Tag: Dental instruments

ISO 7153-1 Surgical Metals

ISO 7153-1, “Surgical Instruments — Materials — Part 1: Metals” was recently updated.  It will replace the 2nd edition, last released in 1991.  One major change to the document is that its scope has been broadened to include a variety of metals used in surgical instruments, as well as stainless steel.   This new 3rd edition is available from Document Center, Inc.  It is available for purchase as a hard copy or for pdf download.

The ISO 7153-1 is a standard developed to provide a general overview of metals commonly used for medical instrumentation.  Medical sectors that may need to employ this standard include general surgery, orthopedics, and dentistry.  The publisher specifies that this standard is not intended to apply to special surgical applications, but parts of the standard may prove useful in these situations.

Medical instrument design and manufacture is a complex process.  Many factors must be taken into account when choosing the materials one may use.  This standard will help you decide which metals are best suited to the specific type of instrument you may be developing.

A general discussion of important considerations for medical instrument design is included.  Aside from this, the lion’s share of this standard is tables.  These tables lay out a variety of metals and the applications they are commonly used in.  Some of these include stainless steel, titanium, and various other hard metal alloys.  Additional tables detail specific properties about each metal, such as grade, Rockwell hardness, Vickers hardness, and standard reference numbers.

The document also includes an Appendix which specifically applies to dental instruments.  This section was designed to remove the guesswork from applying surgical instrument design knowledge to the dental sector.  The information within this section details which dental instruments each metal is commonly used in.  Finally, the document finishes out with a one-page bibliography.

Last, but not least, where do you get it?  Document Center Inc. is an authorized distributor of ISO standards. You can order this at our webstore, www.document-center.com, as well as any other ISO standard you may need.  Here’s a link to the ISO 7153-1 order page for your convenience.

Have questions about ISO 7153-1 or other standards?  Contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been providing guidance through the world of standards since 1982.  Make us your Standards Experts!

New ISO Dentistry Standards Released

ISO has  released three new Dentistry Standards.  Since Document Center Inc. has a number of customers who design, manufacture and market dental products, we like to review new issues when they occur.  Standards play an important role in assuring customers and end-users of safe and effective dental products.  One of these new releases is on endodontic instruments (ISO 3630-3), one is on sealants (ISO 6874) and one is for periodontal instruments (ISO 13397-5).  We’ll review each of these separately.

ISO 3630-3, 2nd Edition, “Dentistry – Endodontic instruments – Part 3: Compactors: pluggers and spreaders”  You’ll get information on size, marking, product designation, safety considerations, labeling and packaging in this standard.

Endodontic instruments are basically used for root canal work.  Part 3 deals exclusively with such instruments used to compact endodontic fillinf materials that are not specified in the other parts of the series.

The new 2nd Edition cancels and replaces the 1st Edition from 1994.  It has been technically revised, with changes occuring in the definition of “condenser” (now “compactor”), updates to clauses 5 and 7 (finger instruments and hand instruments are differentiated), and the deletion of plugger sizes 015 and 020 from Table 1.  Reprocessing requirements have also been added.

ISO 6874, 3rd Edition, “Dentistry – Polymer-based pit and fissure sealants”

This new 3rd Edition cancels and replaces the 2nd Edition from 2005.  However, it is considered a minor revision.  It addresses polymer-based materials that are used as pit and fissure sealants for preventing dental decay.  The materials covered in the ISO 6874 may be hardened either during the mixing process or by external energy (light).  FYI:  The issue of biological hazards of such material are not included, but should be addressed by the use of the ISO 10993 series and ISO 7405.

ISO 13397-5, 1st Edition, Dentistry – Periodontal curettes, dental scalers and excavators – Part 5: Jacquette scalers

The ISO 13397 series provides requirements for periodontal instruments.  As such, the series is slowly expanding to include more parts as the committee is able to produce them.  This new Part 5 is such an expansion.  It provides you with the designs and dimensions for Jacquette scalers.

Periodontal scalers are those sharp instruments that are used to remove deposits from your teeth.  A jacuqette scaler is a straight-bladed scaler with two cutting edges that end in a sharp point.  Your dental technician or dentist will use this device to remove supragingival and/or interproximal deposits (plaque).  It’s also sometimes called a sickle scaler.

Now to get your copies of one or more of these Dental Standards.  You’ll want to use an authorized distributor for your purchase.  So use the Document Center webstore at www.document-center.com.  Here are direct links to the order pages for ISO 3630-3, ISO 6874, and ISO 13397-5.  And here is our Document Center List of Standards on Dental Equipment.  You’ll be able to order your standards in either paper format or for pdf download.

Would you like to include any of the ISO standards in a multi-user “standards in the cloud” service?  Ask our staff about our Standards Online subscription access to the standards you use in your business.  It’s a great way to ensure 24/7 availability of the standards you use.  Contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.  Remember:  We’re your Standards Experts!