The New Zealand Society of Biomedical Technology Incorporated

NZ STANDARDS

  A list of Safety and Performance Standards currently used in New Zealand as either New Zealand specific or joint New Zealand/Australian Standards.

Updated 07 Aug 2010   

AS/NZS 2500 Guide to the safe use of electricity in patient care
AS/NZS 3551.2004 Technical Management Programs for Medical Devices
NZS 6150:1990 Approval and test specification - Medical Electrical Equipment - General requirements for safety
AS/NZS 3200 Approval and Test Specification - Medical Electrical Equipment
AS/NZS 3200.1 General Requirements for Safety
AS/NZS 3200.1.1:1995 Requirements for Medical Electrical Systems
AS/NZS 3200.1.2:2005 Requirements for electromagnetic compatibility
AS/NZS 3200.1.8:2005 Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems
AS/NZS 3200.2.13:2005 Anaesthetic Systems
AS/NZS 3200.2.14:1992 Electroconvulsive Therapy Equipment
AS/NZS 3200.2.16:1992 Haemodialysis Equipment
AS/NZS 3200.2.18:1997 Endoscopic Equipment
AS/NZS 3200.2.200:2005 Oxygen Concentrators for Individual Patient Use
AS/NZS 3200.2.2:2002 High Frequency Surgical Equipment
AS/NZS 3200.2.3:1992 Short-wave Therapy Equipment
AS/NZS 3200.2.4:1993 Cardiac Defibrillators and Cardiac Defibrillator-Monitors
AS/NZS 3200.2.5:1992 Ultrasonic Therapy Equipment
AS/NZS 3200.2.6:1992 Microwave Therapy Equipment
AS/NZS 3200.2.21:1994 Infant Radiant Warmers - includes Amendment 1
AS/NZS 3200.2.22:1997 Diagnostic and Therapeutic Laser Equipment
AS/NZS 3200.2.23:2001 Transcutaneous Partial Pressure Monitoring Equipment
AS/NZS 3200.2.24:1999 Infusion Pumps and Controllers
AS/NZS 3200.2.25:1993 Electrocardiographs
AS/NZS 3200.2.26:2005 Electroencephalographs
AS/NZS 3200.2.27:1996 Electrocardiograph Monitoring Equipment
AS/NZS 3200.2.30:2001 Automatic Cycling Indirect Blood Pressure Monitoring Equipment
AS/NZS 3200.2.31:1996 External Cardiac Pacemakers with Internal Power Source
AS/NZS 3200.2.34:1996 Direct Blood Pressure Monitoring Equipment
AS/NZS 3200.2.35:1999 Blankets, pads, and matresses intended for heating in medical use
AS/NZS 3200.2.38:2007 Electrically and manually operated medical beds for adult use
AS/NZS 3200.2.39:2001 Peritoneal diialysis equipment
AS/NZS 3200.2.4:2006 Cardiac Defibrillators
AS/NZS 3200.2.40:1999 Electromyographs and evoked response equipment
AS/NZS 3200.2.45:1999 Operating Tables
AS/NZS 3200.2.5:2002 Ultrasonic physiotherapy equipment
AS/NZS 3200.2.6:2005 Microwave Therapy Equipment
AS/NZS 3200.2.202:1996 Infant Apnoea Monitors for Domestic Use
AS/NZS 4173:1994 Guide to Safe Use of Lasers in Health Care
AS/NZS 4236:1994 Respiratory Therapy Equipment - Jet Nebulizer Air Pumps
AS/NZS 4237:1994 Respiratory Therapy Equipment - Peak Expiratory Flow Meters
AS/NZS 4374:1996 Ultrasonics - Hand Held probe Doppler Foetal Heartbeat Detectors - Performance Requirements and Methods of Measurement and Reporting
IEC 60601-2-10 Ed 1.1 Nerve and Muscle Stimulators
IEC 60601-2-12 Ed 2.0 Critical Care Ventilators
IEC 60601-2-19 Ed 2.0 Infant Incubators
IEC 60601-2-20 Ed 2.0 Infant Transport Incubators
IEC 60601-2-3 Ed 2.1 Shortwave Therapy Equipment
IEC 60601-2-37 Ed 2.0 Ultrasonic Medical Diagnostic and Monitoring Equipment
IEC 60601-2-47 Ed 1.0 Ambulatory Electrocardiograph Systems
IEC 60601-2-49 Ed 1.0 Multifinction Patient Monitoring Equipment
IEC 60601-2-50 Ed 2.0 Infant Phototherapy Equipment
IEC 60601-2-51 Ed 1.0 Recording and Analysing Single Channel and Multichannel Electrocardiographs
IEC 60601-2-52 Ed 1.0 Medical Beds
NZS 6150:1990 Approval and test specification - Medical Electrical Equipment - General requirements for safety
NZS 7101:1981 Specification for Medical Gas Cylinders, Valves and Yoke Connections