ONORM EN ISO 14607 : 2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
22-11-2018
12-01-2013
Diese ÖNORM legt besondere Anforderungen an Mammaimplantate zur klinischen Anwendung fest. Im Hinblick auf die Sicherheit legt sie Anforderungen an die beabsichtigte Funktion, Konstruktions- merkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und vom Hersteller zu liefernde Informationen fest.
| DevelopmentNote |
Supersedes ONORM EN 12180. (05/2007)
|
| DocumentType |
Standard
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| ISO 14607:2007 | Identical |
| EN ISO 14607:2018 | Identical |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 37:2017 | Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties |
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