The AS/NZS 3551 standard, an Australian / New Zealand standard, outlines the procedures necessary to develop management programs for medical equipment. These procedures cover the protocols and procedures for procurement, acceptance, maintenance activities and finally the disposal of medical equipment throughout its service life. This standard is intended to cover all hospital property, privately owned, loan or trial medical equipment, except for commissioning requirements for permanently installed medical electrical equipment in heart and body protected patient pretreatment areas.
The guideline on the safe use of electricity in patient care reflects the views of clinical engineering consultants and healthcare professionals. Another Australian / New Zealand standard, the AS/NZS 2500 standard, includes a safety triangle that refers to the AS/NZS 3551 standard as the safety standard for medical equipment.
In fact, all medical devices should be designed and tested in accordance with type testing standards such as the IEC 60601 Medical electrical equipment family, and also developed and manufactured in accordance with the ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes standard.
The AS/NZS 3551 standard is only for some on-site testing and in-house management of medical equipment and is therefore only for healthcare organizations.
Today, the AS/NZS 3551 standard is increasingly included in tender invitations from official bodies, requiring medical device suppliers to comply with this standard and provide medical device certification. Furthermore , medical device regulations published in European Union countries require healthcare organizations that manufacture or modify medical devices to meet certain conditions. For example, healthcare organizations must establish an appropriate quality management system, demonstrate compliance with applicable general safety and performance requirements, review experience gained from the clinical use of devices and take necessary corrective actions, justify why the needs of the target group cannot be met by an equivalent device on the market, and provide information to regulatory authorities upon request.
Among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, our organization also provides testing services within the framework of management programs for medical equipment, within the scope of AS/NZS 3551 standard, with its trained and expert staff and advanced technological equipment.
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