New amendment 2011/100/EU released to modify the In-Vitro Medical Device Directive 98/79/EC

The In-Vitro Diagnostic Directive (IVDD) 98/79/EC covers the essential requirements that an in-vitro diagnostic device must meet before being marketed within the European Union.  Document Center now has the recent amendment, 2011/100/EU, which has just been released for the IVDD.

The requirements called out in 98/79/EC are a grouping of requirements covered within the Active Implantable Medical Devices Directive and Medical Devices Directive (MDD) 93/42/EC.

98/79/EC applies to in vitro diagnostic medical devices and their accessories.   ‘In vitro diagnostic medical device` means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.

Because of the way that the Directives are released, all amendments and other changes to Directives first appear as new Directives themselves.  So 98/79/EC has been changed a number of times (both corrigenda and amendments).  Each change first appears as a separate Directive.  With the case of the IVDD, there have also been 2 consolidated editions released, one in 2003 and the other in 2009.

The latest amendment (2011/100/EU) adds “Variant Creutzfeldt-Jakob disease” (vCJD) assays for blood screening, diagnosis and confirmation to List A of Annex II to the IVDD.  This provision will be applied after July 1, 2012.

These Directives and many other Medical Device regulations and standards are all available from Document Center Inc.’s webpage, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  One important product that we offer is our updating service, which can be especially important for these types of documents.  Ask us for more information.

New AWS A2.4, 2012 Edition, on Standard Symbols for Welding, Brazing, Nondestructive Examination

Document Center now has the new AWS A2.4 2012 Edition available for purchase.  Titled “Standard Symbols for Welding, Brazing, Nondestructive Examination,”  AWS A2.4 presents a system of symbols for indicating welding, brazing, and nondestructive examination requirements.  It is one of our most popular AWS standards.

The standard contains detailed information and examples for the construction and interpretation of these symbols. This system provides a means of specifying welding or brazing operations and nondestructive examination, as well as the examination method, frequency, and extent.

AWS A2.4 includes provisions for the graphical representation of welds, brazes, and nondestructive examination methods with conventions for specifying, at a minimum, the location and extent of their application. Optional elements and supplementary symbols provide a means for specifying additional requirements.

The figures included with the text are intended to show how the correct format and applications of symbols may be used to convey welding, brazing, and nondestructive examination information. They are not intended to represent recommended welding, brazing, nondestructive examination, or design practice.

The clause addressing brazing uses the same symbols that are used for welding. The clause on nondestructive examination symbols establishes the symbols to be used on drawings to specify nondestructive examination for determining the suitability of components.

The nondestructive examination symbols included in this standard represent nondestructive examination methods as discussed in the latest edition of AWS B1.10M/B1.10, Guide for the Nondestructive Examination of Welds. Definitions and the details for the use of the various nondestructive examination methods are found in AWS B1.10M/B1.10.

All AWS 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).  We can assist you with all your standard requirements, including document purchases, auditing and monitoring.

AS 9104/1 just issued on Requirements for Aviation, Space, and Defense Quality Management System Certification Programs

AS 9104/1 2012 Edition, “Requirements for Aviation, Space, and Defense Quality Management System Certification Programs,” has just been released by SAE International and is now available at Document Center Inc.  These requirements are applicable to IAQG (International Aerospace Quality Group) global sectors when utilizing Aerospace Industry Controlled Other Party (ICOP) schemes for the assessment and certification of supplier quality systems in accordance with the requirements AS/EN/SJAC 9104.  The new document notes that it,  AS 9104/2 and AS 9104/3, replace the AS 9104 Revision A from 2005.

The AS 9104, “Requirements for Aerospace Quality Management System Certification/Registrations Programs,” was released in 2004.  At that time there was concern that the content was too complex for just one standard.  So work on the now complete 3 section replacements began.  They are:

The new AS 9104/1, “Requirements for Aviation, Space, and Defense Quality Management System Certification Programs,”

AS 9104/2, “Requirements for Oversight of Aerospace Quality Management System Registration/Certification Programs,” and

AS 9104/3, “Requirements for Aerospace Auditor Competency and Training Courses.”

The original AS 9104, however, has not yet been canceled by SAE.

AS 9104/1 defines the basic requirements for managing the AQMS (Aerospace Quality Management System) certification scheme (commonly referred to as the ICOP scheme).  It is the overview document of the 3 standards.  AS 9104/2 and 9104/3 provide specific requirements for defining the oversight process and the AQMS auditor qualification and training requirements respectively.

AS 9104/1 also provides guidance for the use of the required audit process reporting tools (AS 9101) and provides clarifications and process improvements resulting from the lessons learned during the initial operation of the ICOP scheme.

All SAE standards, including the AS, AMS, AIR, ARP, ARD and SAE J documents, are available from Document Center Inc.  You can use 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 have all current editions plus many of the obsolete ones available for you.

New Revision released for UL 796, Printed-Wiring Boards

UL 796 10th Edition, “Standard for Printed-Wiring Boards,” has just been amended by a new change revision.  The change notice includes the new designation as an ANSI approved standard and is now available from Document Center Inc.  Should you purchase the entire document instead, the revision changes will be interfiled into the text for you.

UL 796 applies to rigid printed-wiring boards and flexible printed-wiring board for use as components in devices or appliances. Compliance with the requirements of the standard does not indicate that the product is acceptable for use as a component of an end product without further investigation.

Flexible printed-wiring boards covered by these requirements consist of conductors affixed to insulating base film, with or without a cover-lay film, with midboard connections.

The requirements do not cover flexible printed-wiring boards of laminated-film construction in which the conductors are parallel to each other and are completely covered by the base film with only point-to-point end connections.

UL 796 does not apply to flexible, flex-to-install, rigid, and multilayer rigid flex composite interconnect constructions with and without stiffener and adhesive materials as flexible materials interconnect constructions (FMIC’s) for use as components in devices or appliances.  These are covered by the Standard for Flexible Materials Interconnect Constructions, UL 796F.

All UL 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).  We’ve been in business since 1982 (yes, this is our 30 year anniversary!) and have the expertise to assist you with all your standards requirements.

New AMS 2672 G released on Brazing, Aluminum Torch or Furnace

SAE International has released the new AMS 2672G.  Titled “Brazing, Aluminum Torch or Furnace,” the 7-page standard is available now from Document Center Inc.  It covers the requirements for producing brazed joints on aluminum and alumiinum alloys by torch or furnace brazing.

This process is typically used for joining aluminum and selected aluminum alloys.  It uses filler metal conforming to AMS 4184 or AMS 4185 and flux conforming to AMS 3412.

The new AMS 2672 Revision G is the result of a five-year review process, which is the generally accepted review period for U.S. standards.  We are seeing more of the SAE standards noting this compliance as new revisions are issued.

Document Center Inc. carries both current and historical editions of the SAE standards.  Get them 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 a licensed dealer of  the SAE standards since the 1980’s.

New ISO/IEC-7810 Amendment 2 released on Identification cards — Physical characteristics, Opacity

The popular standard ISO/IEC-7810 3rd Edition has just been modified by a new Amendment 2, which is now available from Document Center Inc.  The 6 page amendment, titled “Identification cards — Physical characteristics, Opacity,” updates opacity requirements by providing criteria to match a new test method that is published in ISO/IEC 10373-1, “Identification cards — Test methods — Part 1: General characteristics.”

ISO/IEC 7810:2003 is one of a series of standards describing the characteristics of identification cards. It is the purpose of ISO/IEC 7810 3rd Edition to provide performance criteria for these cards and to specify the requirements for cards used for international interchange. It takes into consideration both human and machine aspects and states minimum requirements.

ISO/IEC 7810:2003 specifies:

  • four different sizes of identification cards with a nominal thickness of 0,76 mm and dimensions of:
    • ID-000 25 mm x 15 mm,
    • ID-1 85,60 mm x 53,98 mm,
    • ID-2 105 mm x 74 mm,
    • ID-3 125 mm x 88 mm;
  • the conditions for conformance;
  • the dimensions and tolerances of the identification cards;
  • the construction and materials of the identification cards; and
  • the physical characteristics of the cards such as bending stiffness, flammability, toxicity, resistance to chemicals, dimensional stability, adhesion or blocking, warpage, resistance to heat, surface distortions, and contamination.

ISO/IEC 7810:2003, together with the ISO/IEC 10373 series for test methods, provides for interchange between various types of identification card processing devices and systems.

FYI: The ISO/IEC 7810 Amendment 1 covers criteria for cards containing integrated circuits.  Both amendments provide pen and ink changes to the original 2003 Edition of ISO/IEC 7810 so that the standard is not current without the 2 modifying documents.

ISO/IEC standards have been available from Document Center Inc. through license agreements since the 1980’s.  They can be ordered in paper or pdf format 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).  Our expert staff can assist you with all your standards issues and requirements.

New NEMA PB 1, 2011 Edition, just released for Panelboards

There’s a new 2011 Edition for NEMA PB 1, “Panelboards.”  Just released in January 2012, the new standard is for single panelboards or groups of panel units suitable for assembly in the form of single panelboards.

It covers units suitable for assembly in the form of single panelboards, including buses, and with or without switches or automatic overload protective devices (fuses or circuit breakers), or both.  These units are used in the distribution of electricity for light, heat, and power at 600 volts and less with 1600 ampere mains and less or 1200 ampere branch circuits and less.

Excluded are live-front panelboards and panelboards employing cast enclosures for special service.

NEMA has also revised PB 2, “Deadfront Distribution Switchboards.”  The new 2011 Edition covers floor-mounted deadfront switchboards rated 6,000 A or less, 600 V or less, that consist of an enclosure, molded-case circuit breakers, low voltage power circuit breakers, fusible or non-fusible switches, instruments, metering equipment, monitoring or control equipment, with associated interconnections and supporting structures.

ALL NEMA standards, including PB1-2011 and PB2-2011, can be purchased from Document Center Inc. in paper format.  Use 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 can assist you with all your standards requirements.

Editorial Changes have been made to ISTA 2B for 2012, Partial Simulation Performance Tests, Packaged-Products weighing over 150 lb (68 kg)

Each year in January, ISTA reviews all it’s packaged-product test procedures.  This year ISTA 2B, “Partial Simulation Performance Tests, Packaged-Products weighing over 150 lb (68 kg),” has had an editorial correction.

ISTA has added “warehoused” to table on Page 7 of 15 – in explanation of Compensating Factor (Typical range is 3-6, ISTA recommends a minimum of 5 if the packaged-product may be warehoused during distribution; otherwise a minimum of 4 is recommended.)  Also, “Package” was added to PDA/PDT header.

What does this mean for the user of ISTA 2B?  If you have the 2011 Edition, you have the most recent technical information.  You can make the pen and ink change to page 7 or you can purchase the new 2012 Edition with the modified text.

However, if you are using an edition that was printed prior to 2011, you do need to purchase the 2012.  Your technical content is out of date.

Other ISTA test procedures that have had editorial changes in 2012 are 1A, 1B, 1C, 1D, 1E, 1G, 1H, 2A, 2C, 2D, 2E, 2F, 3B, 3E, 3F, 3H, and 7C.   Feel free to check in with me by email at info@document-center.com for more information on the corrections to these additional documents.

Additionally, ISTA 2D, 2E, and 2F are expected to be discontinued in 2013.     7D was expected to be withdrawn this year, but has been extended.  And 3J is expected sometime this year, to replace 3F.

Of course, the ISTA test procedures are all available from Document Center Inc.  Order your ISTA test procedures 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 can provide you with the kind of expertise you need when dealing with all your conformance and technical information issues.

There’s a new RTCA-DO-178 Revision C on Software Considerations in Airborne Systems and Equipment Certification

There’s a new RTCA DO 178 Revision C, “Software Considerations in Airborne Systems and Equipment Certification.”  Compliance with the objectives of DO-178C is the primary means of obtaining approval of software used in civil aviation products.  It provides recommendations for the production of software for airborne systems and equipment to insure that software performs its intended function with a level of confidence in safety that complies with airworthiness requirements.

The new Revision C includes updates to address new software methodologies and technologies not addressed by DO-178B.  DO-178C was released with four supplements that address emerging software trends and technologies, specifically: software tool qualification considerations, model-based design, object-oriented design, and formal methods of certification.

These documents were created by RTCA SC-205 (together with EUROCAE WG-71), a DO-178C working group which includes worldwide members from industry and government agencies. DO-178C supplements include: DO-330, DO-331, DO-332, and DO-333.

DO-178 is the guidance document recommended by the FAA to ensure software will perform safely and reliably in an airborne system.  Advisory Circular AC 20-115B specifies DO-178 as an acceptable means, but not the only means, for receiving regulatory approval for software in systems or equipment being certified under a Technical Standard Order (TSO) Authorization, Type Certificate (TC), or Supplemental Type Certificate (STC).

Even though DO-178 is written as a guideline, it has become the standard practice within the industry.  DO-178 is officially recognized as a de facto international standard by the International Organization for Standardization (ISO).

Get your copy of this new standard from Document Center Inc.  You can order online at www.document-center.com, or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re available in person from 6 am to 5 pm Monday through Friday, California time.

New MIL-PRF-85285 Revision E, Coating: Polyurethane, Aircraft and Support Equipment

MIL-PRF-85285 (formerly MIL-C-85285) has just been issued as the new Revision E and is available from Document Center Inc.   This specification, titled “Coating: Polyurethane, Aircraft and Support Equipment,” covers the requirements for polyurethane coating with a maximum volatile organic compound (VOC) and maximum volatile organic hazardous air pollutants (VOHAPs). The coating is furnished in kit form.

Changes to this new 24-page revision are extensive.  The document specifies types and classes of coating, as well as the PIN number generation scheme and kit size.

The combination of all properties of MIL-PRF-85285 (component, liquid, cured coating, resistance, mixing, application, cleanability, and strippability) along with the composition and solvent content provide the necessary requirements for a polyurethane coating used in the extremes of the naval aviation environment. There are no commercial equivalents that meet the combination of all properties of MIL-PRF-85285E.

Type I of this polyurethane coating is intended for use on aircraft weapons systems and other applications. Type II is intended for use on support equipment. Type III is intended for use on aircraft and support equipment. Type IV is intended for use on aircraft weapons systems where extended weatherability is necessary. Type IV is a direct replacement for Type I on aircraft weapons systems. No additives other than the appropriate thinner for class H or deionized or distilled water for class W to obtain the proper spray viscosity need to be added.

All publicly distributed military specifications and standards (including obsolete editions) are available from Document Center Inc.  You can order on our website, www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  As standards experts, we’re available to answer your questions and provide you with the documentation you need Monday through Friday, 6 am to 5 pm California time.