ÖNORM EN 12322/A1

The European Amendment EN 12322:1999/A1:2001 modifies EN 12322:1999 and has the status of an Austrian Standard. The present amendment ÖNORM EN 12322/A1 was issued after formal vote; it modifies the basic document ÖNORM EN 12322:1999 and is to be used in conjuction with said standard. This Amendment EN 12322:1999/A1:2001 to the EN 12322:1999 has been prepared by Technical Committee CEN/TC 140 "In vitro diagnostic medical devices", the secretariat of which is held by DIN. This Amendment to the European Standard EN 12322:1999 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2002, and conflicting national standards shall be withdrawn at the latest by April 2002. This Amendment to the European Standard EN 12322:1999 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard. Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives