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.

Why are there missing page numbers in my IEC standard?

Here’s a common question users of IEC standards ask us at Document Center Inc.:  “Why are there missing pages in my IEC standard?”

Turns out it’s a simple answer.  You’ve got an English edition of the IEC standard that was compiled from an original bilingual (English and French) edition.  When IEC creates an English edition like this, it simply removes the pages that are in French and prints the English pages only.

Since the IEC protocol for a bilingual edition is to have the French text on the left hand side and the English language on the right, the French pages are even numbers and the English odd.  When the French pages are omitted, this leaves an edition composed entirely of odd numbered pages.

You feel like you only have half the document you should have, and yet if you work in English, you have all the pages you need!

Do you have any questions about the standards you use, or think you ought to use?  Please contact us at any time via our website www.document-center.com, email at info@document-center.com, phone at 650-591-7600 or fax at 650-591-7617.  We’re happy to help you with any standards concern you may have.

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.

New ISO 14155, 2011 2nd Edition, just released – Clinical investigation of medical devices for human subjects — Good clinical practice

Document Center now has the new ISO 14155:2011 Edition available for purchase.  The standard, titled Clinical investigation of medical devices for human subjects — Good clinical practice, withdraws and replaces both the ISO-14155-1 and the ISO-14155-2.

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in ISO 14155:2011 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.

ISO 14155:2011 specifies 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 results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

ISO 14155:2011 does not apply to in vitro diagnostic medical devices.

This new edition, as well as all the ISO standards, is available from Document Center Inc. at our website www.document-center.com.  You can also contact us by phone at 650-591-7600, fax at 650-591-7617 or by email at info@document-center.com.  We’re always happy to help you with any standards needs you may have.

New BS EN 55024 2010 Edition released

BS EN 55024 has just been released as the new 2010 edition.  The popular standard is titled “Information technology equipment. Immunity characteristics. Limits and methods of measurement.”  The date on the new edition is January 2011 and the document is available now from Document Center Inc.

The new BS EN 55024:2010  is the official English language edition of the EN 55024 and is identical to the CISPR 24, 2010 Edition.

It establishes uniform requirements for the electromagnetic immunity of information technology equipment. BS EN 55024 specifies applicable tests, test levels, product operating conditions and assessment criteria.  Test methods are then found in the referenced Basic EMC Immunity standards.

BS EN 55024 sets out the requirements to provide an adequate level of intrinsic immunity.  The goal is for the equipment to operate as intended in its environment.  The standard specifies the immunity test requirements for equipment defined in the scope in relation to continuous and transient, conducted and radiated disturbances, including electrostatic discharges (ESD).

Some tests are specified in defined frequency bands or at selected frequencies because of testing and performance assessment considerations.  Equipment which fulfils the requirements at these frequencies is deemed to fulfil the requirements in the entire frequency range from 0 Hz to 400 GHz for electromagnetic phenomena.

The test requirements are specified for each port considered.

This standard, and many more, are available from Document Cen5ter Inc. at www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Feel free to contact us with additional questions.

RTCA DO 160 New Revision G on Environmental Conditions and Test Procedures for Airborne Equipment

The New Revision G for the widely used RTCA DO-160 on Environmental Conditions and Test Procedures for Airborne Equipment has just been released.  The document is available for purchase from Document Center Inc.

DO-160G provides standard procedures and environmental test criteria for testing airborne equipment for a wide range of aircraft, from light, general aviation planes and helicopters to “jumbo jets” and SST’s.

The standard covers tests for vibration, power input, radio frequency susceptibility, lightning and electrostatic discharge.   It has 26 sections and three appendices.  The new edition replaces RTCA-DO-160F and all other previous editions.  However, the obsolete revisions are available from Document Center Inc. if required.

As a measure of the wide acceptance of the document, it is coordinated with EUROCAE, with EUROCAE/ED-14G being identical to the  RTCA/DO-160G. And it is also adopted as the international standard ISO-7137.

You can get this document by going to the Document Center website at www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ll be happy to provide you with copies of this and many other publicly distributed standards or answer any standards questions you may have.