Scope and object
This clause of the General Standard applies except as follows:
Scope
Addition:
This Particular Standard specifies requirements for the safety, including essential performance, of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT, as defined in 2.101 and hereinafter referred to as EQUIPMENT, whether this EQUIPMENT is stand alone or part of a system. It applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth. It does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa).
1.2
Object Replacement: The object of this Particular Standard is to establish particular requirements for the safety, including essential performance, of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 2.101.
1.3
Particular standards Addition: This Particular Standard amends and supplements a set of IEC publications consisting of: IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety, amendment 1, amendment 2, IEC 60601-1-2:1993, Medical electrical equipment – Part 1: General requirements for safety – 2. Collateral Standard: Electromagnetic compatibility – Requirement s and tests and IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety – 4. Collateral Standard: Programmable electrical medical systems.
For brevity, IEC 60601-1 is referred to, in this Particular Standard, either as the General Standard or as the General Requirement(s).
The term this Standard covers the Particular Standard used together with the General Standard and any Collateral Standards.
The numbering of sections, clauses and subclauses of this Par ticular Standard corresponds with that of the General Standard. 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 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.
Amendment means that the clause or subclause of the General 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 101, additional annexes are lettered AA, BB, etc., and any additional items aa), bb), etc.
Clauses and subclauses for which there is a rationale are marked with an asterisk. These rationales can be found in an informative annex AA. Annex AA should be used in determining the relevance of the requirements addressed, but should never be used to establish additional test requirements.
Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard or Collateral Standard applies without modification.
Where it is intended that any part of the General Standard or Collateral Standard, although possibly relevant, is not to be app lied, a statement to that effect is given in this Particular Standard.
A requirement of this Particular Standard replacing or modifying requirements of the General Standard or Collateral Standard takes precedence over the corresponding General Requirement(s).
