1范围和目的本通用标准条款适用，但以下情况除外:*1.1范围补充:本特殊标准规定了2.101中定义的经皮分压监测设备（以下简称设备）的安全要求，包括基本性能，无论该设备是独立的还是系统的一部分。它适用于成人、儿童和新生儿使用的经皮监护仪，包括在分娩期间使用这些设备进行胎儿监护。它不适用于血红蛋白饱和度血氧仪或应用于皮肤以外的身体表面（例如结膜、粘膜）的装置。 1.2目标替换:本特定标准的目标是为2.101.1.3特定标准中定义的经皮分压监测设备的安全性（包括基本性能）制定特定要求。说明:本特定标准修订和补充了一套IEC出版物，包括:IEC 60601-1:1988，医用电气设备.第1部分:安全通用要求， 修改件1，修改件2，IEC 60601-1-2:1993，医用电气设备？第1部分:安全的一般要求-2。附带标准:电磁兼容性？要求和试验以及IEC 60601- 1-4:1996，医疗电气设备？第1部分:安全的一般要求-4。附带标准:可编程电气医疗系统。为简洁起见，在本特定标准中，IEC 60601-1被称为“通用标准”或“通用要求”。术语“本标准”包括与通用标准和任何附属标准一起使用的特殊标准。本特殊标准的章节、条款和子条款的编号与通用标准的编号一致。对通用标准文本的更改通过使用以下词语进行说明: “替换”是指通用标准的条款或子条款被本特定标准的文本完全替换。“增补”是指本特定标准的文本是对通用标准要求的补充。“修订”是指按照本特定标准的文本对通用标准的条款或子条款进行修订。通用标准中附加的子条款或数字从101开始编号，附加附件的字母为AA、BB等，以及任何附加项目AA）， bb）等。有理由的条款和子条款标有星号*。 这些原理可在资料性附录AA中找到。附录AA应用于确定 要求的相关性得到了解决，但决不能用于建立额外的测试要求。如果本特定标准中没有相应的章节、条款或子条款，则通用标准或附属标准的章节、条款或子条款适用，无需另行说明 修改如果打算不适用通用标准或附属标准的任何部分（尽管可能相关），则应在本专用条款中说明这一点 标准本特定标准的要求取代或修改通用标准或附属标准的要求优先于相应的通用要求。

1 Scope and objectThis clause of the General Standard applies except as follows:*1.1 ScopeAddition: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 ObjectReplacement: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 standardsAddition: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?Requirements 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 Particular 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 applied, 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).