BS PD ISO/TR 14283:2018

BS PD ISO/TR 14283:2018 provides fundamental principles for the design and manufacture of active or non-active implants in order that each implant can achieve its intended purpose.It is often the case that instruments and other equipment are used in association with implants. These devices might be useful or even essential for the safe implantation and/or use of the implants. This document applies to implants, however, it also applies to associated instruments and equipment to the extent that the design and manufacture of the implants is intended to ensure the safe combination and use of the implants with such devices.Requirements for the safe operation and use of associated instruments and equipment are contained in other standards.Cross References:GHTF/SG5/N1R8. 2007ISO 14160ISO 14644ISO 22442ISO 14155GHTF/SG5/N2R8. 2007ISO 15223-1ISO 16142-1ISO 10993-1 ISO 17664ISO 14708-1 (all parts)GHTF/SG1/N055. 2009ISO 13485GHTF/SG1/N71. 2012ISO 11607 (all parts)GHTF/AHWG-UDI/N2R3. 2011ISO 11135ISO 14971GHTF/SG5/N3. 2010ISO 14937GHTF/SG1/N78. 2012ISO 16061ISO 11137 (all parts)GHTF/SG1/N70. 2011GHTF/SG1/N68. 2012IEC 60601-1ISO 14630GHTF/SG1/N044. 2008ISO 17665