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ANSI AAMI ISO 14708-3 pdf free download

ANSI AAMI ISO 14708-3 pdf free download.Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators.
4 Symbols and abbreviated terms This clause of ISO 1 4708-1 applies. 5 General requirements for active implantable medical devices This clause of ISO 1 4708-1 applies, except as follows. Additional subclause: 5.101 Wireless coexistence and wireless quality of service When communication with the implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE is provided through wireless communication channels, the MANUFACTURER shall evaluate wireless coexistence and wireless quality of service through the RISK MANAGEMENT PROCESS and apply the appropriate RISK CONTROL measures to protect the patient from HARM (see 28.1 05). Compliance is checked by the inspection of the RISK MANAGEMENT FILE . 6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES No additional requirements are specified in this clause. 7 General arrangement of the packaging This clause of ISO 1 4708-1 applies. 8 General markings for ACTIVE IMPLANTABLE MEDICAL DEVICES This clause of ISO 1 4708-1 applies. 9 Markings on the sales packaging This clause of ISO 1 4708-1 applies. 10 Construction of the sales packaging This clause of ISO 1 4708-1 applies. 11 Markings on the sterile pack This clause of ISO 1 4708-1 applies.12 Construction of the non-reusable pack This clause of ISO 1 4708-1 applies. 13 Markings on the ACTIVE IMPLANTABLE MEDICAL DEVICE This clause of ISO 1 4708-1 applies. 14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE This clause of ISO 1 4708-1 applies.15 Protection from harm to the patient or user caused by external physical features of the ACTIVE IMPLANTABLE MEDICAL DEVICE This clause of ISO 1 4708-1 applies. 16 Protection from harm to the patient caused by electricity This clause of ISO 1 4708-1 applies. 17 Protection from harm to the patient caused by heat This clause of ISO 1 4708-1 applies except as follows. 17.1 Replacement: In the absence of external influence, an implantable part of the INS, not intended to supply heat to the patient, shall comply with at least one of the following conditions (a, b, or c) when implanted, and when in normal operation, including recharge: NOTE Examples of external influences include exposure to MRI, electrosurgery, external defibrillation, ultrasound, and electromagnetic fields.a) no outer surface greater than 39 °C, b) no tissue receives a thermal dose greater than the CEM43 dose thresholds in Table 1 01 , or c) manufacturer’s evidence that a higher temperature rise, than indicated in Table 1 01 , is justified for a particular application. Because the values in Table 1 01 represent tissue dose thresholds, the manufacturer’s risk assessment shall include an analysis of any effects to the patient due to the time/temperature relationship.18 Protection from ionizing radiation released or emitted from the active implantable medical device This clause of ISO 1 4708-1 applies. 19 Protection from unintended effects caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE This clause of ISO 1 4708-1 applies. 20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by external defibrillators This clause of ISO 1 4708-1 applies except as follows. 20.1 Not used. 21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by electrical fields applied directly to the patient This clause of ISO 1 4708-1 applies. 22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscellaneous medical treatments 22.1 Ultrasonic energy This clause of ISO 1 4708-1 applies.ANSI AAMI ISO 14708-3 pdf download.

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