標準號：IS 8607 Pt.1-1977
發布日期：1978/5/1 12:00:00
實施日期：1999/12/31 12:00:00
適用范圍：1.1 This standard (Part I) covers environmental and test conditions, classi-fication, marking and basic safety requirements of medical electrical equipment designed for use in human or veterinary medicine, under thejurisdiction of a qualified person, and installed, applied, used or kept in locations intended for medical practice, where the environmental conditions specified in 3 prevail.Note — Human or veterinary medicine includes surgery, dentistry and other speciali-ties of the healing art.1.2 This standard (Part I) applies to all medical electrical equipment except as otherwise stated in the individual specification for the particular medical equipment for which additional or modified requirements may be specified.1.3 The equipment covered by this standard may be mains-operated, or supplied by an internal power source.1.4 The scope of this standard shall be restricted to equipment intended to be applied in the vicinity of a patient or related in such a way to the patient that the patient's safety can be influenced.1.5 The scope of this standard includes systems, equipment and accessories, which are described in other Indian Standards but are applied in medical practice.In the case of discrepancy, the safety requirements of this standard shall take priority over possible differing requirements in other Indian Standards.1.6 The requirements of extension cords are not covered by this standard.