Tag: ISO 14630

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 It supersedes BS EN ISO 14630 2009 Edition, which is withdrawn.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

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.

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.

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.

New ISO/TS 12417 covers Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products

ISO/TS 12417, titled “Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products,” has just been issued as the new 1st Edition.  These combination products are medical devices with various clinical indications for use in the human vascular blood system.

A ISO/TS is actually an ISO technical specification.  It offers a technical solution to a particular problem,  without conflicting with existing International Standards.  For implanted products, ISO/TS 12417 should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. ISO/TS 12417 should also be considered as a supplement to relevant device-specific standards, such as the ISO 25539-1 and ISO 25539-2 series specifying requirements for endovascular devices. Requirements listed in ISO/TS 12417 also address VDDCPs that are not necessarily permanent implants.

ISO/TS 12417:2011 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. A VDDCP incorporates, as an integral part, substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action of the device.

With regard to safety, ISO/TS 12417 outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging, and information supplied by the manufacturer.

Delivery systems or parts of the delivery system are included in the scope of ISO/TS 12417 if they comprise an integral component of the vascular device and if they are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires).

Pumps and infusion catheters which do not contain drug coverings, and whose primary mode of action is to deliver a drug, are not addressed in ISO/TS 12417.

Procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) are excluded from the scope of ISO/TS 12417 if they do not affect the drug-related aspects of the device.

ISO/TS 12417 is not comprehensive with respect to the pharmacological evaluation of VDDCPs. Some information on the requirements of different related national and regional authorities is given in an annex.

Bioabsorbable components of VDDCPs (e.g. coatings) are addressed by ISO/TS 12417 in their connection with drug-related aspects of the device.

ISO/TS 12417 does not address issues associated with viable tissues and non-viable biological materials.

This standard, and 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).  Our expert staff can assist you with all your standards requirements and questions.