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Does anyone know of an official source that details an implementation schedule for ISO 10993-7:2008 in the European Union? In particular, I am wondering if there is a transition period for complying with the tighter EO residual requirements.
Background:
...ISO 10993-7:2008 is listed in the Official Journal of the European Union as a harmonized standard under the MDD. However, in relevant columns in the table, no reference is made to the 2008 version superseding the 1995 version. (C41, 19.2.2009, pg. 18.)
...FDA recognized the 2008 version on 8 Sept 2009, but states "Transition Period: FDA recognition of AAMI/ANSI/ISO 10993-7:1995 (R) 2001 will be superseded by recognition of AAMI/ANSI/ISO 10993-7:2008 as of December 1, 2011." (Recognition List 22, published 8 Sept 2009. Recognition Number 14-279.) I include this FDA background information for readers' general awareness of status in USA, knowing it has no bearing on status of the standard in the EU.
Background:
...ISO 10993-7:2008 is listed in the Official Journal of the European Union as a harmonized standard under the MDD. However, in relevant columns in the table, no reference is made to the 2008 version superseding the 1995 version. (C41, 19.2.2009, pg. 18.)
...FDA recognized the 2008 version on 8 Sept 2009, but states "Transition Period: FDA recognition of AAMI/ANSI/ISO 10993-7:1995 (R) 2001 will be superseded by recognition of AAMI/ANSI/ISO 10993-7:2008 as of December 1, 2011." (Recognition List 22, published 8 Sept 2009. Recognition Number 14-279.) I include this FDA background information for readers' general awareness of status in USA, knowing it has no bearing on status of the standard in the EU.
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