请注意:此版本的所有临时修订版将在您购买时提供。1.1范围1。1本标准适用于医用电气设备的安全（定义见第2.2.15款）。尽管本标准主要关注安全，但它包含一些与安全相关的可靠运行要求。不考虑本标准涵盖的设备预期生理功能造成的安全危害。本标准中的附录不是强制性的，除非在正文中有明确说明。 1.1将1.1的第三段替换为以下内容:1.1不考虑本标准所涵盖设备的预期生理功能造成的安全危害。这些要求并不考虑对电离辐射或放射性同位素的防护进行调查。此类设备受联邦辐射标准（21CFR第1020部分）的约束，该标准根据1968年《健康与安全辐射控制法》颁布。1.2.1。2本标准的目的是规定医用电气设备安全的一般要求，并作为特殊标准安全要求的基础。 1.3*特殊标准1。3特定标准优先于本通用标准。1.4环境条件1。4见第二节。1.5抵押品标准1。5在IEC 601系列中，附属标准规定了适用于以下各项的一般安全要求:1。-一组医用电气设备（如放射设备）；2.-通用标准中未完全提及的所有医用电气设备的特定特性（例如电磁兼容性）。如果抵押品标准适用于特定标准，则特定标准优先于抵押品标准。

Please note: All interim revisions for this edition available at time of your purchase will be included.1.1 Scope1.1 This Standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 2.2.15).Although this Standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety.SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this Standard are not considered.Appendices in this Standard are not mandatory unless made so by an explicit statement in the main text.1.1 Replacement of the third paragraph of 1.1 with the following:1.1 SAFETY HAZARDS resulting from intended physiological function of EQUIPMENT covered by this Standard are not considered. These requirements do not contemplate the investigation of protection against ionizing radiation or radioactive isotopes. Such EQUIPMENT is subject to Federal radiation Standards (21CFR Part 1020) promulgated under the Radiation Control for Health and Safety Act of 1968.1.2 Object1.2 The object of this Standard is to specify general requirements for the safety of MEDICAL ELECTRICAL EQUIPMENT and to serve as the basis for the safety requirements of Particular Standards. 1.3 *Particular Standards1.3 A Particular Standard takes priority over this General Standard.1.4 Environmental conditions1.4 See Section Two.1.5 Collateral Standards1.5 In the IEC 601 series, Collateral Standards specify general requirements for safety applicable to:1. - a group of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment);2. - a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT not fully addressed in the General Standard (e.g. electromagnetic compatibility).If a Collateral Standard applies to a Particular Standard, then the Particular Standard takes priority over the Collateral Standard.