The recent Panorama programme on surgical instruments highlighted the fact that to achieve the CE mark, you can effectively self-certificate. By registering in the UK
Read moreMonthly Archives: August 2011
How do we know where a piece of steel began its life? Every piece of stainless steel that is used to manufacture a surgical instrument
Read moreCompanies that are selling instruments CE marked, should certainly have the CE mark appearing on the device. In addition to this, a LOT number and
Read moreGS1 Laser Marking on Surgical Instruments
GS1 laser marking has become very relevant in the past year, with high-risk trays such as neurology needing to
Different chemical compositions are suitable for different surgical instruments. BS 5194 : Part 1:1991 gives a more in depth breakdown for the uses, but as
Read moreWho Regulates the Sale of Surgical Instruments?
Although companies are monitored by notified bodies, such as SGS (www.sgs.com), ultimately, the government monitor all medical devices
There are no harmonised standards in place that Surgical Instruments can be assessed against to prove quality, specific to their functionality. Standards such as ISO
Read moreLike all industries, the selling of Medical Devices is subject to legislation and monitoring. The law that Surgical Holdings have to comply with, in order
Read moreEach medical Device placed on the market, falls under a classification in the Medical Device Directive, which is determined by its function, use and period
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