New ISO 15223-1 2012 Edition, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements, replaces EN 980

ISO 15223-1:2012, “Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements,” has just been released and is now available from Document Center Inc.   This second edition cancels and replaces the first edition (ISO 15223-1:2007) which has been technically revised. It also incorporates the amendment ISO 15223-1:2007/Amd.1:2008.

This part of ISO 15223 constitutes a technical revision of both ISO 15223-1:2007 and EN 980:2008, combining the symbols and requirements of both standards for the first time. There has been a steady convergence of the symbol requirements in ISO 15223-1 and EN 980 over recent years, with many of the previous differences between the standards resolved.  Users of EN 980, “Symbols for use in the labelling of medical devices,” will want to upgrade to EN ISO 15223-1, 2012 Edition, as the EN 980 is now withdrawn and obsolete.

ISO 15223-1 represents a significant advance in the safe and effective use of symbols to transcend language, giving manufacturers, regulators and others a single set of global symbols for use with medical devices.  The standard is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.  These symbols presented may be used on the medical device itself, on its packaging or in the associated documentation.

All current ISO standards and many of the obsolete revisions are available from Document Center Inc. at our website, www.document-center.com.  They are available in paper format or in the United States as pdf format as well.  You may want to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We are here to assist you with any standards-related questions or requirements.

Why are there so many editions of the Standard 60601-1?

Here at Document Center Inc. we often get asked “What’s the difference between a national or regional adoption of an IEC standard and the original standard itself?”  This is a tricky question, since IEC adoptions are not so clear as adoptions of ISO standards at all.

Many national standards are based on IEC documents.   However, these standards may contain national deviations which is why the numbering schema for these adoptions is different than for the ISO standards.  When an ISO standard is adopted, usually the number becomes the acronym for the country (or region), then the original ISO number complete.  For example, the British adoption of ISO 10002 is BS ISO 10002.  However the adoption of an IEC standard is just the jurisdiction acronym and the IEC numeric designation, as in IEC 60950-1 and UL 60950-1.

If you’ve done any traveling outside the U.S., you’ll know the wide array of plug adapters, transformers, etc., that you may require to make your electronic devices and appliances work from country to country.  The fact that the IEC standards are based on electricity (after all, IEC is the International Electrotechnical Commission) is the reason that the standards often cannot be adopted “as is.”

These jurisdiction-specific deviations include the requirements of a country’s electrical code, conflicting national standards for product types or components, and different component requirements, like modified marking requirements.  So a national standards-writing body may decide that the IEC standard can be  adopted only by modifying, deleting, or adding requirements.

Determining the differences between the various adoptions of any given IEC standard can be challenging.  So to help the user out, often the national adoption will specify in the forward or other area of the document what the specific modifications are.

So for our original IEC 60601-1, the many reprints of the standard all represent potential variations from the original material.   Having said that, manufacturers need to design and test their products to the worst-case conditions of the tests that apply to their target markets.

Document Center advises customers to identify all target markets before the design phase is completed and review all IEC standards plus the national adoptions when applicable.  Compliance is a critical issue for our customers and one that our wide range of services supports.

Find the standards you need 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 with a wide variety of questions and requirements to assure your organization of compliance in today’s competitive marketplace.

New DoD 51000.76-M, Physical Security of Sensitive Conventional Arms, Ammunition, and Explosives (AA&E), 2012 Edition available

The new 2012 Edition of DoD 5100.76-M, “Physical Security of Sensitive Conventional Arms, Ammunition, and Explosives (AA&E),” is now available from Document Center Inc. in either paper or pdf format.  This DoD Manual is the guide for minimum standards and criteria for the physical security of DoD sensitive conventional AA&E in the custody of any DoD Component, DoD contractor, and foreign military sales or security cooperation programs.

With recent “Fast and Furious” scandal rocking the White House and worries over internal sabotage, the Department of Defense takes no chances with it’s requirements on the handling of arms and armaments.   It is DoD policy that the security of sensitive conventional AA&E is of the highest importance.  If AA&E is compromised, sabotaged, stolen, misused, or vulnerable to malicious mischief or acts of terrorists, subversives, criminal elements, or willful interference, it has the potential to jeopardize the safety and security of personnel, activities, missions, and installations worldwide. Continuous program and policy oversight is required to ensure protection of AA&E within the Department of Defense.

The DoD 5100.76-M 2012 Edition establishes requirements to  adequately protect sensitive conventional AA&E stored at DoD and DoD contractor AA&E activities/facilities during peacetime conditions.  The new 84-page Manual replaces the previous (now obsolete) DoD 5100.76-M from August 2000.

This DoD Manual and all publicly distributed (non-classified) DoD documents are available from Document Center Inc. on our website, www.document-center.com, in both paper and pdf format.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Government documents can be confusing, so we’re happy to assist you however we can.

New MS 35489 Revision K from 2012 for Grommets, Synthetic and Silicone Rubber, Hot-Oil and Coolant Resistant

MS 35489, “Grommets, Synthetic and Silicone Rubber, Hot-Oil and Coolant Resistant,” has just been updated to the new Revision K and is now available from Document Center Inc. in paper or pdf format.

This is the first modification of the specification since the 1989  issue of MS 35489J, which is now obsolete.  The new MS 35489K is to be used in conjunction with procurement specification NASM 3036 (formerly MIL-G-3036), “Grommets, Rubber, Hot-Oil and Coolant Resistant.”  FYI: MS 35489 also replaced MS 35490, again now obsolete.

Marginal notations are not used in this revision to identify changes with respect to the previous issue due to the extent of the changes.

“MS” stands for Mil Spec drawing.  This series of military documents covers a wide range of products and follows a drawing type of format.  In this case, there are 2 sectional views of the grommet on the first page, a table of dash numbers and dimensions on page 2, requirements for material, color, part number and tolerances on page 3, and a table of replacement part numbers on page 4.

All publicly distributed U.S. military specifications and standards are available from Document Center Inc. in paper and pdf format via 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 providing customers with standards since 1982 from our Silicon Valley location.

New ASTM F86 2012 Edition on Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

ASTM F86 2012 Edition, “Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants,” has just been released and is now available in paper or pdf format from Document Center Inc.   The surface treatments documented in this practice are intended to improve the corrosion resistance of metallic surgical implants manufactured from iron, cobalt, titanium, and tantalum base materials.

Iron particles, ceramic media, and other foreign particles may become smeared over or imbedded into the surface of implants during processing operations such as forming, machining, tumbling, bead blasting, and so forth. These particles should be removed to minimize localized rust formation and superficial blemishes.

The need for an additional implant surface treatment such as secondary passivation in nitric acid should be evaluated for localized implant surfaces that have electrochemical or laser product markings created after the final surface treatment.  This practice provides a description of surface characteristics, methods of surface preparation, and methods of marking for metallic surgical implants.

The 3-page ASTM F86-12 replaces the ASTM F86-04(2009) (2004 Edition reaffirmed in 2009) which is now obsolete.   Values are stated in inch-pound units with mathematical conversions to SI units in parentheses (for your information only — not to be considered standard).

All current ASTM standards and many obsolete revisions are available from Document Center Inc. at our website, www.document-center.com.  Many ASTM’s are available in redline editions as well, just ask us about this if you’re interested.  FYI: A listing of all ASTM standards on Surgical Implants will be available on our website when the new updated version is released in early July.  Be sure to check it out!

You may also contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Our staff is available during business hours California time to assist you with all your standards needs and questions.

New Tappi T 802 2012 Edition, Drop test for fiberboard shipping containers

TAPPI has just released the TAPPI T 802 2012 Edition, “Drop test for fiberboard shipping containers,” and it is available from Document Center Inc. in either paper or pdf format.  The 7-page update replaces the previous T 802-07 Edition, which is now obsolete.

This method describes procedures for determining the ability of fiberboard containers to protect their contents and/or to withstand impact in free-fall drops. These procedures are specifically designed for controlled drop testing of solid fiber or corrugated shipping containers.

TAPPI T 802-12 test does not apply to cylindrical containers or cans made of fiber.  Also, it is not normally used on packages heavier than 68 kg (150 lb).

Heavier packages may rarely be tested, but are unwieldy and usually undergo other tests such as incline impact or rotational edge/corner/flat drops. These tests are not defined in this method.

No single procedure is applicable to all handling, transportation and environmental conditions. Alternative test procedures are available in the literature cited in the References section.

Document Center Inc. sells the TAPPI standards under license agreement 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 are here to assist you with all your standards questions and requirements.

ARP 4001, Lavatory Smoke Detectors, has been Stabilized

SAE International’s Aerospace Recommended Practice ARP 4001, “Lavatory Smoke Detectors,” has just been reissued in a “Stabilized” Revision B.  This new 8-page edition is available now from Document Center Inc. in either paper or secure pdf format.

ARP 4001B describes key features to incorporate in lavatory smoke detector systems. Consideration has been given to existing requirements of the FAA and to recommendations of aircraft operators and manufacturers.

This document is deliberately not specific in all areas in order to maximize the freedom to use state-of-the-art design and manufacturing technologies. Safe, reliable, and effective lavatory smoke detectors remain the primary goal of ARP 4001.

The intent of installing smoke detectors in aircraft lavatories is to enhance, through auditory and visual signals, the ability of flight attendants to detect fires in the cabin, and not to serve as primary detectors such as those used in isolated cargo compartments.  By issuing a “stabilized” edition of this standard, SAE International is moving the document out of the 5 year review cycle routine.

What does the “stabilized” designation mean for SAE Standards?  This particular recommended practice will no longer be periodically checked for technical changes as it has been unchanged for the past 12 years.  In other words, SAE anticipates that the document will continue to be effective in it’s present state and will not review it again unless someone brings an issue to their attention.

All current and many obsolete SAE standards are available from Document Center Inc. in both paper and secure pdf format.  Order on our website, www.document-center.com.  Or contact our sales staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We respond promptly to your requests.

And be sure to check out our website in July when we unveil our new updated site!  Your feedback is very important to us since that’s what ensures that the site is as useful and easy-to-use as possible.

ISO releases new 3rd Edition for ISO 9227, Corrosion tests in artificial atmospheres — Salt spray tests

ISO 9227:2012, “Corrosion tests in artificial atmospheres — Salt spray tests,” has just been released and is now available from Document Center Inc. in either paper or pdf format.   This International Standard specifies the apparatus, the reagents and the procedure to be used in conducting the neutral salt spray (NSS), acetic acid salt spray (AASS) and copper‑accelerated acetic acid salt spray (CASS) tests for assessment of the corrosion resistance of metallic materials, with or without permanent or temporary corrosion protection.

ISO 9227 also describes the method employed to evaluate the corrosivity of the test‑cabinet environment.  It does not specify the dimensions of test specimens, the exposure period to be used for a particular product, or the interpretation of results.  Such details are provided in the appropriate product specifications.

Salt spray tests are generally suitable as corrosion protection tests for rapid analysis for discontinuities, pores and damage in organic and inorganic coatings. In addition, for quality control purposes, comparison can be made between specimens coated with the same coating. As comparative tests, however, salt spray tests are only suitable if the coatings are sufficiently similar in nature.

This 25-page third edition is a minor revision of the second edition (ISO 9227:2006), which is now obsolete.  ISO 9227 also replaced the cancelled ISO 3768, “Metallic coatings — Neutral salt spray test (NSS test),” in December, 1990.

Order current or obsolete ISO standards 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 have been a licensed dealer of ISO standards since the 1980’s.

New ASTM F50 2012 Edition — An important Clean Room Standard for Single Particle Counting Devices

ASTM F50, “Standard Practice for Continuous Sizing and Counting of Airborne Particles in Dust-Controlled Areas and Clean Rooms Using Instruments Capable of Detecting Single Sub-Micrometre and Larger Particles,” has just been revised and is now available from Document Center Inc. in either paper or pdf format.  The 6-page standard describes a procedure for collecting near real-time data on airborne particle concentration and size distribution in clean areas as indicated by single particle counting techniques.  It replaces the ASTM F50-07 from 2007 which is now obsolete.

The processing requirements of many products manufactured in a clean room involves environmental cleanliness levels so low that a single particle counter with capability for detecting very small particles is required to characterize clean room air.

Real-time information on concentration of airborne particles in size ranges from less than 0.1 μm to 5 μm and greater can be obtained only with an SPC (single particle counting device).  Definition of particles larger than approximately 0.05 μm may be carried out with direct measurement of light scattering from individual particles.  Other techniques may be required for smaller particles, such as preliminary growth by condensation before particle measurement.  Implementation of some government and industry specifications requires acquisition of particle size and concentration data using an SPC.

In applying ASTM F50-12, the fundamental assumption is made that the particles in the sample passing through the SPC are representative of the particles in the entire dust-controlled area being analyzed. Care is required that good sampling procedures are used and that no artifacts are produced at any point in the sample handling and analysis process; these precautions are necessary both in verification and in operation of the SPC.

All current and many obsolete ASTM standards are available from Document Center Inc.  Order 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).  Our expert staff can assist you with all your standards requirements and questions.

MIL-F-13926 comes “back to life” with the new Reactivation Notice 1

MIL-F-13926 Revision B, “Fire Control Materiel, Manufacture and Inspection, General Specification For,” has been brought back from “limbo” with the release of the new Reactivation Notice 2, replacing the Inactivation Notice 1 from 1995.  The specification covers the general requirements for the procurement, manufacture and inspection of systems, components and assemblies used in fire control material.  It is available now from Document Center Inc. in both paper and pdf format.

The Inactivation Notice 1 from February 1995 made the specification inactive for new design so that it should have only been used for replacement purposes (repairing or supporting existing applications).  However, with the release of the new Reactivation Notice 2 on June 5, 2012, MIL-F-13926B may be used for either new or existing design acquisition.  By the way, the MIL-F-13926 replaced the cancelled MIL-STD-1242, “Machining Standards for Fire Control Material,” back in 1984.

At Document Center Inc., we continue to monitor customer purchases even when the documents have been inactivated or cancelled.  The reason why is that you can never tell when a document that the caretaker thinks is obsolete may be actually widely used by the supporting vendor base.  This disparity sometimes results in the caretaker reevaluating the rationale for supporting the technology for the sake of the user base.  To miss this type of transition could be as harmful to your business as missing a new revision level release.

You can purchase military specifications and standards like the MIL-F-13926 from 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).  Our new edition of our website is nearing completion and we’re looking forward to your comments when we bring it online in July!