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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.

Product Details

Published:

01/10/2018

ISBN(s):

9780580890680

Number of Pages:

28

File Size:

1 file , 790 KB

Same As:

ISO/TR 14283:2018

Product Code(s):

30317626, 30317626, 30317626