ANSI AAMI ISO 14708-1 pdf free download

ANSI AAMI ISO 14708-1 pdf free download.Implants for surgery — Active implantable medical devices — Part 1 : General requirements for safety, marking and for information to be provided by the manufacturer.
5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES 5.1 General requirements for non-implantable parts The non-implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE which is connected to or equipped with an electrical power source shall comply with the appropriate requirements of IEC 60601 -1 :2005 + A1 :201 2, as determined in the RISK ANALYSIS , unless a requirement in that standard is superseded by a requirement in this part or other parts of ISO 1 4708. NOTE Other subclauses in this part of ISO 1 4708 require compliance with some subclauses of IEC 60601 –1 :2005 + A1 :201 2 even for non-implantable parts that are not electrically powered. Compliance is checked by assessment of the test report and the RISK ANALYSIS provided by the MANUFACTURER . 5.2 General requirements for software Software of an ACTIVE IMPLANTABLE MEDICAL DEVICE or software that falls within the definition of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall be designed according to software life cycle process activities compliant with IEC 62304:2006 and shall be validated. Compliance is checked by assessment of the software life cycle PROCESS in accordance with IEC 62304:2006, 1 .4 and assessment of the VALIDATION report provided by the MANUFACTURER.5.3 U SABILITY of non-implantable parts 5.3.1 U SABILITY of non-implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE connected to or equipped with an electrical power source The MANUFACTURER shall address in a USABILITY ENGINEERING PROCESS the RISK of poor USABILITY , including those associated with identification, MARKING , and documents. Compliance is checked by assessment of the MANUFACTURER ‘s documentation that the acceptance criteria of the USABILITY VALIDATION plan have been met (see IEC 62366:2007, 5.9). 5.3.2 U SABILITY of non-implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE not connected to or equipped with an electrical power source The non-implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall provide adequate USABILITY such that the RISKS resulting from CORRECT USE and USE ERRORS are acceptable. Compliance is checked by assessment of the MANUFACTURER ’s documentation that the acceptance criteria of the USABILITY VALIDATION plan have been met (see IEC 62366:2007, 5.9). 5.4 Data security and protection from HARM caused by unauthorized information tampering When communication with the implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE through wireless communication channels is provided, the MANUFACTURER shall evaluate INFORMATION SECURITY through the RISK MANAGEMENT PROCESS and apply the appropriate RISK CONTROL measures to protect the patient from HARM . Compliance is checked by the inspection of the RISK MANAGEMENT FILE.5.5 General requirements for RISK MANAGEMENT 5.5.1 R ISK MANAGEMENT policy The MANUFACTURER shall define and document a policy for determining acceptable RISK and the acceptability of the RESIDUAL RISK ( S ) as required in ISO 1 4971 . Compliance is checked by inspection of the MANUFACTURER ‘ S policy for determining criteria for RISK acceptability. 5.5.2 Risk management file The MANUFACTURER shall establish and maintain a RISK MANAGEMENT FILE complying with those requirements of ISO 1 4971 necessary to satisfy the requirements of this part of ISO 1 4708. Compliance is checked by confirming the existence of an index containing references or pointers to the RISK MANAGEMENT documentation required by this part of ISO 1 4708.ANSI AAMI ISO 14708-1 pdf download.