Belmont, CA (PRWEB) August 13, 2010
For those of you in the Medical Device field, the ISO-10993 series is a must-have set of standards. So when a new edition of one of the documents is released, you need to know about it.
Customers of Document Center Inc. have already been notified that the new 3rd Edition of the ISO-10993-10 standard is available. It’s titled Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. The document is dated 8/1/2010 and replaces the ISO 10993-10:2002 Edition. There is no specific information provided regarding the changes from one edition to the next, other than to note that the document has been technically revised.
ISO describes this document as follows:
ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
ISO 10993-10:2010 includes:
- pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
- details of in vivo (irritation and sensitization) test procedures;
- key factors for the interpretation of the results.
Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.
Give us a call at 650-591-7600 or email us at info(at)document-center(dot)com to get your copy.
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Document Center Inc. is an information distributor based in Silicon Valley. Selling standards since 1982 and on the web at http://www.document-center.com since 1993, Document Center Inc. is a leader in the dissemination of conformance information for business. Document Center offers out-sourced management services for standards collections for regulatory compliance, as well as individual document sales. ISO-9000 and FDA support products cover document auditing, monitoring, and periodic reporting services. The company is in the top 3% of woman-owned businesses in the United States.