MIL-P-50884, one of the primary military printed wiring specs, is released with new Amendment 3

MIL-P-50884, Revision E, has a new Amendment 3 dated 9/1/2010.  The document, Printed Wiring Board, Flexible or Rigid-Flex, General Specification for, is a mainstay of the military specifications in this classification.  Inactive since 1999, the document is still available for use for replacement parts.  Compliance with the new changes is mandated by 12/1/2010.

Following the new protocol allowed by the creation of these documents in word processing programs, the amendment is interfiled within the body of the document.  While this makes using the document easier, it does present the reader with the challenge of identifying changes to the specification.  Unfortunately, there are no redline editions of the military documents available.  But this specification does at least have lines in the margins to identify areas with corrections.

MIL-PRF-31032 has been added to the referenced documents section.

In Appendix A, paragraph A.3.5.1.1 has also been modified, as has paragraph A.3.5.2.7.  There are also 5 new subclauses for A.3.5.4.  And tables A-IV and A-VI have been corrected as well.  Sections A.3.6.7.4, A3.7.4.6, A.3.7.4.8.2, A.3.7.5.1, A.4.5.2.1, A4.5.2.2, A.4.5.4.4, A.4.6.2 parts, A.4.8.1.8 and subsequent parts, A.4.8.2, A.4.8.4.1, A.4.8.4.6, A.4.8.4.9, A.4.8.6.2.1,  and A.7.3 have also been amended.  Sections A.7.18 and A.7.19 have been added.

Appendix B is untouched, but section C.6.3 has been corrected in Appendix C.  Appendix D adds the previous edition of this specification, MIL-P-50884 Revision E with Amendment 2, to the documents it replaces, understandably so.  And Appendix E has been completely deleted.

In Appendix G, Figure G-9 has been modified, as has Figure G-16.  In Appendix H, Table H-1 is also amended.  Sections H.4.3.4.1,  H.4.3.9, and Figure H-4 have corrections as well.

The new issue is 138 pages and is available from Document Center Inc. at www.document-center.com, or by email at info@document-center.com, phone at +650-591-7600 , or fax at +650-591-7617.


The new NFPA 70 F 2011 Edition of the National Electrical Code (NEC) is here!

The new 2011 Edition of the National Electrical Code, NFPA-70, is scheduled for public release 10/10/2010.  It is the source for safe installation of wiring and equipment.  The code, commonly called the NEC, is widely cited in state (all 50!) and local laws and is considered the de facto standard for electricity.  It covers electrical requirements for buildings and other public and private structures, such as mobile homes, RV’s and parking garages.  It also covers the installation of conductors and equipment that connect to electricity supplies.

NFPA revises the document every 3 years.  The 2011 NEC is the current edition (effective date August 25, 2010).  However, it will be available for public distribution in early October.  It is a step in moving towards greener technologies, by providing rules and regulations to keeping alternative energy sources safe.  It even includes requirements for charging connections for plug-in hybrid vehicles.

Here is an abbreviated Table of Contents of the new Code:

Introduction

Chapter 1 General

Chapter 2 Wiring and Protection

Chapter 3 Wiring Methods and Materials (with article 399, incorporating requirements for overhead distribution systems for large electrical system users – over 600 volts, such as school or business campus settings)

Chapter 4 Equipment for General Use

Chapter 5 Special Occupancies

Chapter 6 Special Equipment (includes: 625 with updates for safe battery charging for plug-in hybrid vehicles that reduce the risk of explosion and 694 for small wind electric systems – first time addressed)

Chapter 7 Special Conditions (includes 705 which covers interconnecting generators, windmills, and solar and fuel cells with other power supplies)

Chapter 8 Communications Systems (includes 840 for the increased demand for broadband communications systems with requirements for wireless, routers, and wireless disconnects)

Chapter 9 Tables

Index

Buy the new NFPA 70F, 2011 Edition, from Document Center Inc. on our website at www.document-center.com, by email at info@document-center.com, or phone (650-591-7600) and fax (650-591-7617).  We’re taking pre-orders so that your copy can ship as soon as the standard is released from the printers.  This is one Code you can’t afford to fall behind on!

AAMI-ST79 – The new 2010 Edition is available for preorder now

The AAMI recommended practice ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is now approved in a new 2010 Edition and public distribution is pending.

The standard consolidates 5 previous AAMI steam sterilization standards, the AAMI ST33, AAMI ST35, AAMI ST37, AAMI ST42 and AAMI ST46.  It was the first AAMI standard to be released in a binder edition, since the material covered is extensive.  The binder format facilitates easy access to the various topics, like lowering and limiting bioburden before sterilization, properly preparing items for sterilization, selecting the appropriate sterilization parameters, and establishing and implementing controls to maintain the sterility of sterilized items until they are used.

Users of this standard will find guidance to promote assurance of sterility and to guide health care personnel in the proper use of processing equipment.  The document includes functional and physical design criteria for a number of sterilization processing areas  including decontamination, preparation, sterilization, and sterile storage areas.  There are sections to assist with staff qualifications, education and other personnel considerations.  Also covered are  processing procedures,  installation, care and maintenance of steam sterilizers, quality control and, of course, quality process improvement.

The new ANSI/AAMI-ST79:2010 replaces the previous 2006 Edition with both Amendments 1 and 2, which is no longer available.  Because the new ANSI/AAMI-ST79 was only recently approved (9/3/2010), there will be a delay until the new edition is available.  Normal lag time can be from 1 to 3 months for the formatting and publishing functions to take place and the standard to become publicly available.

To purchase your copy of ANSI/AAMI-ST79, use our website at www.document-center.com, or call us at 650-591-7600, fax 650-591-7617, or email to info@document-center.com.

Your order can be placed now and shipped as soon as it is released.

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 www.document-center.com, info@document-center.com, 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 info@document-center.com or order on our website at www.document-center.com.

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 www.document-center.com 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 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 10993-8Withdrawn – 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 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.

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