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!
