標準號：SIS SS 486 03 01-1982
中文標準名稱：電子醫療設備．一般安全要求
英文標準名稱：Electromedical equipment - General safety requirements
發布日期：1982/11/15 12:00:00
實施日期：1999/12/31 12:00:00
適用范圍：This Standard applies to MEDICAL ELECTRICAL EQUIPMENT intended for use by or under the supervision of qualified personnel in the PATIENT ENVIRONMENT, or related to the PATIENT in such a way that the safety of persons or animals in that environment is directly affected.This Standard specifies requirements for the transport, storage, installation, use and main-tenance of such EQUIPMENT under the environmental conditions specified in Sub-clause 1.4 or by the manufacturer or as prescribed in Particular Standards.Although this Standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety.Dangers resulting from the physiological effects produced by the intended function of EQUIPMENT covered by this Standard are not considered.A (non-exhaustive) survey of MEDICAL ELECTRICAL EQUIPMENT is given in Appendix A.