Projekti

Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

90.92   Odluka o izmeni ili reviziji standarda

Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment — Amendment 1

60.60   Standard objavljen

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

90.92   Odluka o izmeni ili reviziji standarda

Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation — Amendment 1

60.60   Standard objavljen

Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle

60.60   Standard objavljen

Medical devices – Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence

40.99   Nacrt standarda prihvata se kao definitivni tekst nacrta standarda

<em>Medical devices – Guidance </em><em>on the application of ISO 14971 – Part 3: Combination products</em>

20.99   Prednacrt standarda prihvata se kao nacrt standarda

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - General requirements (Fragment 1)

20.99   Prednacrt standarda prihvata se kao nacrt standarda

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Ionizing radiation hazards (Fragment 10)

30.20   Početak izjašnjavanja o nacrtu komisije standarda

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Electromagnetic exposure hazards (Fragment 11)

30.20   Početak izjašnjavanja o nacrtu komisije standarda

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Electromagnetic disturbances hazards (Fragment 12)

30.20   Početak izjašnjavanja o nacrtu komisije standarda

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Physical environment hazard (Fragment 2)

20.99   Prednacrt standarda prihvata se kao nacrt standarda

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - User interface hazards (Fragment 3)

20.99   Prednacrt standarda prihvata se kao nacrt standarda

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Materials hazards (Fragment 4)

20.99   Prednacrt standarda prihvata se kao nacrt standarda

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - PEMS related hazards (Fragment 5)

30.20   Početak izjašnjavanja o nacrtu komisije standarda

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Electrical hazards (Fragment 6)

30.20   Početak izjašnjavanja o nacrtu komisije standarda

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Mechanical hazards (Fragment 7)

30.20   Početak izjašnjavanja o nacrtu komisije standarda

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Thermal and fire hazards (Fragment 8)

30.20   Početak izjašnjavanja o nacrtu komisije standarda