The BS EN ISO 14630:2012, “Non-active surgical implants. General requirements,” has just been released and is available now from Document Center Inc. This British Standard is the UK implementation of EN ISO 14630:2012. It supersedes BS EN ISO 14630 2009 Edition, which is withdrawn. It is the text of ISO 14630:2012, approved by CEN as a EN ISO 14630:2012 without any modification.
In addition to the ISO 14630, the document also contains an Annex ZA, “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC.” This Annex maps out the clauses of the ISO document with regards to the various requirements of the Medical Devices Directive. The good news is that the “Qualifying Remarks/Notes” column in this Annex is empty!
The BS EN editions are the official English language editions, but alternative publications in English can be found. For any questions you might have regarding multiple editions of any EN standard, please contact us. We’ll be happy to help you understand the differences.
We do suggest that if you are certifying with a European auditor, you may prefer to purchase the EN editions of ISO standards. This is because the EN edition is actually called out in the “list of harmonized standards” for each applicable Directive.
All BS EN standards are available from Document Center Inc. at our webstore, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’ve been here since 1982 to help you with all your standards purchases and management requirements.