Standards Development

Scope

NOTE 1 There is guidance or rationale for this Clause contained in Clause AA.2.1.

IEC 60601‑1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:

NOTE 2 The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.

201.1.1 Scope

IEC 60601-1:2005+AMD1:2012, 1.1 is replaced by:

This document applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as ME equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document only applies to all electrical clinical thermometers that are used for measuring the temperature of patients.

This document is also applicable to those accessories intended by their manufacturer to be connected to the clinical thermometer, where the characteristics of those accessories can affect the basic safety or essential performance of the clinical thermometer.

EXAMPLE 1         Probes, probe cable extenders and probe covers.

Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME systems. This document does not apply to auxiliary equipment.

ME equipment that measures the temperature of a patient is within the scope of this document.

EXAMPLE 2 ME equipment using accessories such as a pulmonary artery catheter for the determination of cardiac output by thermodilution is in the scope of this document if it displays a temperature.

EXAMPLE 3 ME equipment using accessories such as a Foley catheter that includes a temperature probe is in the scope of this document.

This document does not specify requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of humans under indoor environmental conditions, whose laboratory accuracy requirements are described in IEC 80601‑2‑59[4].

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.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1.

NOTE Additional information can be found in IEC 60601–1:2005+AMD1:2012, 4.2.

201.1.2 Object

Replacement:

The object of this particular document is to establish particular basic safety and essential performance requirements for a clinical thermometer, as defined in 201.3.205, and its accessories.

NOTE Accessories are included because the combination of the clinical thermometer and the accessories needs to be safe and effective. Accessories can have a significant impact on the basic safety and essential performance of a clinical thermometer.

201.1.3 Collateral standards

IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.3 applies with the following addition:

Addition (add after existing text):

This document refers to those applicable collateral standards that are listed in general standard, as well as 201.2 of this document.

IEC 60601‑1‑2:2014+AMD1:2020, IEC 60601‑1‑6:2010+AMD1:2013+AMD2:2020, IEC 60601‑1‑8:2006+AMD1:2012, IEC 60601‑1‑11:2015+AMD1:2020 and IEC 60601‑1‑12::2014+AMD1:2020 apply as modified in Clauses 202, 206, 208, 211 and 212, respectively. IEC 60601‑1‑3[5] does 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 define basic safety and essential performance requirements, and may modify, replace or delete requirements contained in the general standard as appropriate for the particular ME equipment under consideration.

A requirement of a document takes priority over the general standard and its collateral standards.

For brevity, IEC 60601‑1:2005+AMD1:2012+AMD2:2020 is referred to in this document as the general standard. Collateral standards are referred to by their document number.

The numbering of sections, 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 60601-1-2 collateral standard, 206.4 in this document addresses the content of Clause 4 of the 60601-1-6 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 particular 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.

Clauses, subclauses or figures which are additional to those of the general standard are numbered starting from 201.101, Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Clauses, subclauses or figures 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, 206 for IEC 60601‑1‑6, etc.

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

Where there is no corresponding section, clause or subclause in this document, the section, 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.