This Standard specifies procedures required to develop equipment management programs for medical devices. Some of these include procedures for procurement, acceptance, fault management, routine testing and disposal of medical devices.This Standard now requires essential safety and performance testing in addition to the electrical safety tests prescribed in the first edition. Section 4 details how to identify the safety and performance parameters that are essential for the safe operation of each device and how to determine appropriate test intervals.The scope of this Standard exceeds that of the previous edition and of the AS/NZS 3200.2 series of Standards by covering certain non-electrical medical devices, such as ventilators, which may be solely pneumatic or fluidic in operation.This Standard is to be seen as a document defining good practice in the management of medical devices.Many tests in this Standard concern medical electrical devices and are derived from the parallel type approval tests specified in AS 3200.1.0/NZS 6150, Approval and test specification-Medical electrical equipment, Part 1.0- 1990: General requirements for safety- Parent Standard (as amended) and in no case are intended to be more stringent than those in that document. Where acceptance values of a part 2 Standard for particular medical devices are not in agreement with the specifications of this Standard, the Part 2 Standard overrides this document. For example, the normal limit for mains contact current is 50 mA per patient connection, while in AS/NZS 3200.2.4 which specifies an allowable current of 100 mA for Type CF defibrillator applied parts.NOTES:1 This Standard is intended to cover all medical devices, whether hospital property, privately owned, on loan or on trial, except for the commissioning requirements of permanently installed medical electrical devices in cardiac- and body-protected patient treatment areas, for which reference shall be made to AS 3003.2 The principles and recommendations specified herein have been framed in a manner considered suitable for application by most service organizations, hospital and private, supporting the use of medical devices.