ISO-14971 – A guide to the document and it’s many reprints

ISO-14971:2007,  Medical devices — Application of risk management to medical devices, is a critical component to any medical device manufacturers core standards collection. However, many users get confused by the many adoptions and reprints of this standard.

According to ISO, the document itself “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.”

It is an integral part of the Medical Device Quality Management System outlined by ISO-13485, Medical devices — Quality management systems — Requirements for regulatory purposes.

But the fact that the document is essential to a Medical Devices Quality system has meant that the document has been adopted and reprinted the world over.  The existence of many documents with “ISO-14971” in the document number but with differing dates makes choosing the right document difficult for some.

The reason for the many adoptions is the very popularity of the document itself.  For example, the European union has a scheme in place (harmonized standards) so that the requirements of legislation translate into regulation based on EN standards.   These standards have been produced under a mandate from the European Commission and adopted by Member States under the “New Approach” Directive.  And the EU is partial to the use of ISO standards whenever possible.

When legislation requires risk management to be adopted by companies selling medical devices in Europe, the use of the ISO-14971 is promptly identified as the standard to use.  However, the administrative process requires the ISO document to be adopted by the EU as an EN standard and then made publicly available as adoptions by the various countries of the EU as they are being put into use.  The BS-EN-ISO-14971 is the official English language edition, DIN-EN-ISO-14971 is the official German language edition, and so on.

Unfortunately, administrative activities have caused the issuance of 2009 Editions of the EN adoptions, out of sync with the current 2007 Edition of the ISO source document.  Customers do not realize that the ISO itself is stable in both the EN-14971:2007 and EN-14971:2009 Editions.  Only the administrative EN information has changed.

Another factor in the widespread reissuing of this document is the fact that when a country participates in the development of an ISO standard, they receive the right to reprint the standard in a national translation.  So, because AAMI is the U.S. “tag” (participant) for this committee, we have an American release of this standard, ANSI/AAMI/ISO-14971 2007 Edition.  The document has administrative information particular to the U.S. in the opening pages, much like the EN adoption.   Then the ISO edition is reprinted verbatim, except where English spelling conventions have been translated into the U.S. format (like “colour” vs. “color”).

You will find similar adoptions in Canada, Russia, Japan, and so on.

Our only comment to our customers is that the higher up the food chain you go, the “fresher” your information will be.  That is, the source document, ISO-14971, changes first and is released first.  Then each organization that issues a reprint of the item must go through the administrative formalities of adopting the new information.

However, many times the national translations of the ISO documents can be less expensive than the source material.  So if cost is a concern, you may want to check out the AAMI/ISO edition of the 14971.

Of course, to purchase ISO-14971 or the other documents mentioned above, they’re available from Document Center Inc. at,, and by phone at +650-591-7600 or fax at +650-591-7617.

IPC-A-610 New Revision E is a must-have for Electronic Assembly Quality

IPC-A-610, Acceptability of Electronic Assemblies, remains the perennial Top Quality Standard for electronic assembly facilities world-wide.  The new Revision E dated 4/1/2010 covers workmanship criteria for electronic assemblies with 809 full-color photographs and illustrations.

Users of the new IPC-A-610E will find the document an invaluable guide to improving process control and design.  Topics include flex attachment, board in board, part on part, lead free, component orientation and soldering criteria for through-hold, SMT  (new termination styles) and discrete wiring assemblies, mechanical assembly, cleaning, marking, coating and laminate requirements.

Further, according to IPC, the new 400 page revision has been “critically reviewed for clarity and accuracy.”  Commonly used with IPC/EIA-J-STD-001, Requirements for Soldered Electrical and Electronic Assemblies, the two documents have been brought into closer alignment with the simultaneous release of new editions for both documents.

To purchase the new IPC-A-610 Revision E and the new IPC/EIA-J-STD-001 Revision E, both are available from Document Center Inc.  Call us at 650-591-7600, email us at or order on our website at

Top Quality Standards for the Aerospace Industry

Our Top Quality Standard for the Aerospace Industry is the AS-9100,  Quality Management Systems – Requirements for Aviation, Space and Defense Organizations.  It is the successor document to the first Aerospace Quality Standard, the now obsolete AS-9000.  The current Revision C dated in 2009 will replace the previous Revision B in July 2012.

SAE International states that the document “specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.”

The next Quality Standard is the AS-9110, Quality Management Systems – Requirements for Aviation Maintenance Organizations.  This is the standard for certification for Maintenance groups.  Built on the foundation of ISO-9001, the additional aviation maintenance industry requirements, definitions and notes are highlighted in the text of this standard.

And the final certification standard in the series is the AS-9120,  Quality Management Systems – Requirements for Aviation, Space and Defense Distributors.  Again, the document is based on the ISO-9000, with deviations in the text highlighted for use by distributors.

Next on our list is the AS-9101, Quality Management Systems Audit Requirements for Aviation, Space, and Defense Organizations.  This essential standard provides you with the requirements for the actual audit.  It is the guide by which a certification process will be judged.

We should also mention AS-9003 at this point,  Inspection and Test Quality System.  SAE International states, “This document contains the minimum requirements for supplier Inspection and Test Quality System. It is emphasized that the quality system requirements specified in this standard are complementary (not alternative) to the contractual and applicable law and regulatory requirements.”

Another standard in this series is the AS-9006,  Deliverable Aerospace Software Supplement for As9100a.  However, as the AS-9100 Revision A is now obsolete, this document is not useful for new projects.

And the last standard we need to reference in this list is AS-5553, Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition.  With the quality concerns that arise from the use of sub-standard component parts, this standard is essential to the manufacture of safe products.

At the time of this post, draft documents are under review for the AS-9110, AS-9003 and AS-5553 Standards.

ASME-Y14.5 – 2009 Edition – One of our top-selling engineering standards

ASME-Y14.5 – 2009, Geometric Dimensioning and Tolerancing, is one of Document Center Inc.’s all-time top selling engineering standards.  It is the basic document for stating and interpreting geometric dimensioning and tolerancing requirements for use on engineering drawings and in related documents.

The history of the Y14 series on engineering drawings goes back to 1915, some 35 years after the ASME organization was founded.   It’s roots come from the need of automobile manufacturers and other industrial facilities to standardize engineering drawings and terminology among their suppliers.  The ASME-Y14.5 (also known as ASME-Y14.5M, from it’s now obsolete 1982 metric edition) is the centerpiece of this well-used series.

Important changes in the new ASME Y14.5 – 2009 include datum references and degrees of freedom, composite position tolerances, surface boundaries and axis methods of interpretation, profile tolerances, and symbology and modifiers tools.

You can purchase a copy at or call us at 650-591-7600.

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  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 10993-8Withdrawn – 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

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 to get your copy.

Document Center Inc.

111 Industrial Road Suite 9, Belmont, CA 94002 USA

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 or check out the website at