Projects

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

40.99   Full report circulated: DIS approved for registration as FDIS

Medical electrical equipment - Part 2-xx: Particular requirements for basic safety and essential performance of non-invasive arterial tonometer equipment

20.99   WD approved for registration as CD

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

20.99   WD approved for registration as CD

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

50.00   Final text received or FDIS registered for formal approval

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

50.60   Close of voting. Proof returned by secretariat

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

40.60   Close of voting

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

40.60   Close of voting

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   Close of voting

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

40.99   Full report circulated: DIS approved for registration as FDIS

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

40.20   DIS ballot initiated: 12 weeks

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   DIS ballot initiated: 12 weeks

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

40.20   DIS ballot initiated: 12 weeks

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

20.99   WD approved for registration as CD

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

20.00   New project registered in TC/SC work programme

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

30.60   Close of voting/ comment period

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

30.20   CD study/ballot initiated

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

20.99   WD approved for registration as CD

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   Approval to ballot proposal for new project