BS PD ISO/TR 14283:2018为主动或非主动植入物的设计和制造提供了基本原则，以便每个植入物都能达到其预期目的。通常情况下，器械和其他设备与植入物一起使用。这些设备可能对安全植入和/或使用植入物有用，甚至是必不可少的。本文件适用于植入物，但也适用于相关仪器和设备，只要植入物的设计和制造旨在确保植入物与此类装置的安全组合和使用。相关仪器和设备的安全操作和使用要求包含在其他标准中。交叉引用:GHTF/SG5/N1R8。2007ISO 14160ISO 1464ISO 22442ISO 14155GHTF/SG5/N2R8。 2007年ISO 15223-1ISO 16142-1ISO 10993-1ISO 17664ISO 14708-1（所有零件）GHTF/SG1/N055。2009年ISO 13485GHTF/SG1/N71。2012年ISO 11607（所有部分）GHTF/AHWG-UDI/N2R3。2011 ISO 11135ISO 14971GHTF/SG5/N3。2010ISO 14937GHTF/SG1/N78。2012 ISO 16061ISO 11137（所有零件）GHTF/SG1/N70。2011GHTF/SG1/N68。2012IEC 60601-1ISO 14630GHTF/SG1/N044。2008年ISO 17665购买本文件时可获得的所有现行修订均包含在购买本文件中。

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 10993-1ISO 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 17665All current amendments available at time of purchase are included with the purchase of this document.