BS EN ISO 80601-2-55:2018

This standard BS EN ISO 80601-2-55:2018 Medical electrical equipment is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

IEC 60601-1:2005+Amd 1:2012, Clause 1 applies, except as follows:

201.1.1 *Scope

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

This document specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient.

This document specifies requirements for

• anaesthetic gas monitoring,

• carbon dioxide monitoring, and

• oxygen monitoring.

NOTE 1 An rgm can be either stand-alone me equipment or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator.

This document is not applicable to an RGM intended for use with flammable anaesthetic agents.

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+Amd 1:2012, 7.2.13 and 8.4.1.

NOTE 2 Additional information can be found in IEC 60601-1:2005+Amd 1:2012, 4.2.

201.1.2 Object

IEC 60601-1:2005+Amd 1:2012, 1.2 is replaced by:

The object of this document is to establish particular basic safety and essential performance requirements for an rgm (as defined in 201.3.210) and its accessories.

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

201.1.3 Collateral standards

IEC 60601-1:2005+Amd 1:2012, 1.3 applies with the following addition:

This document refers to those applicable collateral standards that are listed in IEC 60601-1:2005+Amd 1:2012, Clause 2, as well as those listed in 201.2 of this document and to the following exceptions:

IEC 60601-1-3:2008 and IEC 60601-1-9:2007+Amd 1:2013 do not apply.

201.1.4 Particular standards

IEC 60601-1:2005+Amd 1:2012, 1.4 is replaced by:

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

A requirement of a particular standard takes priority over IEC 60601-1:2005+Amd 1:2012 or the collateral standards.

For brevity, IEC 60601-1:2005+Amd 1:2012 is referred to in this 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 those 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 “2xx” where xx is the final digits of the collateral standard document number (e.g. 202.4 addresses the content of IEC 60601-1-2, Clause 4 collateral standard, 208.4 addresses the content of IEC 60601-1-8, Clause 4 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 IEC 60601-1:2005+Amd 1:2012 or the 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 IEC 60601-1:2005+Amd 1:2012 or the applicable collateral standard.

• “Amendment” means that the clause or subclause of IEC 60601-1:2005+Amd 1:2012 or the applicable collateral standard is amended as indicated by the text of this document.

Subclauses or figures that 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.

Subclauses or figures that 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 standard” is used to make reference to IEC 60601-1:2005+Amd 1:2012, any applicable collateral standards, and this document taken together.

Where there is no corresponding clause or subclause in this document, the clause or subclause of IEC 60601-1:2005+Amd 1:2012 or the applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601-1:2005+Amd 1:2012 or the applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this document.