TFL Vsebine / Revija SIR*IUS

Standards and guidance documents for medical software development

V okviru razvoja medicinske programske opreme je treba posvetiti pozornost ključnim zahtevam medicinske direktive – Aneksu I dokumenta (European Council, 1993) in jim slediti skozi vse korake življenjskega cikla razvoja medicinske programske opreme (ISO/IEC 62304:2006, 2006). Pomembno je, da upoštevamo domensko specifične standarde ter priporočila, pri čemer nikakor ne smemo spregledati področja zagotavljanja kakovosti (ISO/IEC 13485:2016, 2016) in upravljanja tveganj (ISO/IEC 14971:2007, 2007), saj gre za razvoj življenjsko kritičnega informacijskega sistema. V prispevku bomo pregledali osnovne standarde, ki vključujejo proces razvoja medicinske programske opreme, jih povezali s ključnimi zahtevami medicinske direktive in upravljanjem tveganj ter opisali minimalno vsebino osnovne tehnične mape, ki jo mora imeti na voljo vsak medicinski pripomoček. Vsebina mape je osnova za certifikacijo in tudi revizijski postopek.

In medical software development, special attention needs to be devoted to the essential requirements of the Medical Devices Directive, Annex I (European Council, 1993), which have to be followed through all the stages of the development cycle and the production process of the devices (ISO/IEC 62304:2006, 2006). Specific standards and recommendations have to be observed, both in terms of quality (ISO/IEC 13485:2016, 2016) and risk management (ISO/IEC 14971:2007, 2007) in the development of this vital information system. The article gives a survey of the basic standards included in the process of medical software development life cycle and combines them with the essential requirements of the Medical Devices Directive and the risk management involved. It is followed by a description of the minimum information contained the basic technical file accompanying each and every medical device, which is then the basis for certification and audits.