The new revision of ASME B46.1-2009, Surface Texture (Surface Roughness, Waviness, and Lay), is expected to ship from Document Center Inc. in September, 2010, when it will be released from the printer’s. The new 120 page edition of this frequently referenced standard is expected to be widely adopted.
ASME states: “This Standard is concerned with the geometric irregularities of surfaces. It defines surface texture and its constituents: roughness, waviness, and lay. It also defines parameters for specifying surface texture. The terms and ratings in this Standard relate to surfaces produced by such means as abrading, casting, coating, cutting, etching, plastic deformation, sintering, wear, erosion, etc.”
ASME-B46.1 has changed over recent years to keep pace with comparable International Standards, like ISO-4287.
ASME-B46.1-2009 may be purchased from Document Center Inc. at www.document-center.com. Document Center Inc. is a leading reseller of specifications and standards, in business since 1982 and on the web since 1993. The company is among the top 3% of women-owned businesses in the United States.
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 firstname.lastname@example.org to get your copy.
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