Vážení zákazníci, v letošním roce budeme expedovat poslední objednávky ve středu 18. 12. 2024.

Těšíme se s vámi na shledanou od pondělí 06. 01. 2025.

 

Cena s DPH / bez DPH
Hlavní stránka>PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
Sponsored link
sklademVydáno: 2017-06-23
PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy

PD IEC/TR 60601-4-1:2017

Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy

Formát
Dostupnost
Cena a měna
Anglicky Zabezpečené PDF
K okamžitému stažení
10230 Kč
Čtěte normu po dobu 1 hodiny. Více informací v kategorii E-READING
Čtení normy
na 1 hodinu
1023.00 Kč
Čtěte normu po dobu 24 hodin. Více informací v kategorii E-READING
Čtení normy
na 24 hodin
3069.00 Kč
Anglicky Tisk
Skladem
10230 Kč
Označení normy:PD IEC/TR 60601-4-1:2017
Počet stran:84
Vydáno:2017-06-23
ISBN:978 0 580 84736 3
Status:Standard
Popis

PD IEC/TR 60601-4-1:2017


This standard PD IEC/TR 60601-4-1:2017 Medical electrical equipment is classified in these ICS categories:
  • 11.040.01 Medical equipment in general
  • 33.160.30 Audio systems
IEC TR 60601-4-1:2017(E) is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy (DOA).
This document provides a definition of DOA of MEE or MES and a medical robot, and also provides guidance on:
- methodologies to perform the risk management process and usability engineering for an MEE or MES with a DOA;
- considerations of basic safety and essential performance for an MEE and MES with a DOA; and
- identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and
- distinguishing between medical robots, and other MEE and MES.
Unless specified otherwise, this document considers MEE and MES together.
The manufacturer of an MEE or MES with a DOA is expected to design and manufacture an MEE or MES that fulfils its intended use and does not have unacceptable risk throughout its life-cycle.
This document provides guidance to help the manufacturer in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES with DOA. The document is also intended as guidance for future standard writers.
There are no prerequisites to this document.