ANSI AAMI ISO 14708-1:2014 pdf download – Implants for surgery – Active implantable medical devices
19.3 An ACTIVE IMPLANTABLE MEDICAL DEVICE shall be designed so that the failure of any single component, part, software of the ACTIVE IMPLANTABLE MEDICAL DEVICE , or software that falls within the definition of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall not result in an unacceptable RISK . The RISK ANALYSIS of the failure of any single component or part, the RISK EVALUATION and any subsequent RISK CONTROL shall be carried out according to 5.5.4 and shall be documented in the RISK MANAGEMENT FILE . The software of the ACTIVE IMPLANTABLE MEDICAL DEVICE or software that falls within the definition of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall comply with 5.2. NOTE IEC 62304:2006, 4.2 requires application of a RISK MANAGEMENT PROCESS consistent with 5.5.4. Compliance is checked by assessment of the documentation in the RISK MANAGEMENT FILE that demonstrates the RESIDUAL RISK is acceptable.
19.4 Possible side effects arising from the intended use of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall not result in an unacceptable RISK . Side effects and benefits from the intended use of the ACTIVE IMPLANTABLE MEDICAL DEVICE shall be identified either by reference to current medical practice and demonstrated by analogy, or by reference to clinical investigations concluded according to ISO 141 55. Compliance is checked by assessment of the MANUFACTURER ‘ S documentation.
19.5 If the implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE is intended to administer a MEDICINAL SUBSTANCE , then the parts of the ACTIVE IMPLANTABLE MEDICAL DEVICE intended to come in contact with the MEDICINAL SUBSTANCE shall be designed and manufactured in such a way as to be compatible with the MEDICINAL SUBSTANCE concerned. Compliance is checked by assessment of the design analysis provided by the MANUFACTURER , supported by the MANUFACTURER ‘ S calculations and data from test studies, as appropriate.
21.1 Implanted electrically conductive parts (of an ACTIVE IMPLANTABLE MEDICAL DEVICE ) in contact with the body shall be constructed so that effects caused by known electrical treatment applied directly to the patient will not damage the ACTIVE IMPLANTABLE MEDICAL DEVICE , provided that the implanted parts neither lie directly in the applied current path nor lie within the part of the body being treated. Compliance is checked by assessment of the design analysis provided by the MANUFACTURER , supported by the MANUFACTURER ‘ S calculations and data from test studies as appropriate. The MANUFACTURER shall declare and provide information if a patient wearing an ACTIVE IMPLANTABLE MEDICAL DEVICE is contraindicated for known electrical treatments identified as having the potential to damage the ACTIVE IMPLANTABLE MEDICAL DEVICE (for example, application of diathermy). Compliance is checked by inspection of the accompanying document (see 28.26).
21.2 Requirements for protection of particular ACTIVE IMPLANTABLE MEDICAL DEVICES susceptible to electrical fields applied directly to the patient are not detailed in this part of ISO 1 4708, but they can be specified in subsequent parts of ISO 1 4708.