Non-active surgical implants - General requirements Archives

New BS EN ISO 14630 2012 Edition for Non-active surgical implants.

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 It supersedes BS EN ISO 14630 2009 Edition, which is withdrawn.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!

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New ISO 14630 2012 Edition – Non-Surgical Medical Implants

ISO has just released the ISO 14630 4th Edition, “Non-active surgical implants — General requirements,” and it’s available now from Document Center Inc. in both paper and pdf format. This 2012 edition cancels and replaces the third edition (ISO 14630:2008), which has been technically revised. You may want to review the complete revision history here.

This International Standard provides a method of addressing the fundamental principles outlined in ISO/TR 14283 as they apply to non-active surgical implants. It also provides a method for demonstrating compliance with the relevant essential requirements as outlined in the general terms in Annex 1 of the European Council Directive 93/42/EEC (medical devices) as they apply to non-active surgical implants.

With regard to safety, ISO 14630:2012 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.

ISO 14630:2012 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intraocular lenses and implants utilizing viable animal tissue.

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