Archive for July, 2012

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New Revision S released for AMS 2430, “Shot Peening, Automatic”

Tuesday, July 31st, 2012

SAE has released a new Revision S for AMS 2430, “Shot Peening, Automatic,” and it is available now from Document Center Inc. in both paper and pdf format.  This specification covers the requirements for automatic shot peening of surfaces of parts by impingement of media, including metallic, glass, or ceramic shot.

AMS-2430S results from a complete review of industry requirements and replaces both the previous AMS 2430R Edition and the AMS-S-13165 (cancelled in 2007).

This document includes requirements for the set-up, operation and verification of the shot peening process. Related peening processes, like tumble peening, manual peening, peen forming and straightening, etc. are not a part of this specification.

Shot peening is used to induce residual surface compressive stresses in metal parts to increase fatigue strength and resistance to stress-corrosion cracking.  Commonly it’s used for axles, springs, gears, shafting, aircraft landing gear, and structural parts. Ceramic and glass shot peening are used when iron contamination of non-ferrous or stainless steel parts is a concern.

All SAE standards are sold under license agreement by 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).  Our expert staff is available to answer your questions about the standards you use.  And we provide a wide range of services to support the use of standards within your organization.

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New TL 9000 Book 2 2012 Edition, “Quality Management System (QMS) Measurements Handbook”

Monday, July 30th, 2012

There’s a new 2012 Release 5.0 for the TL 9000 Book 2, “Quality Management System (QMS) Measurements Handbook,” and it’s available from Document Center Inc. now.  The handbook is a comprehensive guide to measurements processing, usage, responsibilities and requirements for ISO 9000 compliance.

TL 9000-2 defines the minimum set of performance measurements to assess progress and evaluate results of quality management system implementation.  It identifies performance measurements in the key areas of hardware, software, common, outage and service quality.

Five new measurements are introduced in this release:

  • On-time delivery to supplier promise date (OTIP) – Applies to all product categories.
  • Basic Return Rate (BRR) – Replaces ERI, YRR, LTR, and NYR in certain product categories where long-term returns are not expected.
  • Mean-time to Restore Service (MTRS) – An outage measurement applicable in product category 7.3.2, Network Operators Center.
  • Global Service Impact (GSI) – An outage measurement applicable in network operator categories (9.x).
  • End-Customer Complaint Report Rate (CCRR) – A service quality measurement applicable in network operator categories (9.x).

Many ISO 9000 certified companies use both the Book 1 and the Book 2 of the TL 9000 series to help them assess progress and evaluate results of their implementation.  The Handbooks 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).  Our expert staff can assist you with all your standards needs.

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New IEC 61326-1 Edition 2.0 from 2012, “Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements”

Friday, July 27th, 2012

IEC 61326-1:2012, “Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements,” has just been released and is now available from Document Center Inc.  The document specifies requirements for immunity and emissions regarding electromagnetic compatibility (EMC) for electrical equipment, operating from a supply or battery of less than 1 000 V a.c. or 1 500 V d.c. or from the circuit being measured.

Types of equipment covered by IEC 61326-1 are intended for professional, industrial-process, industrial-manufacturing and educational use. These include equipment and computing devices for
– measurement and test,
– control,
– laboratory use,
– accessories intended for use with the above (such as sample handling equipment),
all intended to be used in industrial and non-industrial locations.

This 46-page second edition cancels and replaces the first edition, published in 2005.  It constitutes a technical revision.

The significant technical changes with respect to the previous edition are:
- the immunity test levels and performance criteria have been reviewed,
- requirements for portable test and measurement equipment have been clarified and amended, and
- the description of the electromagnetic environments has been improved.

Document Center is a licensed dealer of IEC standards, which you can purchase at Document Center’s website, www.document-center.com.  Or you may want to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  If you haven’t used our website in a while, please check it out.  We recently upgraded the site providing users with easier searching and ordering functionality.

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Newly revised IPC/WHMA-A-620AS Supplement released – Space Applications Electronic Hardware Addendum

Thursday, July 26th, 2012

IPC has just released IPC/WHMA-A-620AS with amendment 1, “Space Applications Electronic Hardware Addendum,” and it’s available now from Document Center Inc.  This document is a supplement for the IPC/WHMA-A-620, “Requirements and Acceptance for Cable and Wire Harness Assemblies.”

The addendum provides additional requirements over those published in IPC/WHMA-A-620A to ensure the performance of cable and wire harness assemblies that must survive the vibration and thermal cyclic environments getting to and operating in space.

When required by procurement documentation/drawings, this Addendum supplements or replaces specifically identified requirements of IPC/WHMA-A-620A.  Where content criteria are not supplemented, the Class 3 requirements of IPC/WHMA-A-620A apply.

Clauses that are modified or added by IPC-A-620AS are clearly identified in the Table of Contents.  However, there are no clear markings of changes provided by the included amendment.

IPC standards are available from Document Center Inc. at our website, www.document-center.com.  Or consider contacting us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our expert staff are available to assist you with all your standards questions and requirements.

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New JESD 47 Revision I released for Stress-Test-Driven Qualification of Integrated Circuits

Wednesday, July 25th, 2012

JEDEC has just released the new JESD 47 Revision I, “Stress-Test-Driven Qualification of Integrated Circuits,” and it’s available now from Document Center Inc. in either paper or pdf format.  This standard describes a baseline set of acceptance tests for use in qualifying electronic components as new products, a product family, or as products in a process which is being changed.  Qualification is aimed at components used in commercial or industrial operating environments.

JESD 47I replaces the JESD 47H, which is now obsolete.  Changes include modifications to Clauses 1 and 5.5, as well as added details in Figure 1.

These tests are capable of stimulating and precipitating semiconductor device and packaging failures. The objective is to precipitate failures in an accelerated manner compared to use conditions.

Failure Rate projections usually require larger sample sizes than are called out in qualification testing. For guidance on projecting failure rates, refer to JESD85 Methods for Calculating Failure Rates in Units of FITs.

This qualification standard is aimed at a generic qualification for a range of use conditions, but is not applicable at extreme use conditions such as military applications, automotive under-the-hood applications, or uncontrolled avionics environments, nor does it address 2nd level reliability considerations, which are addressed in JEP150.

Where specific use conditions are established, qualification testing tailored to meet those specific requirements can be developed, using JESD94 that will result in a better optimization of resources.

All current JEDEC standards (as well as many obsolete ones) can be purchased from Document Center Inc. using our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Based in Silicon Valley, Document Center provides you with complete sales, monitoring, auditing and reporting services for the standards you use in your business.

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New BS EN ISO 14971 2012 Edition released on Medical devices. Application of risk management to medical devices

Tuesday, July 24th, 2012

BS EN ISO 14971:2012, “Medical devices. Application of risk management to medical devices,” has been released and is now available from Document Center Inc.   It is the UK implementation of EN ISO 14971:2012. It is identical to ISO 14971:2007 (Corrected Version from 10/2007).  FYI: The 2012 Edition supersedes BS EN ISO 14971:2009 which is withdrawn.

This new edition provides the user with important new information on the differences between the ISO 14971 and the requirements of the 93/42/eec, 90/385/eec and 98/79/ec Directives.  In other words, Annexes ZA, ZB and ZC explain to which requirements, under which conditions and to what extent presumption of conformity can be claimed.

This is the first time that I recall seeing such a clear and detailed explanation of differences between the standard and the directive in the EN Annexes that are now appearing at the head of many of the ISO adoptions.  Here, for each directive referenced by Annex, there are about 7 areas with differing requirements.  Furthermore, information on corrective action is also given.

Here is an example of the new guidance provided:

“1. Treatment of negligible risks:
a) According to standard ISO 14971, the manufacturer may discard negligible risks.
b) However, Sections 1 and 2 of Annex I to Directive 93/42/EEC require that all risks, regardless of their dimension, need to be reduced as much as possible and need to be balanced, together with all other risks, against the benefit of the device.
c) Accordingly, the manufacturer must take all risks into account when assessing Sections 1 and 2 of Annex I to Directive 93/42/EEC.”

As you can see, this material is essential to conformance with the EN requirements and will make the purchase of the EN edition (BS EN ISO 14971 is the official English language edition) mandatory for medical device manufacturers certifying to the standard for sales in Europe.

All BS EN 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).  Our expert staff can assist you in all your regulatory documentation requirements.

 

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New Amendment 1 for IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

Monday, July 23rd, 2012

IEC 60601-1 Edition 3.0 from 2005, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance,” has just been modified with the release of the IEC 60601-1-am1.  This new 236-page Amendment 1 is available from Document Center Inc. now.

Corrections to the third edition of IEC-60601-1 were initiated to address the way in which risk management has been introduced into IEC 60601-1:2005 and the way the concept of essential performance is used in the standard as well.  However, in the end a wide range of modifications have made their way into this update.

The Amendment 1 itself is divided into 2 parts — pages 1 to 114 cover the changes to the English language portion of the standard and pages 115 to the end cover corrections to the French language side.  The pen-and-ink changes are extensive and cover the document from stem to stern.

I suspect that because of the importance of this standard, we should see an interfiled Edition 3.1 soon.  However, so far there are no indications of when such a  revision might be available.

All IEC standards are available under license agreement from Document Center Inc. at our website, www.document-center.com.  Or consider contacting us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can assist you with all your standards questions and requirements.

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New ASTM A513 2012 Edition for Electric-Resistance-Welded Carbon and Alloy Steel Mechanical Tubing

Friday, July 20th, 2012

ASTM A513, “Standard Specification for Electric-Resistance-Welded Carbon and Alloy Steel Mechanical Tubing,” has just been released as the new 2012 Edition and has been redesignated as ASTM A513/A513M at the same time.  Available now from Document Center Inc. in paper or pdf format, the new edition includes both SI units and inch-pound units.  It covers round, square, rectangular, and special shape electric-resistance-welded carbon and alloy steel mechanical tubing produced by hot- or cold-rolling.

The types of tubing in the new 20 page ASTM A513 / A513M – 12  are:

  • Type 1a, as-welded from hot-rolled steel (with mill scale),
  • Type 1b, as-welded from hot-rolled pickled and oiled steel (mill scale removed),
  • Type 2, as-welded from cold-rolled steel,
  • Type 3, sink-drawn hot-rolled steel,
  • Type 4, sink-drawn cold-rolled steel,
  • Type 5, drawn over a mandrel, and
  • Type 6, special smooth inside diameter.

Heat and product analyses are used to determine the percentages of chemical elements, to which the steel specimens need to conform. Tubing must be free of injurious defects with a workmanlike finish. When specified, tubing can be coated with a film of rust retarding oil before shipping.

All current ASTM standards and many obsolete revisions 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).  We’ve been selling ASTM standards under contract since the 1980′s and can assist you with any questions you may have.

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Have you seen our updated website www.document-center.com lately?

Wednesday, July 18th, 2012

At the beginning of the month we switched over to our new website, www.document-center.com, and if you haven’t visited it in a while, you’re going to like the new look and functionality.

The site has a number of ways for you to find the documents you need, like our Lists by Industry Sectors and Standards by Regulation pages.  When you use our search function, you’ll get straight forward results pages, and informative document pages for the standards you use.

You’ll also enjoy the ease of ordering on our updated site.  Standards are available for you to order in paper or pdf format.  Reviewing and refreshing your shopping cart is easy and finishing up your order is a breeze.

You can use the new site to learn more about standards as well.  We have pages on the basics of standardization as well as our “Standards U.” for advanced training.

Our customers love the new site and we’d like to know what you think, too.  Contact us at info@document-center.com, or give us a phone call at 650-591-7600.  Here at Document Center Inc. we’re working hard to help you succeed using the standards you need.

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New 2012 Edition for ISO 10993-12, Biological evaluation of medical devices – Part 12: Sample preparation and reference materials

Tuesday, July 17th, 2012

Another important Medical Device Standard has just been revised — ISO 10993-12, “Biological evaluation of medical devices – Part 12: Sample preparation and reference materials.”  The new 4th edition cancels and replaces the 3rd edition (ISO 10993-12:2007), which has been technically revised.  The new release is available now from Document Center Inc.

The ISO 10993-12:2012 specifies methods of sample preparation and provides requirements and guidance for the selection of reference materials for the biological evaluation of medical devices.

This part of ISO 10993 addresses the following:

  • test sample selection,
  • selection of representative portions from a device,
  • test sample preparation,
  • experimental controls,
  • selection of, and requirements for, reference materials,
  • and preparation of extracts.

ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

If you need additional information on the rest of the series,  review our complete list of the ISO 10993 series standards on Biological evaluation of Medical Devices.

All ISO standards are available on 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 happy to assist you with all your standards requirements.

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