BS EN ISO 80601-2-55:2011

Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors | Status: Superseded, Withdrawn

1 Scope

201.1 Scope, object and related standards

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

201.1.1 * Scope

Replacement: This International Standard specifies particular requirements for the basicsafety and Essentialperformance of a respiratorygasmonitor (rgm), hereafter referred to as me equipment, intended for continuousoperation for use with a patient. This International Standard specifies requirements for

• — anaesthetic gas monitoring,
• — carbon dioxide monitoring, and
• — oxygen monitoring.

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

This International Standard is not applicable to an rgm intended for use with flammable anaesthetic agents. Environmental aspects are addressed in Annex BB.

NOTE 2 Additional aspects of environmental impact are addressed in ISO 14971 and IEC 60601-1-9.

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 standard are not covered by specific requirements in this particular standard, except in 7.2.13 and 8.4.1 of the general standard (IEC 60601-1).

NOTE 3 See also 4.2 of the general standard.

201.1.2 Object

Replacement: The object of this particular standard is to establish particular basicsafety and essentialperformance 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 basicsafety and essentialperformance of an rgm.

201.1.3 Collateral standards

Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-3 does not apply.

201.1.4 Particular standards

Subclause 1.4 of the general standard is replaced by: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard as appropriate for the particular me equipment under consideration, and may add other basicsafety and essentialperformance requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this particular standard 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 particular standard addresses the content of Clause 4 of the IEC 60601-1-2:2007 collateral standard, 206.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-6:2010 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 standard. “Addition” means that the text of this particular standard 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 particular standard. 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. 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 60601-1-2:2007, 203 for IEC 60601-1-3:2008, etc. The term “this standard” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding section, clause or subclause in this particular standard, 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 particular standard.