Medical electrical equipment – Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems Amendment 1
|Publication Date:||1 May 2006|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
In response to requests for harmonization between the current European and International standards for anaesthetic workstations this standard has been developed by the IEC/ISO Joint Working Group to specify requirements for ANAESTHETIC SYSTEMS supplied complete, as well as requirements for individual devices which are intended to be part of an ANAESTHETIC SYSTEM. It applies in conjunction with IEC 60601-1:1988 (Including all amendments) hereafter referred to as the General Standard. As stated in 1.3 of IEC 60601-1-1988, the requirements in this standard take priority over those of the General Standard.
This standard has been structured to allow USERS to configure an ANAESTHETIC SYSTEM in conformance with professional guidelines and to meet the needs of their clinical practice. In order to achieve this aim, the standard identifies particular requirements pertinent to specific devices, and to their associated MONITORING DEVICE(S), ALARM SYSTEM(s) and PROTECTION DEVICE(S), and defines the interfaces. This standard also specifies requirements for optional devices, together with their respective MONITORING DEVICE(S), ALARM SYSTEM(S) and PROTECTION DEVICE(S).
The indicated requirements are followed by specifications for the relevant tests. An asterisk (*) denotes clauses for which there is a rationale comment in Annex AA. It is considered that knowledge of the reasons for these requirements will facilitate the proper application of the standard and be of use in any revision that may be necessitated by changes in clinical practice or as a result of developments in technology.
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