New ASME-B46.1-2009 Edition on Surface Texture is Now Available

The new revision of ASME B46.1-2009, Surface Texture (Surface Roughness, Waviness, and Lay), is expected to ship from Document Center Inc. in September, 2010, when it will be released from the printer’s.  The new 120 page edition of this frequently referenced standard  is expected to be widely adopted.

ASME states: “This Standard is concerned with the geometric irregularities of surfaces. It defines surface texture and its constituents: roughness, waviness, and lay. It also defines parameters for specifying surface texture. The terms and ratings in this Standard relate to surfaces produced by such means as abrading, casting, coating, cutting, etching, plastic deformation, sintering, wear, erosion, etc.”

ASME-B46.1 has changed over recent years to keep pace with comparable International Standards, like ISO-4287.

ASME-B46.1-2009 may be purchased from Document Center Inc. at www.document-center.com.  Document Center Inc. is a leading reseller of specifications and standards, in business since 1982 and on the web since 1993.  The company is among the top 3% of women-owned businesses in the United States.

The ISO 10993 Series on Biological evaluation of medical devices

The ISO-10993 Series on Biological Evaluation of Medical Devices is an essential part of every Medical Device company’s standards collection.  They are among Document Center’s all-time best selling Medical Device Standards.

The ISO-10993 Parts cover a broad range of principles and tests for the biological evaluation of medical devices within a risk management process.  Medical devices are categorized by the nature and duration of the contact of the device with the body.  The series helps the user identify and evaluate existing relevant data, identify gaps using risk analysis, identify where further information is necessary, and provides guidance on needed testing.  It is a must-have series for medical device manufacturers, researchers, laboratories, and regulators.

New releases in this  series (dated in 2010) are the Corrigendum 1 (Correction Sheet) for the ISO-10993-1, the ISO-10993-10:2010, the ISO-10993-13:2010, and the ISO-10993-16:2010.

Here’s the complete list of 10993 Standards.

  • ISO 10993-1 – Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
  • ISO 10993-2 – Biological evaluation of medical devices Part 2: Animal welfare requirements
  • ISO 10993-3 – Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-4 and Amd 1 – Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
  • ISO 10993-5 – Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-6 – Biological evaluation of medical devices Part 6: Tests for local effects after implantation
  • ISO 10993-7 – Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
  • ISO 10993-8 – Withdrawn – Biological evaluation of medical devices Part 8: Selection and qualification of reference materials for biological tests
  • ISO 10993-9 – Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
  • ISO 10993-10 – Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
  • ISO 10993-11 – Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • ISO 10993-12 – Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
  • ISO 10993-13 – Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993-14 – Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
  • ISO 10993-15 – Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
  • ISO 10993-16 – Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
  • ISO 10993-17 – Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
  • ISO 10993-18 – Biological evaluation of medical devices Part 18: Chemical characterization of materials
  • ISO/TS 10993-19 – Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
  • ISO/TS 10993-20 – Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices

The complete set can be purchased as a package as well (ISO-10993-Package).  Contact Document Center Inc. at 650-591-7600 or on our website at www.document-center.com.

New ISO 10993-10:2010 3rd Edition is now available

For those of you in the Medical Device field, the ISO-10993 series is a must-have set of standards.  So when a new edition of one of the documents is released, you need to know about it.

Customers of Document Center Inc. have already been notified that the new 3rd Edition of the ISO-10993-10 standard is available.  It’s titled Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. The document is dated 8/1/2010 and replaces the ISO 10993-10:2002 Edition.  There is no specific information provided regarding the changes from one edition to the next, other than to note that the document has been technically revised.

ISO describes this document as follows:

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

ISO 10993-10:2010 includes:

  • pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
  • details of in vivo (irritation and sensitization) test procedures;
  • key factors for the interpretation of the results.

Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.

Give us a call at 650-591-7600 or email us at info@document-center.com to get your copy.

Document Center Inc.

111 Industrial Road Suite 9, Belmont, CA 94002 USA

www.document-center.com

The Plating Spec Poster – A handy tool for plating and coating specialists

Techplate’s Plating and Anodizing Specifications Chart is a handy wall chart developed to summarize a variety of frequently referenced plating specs.

The 2006 Edition covers a wide variety of metals and coatings.  Various classes are covered, along with thicknesses, and applications.  It’s 18 inches wide by 24 inches high, so it’s easy to post and reference.

Here is a list of some of the coatings covered and specs that apply:

Anodic Coatings MIL-A-8625
Black Chromium Plating MIL-DTL-14538
Black Oxide Coating MIL-DTL-13924 and AMS-2485
Cadmium Plating AMS-2700 and ASTM-B766
Chemical Conversion Coatings MIL-DTL-5541
Chromium Plating AMS-2460
Chemical Finish Black MIL-F-495
Copper AMS-2418
Electroless Nickel Coatings AMS-2404 and AMS-C-26074
Electropolish ASTM-B912
Gold Plating ASTM-B488 and AMS-2422
Lubricant, Solid Film MIL-PRF-46010
Magnesium Anodic Treatment AMS-M-45202 and ASTM-D1732
Magnesium Chromic Treatment AMS-M-3171
Nickel Coatings AMS-QQ-N-290 and AMS-2403
Passivation Treatments AMS-2700
Light Phosphate Coating TT-C-490
Heavy Phosphate Coating MIL-DTL-16232
Salt Bath Nitride AMS-2753
Silver Plating ASTM-B700
Sulfamate Nickel MIL-P-27418
Tin Coatings ASTM-B545
Tin Lead Plating AMS-P-81728
Vacuum Cadmium Plating AMS-C-8837
Zinc ASTM-B633
Zinc Alloy Plating ASTM-B840 and ASTM-B841

The ISO 9000 Compendium – The top quality standards at a low price

The ISO-9000 Compendium 12th Edition is a real bargain in the world of standards.  You get a real cross-section of the important quality standards at a reasonable price.  Yes, it is only available in CD Rom format (Now in pdf format as well.)  But you will be able to review many more documents than you could otherwise.

Of course, there is one major problem with ordering any compilation of standards.  The documents may be revised individually while the compilation stays static.  This is certainly the case with the current issue of the ISO 9000 Compendium.  The final draft for the ISO-9004 has been approved and is now available as an authorized edition, rather than the draft included in the compendium.

So, if you need to be sure you’re meeting the ISO-9001 certification requirements but want to take a look at the balance of the collection just for informational purposes only, you may want to purchase the compendium.  Then, get notification service for the ISO-9001 document.  That way, you’ll find out right away when any changes are made to the document you use for certification.

Here’s the contents of the current  Twelveth Edition  (along with links to the current edition of each item as a solo purchase):

  • ISO 9000 : 2005 Quality management systems — Fundamentals and vocabulary
  • ISO 9001 : 2008 Quality management systems — Requirements (With Technical Corrigendum)
  • ISO 9004 : 2000 Quality management systems — Guidelines for performance improvements
  • ISO 10001 : 2007 Quality management systems — Customer Satisfaction — Guidelines for codes of conduct for organizations
  • ISO 10002 : 2004 Quality management systems — Customer Satisfaction — Guidelines for complaints handling in organizations
  • ISO 10003: 2007 Quality management systems — Customer Satisfaction — Guidelines for dispute resolution external to organizations
  • ISO 10005 : 2005 Quality management systems — Guidelines for quality plan
  • ISO 10006 : 2003 Quality management — Guidelines for quality management in projects
  • ISO 10007 : 2003 Quality management systems — Guidelines for configuration management
  • ISO 10012 : 2003 Measurement management systems — Requirements for measurement processes and measuring equipment
  • ISO/TR 10013 : 2001 Guidelines for quality management system documentation
  • ISO 10014 : 2006 Quality management — Guidelines for realizing financial and economic benefits (With Technical Corrigendum)
  • ISO 10015 : 1999 Quality management — Guidelines for training
  • ISO/TR 10017 : 2003 Guidance on statistical techniques for ISO 9001:2000
  • ISO 10019 : 2005 Guidelines for the selection of quality management system consultants and use of their services
  • ISO 19011 : 2002 Guidelines for quality and/or environmental management systems auditing
  • ISO/DIS 9004 Managing for the sustained success of an organization — A quality management approach

Out of Sync — Why EN-ISO’s are changing and the core ISO’s are not…

There’s been a lot of confusion in the standards-using community over recent EN-ISO revisions just issued on some very popular ISO titles.  Some examples?  The EN- ISO-10993 series is out in 2009 Editions, while the ISO-10993 series itself hasn’t changed.  Another?  EN-ISO-11607-1 was upgraded to a 2009 Edition replacing the 2006 Edition, yet still remains identical to the ISO-11607-1 1st Edition from 2006.

How can the EN adoption of the ISO come out in a new edition and still be identical to the original ISO document?

Here’s the reason — The EN (European Union) administrative information has been modified, which has prompted the revision of the document even though the ISO document which it adopts remains the same.

So for the EN-ISO-11607-1, the change is the addition of Annex ZA, which is an informative annex only.  This 1 page addition to the document has a table which identifies the relationship between the EN-ISO-11607-1 and the essential requirements of EU Directive 93/42/EEC.

How about the EN-ISO-10993-1?  It has the insertion of 2 Annexes, both informative:  ZA, again on the relationship between this standard and the EU Directive 93/42/EEC, and ZB, on the relationship of EN-ISO-10993-1 to Directive 90/385/EEC.

The rest of the EN-ISO-10993 series has been revised for the very same insertions.

If you reference the EN-ISO documents in your documentation, you are required to purchase the new revisions or risk being out of compliance.

If you reference the source ISO standards instead, no revisions are necessary, as the underlying ISO documentation remains stable.

More questions?  Contact us at info@document-center.com or check out the website at www.document-center.com.

ISO 9001:2008 – Are you using the right edition?

If you’re certified to ISO 9001, Quality Management Systems – Requirements, you’ll want to make sure you’re using the right edition of the document.

With new changes released in 2009, there’s some confusion over exactly what is the current edition of the ISO-9001:2008.

The problem stems from having a corrected and reprinted edition released at the same time the Technical Corrigendum was issued (7/15/2009).

So in fact, you can have your document one of two ways, and you’re going to be just fine:

1.  You can use the corrected and reprinted 4th Edition from 7/15/2009.  This is a completely reprinted copy with the changes integrated into the text of the standard.

or

2.  You can use the original 4th Edition from 11/15/2008 and the Technical Corrigendum from 7/14/2009.  In this case, the changes are contained in the Corrigendum (correction sheet) only.  So you’ll have to manually integrate the 7 pages of changes into the original 11/15/2008 copy of the standard.

What determines which path you take?  If you get the reprinted and corrected document, you’ll have to pay for the standard again.  If you just get the corrigendum, the costs will be minimal.  But you’ll have to spend the time to get the changes integrated into your original copy.

In either case, Document Center Inc. can help you with copies available of all 3 components.  Just get in touch with us at info@document-center.com, by phone at 650-591-7600 or on our website at www.document-center.com.

Administrative Changes to Standards — What does it all mean?

One of our customers called today just to ask us what some of those odd changes to Standards actually mean.

Since purchasing standards can be expensive, it’s best to know what you’re going to be getting before you plunge ahead.  So let’s review some kinds of changes that can happen to standards and discuss if they should signal a buying opportunity for you or not.

First up: Reapproval, Reaffirmation and Validation.  All three terms mean the same thing — the standard has been reviewed and is still wonderful just the way it was.  If the standard’s still great, why issue this notice or republication?

For the folks who oversee standards, there is a need to prove to the public that the documents are being maintained.  So good standards practice suggests reviewing every standard you’re responsible for (caretaker of) every five years.  The issuing of a notice or the republication of a standard with a reapproval or reaffirmation date is a way to permanently confirm that good practices have been met.  And this periodic review is mandatory for compliance with the rules of  adoption for American National Standards Institute (ANSI) documents.

FYI:  The validation notice states that a document is still valid for U.S. Department of Defense (DOD) procurement.  It is issued by the DOD and reminds us that the mil-spec system is basically support for military purchases.

Next on the list: Editorial Changes.  Most notably used by ASTM International (formerly the American Society for Testing and Materials), an editorial change modifies the document but doesn’t affect the technical content.  You’ll see them as part of the  revision level information in the document number, i.e., ASTM-B899-09e1.  This is the document ASTM B899, 2009 Edition with 1 editorial change.

What could be an editorial change?  Perhaps an association was mentioned in the standard and the address of the association has changed.  Perhaps a phone number was included and the phone number has changed.  Remember, the change will not affect the technical content, so its going to be a non-essential piece of information.

How about a Non-Current or Inactive notification?  Both mean the same thing — The standard is good to use for replacement purposes but is not authorized for new design.  That is, if you have an existing product to maintain, it’s OK to use the standard.  But if you’re going to design something new, use something else.  With luck, the notification will point you to a replacement.  But not always…

A Cancellation Notices is another kind of notice that you may or may not need.  It will be issued for two reasons.  It presents an authorized notification that a standard has been withdrawn and is no longer valid.  And it may provide the caretaker with a way to direct users to a replacement document or to let them know the standard has no superseding document.

All of the changes above are primarily administrative in nature.  They do not make technical changes to the document.  Are they necessary to purchase?

My answer is always, “It depends on the situation.”  For reaffirmations, reapprovals and validations — not necessary unless you have an auditor coming in.  If you use the document for compliance, you’ll want every little thing every time.  If not, then these items are not so critical.

For editorial changes, it’s very much the same situation.  The information can certainly be useful, but if money’s tight it’s not essential.

Cancellation notices are often notated in databases and catalogs.  So unless you need a paper trail (or again, you’re getting audited), it may not be necessary.  But if you have a customer who thinks you should be using an obsolete document, then a cancellation notice or cancellation revision can support your case about as strongly as you would ever want!

There’s a couple more kinds of notices that do cause confusion.  The first is the technical corrigendum.  This is just a fancy name for a change notice.  Don’t let this one go by — It’s got corrections to the document that you will want to know about.  Errata are the same, document corrections that you need to have (usually printing errors to tell you the truth).

Amendments and change notices are in the same category but usually are longer and may offer new information to add to the standard.  Again, don’t leave home without it.

Do you have any questions about the many little things that can be called out to accompany a standard that you’re using or that you need?  Check in with us at Document Center (www.document-center.com) by email at info@document-center.com or give us a call at 650-591-7600.  We’ll be happy to answer your questions and perhaps it will even be included in this posting or a new one!

Attack of the Clones: Why are there so many versions of some ISO standards?

Here is a question I get asked all the time:  “Which standard should I use:  ASQ-Q9000, ISO-9000 or BS-EN-ISO-9000?”

And every day I look at the 2002 poster for World Standards Day with the tag line “One standard, One test, Accepted everywhere.”

So the question is, why are there so many editions of some ISO documents when our stated goal is to just have one?

To get to the bottom of this question, we’ll be talking about 3 concepts:  Jurisdiction, Adoption, and Translation.  When we get done, you’ll at least know the reason for the many “clones” of some of the most widely used ISO standards.

First of all, the concept of jurisdiction.  The ISO standards are meant to be International Standards, hence ISO, International Organization for Standardization.  However, there are other jurisdictions as well — Regional (like the European Union) and National (like the United States).

You might think that once an International Standard is published, everyone should be free to use it and that would be the end of the story.

But no — In the European Union, for example, regional standards are a response to legal regulation (the directives).  In order  to assure legal compliance to regional regulation and laws, EN standards are created as designated by applicable directives.

If an ISO document meets  the requirements of a particular directive, it can be adopted by the European Standards Body (CEN).  Then, it is published for public distribution by each country in Europe as the document is implemented.  That way, it is clear which countries are in compliance at any given time.

So, with the ISO-9000, EN adoption creates 27 differently numbered documents (like, BS-EN-ISO-9000, the official English language edition, DIN-EN-ISO-9000, the official German language edition, and so on), one for each country in the European Union.

ISO standards are also adopted by  countries as well as regions.  An example of this is the Canadian Standards Association document  CSA-ISO-9000.  In this case, the ISO-9000 is republished when Canada adopts the standard, at the national rather than  regional layer of jurisdiction.

One feature to pay attention to is the fact that the ISO standard will be reprinted in it’s entirety when adopted, but will have cover sheet administrative information as well in most cases.  This information may be about what national documents were withdrawn in favor of the ISO or EN adoption, or when the standard must be implemented by users.

And lastly, a country that is involved in the development of an ISO standard has the right to republish the document as a country-specific translation.  So, because ASQ (the American Society for Quality)  participates for the U.S.  in the Quality committee at ISO, the ASQ-Q9000 is the U.S. translation of the ISO-9000.  The U.S. translations are almost word-for-word identical to the English language ISO originals — the only difference is that the ISO standard uses British English spelling, and the U.S. uses American.  So if an ISO standard includes the word “colour” the U.S. translation would have the word spelled “color.”

So in 1992, there were 42 adoptions or translations of ISO-9000 in existence.  In 2002, 134 countries were issuing certificates of compliance and in 2007 there were 175 countries counted.

Our advice to customers is to use the highest level of jurisdiction whenever possible, because it will be revised first at the highest level.  So for the ISO-9000 standard series, ISO (the international jurisdiction) will be the first to issue technical content changes.  All adoptions and translations will happen after the initial ISO release.

However, sometimes there are reasons to choose other editions.  If cost is a factor, a national translation may often be the least expensive way to go, as all revenues go to the publishing organization only, as a way to cover the costs of committee participation.

Another reason to choose a different edition is to cater to either an important customer or a particular auditing body.  If your auditor is from BSI, you might choose the BS-EN-ISO-9000 series so that your auditor is impressed by your concern to follow the administrative information that is published in the adoption section of the publication.  If you do business in Australia, you might use the AS/NZS ISO 9000, the Australian/New Zealand joint adoption of the ISO standard.

This is always a hard concept for many people to understand.  If you’ve still got questions, please ask us by emailing us at info@document-center.com.

For our next blog, we’ll be looking at this same issue but from a different viewpoint.  I’m getting a lot of questions about why EN adoptions of ISO standards are coming out with new revisions when the ISO documents remain unchanged.  So, until next time…