BSI BS EN IEC 80601-2-59:2019

Clause 1 of the general standard² applies, except as follows:

201.1.1 Scope

Replacement:

This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME EQUIPMENT. This document sets laboratory characterization test limits for the SCREENING THERMOGRAPH.

NOTE 101 A SCREENING THERMOGRAPH is intended for screening of a human subject and detection of SKIN TEMPERATURE elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see ISO 80601‑2‑56 [30]).

NOTE 102 The main part of such equipment is commonly referred to as an infrared camera.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

201.1.2 Object

Replacement:

The object of this particular document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for SCREENING THERMOGRAPHS as defined in 201.3.209.

201.1.3 Collateral standards

Addition:

This particular document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this document.

• IEC 60601‑1‑2:2014, IEC 60601‑1‑6:2010 and IEC 60601‑1‑6:2010/AMD1:2013 apply as modified in Clauses 202 and 206 respectively.
• IEC 60601‑1‑3, IEC 60601‑1‑10, IEC 60601‑1‑11 and IEC 60601‑1‑12 do not apply.
• All other published collateral standards in the IEC 60601-1 series apply as published.

201.1.4 Particular standards

Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance requirements.

A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601‑1:2005 and IEC 60601‑1:2005/AMD1:2012 are referred to in this particular document as the general standard. Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this document corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”, where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of the IEC 60601‑1‑2 collateral standard, 203.4 in this document addresses the content of Clause 4 of the IEC 60601‑1‑3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:

• 'Replacement' means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this document.
• 'Addition' means that the text of this document is additional to the requirements of the general standard or applicable collateral standard.
• 'Amendment' means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this document.

Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‑1‑2, 203 for IEC 60601‑1‑3, etc.

The term 'this document' is used to make reference to the general standard, any applicable collateral standards and this particular document taken together.

Where there is no corresponding clause or subclause in this document, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this document.