Projekti

Medical electrical equipment -- Part 2-97: Particular requirements for basic safety and essential performance of respiratory home high-flow therapy equipment

20.99   Prednacrt standarda prihvata se kao nacrt standarda

Amendment 1 - Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

50.00   Evidentiranje podataka o definitivnom tekstu nacrta standarda

Amendment 1 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

50.60   Završetak postupka odobravanja definitivnog teksta nacrta standarda

Medical electrical equipment — Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

40.60   Završetak javne rasprave

Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers

40.60   Završetak javne rasprave

Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

40.60   Završetak javne rasprave

Medical electrical equipment — Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment — Amendment 1

40.99   Nacrt standarda prihvata se kao definitivni tekst nacrta standarda

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

40.20   Nacrt na javnoj raspravi 60 dana

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

40.20   Nacrt na javnoj raspravi 60 dana

Medical electrical equipment — Part 2-86: Particular requirements for the basic safety and essential performance of electrocardiographs, including diagnostic equipment, monitoring equipment, ambulatory equipment, electrodes, cables and leadwires

40.00   Dopunjavanje i evidentiranje podataka o nacrtu standarda

Part 4-1: Guidance and interpretation – Medical electrical equipment and medical electrical systems employing a level of autonomy

20.99   Prednacrt standarda prihvata se kao nacrt standarda

Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a level of autonomy

20.00   Novi projekat upisuje se u plan rada komisije za standarde

Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts

30.60   Završetak izjašnjavanja o nacrtu komisije standarda

Health software and health IT systems safety, effectiveness and security - Part 4-1 Application of risk management in the Implementation and Clinical Use

20.99   Prednacrt standarda prihvata se kao nacrt standarda

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

20.99   Prednacrt standarda prihvata se kao nacrt standarda

Interpretation Sheet 2 - Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle

00.99   Predlog novog projekta se prihvata

Health software and health IT systems safety, effectiveness and security - Part 5-2: Security Risk Management for Manufacturers

20.99   Prednacrt standarda prihvata se kao nacrt standarda

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

10.99   Novi projekat se prihvata