医用电气设备 成人医用床基本安全和基本性能的特殊要求

[中文适用范围]： 本标准适用于按照201.3.214定义的、旨在用于按照201.3.222定义的成人的医疗床的基本安全和基本性能。范围包括电气和非电气（手动）医疗床，无论是否具有可调节功能。本文档适用于床升降器或可拆卸的床垫支撑平台或两者。床升降器或可拆卸的床垫支撑平台与制造商指定的兼容非医疗床的组合也被视为医疗床。本文档不适用于：儿童和患有非典型解剖结构的成人（超出201.3.222定义的成人）的医疗床，这些由IEC 80601-2-89覆盖；由ISO 20342系列覆盖的专业床垫；主要用于检查或在医疗监督下运输的设备（例如担架、检查台）；以及具有特殊功能的医疗床的所有要求。如果一个条款或子条款专门适用于医疗床或仅适用于ME系统，则该条款或子条款的标题和内容将如此说明。如果不是这种情况，则该条款或子条款同时适用于医疗床和ME系统（视情况而定）。在本文件范围内的医疗床或ME系统预期生理功能固有的危害不包括在本文件的具体要求中，但IEC 60601-1:2005、IEC 60601-1:2005/AMD1:2012和IEC 60601-1:2005/AMD2:2020的7.2.13和8.4.1除外。注1：另见IEC 60601-1:2005、IEC 60601-1:2005/AMD1:2012和IEC 60601-1:2005/AMD2:2020的4.2。注2：当在IEC 60601标准系列中使用术语“医用电气设备（MEE，ME EQUIPMENT）”时，它指的是医疗床（电气和非电气）。 [外文原描述]： IEC 80601-2-52:2026 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS as defined in 201.3.214, intended for ADULTS as defined in 201.3.222. Included in the scope are both electrical and non-electrical (manual) MEDICAL BEDS with or without adjustable functions. This document is applicable to either a BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM or both. The combination of BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM with a compatible non-MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL BED. This document does not apply to: - MEDICAL BEDS for CHILDREN and ADULTS with atypical anatomies (ADULTS ranging outside the definition for ADULTS in 202.3.222) covered by IEC 80601-2-89; - SPECIALITY MATTRESS covered by ISO 20342 series; - devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table); - all requirements for MEDICAL BEDS with special functionality. If a clause or subclause is specifically intended to be applicable to a MEDICAL BED 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 MEDICAL BED and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.