BS EN ISO 14630:2009 specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.

With regard to safety, BS EN ISO 14630:2009 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.

NOTE- BS EN ISO 14630:2009 does not require that the manufacturer have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure the implant achieves its intended performance.

Cross References:
ISO 31
ISO 8601
ISO 10993-1
ISO 10993-7
ISO 11135-1
ISO 11137-1
ISO 11137-2
ISO 11607-1
ISO 13408-1
ISO 14155-1
ISO 14155-2
ISO 14160
ISO 14937
ISO 14971
ISO 17664
ISO 17665-1
ISO 22442-1
ISO 22442-2
ISO 22442-3
ISO/TR 14283:2004
ISO/IEC Guide 51:1999
ISO 16061
ISO 14602
ISO 21534
ISO 5840
EN 12006-2
EN 12006-3
ISO 7197
ISO 14607
ISO 21535
ISO 21536
ISO 1000
ISO 7000
ISO 12891-1
ISO 13485
ISO 16429
IEC 60068-2-27
IEC 60068-2-32
IEC 60068-2-47
IEC 60601-2-33
ASTM F 2052-02
ASTM F 2119-01
ASTM F 2182
ASTM F2213
ASTM F2503-05
2001/83/EC
93/42/EEC


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