DIN EN ISO 14607:2018
非活性外科植入物 乳腺植入物 特殊要求（ISO 14607:2018，修正版 2018-08）；德文版 EN ISO 14607:2018

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08); German version EN ISO 14607:2018

被代替

标准号

DIN EN ISO 14607:2018

发布

2018年

发布单位

德国标准化学会

替代标准

DIN EN ISO 14607:2018-10

当前最新

DIN EN ISO 14607:2018-10

 

 

引用标准

ASTM D2240-15 ASTM D412-16 ASTM D624-00 ASTM D792-13 ASTM F703-18 CR 14060-2000 DIN EN ISO 10993-18:2009 DIN EN ISO 10993-1:2010 DIN EN ISO 10993-5:2009 DIN EN ISO 11607-1:2017 DIN EN ISO 11607-2:2017 DIN EN ISO 14155:2012 DIN EN ISO 14630:2013 DIN EN ISO 14971:2013 DIN EN ISO 16054:2002 DIN EN ISO 25178-2:2012 DIN EN ISO 4287:2010 DIN ISO 34-1:2016 DIN ISO 7619-1:2012 ISO 1 ISO 10993-18:2005 ISO 10993-1:2009 ISO 10993-5:2009 ISO 34-1:2015 ISO 37:2017 ISO 4287:1997 ISO 7619-1:2010

被代替标准

DIN EN ISO 14607:2009 DIN EN ISO 14607:2017

适用范围

This standard specifies specific requirements for mammary implants fo clinical practice. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

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