Yes, it’s the end of the year and what better time to highlight our best selling standards of 2011! Here’s what Document Center customers wanted this year:
- ISO 14155, 2nd Edition and Technical Corrigendum (correction sheet) from 2011, “Clinical investigation of medical devices for human subjects – Good clinical practice”
- ISO 19011, 2nd Edition, 2011, “Guidelines for auditing management systems”
- AMS 2700, Revision E, “Passivation of Corrosion Resistant Steels”
- 21CFR(800-1299), 2011 Edition, “Code of Federal Regulations – Food and Drug Administration Parts 800 through 1299”
- BS EN ISO 14971, 2009 Edition with Corrigendum 1 (correction) from 2011, “Medical devices. Application of risk management to medical devices”
- ASTM F1980, 2007 R2011 Edition (reapproved in 2011), “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices”
- IPC A 610, Revision E from 2010, “Acceptability of Electronic Assemblies”
- AS 9100, Revision C from 2011, “Quality Management Systems – Requirements for Aviation, Space & Defense Organizations”
- ASME Y14.5, 2009 Edition, “Dimensioning and Tolerancing”
- ASQ Z1.4, 2008 Edition, “Sampling Procedures and Tables for Inspection by Attributes”
- ASTM E1417, 2011 Edition, “Standard Practice for Liquid Penetrant Testing”
- ISTA 2A, 2011 Edition, “Performance Tests for Packaged-Products, Packaged-Products 150 lb (68 kg) or Less”
- ISO 9001, 4th Edition, Corrected and reprinted in 2009, “Quality management systems — Requirements”
- SOR/98-282, 2011 Edition, “Canadian Medical Devices Regulation”
- ASTM D4169, 2009 Edition, “Standard Practice for Performance Testing of Shipping Containers and Systems”
- ASTM E1444, 2011 Edition, “Standard Practice for Magnetic Particle Testing”
- BS EN 60601-1, 2006 Edition with Corrigendum 1 (correction sheet) from 2011, “Medical electrical equipment. General requirements for safety”
- ISO 10993-1, 4th Edition with Technical Corrigendum 1 (correction sheet) from 2011, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
- ISO 13485, 2nd Edition with Technical Corrigendum 1 (correction sheet) from 2009, “Medical devices – Quality management systems – Requirements for regulatory purposes”
- ASTM A240, 2011a Edition, “Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications”
These documents are all available from Document Center Inc. at our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information. We’re happy to help you with all your standards questions and requirements.
Happy New Year!