Document Center's Standards Forum - Page 120 of 154 - A Review of New Standards and Questions Standards Users Have

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

EN 473 has been replaced by EN ISO 9712, Non-destructive testing. Qualification and certification of NDT personnel

Here’s another example of a new ISO release being adopted as an EN standard, replacing a European document in the process. EN 473 (sold in the official English language edition as BS EN 473), “Non-destructive testing. Qualification and certification of NDT personnel. General principles,” has been withdrawn in favor of the new EN ISO 9712. The new BS EN ISO 9712:2012, “Non-destructive testing. Qualification and certification of NDT personnel,” is available now from Document Center Inc.

The text of ISO 9712:2012 has been approved by CEN as a EN ISO 9712:2012 without any modification. However, the text of the EN adoption does differ from the ISO publication because it has the addition of Annex ZA, “Relationship between this European Standard and the Essential Requirements of EU Directive 97/23/EC.”

This BS EN ISO 9712 table provides the user with the relationship of the Essential Requirements (ERs) of Directive 97/23/EC and the Clause(s)/sub-clause(s) of this European Standard. In other words, it provides the link between the directive and the implementation via the standard, clause to clause.

As noted in previous blogs, there is a concerted effort on the part of the EU to harmonize the EN standards with ISO and IEC publications by the adoption process. While admirable in intent, the proliferation of these republications by the various countries in Europe does lead to confusion on the part of U.S. users. Additionally, the decision to the purchase of the International (ISO and IEC) versus regional (EN) publications for certification purposes is another challenge for U.S. companies.

In any event, the standards can be purchased from Document Center Inc. 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 hope that these blogs shed light on the questions you have about standards. Our staff can assist you with similar issues for documents you use that we have not already commented on.

BS EN 980 replaced by new release BS EN ISO 15223-1, Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling And Information To Be Supplied. General Requirements

For all of you in the medical device field, the BS EN 980 (Official English language edition of EN-980) “Symbols for use in the labelling of medical devices” has been a must-have in your conformance documentation collection. Now the European standard has been withdrawn and replaced by the new 2012 issue of BS EN ISO 15223-1, “Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling And Information To Be Supplied. General Requirements.” Available at Document Center Inc., the new integrated standard provides consolidated International and European requirements for symbols used in medical device labelling.

The text of ISO 15223-1:2012 was approved by CEN as a EN ISO 15223-1:2012 without any modification. Use of the standard is a means of conforming to the New Approach Directive 93/42/EEC on medical devices.

In addition to the text of ISO 15223-1, the EN adoption BS EN ISO 15223-1:2012 contains three informative Annexes. The first is Annex ZA, “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical device.” The second is Annex ZB, “Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices.” And the third is Annex ZC, “Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices.”

Expect to see more adoptions of the ISO 15223-1:2012 across various jurisdictions during the next few months.

All these documents plus a wide variety of other standards used by the Medical Device Industry are available from Document Center Inc. at our website, www.document-center.com. Or contact us by phone at +650-591-7600, fax at +650-591-7617 or by email at info@document-center.com. You may also want to review our other audit and monitoring services for standards that are particularly helpful to organizations who are required to pass conformance audits on a regular basis.

New ISO 9712 2012 Edition, Non-destructive testing — Qualification and certification of NDT personnel

ISO 9712, “Non-destructive testing — Qualification and certification of NDT personnel,” has just been issued as the new 4th Edition and is now available from Document Center Inc. The standard was developed for evaluating and documenting the competence of personnel whose duties require theoretical and practical knowledge of non-destructive tests.

This fourth edition cancels and replaces the third edition (ISO 9712:2005), which has been technically revised. It has already been adopted by the European Union and can be purchased in the official English language edition from us as BS-EN-ISO-9712.

The new ISO 9712:2012 includes the following changes:

clarification of responsibilities for the certification body, the qualification body, and the examination center,
redrafting of the clause “training” for clarification and change in the number of required hours,
redrafting of the clause “experience” for clarification,
introduction of “digital certificates”,
and other minor technical and editorial changes.

This new ISO edition is available in paper (or pdf format within the U.S.) 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 your Standards Experts!

L-P-535 Revision E, Plastic Sheet (Sheeting): Plastic Strip: Poly (Vinyl Chloride) And Poly (Vinyl Chloride-Vinyl Acetate), Rigid, has been reactivated

L-P-535, “Plastic Sheet (Sheeting): Plastic Strip: Poly (Vinyl Chloride) And Poly (Vinyl Chloride-Vinyl Acetate), Rigid,” has been reactivated and is now available from Document Center Inc. The Revision E from 1979 had been inactivated for new design in 1999, but is now reactivated.

Reactivation means that the document may be used for either new or existing design acquisition. So when the inactivation notice 3 was released in 1999, the document could only be used for replacement purposes. Now with the release of the Reactivation Notice 4, the document may be called out in a contract under any circumstances.

The document L-P-535E is a Federal Specification, part of the L-P series on plastics. The documents have been frequently referenced in the past, but in the main have been cancelled.

Federal Specifications, including all current documents and many obsolete revisions, are available from Document Center’s 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 your standards requirements, purchases, and questions.