersecurity requirements for medical electrical equipment. A regulator's review specification for Class II standalone software lists it among its references.
The text of this standard is sold by China industry standard (YY) and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
No market listing is published yet.
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: IEC 81001-5-1, JIS T 81001-5-1, ISO/IEC 29147, ISO/IEC 30111, ISO/IEC 27001, IEC 80001-5-1, AAMI TIR57, ANSI/CAN/UL 2900-1, ANSI/CAN/UL 2900-2-1, IEC 80001-1. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.