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.
All ISO standards are available from Document Center Inc. at our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We have been an authorized dealer of ISO standards since the 1990’s and can provide you with expert assistance on these and many other documents you may use in your business.
