BS EN ISO 14607:2018 - Non-active surgical implants. Mammary implants. Particular requirements

BS EN ISO 14607:2018

Non-active surgical implants. Mammary implants. Particular requirements

Status : Current, Under review   Published : May 2018



Standard NumberBS EN ISO 14607:2018
TitleNon-active surgical implants. Mammary implants. Particular requirements
StatusCurrent, Under review
Publication Date24 May 2018
Normative References(Required to achieve compliance to this standard)ISO 10993-18, ISO 7619-1, ISO 10993-1, ISO 10993-5, ASTM D2240-15, ISO 11607-1, ASTM D792-13, ISO 14155, ASTM D412-16, ISO 4287, ASTM D624-00 (2012), ISO 14630:2012, EN ISO 11607-1:2017, EN ISO 10993-18:2009, ISO 37:2017, ISO 34-1:2015, EN ISO 4287:1998/AC:2008, EN ISO 10993-5:2009, EN ISO 10993-1:2009/AC:2010, EN ISO 14155:2011, EN ISO 10993-1:2009, EN ISO 4287:1998/A1:2009, EN ISO 14630:2012
Informative References(Provided for Information)ISO/TR 14969:2004, ASTM F703 - 18, ISO 14971, ISO 25178-2, TR 14283, ISO 11607-2, ISO 16054, CR 14060
ReplacesBS EN ISO 14607:2009, BS EN ISO 14607:2007
International RelationshipsEN ISO 14607:2018,ISO 14607:2018
Amended ByCorrigendum, September 2018
DescriptorsMedical equipment, Packaging, Design, Implants (surgical), Safety measures, Performance testing, Instructions for use, Sterilization (hygiene), Performance, Prosthetic devices, Breasts
Title in FrenchImplants chirurgicaux non actifs. Implants mammaires. Exigences particulières
Title in GermanNichtaktive chirurgische Implantate. Mammaimplantate. Besondere Anforderungen
ISBN978 0 539 02286 5
File Size1.303 MB

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