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. 2007

ISO 14160

ISO 14644

ISO 22442

ISO 14155

GHTF/SG5/N2R8. 2007

ISO 15223-1

ISO 16142-1

ISO 10993-1

ISO 17664

ISO 14708-1 (all parts)

GHTF/SG1/N055. 2009

ISO 13485

GHTF/SG1/N71. 2012

ISO 11607 (all parts)

GHTF/AHWG-UDI/N2R3. 2011

ISO 11135

ISO 14971

GHTF/SG5/N3. 2010

ISO 14937

GHTF/SG1/N78. 2012

ISO 16061

ISO 11137 (all parts)

GHTF/SG1/N70. 2011

GHTF/SG1/N68. 2012

IEC 60601-1

ISO 14630

GHTF/SG1/N044. 2008

ISO 17665

All current amendments available at time of purchase are included with the purchase of this document.