![]() Relationship of EN 62304 to other standards. Although medical software has been written and applied for at least three decades, the first edition of the EN 62304 standard harmonized in 2008 is the first standard dealing with standalone software (before, all software fell within the scope of the EN 6 standard on programmable electrical medical systems). As the European state-of-the-art is represented by harmonized standards, this implies the application of the EN ISO 13485 standard on quality management systems for medical devices, the EN 62304 standard on medical device software life-cycle processes and the EN ISO 14971 standard on the application of risk management to medical devices together with the IEC/TR 80002-1 technical report providing guidance on its application to medical device software (Figure 1). It states that standalone software for diagnostic and/or therapeutic purposes is considered a medical device, and that for medical devices which incorporate or are software, the software must be validated according to the state-of-the-art taking into account the principles of development life-cycle, risk management, validation and verification. Only the last amendment 2007/47/EC of said directive clarifies the software-related requirements by an extension of the so-called essential requirements laid down in Annex I which are applicable to all medical devices regardless of whether they are placed on the market or not. ![]() Its Article 1 definition of a medical device includes the software necessary for its proper application, while its Annex IX points out that software, which drives or influences the use of a medical device, automatically falls in the same class as the device itself, both statements mainly referring to software embedded in electronic devices. ![]() The European Council Directive 93/42/EEC (Medical Device Directive) covers the placing on the market and putting into service of medical devices.
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