Questionnaire results:
Most of the cited standards are issued by ISO; some of them are also harmonized (=approved) by the European Commission and in this case they are identified by the EN code. Since the EN version contains more information than the general version, links are provided to the EN version in English language if appropriate.
| Question | Standard | Description |
|---|---|---|
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Is your device “implantable” and “not active”?
You answered: No |
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Is your device “active” and its source of energy is electrical?
You answered: Yes |
IEC 60601-1:2005+AMD1:2012 CSV (consolidated version) | This standard specifies requirements for electromedical devices; it has more than 60 related publications, that describe very specific areas of electromedical devices. |
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Is your device a software or does it contain software (applies also to firmware)?
You answered: Yes |
EN 62304:2006+A1:2015 | This standard specifies how to design and code software for medical devices and sets requirements for SW change control. |
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Is the device containing software intended to be part of a IT-network?
You answered: No |
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Is your device “implantable” and “active”?
You answered: No |
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Is your device intended to be sterile?
You answered: No |
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Does your device come in contact to the human body (any kind of contact, brief or permanent, in any location of the human body)?
You answered: No |
The following standards and guidelines are applicable to all devices, regardless the kind and risk classification:
| Standard | Description |
|---|---|
| EN ISO 13485:2016 | This standard specifies requirements for all entities involved in medical devices, in all stages of the product life cycle: from design to manufacture to installation to disposal. Ubora Platform is structured to be a guideline for design activities in compliance to this standard. |
| EN ISO 14971:2012 | This standard specifies requirements for designers and manufacturers of medical devices, in order to minimize the risk of the device itself. There is no “risk zero” device but many activities can be implemented to reduce and manage risk. This standard provides useful checklists and also guidance on the most widespread risk management techniques such as FMEA. |
| MEDDEV 2.7.1 rev 4 CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC | This guideline provides information on methods used to assess the clinical performance and the clinical benefit of a medical device. It is provided for free by the Commission at http://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/en/renditions/native. |
| IEC 62366-1 | This standard provides guidance on how to manage the human factors while designing a medical device (usability engineering). NOTE: chapter -2 of ths same standards will provide comments and integrations |
| EN ISO 15223-1:2016 | This standard lists a series of symbols that may be applicable in labels of medical devices |
There may be product specific standards that apply, talk to your mentor.