BAS EN ISO 14607:2019
Non-active surgical implants - Mammary implants - Particular requirements
General Information
Status: Published
No. of pages: 48
Language: English
Edition: 3.
Adoption method: Endorsment
Publication date: 11.12.2019
Technical committee:
Directive:
93/42/EEC, Medical devices
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Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 14607:2018, identical
- ISO 14607:2018, identical