SS-EN-ISO-14607 › Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018)
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ISO 14607:2018 specifies particular requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.
To find similar documents by classification:
Medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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Designation Name
SS-EN ISO 14607:2018
Revision Level
2018 EDITION
Status
Current
Publication Date
May 22, 2018
Language(s)
English
Page Count
64
International Equivalent
EN ISO 14607:2018(IDT); ISO 14607:2018(IDT)