New 2011 Edition of the NBS HDBK 44 on weighting and measuring devices is now available

NBS HDBK 44, Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices, is now available in the 2011 Edition.  The 479 page standard was adopted by the 95th National Conference on Weights and Measures (NCWM) in 2010.

Handbook 44 was first published in 1949, having been preceded by similar handbooks of various designations and in several forms, beginning in 1918.  It is reviewed annually by the NCWM.

The handbook conforms to the concept of primary use of SI (metric) measurements recommended in the Omnibus Trade and Competitiveness Act of 1988.  In some cases, however, trade practice is currently restricted to the use of inch-pound units; therefore, some requirements continue to specify only inch-pound units until the NCWM achieves a broad consensus on the permitted SI units.

The purpose of Handbook 44 is to prevent the use of weights and measures and weighing and measuring devices that give readings that are false,  faulty (that is, that are not reasonably permanent in their adjustment or will not repeat their indications correctly), or that facilitate the perpetration of fraud.

It has been designed to be a working tool for federal, state, and local weights and measures officials, the equipment manufacturers, installers, and service agencies/agents.  Many organizations cite the Handbook in calibration or quality documentation.

This NBS Handbook, and other standards on calibration and measurement,  is available from Document Center Inc.’s website, www.document-center.com.  You can also order by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  If you have any questions about this standard, please get in touch.

BS EN ISO 14155 2011 Edition on Human Clinical Trials for Medical Devices just released

BS EN ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice, has just been released for public distribution.  The ISO 14155:2011 standard is adopted by the European Union for meeting the requirements of the Medical Device Directive (93/42/EEC).

BS EN ISO 14155 is the standard that specifies the general requirements intended to:

  • Protect the rights, safety and well-being of human subjects
  • Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results
  • Define the responsibilities of the sponsor and principal investigator
  • Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

It does not apply to in vitro diagnostic medical devices.

The document is identical to ISO 14155:2011, but does contain 2 informative annexes that are part of the EN administrative information regarding the adoption of the ISO standard.  These 2 annexes are:

Annex ZA:  Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices and

Annex ZB:  Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EECon active implantable medical devices

The principles set forth in BS EN ISO 14155 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

The document withdraws and replaces two documents, BS EN ISO 14155-1 and BS EN ISO 14155-2, which are now obsolete.

The new BS EN ISO 14155 can be purchased on Document Center’s website, www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Should you have any questions about this document or any other standard, please get in touch.  Our expert staff is available to help you during business hours (8 am to 5 pm California time).

New SAE AMS 2418 H on Copper Plating released 2/18/2011

AMS 2418 new Revision H on Copper Plating was just released on 2/18/2011.  This Aerospace Material Specification covers the requirements for electrodeposition of copper on metals and the properties of the deposit.

This process has been used typically to provide an anti-seize surface, to prevent carburizing of surfaces on which carburizing is neither required nor permitted, to prevent decarburization, to enhance solderability, or to provide a source of copper for furnace brazing, but usage is not limited to such applications.

The standard is one of the primary plating spec standards in use all over the world.

It is available from Document Center Inc. at our website, www.document-center.com, via phone at 650-591-7600, fax 650-591-7617, and email info@document-center.com.  Any questions are welcome.

ASTM releases new standard on fungal growths in buildings

If you’ve got an interest in mold assessment in any building, ASTM’s new standard ASTM D7338 will be of interest.  Titled Guide for the Assessment of Fungal Growth in Building, the document provides the user with options for a systematic assessment of fungal growth in buildings.  This standard is available from Document Center Inc. now.

The guide describes minimum steps and procedures for collecting background information on a building in question, procedures for evaluating the potential for moisture infiltration or collection, procedures for inspection for suspect fungal growth, and procedures beyond the scope of a basic survey that may be useful for specific problems.

However, ASTM D7338 does not describe a set of uniform steps that will always be performed during an assessment, as would a standard practice.  The user of the guide must decide which steps are appropriate for a given situation or building.

This standard is one of four planned on the topic by the D22 committee of ASTM International.  Already released ASTM D7391,
Standard Test Method for Categorization and Quantification of Airborne Fungal Structures in an Inertial Impaction Sample by Optical Microscopy, covers procedures for categorizing and enumerating fungal structures by morphological type.  The other two planned standards will cover the Examination of Fungal Structures on Tape Lift Samples by Optical Microscopy and the  Collection of Total Airborne Fungal Spores via Inertial Impaction Methodology.

Why produce these particular standards?  The lack of consensus standards in the fungal sampling and analysis practice was the driving force for the ASTM D22 committee.  Anyone who has an interest in indoor air quality or mold/fungal assessment, remediation and analysis should find these four standards essential.

All ASTM International standards are available in paper or pdf format from Document Center Inc. at our website, www.document-center.com.  Orders and questions are always welcome by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com).

ASME B31.3 Process Piping 2010 – an International Piping Code – due out in April

The new ASME B31.3 2010 Edition on Process Piping is scheduled for release in April 2011 and can be pre-ordered from Document Center Inc. now.  This international code focuses on piping typically found in petroleum refineries; chemical, pharmaceutical, textile, paper, semiconductor, and cryogenic plants; and related processing plants and terminals.

It prescribes requirements for materials and components, design, fabrication, assembly, erection, examination, inspection, and testing of piping. This Code applies to piping for all fluids including: (1) raw, intermediate, and finished chemicals; (2) petroleum products; (3) gas, steam, air and water; (4) fluidized solids; (5) refrigerants; and (6) cryogenic fluids. Also included is piping which interconnects pieces or stages within a packaged equipment assembly.

The code is part of the ASME B31 series, the standards most often referenced for Pressure Piping.

Of course, you may want to know why the 2010 edition of the ASME B31.3 is only now becoming available.  This is a common situation due to the practice of dating a standard when it finishes the administrative development process.  Since the standard must then go to the printers for actual publication, there is a lag time between the issue date and the real public release date.  Electronic publishing has reduced this delay in many cases, but it’s rare to find a standard available on the actual cover date.

This and all ASME standards are available from Document Center Inc., and can be ordered at www.document-center.com or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  If you have any questions about codes or standards, please get in touch with us at Document Center as well.

New BS EN ISO 14971 Medical devices. Application of risk management to medical devices Corregendum 1 for 2009 Edition

BS EN ISO 14971:2009 has been reissued with a new Corrigendum 1 as of February 2011.  The document is titled “Medical devices. Application of risk management to medical devices.”  It’s available for purchase from Document Center Inc.

The EN Corrigenda are corrections that are interfiled directly into the standard they modify.  For example, the Corrigendum 1 for  the BS EN ISO 14971:2009 corrects the pagination of the document.  So, there is no page within the document that describes the change.  It is just included by correcting the way the pages are numbered.

The EN ISO 14971 is a major European medical devices standard.  The BS EN ISO 14971 is the official English language edition.  It continues to adopt the ISO-14971:2007 Edition.

The standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 and its various adoptions are applicable to all stages of the life-cycle of a medical device.

The EN ISO 14971 is one of the “harmonised” standards for the Medical Devices Directive (93/42/eec), which means that by meeting the requirements of the standard there is the presumption of conformity with the essential requirements of the directive.

Both ISO 14971 and BS EN ISO 14971 are available for purchase from Document Center Inc.  Check out our website at www.document-center.com or send us an email at info@document-center.com, phone us at 650-591-7600 or send a fax to 650-591-7617.  We’re happy to help you with all your Standards Requirements.

ISTA 2A New 2011 Edition for Packaged Products is now available

ISTA 2A, Packaged-Products 150 lb (68 kg) or Less, has just been released as the 2011 Edition.  The new revision includes both technical and editorial corrections.  It is available for sale from Document Center Inc.

This standard is a partial simulation test for individual packaged-products.  ISTA suggests that it should be considered for the evaluation of packaged-products intended for international distribution.  The package and product are considered a unit in this procedure.  They also suggest that not only should an organization use the procedure to evaluate the performance of a packaged-product, but also to compare different package and product design alternatives.

At Document Center, we often get clients asking about the issue dates on ISTA procedures like the 1A, 1B, 2A, 2B and so on.  This is because ISTA releases each of their procedures annually with the new year as the date on the cover in the upper right hand corner.

To really understand the situation for each standard, you’ll need to look at the left hand sidebar on the cover of each.  There you’ll find a section called “Version Date.”  Underneath it will have the date of the last technical change and the last editorial change, if applicable.

A technical change is a change that impacts the technical content of the standard.  It has the potential to impact the validity of the application of the standard.  If you use an ISTA procedure, and there is a technical change to the document, you should get the new edition just to make sure you’re still in compliance.

An editorial change, on the other hand, is a modification to the document that does not impact the technical content.  It could be a change in the address of a referenced organization, a modification in the format of a table, or some other change for the sake of editorial improvement of the document.  It can be important to have if you’re getting audited, but not so important if all you’re interested in is the technical content.

ISTA has also been providing an additional type of change to their documents – a change they’re calling Clarification.  An example of this would be the new edition of the ISTA 3H which has the new clarification, “Before You Begin Compression revised for clarification when using the Apply & Release method.”

If you need any of the ISTA procedures or have any additional questions, please contact Document Center Inc. via our website at www.document-center.com, or phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re always ready to assist you with your standards requirements.

IEC 60825-1 Interpretation Sheet 2 now available

Interpretation sheet 2 for IEC 60825-1, SAFETY OF LASER PRODUCTS – Part 1: Equipment classification and requirements, has just been released and is available from Document Center Inc.

This leads to the question, “What is an interpretation sheet?”  The answer is straight-forward.  It is an explanation of a section of the standard written by the committee to help people properly fulfill the requirements of the standard.

Interpretation sheets are generated by a request from a user for guidance on a clause or sub-clause.  The Interpretation Sheet 2 for IEC 60825-1 covers Subclause 8.3 f 3) and provides the user with additional information to clarify this part of the standard.  It’s 4 pages long and is dated 1/31/2011.  Two of the pages are in English and two are in French.

The request for clarification may come directly from a user or perhaps from a certifying organization.  The committee receives the request, creates the information sheet, votes on it, and if accepted releases it as an additional component of the document.

Document Center Inc. has this and all of the IEC standards in stock for immediate fulfillment.  You can purchase standards at our website www.document-center.com, or by phone at 650-591-7600, fax at 650-591-7617 or email at info@document-center.com.  Should you have any further questions about this or any standard, please get in touch.

47 CFR Code of Federal Regulations New 2010 Edition now available

Title 47 of the Code of Federal Regulations is currently being released with the October 2010 publication date and is available from Document Center Inc.  47 CFR is released in 5 books, the most notable being the volume with Parts 0 to 19.  That’s because it includes Part 15, the Federal Communications Commission (FCC) rules and regulations regarding unlicensed transmissions.  Why so widely used?  Because nearly every telecommunications device sold in the United States, from medical devices to computers, must comply with Part 15.

The Code of Federal Regulations is the “Compendium” of U.S. regulations.  Title 47 is specifically the Telecommunications regulations.  Each October 1, all the regulations under the jurisdiction of the FCC (Federal Communications Commission) are “frozen” for publication in this series.  Each Part is included in the 5 volumes exactly as it was in force on that date.

Changes can be made to the regulations throughout the year, by the process of being published in the Federal Register.  For many folks, its much easier to get the CFR volumes with the regulations that impact them than to try to keep up with the information on a daily basis.

How did the CFR’s come into existence?  They’re a result of the Reduction of Paperwork Act.

All of the CFR’s and many government documents are available from Document Center Inc. at our website www.document-center.com.  Or feel free to call us at 650-591-7600, fax us at 650-591-7617 or send us an email at info@document-center.com.  We’ll be happy to provide you with the volumes you need or answer any questions you may have about regulatory and compliance information.

New MIL-STD-2073/1E with Change Notice 1 is now available

MIL-STD-2073/1 Revision E with Change Notice 1 interfiled has just been released and is available for sale from Document Center Inc.   The document is titled Standard Practice for Military Packaging and is widely used in fulfillment of U.S. government contracts.

The MIL-STD-2073/1 outlines standard processes for the development and documentation of military packaging.  This standard covers methods of preservation to protect materiel against environmentally induced corrosion and deterioration, physical and mechanical damage, and other forms of degradation during storage, multiple handling, and shipment of materiel in the defense transportation system. A decision chart is included for determining how to develop military packaging requirements.  If military packaging is applicable, the chart will further aid in the development of detailed packaging requirements.

The standard states that changes from the previous issue are not notated in the margins, but this appears to be incorrect.  The notation lines that are used to alert users to changes in specific parts of the text can be found where changes have been made.  There are a number of these changes for users to review.

This new MIL-STD-2073/1E with Change Notice 1 and all other publicly available U.S. military documents can be purchased from Document Center Inc. through our website, www.document-center.com.  Or contact us by phone at 650-591-7600, by fax at 650-591-7617, or by email at info@document-center.com.  And if you have any questions about MIL Specs and Standards, please get in touch.  We’re happy to help.