ANSI/AAMI/ISO 14708-1-2014 pdf download.Implants for surgery — Active implantable medical devices — Part 1 : General requirements for safety, marking and for information to be provided by the manufacturer
This part of ISO 14708 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES.
NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular parts of ISO 14708.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance.
This part of ISo 14708 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs).
This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the ACTVE IMPLANTABLE MEDICAL DEVICES.
NOTE 2 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be eitherparially or totally implantable, but there is a need to specity some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE3 In this part of ISo 14708, terms printed in small capital ltters are used as defined in Clause 3. Where a defined term is used as a qualifer in another term, it is not printed in small capital ltters unless the concept thus qulified is also defined.
NOTE 4 The terminology used in this part of IsO 14708 is intended to be consistent with the terminology of ISO/TR 14283:2004.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edtion of the referenced document (including any amendments) applies.
ISO 8601 :2004, Data elements and interchange formats一- Information interchange一Representation of dates and times
ISO 10993-1, Biological evaluation of medical devices一Part 1: Evaluation and testing within a risk management process
ISO 11607-1, Packaging for terminally sterilized medical devices一- Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 14155, Clinical investigation of medical devices for human subjects一Good clinical practice
ISO 14971:2007, Medical devices一Application of risk management to medical devices
IEC 60068-2-14:2009, Environmental testing一Part 2-14: Tests 一Test N: Change of temperature.ANSI/AAMI/ISO 14708-1 pdf download.