TS 12426/T2
Competent services - Medical devices - Rules
This standard includes rules for management technical equipment structrural characteristics and personnel characteristics of the compenent services of medical equipments
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About This Item
TS 12426/T2 sets out rules for competent services dealing with medical devices. It brings together structural characteristics, management arrangements, technical equipment, personnel characteristics and certification-related requirements, forming a framework for service operations that are intended to be controlled, traceable and professionally organised rather than ad hoc.
What a competent medical-device service needs to organise
In this context, a competent service is a service organisation that carries out maintenance, repair, inspection and related work on medical devices under defined rules. Because medical devices cover a wide range of technologies, the service environment must be matched to the equipment handled: suitable premises, appropriate technical tools, clear responsibilities and qualified staff all matter. The standard provides a general structure for aligning service practice with the device manufacturer’s instructions and for supporting documented service processes.
Why these rules matter in medical-device servicing
Medical devices may be used for diagnosis, monitoring, therapy or laboratory work, so servicing them can require a higher level of control than ordinary technical repair work. Staff competence, the suitability of test and control equipment, and the organisation of the service facility all influence the quality and consistency of the work. As a general technical matter, this type of standard supports orderly service management; it does not, from the supplied scope, indicate detailed performance-test methods or step-by-step maintenance procedures for specific device groups.
The document also includes certification-related rules. That makes it relevant for understanding how competent services are identified, how their capability is demonstrated, and how their activities are kept within a traceable framework. For readers seeking the service-side organisation of the medical-device sector, it is a practical standard focused on the relationship between premises, personnel and technical resources.
- Publication Date: 18.12.2017
- Standard Status: U (Yürürlükteki Standard/Standard)
- Publisher: TSE
- Document Language: tr
- ICS Classification: 11.040 Tıbbi Ekipman; 03.080.30 Tüketiciler İçin Hizmetler
- Pages: 1
- Source Standard: - 6502 Sayılı Tüketicinin Korunması Hakkında Kanun, - T.C. Sağlık Bakanlığı, “Tıbbi Cihazlar Yönetmeliği” (Medical Devices Directive), - T.C. Sağlık Bakanlığı, “Vücut Dışında Kullanılan (In-vitro) Tıbbi Tanı Cihazları Yönetmeliği” (In-vitro Diagnostic Directive), - T.C. Sağlık Bakanlığı, “Vücuda Yerleştirilebilir Aktif Tıbbi Cihazlar Yönetmeliği” (Active Implantable Medical Devices Directive), - Medical equipment maintenance programme overview 2011, WHO Medical device technical series - Cihazlar ile ilgili tamir bakım ve servislerinin görülüp incelenmesi ve teknik sorumluları ile yapılan görüşmeler
- International Equivalents: 12426--
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