Document Center's Standards Forum - Page 107 of 154 - A Review of New Standards and Questions Standards Users Have

New ASTM E112 2012 Edition revises Standard Test Methods for Determining Average Grain Size

There is a new ASTM E112 2012 Edition, “Standard Test Methods for Determining Average Grain Size,” that has just been released and is available from Document Center Inc. in either paper or pdf format. Commonly used to determine the quality of a specific alloy, the standard provides the methodology for a tester to compare the grain structure of a sample to a series of graded images using wall charts, clear plastic overlays, or a grain counting eyepiece reticle.

The widely cited ASTM E112 not only covers the measurement of average grain size by the comparison procedures (as noted above), but also the planimetric (or Jeffries) procedure and the intercept procedures. Testers use the standard to determine the average grain size of specimens with a unimodal distribution of grain areas, diameters, or intercept lengths.

To see the differences between the new ASTM E112-12 and the previous (now obsolete) ASTM E112-10 (from 2010), you may want to purchase the redline edition. This will give you two copies of the standard. The current 2012 edition comes in a “clean” copy, and an additional copy of the 2010 is included with all changes “marked up.”

For determining the mean grain size, and the distribution of grain intercept lengths or grain areas, for polycrystalline metals and nonmetallic materials with equiaxed or deformed grain shapes, with uniform or duplex grain size distributions, and for single phase or multiphase grain structures, use the companion standard ASTM E1382.

Use Document Center’s website, www.document-center.com, to purchase all your ASTM standards. The document not only can be delivered as soon as you place your order, but will be tracked by our notification service at no additional charge. This means that you will receive an email update each time the standard is revised. For more information, contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re here to assist you with all your standards questions and requirements.

New TT-C-490 Revision F released for Chemical Conversion Coatings and Pretreatments for Metallic Substrates (Base for Organic Coatings)

TT-C-490 Revision F, “Chemical Conversion Coatings and Pretreatments for Metallic Substrates (Base for Organic Coatings),” has just been released and is available now from Document Center Inc. in either pdf or paper format. This federal specification replaced MIL-C-490 and MIL-P-14504 and is one of the most commonly used plating specifications we sell.

TT-C-490F covers processes, pre-treatments, and pre-primer surface preparations of metallic substrates for coating applicators. It covers metal surface preparation for delaying corrosion initiation and promoting primer adhesion. In addition, this specification covers the testing requirements for qualification of conversion coatings, the pre-treatments and pre-primer coatings.

The new 24-page revision has extensive changes from the now-obsolete 17-page TT-C-490E from 2002, so there are no lines in the margins showing you the updated material. Changes appear to have been made throughout the document.

Document Center Inc. has been providing mil-specs and standards to industry for over 30 years, and since 1993 on our website, www.document-center.com. You can count on us to provide you with the latest information and updating services that are not available from many other sources. Feel free to get in touch with us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We have the expertise to assist you with not only your standards purchases but other management services you need to keep your collection in good working order.

Yesterday’s Executive Order on Cyber Security to impact U.S. Standards Development

President Obama’s February 12th Executive Order, Improving Critical Infrastructure Cybersecurity, is definitely going to impact the standards community. In it, the President specifically states “It is the policy of the United States to enhance the security and resilience of the Nation’s critical infrastructure and to maintain a cyber environment that encourages efficiency, innovation, and economic prosperity while promoting safety, security, business confidentiality, privacy, and civil liberties. We can achieve these goals through a partnership with the owners and operators of critical infrastructure to improve cybersecurity information sharing and collaboratively develop and implement risk-based standards.”

First steps include the development of methodologies for identifying specific threats and providing unclassified government reports that can be widely shared with industry. In the classified arena, the Defense Industrial Base pilot will be renamed and expanded as the Enhanced Cybersecurity Services program, for companies and individuals with security clearances.

NIST (the National Institute of Standards and Technology) will spearhead the development of a Cybersecurity Framework. This framework will include a set of standards, methodologies, procedures, and processes to address cyber risks.

NIST has been playing an active role in recent years in bringing together regulators and industry standards developers in order to align the interests of government with the resources and infrastructure development provided by U.S. industry associations.

As far as industry is concerned, organizations to watch include:

the Internet Security Alliance, a consortium focused on developing policy and providing advocacy
ANSI (the American National Standards Institute), spearheading a joint standards-development strategy
IEEE, working on standards in the area of electric utility control systems
ISA (International Society of Automation), providing standards on computerized control system security
ISO/IEC JTC1 (Joint Technical Committee 1), developing security management systems at the international level
IETF (Internet Engineering Task Force), the fundamental Internet standards developer
ITU T Study Group 17, develops Recommendations on Cybersecurity

You should also be aware that since 9/11, one notable area of joint effort has been the ANSI Homeland Security Standards Panel. This forum for the co-ordination of standards development between ANSI accredited standards developers and the Department of Homeland Security is sure to be a part of this new cybersecurity effort.

Congress has been working on a similar piece of legislation, Cyber Information Sharing & Protection Act (CISPA), which so far hasn’t managed be passed. This is another reporting effort, this time providing for information sharing between private companies and the government about cyber threats. The executive order only provides for information sharing from government to industry, lessening concerns about the transmittal of private information without permission.

You can expect that, as with healthcare information, when the government decides to set a firm course on how it will secure and exchange this type of information, there is a great deal of opportunity for the players in this space. And the final results will impact our information infrastructure far beyond the scope of work as currently defined.

Find out more about 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). We’re in the business of standards and are here to assist you with any and all questions and requirements you may have.

New ASME B30.3 2012 Edition just released for Tower Cranes

The new ASME B30.3 2012 Edition, “Tower Cranes,” has just been released and can be purchased now from Document Center Inc. ASME B30.3 is used for tower cranes that are powered by electric motors or internal combustion engines. These types of cranes adjust their operating radius by means of a luffing boom mechanism, a trolley traversing a horizontal jib, or a combination of the two.

ASME has been publishing standards on construction cranes since 1916. This particular standard was first released in 1975. Since the last edition in 2009, the standard has covered both construction and permanently mounted tower cranes.

ASME B30.3-2012 includes major changes and additions to the scope of work for erecting, dismantling and climbing tower cranes, as well as new consideration of the impact of wind zone regions across the United States.

Strength and stability requirements have been changed to conform with EN 14439, and the inspection section now includes requirements for “Major Inspections” (to be conducted at 60 month intervals.)

The committee notes that this is a complete re-write of ASME B30.3-2009 and includes many new subjects and requirements that have been updated to reflect the changing work environment in which tower cranes operate. If you use this standard, you’ll want the new edition right away.

ASME standards can be purchased at Document Center’s webstore, 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 here to assist you with all your standards purchases and management requirements.

New MEDDEV 2.12-1 Revision 8 released for Guidelines on a Medical Devices Vigilance System

MEDDEV 2.12-1, “Guidelines on a Medical Devices Vigilance System,” has just been revised with the release of Revision 8 and it’s available now from Document Center Inc. We’ve discussed this particular Guideline in general in a previous blog.

All MEDDEV guidelines are regularly updated accordingly with regulatory developments. For this reason, the latest version of the guidelines should always be used.

This 2013 revision of MEDDEV 2.12-1 has:

carefully considered and transposed into the European context the Global Harmonisation Task Force (GHTF) international regulatory guidance documents on vigilance and postmarket surveillance,
addressed the introduction of European medical device database EUDAMED and
amended the document in light of experience with previous clauses.

Additionally, MEDDEV 2.12-1 Revision 8 explicitly includes IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual. This newly revised 64-page guidance document will be applicable as of July 2013.

If you’re in the Medical Device industry and want to keep up with the latest releases of both standards and regulatory documents, you’ll want to use Document Center’s website, www.document-center.com, on a regular basis. We provide information on Standards for the Medical Device Industry as well as information on Regulations and Harmonized Standards. Feel free to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) if we can personally help you in any way. We are dedicated to improving the way companies like yours procure and use compliance information.

New ASTM E662 2013 Edition released for the Standard Test Method for Specific Optical Density of Smoke Generated by Solid Materials

ASTM E662-13, “Standard Test Method for Specific Optical Density of Smoke Generated by Solid Materials,” has just been released and is available from Document Center Inc. This new 24-page standard covers determination of the specific optical density of smoke generated by solid materials and assemblies mounted in the vertical position in thicknesses up to and including 1 in. (25.4 mm).

This new revision of the well established smoke test is used for construction, maritime and railway applications throughout the world. It is similar to the ISO 5659-2:2012 and BS 6401:1983. The 2013 Edition is the first revision of the ASTM E662 since 2009.

The test itself requires a smoke chamber. The test specimens are exposed to both flaming and nonflaming conditions. Then a photometric system with a vertical light path is used to measure the varying light transmission as smoke accumulates. The light transmittance measurements are used to calculate specific optical density of the smoke generated during the time period to reach the maximum value.

All current ASTM standards and many obsolete revisions are available from Document Center’s webstore, www.document-center.com. Most are available in both pdf and paper format. Should you prefer, you can always get in touch with us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’ve been providing our customers with licensed copies of ASTM standards since the 1980’s.

New NFPA 496, 2013 Edition, addresses the issue of Purged and Pressurized Enclosures for Electrical Equipment

There’s a new NFPA 496 2013 Edition, “Standard for Purged and Pressurized Enclosures for Electrical Equipment,” and it’s available now from Document Center Inc. The standard provides the user with the requirements for the design and operation of purged and pressurized electrical equipment enclosures.

The protection technique covered by NFPA 496: 2013 is used in Class I and Class II hazardous (classified) locations to reduce or prevent the presence of flammable materials within electrical equipment enclosures as specified by NFPA 70, the National Electrical Code. It also includes chapters covering protection of analyzers and rooms housing analyzers and a chapter on pressurized control rooms.

This new edition provides the following changes:

Revisions to the definitions for Type X Pressurizing, Type Y Pressurizing, and Type Z Pressurizing clarify that pressurizing keeps a flammable atmosphere around a protected enclosure from entering an enclosure, which enables the use of either ignition-capable equipment (in Type X Pressurizing or Type Z Pressurizing) or Division 2 or Zone 2 equipment (Type Y Pressurizing) inside an enclosure.
The addition of a new requirement affecting electrical alarm actuators in Type Y Pressurizing to require them to be identified for a Division 1 or Zone 1 location.
Clarification of requirements affecting cutoff switch actuators in Type X Pressurizing.

All current NFPA standards are 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) in order to get more information about ordering, etc. We accept orders from U.S. companies using PO’s on a net 30 basis or with credit card payment. For all non-U.S. purchases, prepayment is required.

Document Center’s 20 Top Selling Standards of 2012

Yes, it’s time to review Document Center‘s top selling standards of 2012. Do you use any of these popular items?

BS EN ISO 13485, New 2012 Edition, Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes
BS EN ISO 14971, New 2012 Edition, Medical Devices. Application of Risk Management To Medical Devices
ISO 15223-1, New 2nd Edition, Medical Devices – Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied – Part 1: General Requirements
BS EN ISO 15223-1 (paper or CD Rom format), New 2012 Edition (replaces BS EN 980), Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied. General Requirements
ASTM F2096, 2011 Edition, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
AMS 2750, New Revision E, Pyrometry
21 CFR Parts 800-1299, 2012 Edition, Code of Federal Regulations – Title 21–Food and Drugs (Parts 800 To 1299)
ISO 19011, 2011 Edition, Guidelines for Auditing Management Systems
SOR/98-282, 2012 Consolidated Edition, Medical Devices Regulations (Canada)
IEC 60601-1, Consolidated Edition 3.1 with Corrigendum, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
MEDDEV 2.12/1, New 8th Revision, Guidelines on a Medical Devices Vigilance System
ASTM E1417, 2011 Edition with Editorial Change, Standard Practice for Liquid Penetrant Testing
ASTM E18, 2011 Edition, Standard Test Methods for Rockwell Hardness of Metallic Materials
ASTM A370, 2012A Edition, Standard Test Methods and Definitions for Mechanical Testing of Steel Products
IPC-A-610, Revision E, Acceptability of Electronic Assemblies
ISO 11137-2, 2012 Edition, Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose
ASTM A240/A240M, 2012A Edition, Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
ASQ Z1.4, 2008 Edition, Sampling Procedures and Tables for Inspection by Attributes
ISTA 2A, 2012 Edition, Performance Tests for Packaged-Products, Packaged-Products 150 Lb (68 Kg) or Less
IPC/WHMA-A-620, Revision B, Requirements and Acceptance for Cable and Wire Harness Assemblies — tied with the all time favorite: ISO-9000, 2005 Edition, Quality Management Systems – Fundamentals and Vocabulary

All these standards are available from Document Center Inc. at our webstore, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re here to assist you with both your standards purchases and the services you need to maintain your standards collection.

New ISO 14708-7 released on Implants for Surgery – Active Implantable Medical Devices – Part 7: Particular Requirements for Cochlear Implant Systems

For those of you in the medical device field, you may be interested in the new ISO 14708-7 1st Edition, “Implants for surgery – Active implantable medical devices – Part 7: Particular requirements for cochlear implant systems,” available now from Document Center Inc. in either paper or pdf format. It specifically addresses the particular requirements for devices used to treat hearing impairment via electrical stimulation.

The challenge of cochlear implant systems (or auditory brainstem implant systems) is the fact that the device is usually composed of both implantable and non-implantable parts. For example, the power source may be part of the implantable component or not. Then too, since the system is designed to restore hearing by the use of electrical stimulation of the auditory pathway, externally processed information may be used to adjust the parameters of the device via a non-implantable accessory.

The ISO 14708 series is one of our best-selling medical device sets, comprised of the following standards:

ISO 14708-1:2000, Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ISO 14708-2:2012, Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
ISO 14708-3:2008, Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
ISO 14708-4: 2008, Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pumps
ISO 14708-5:2010, Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
ISO 14708-6:2010, Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
ISO 14708-7:2013, Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems

All ISO standards can be purchased at our webstore, www.document-center.com. Please be aware that certain territorial restrictions do apply. You can also get in touch with us via phone (650-591-7600), fax (650-591-7617), and email (info@document-center.com). We’re happy to assist you with any and all standards questions and requirements you may have.

New ISO 17351 addresses the use of Braille on packaging for medicinal products

ISO 17351 1st Edition, “Packaging – Braille on packaging for medicinal products,” has just been released and is available from Document Center Inc. in both paper and pdf format. The document was developed to meet national and regional requirements for the use of Braille on the packaging of medical products, a direct reflection of the impact of an aging population in developed countries.

The 20-page ISO 17351:2013 specifies requirements and provides guidance for the application of Braille to the labeling of medicinal products. It is a direct descendant of EN 15823:2010, generated in response to Directive 2004/27/EC. The Directive requires Braille labeling on the outer packaging for medicinal products within the EU, including the name of the product, and in some cases, the form and strength as well.

ISO Technical Committee 122, which developed the standard, envisions additional accessible packaging technologies to continue to emerge, with the probable development of additional standards in the future.

ISO standards are sold under license agreement by Document Center Inc. at our webstore, www.document-center.com. Please note: Territorial restrictions do apply. And all purchases of ISO standards come with our free update notification service. You may find it easier to get in touch with us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We are here to assist you with not only your standards purchases, but also with those questions that the use of these technical documents generate from time to time.