scope:

Foreword

This document (EN ISO 15883-1:2009/A1:2014) has been prepared by Technical Committee ISO/TC 198 "Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102 "Sterilizers for medical purposes" the secretariat of which is held by DIN.

This Amendment to the European Standard EN ISO 15883:2009 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2015, and conflicting national standards shall be withdrawn at the latest by January 2015.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document 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 document.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.