New ASTM D445 2011 Edition on Kinematic Viscosity issued

ASTM D445:2011 titled Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids (and Calculation of Dynamic Viscosity) has just been issued by ASTM’s D02.07 committee.   The standard is widely used in a variety of industrial settings.

Many petroleum products, and some non-petroleum materials, are used as lubricants, and the correct operation of the equipment depends upon the appropriate viscosity of the liquid being used. In addition, the viscosity of many petroleum fuels is important for the estimation of optimum storage, handling, and operational conditions. Thus, the accurate determination of viscosity is essential to many product specifications.

This test method specifies a procedure for the determination of the kinematic viscosity, ν, of liquid petroleum products, both transparent and opaque, by measuring the time for a volume of liquid to flow under gravity through a calibrated glass capillary viscometer. The dynamic viscosity, η, can be obtained by multiplying the kinematic viscosity, ν, by the density, ρ, of the liquid.

ASTM-D445:2011, as well as past revision levels and all ASTM standards, is available from Document Center Inc. at our website www.document-center.com.  More information on the standard can be found at our StandardsCatalog.com development site too.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) with document requests or questions.  Our expert staff is always happy to help.

New ASME A17.1 2010 Edition for the Safety Code for Elevators and Escalators

ASME A17.1 (also known as ASME A17.1/CSA B44), Safety Code for Elevators and Escalators, has just been released as the new 2010 Edition.  This Code covers the design, construction, operation, inspection, testing, maintenance, alteration, and repair of elevators, escalators, moving walks, materials lifts and dumbwaiters.

Major changes for the 2010 edition include:

(a.)  former periodic inspections now being covered under maintenance requirements;
(b.)  additional types of suspension means;
(c.)  elevator illumination updated;
(d.)  allowance of energy conservation methods in escalator usage;
(e.)  revisions of folding car-door requirements covering top-of-car clearances;
(f.)  updated communication requirements in elevators and;
(g.)  additional Type B Material Lift requirements.

While the ASME A17.2 companion standard, Guide for Inspection of Elevators, Escalators, and Moving Walks, has also been released as a new 2010 Edition, it does not fully reflect the latest requirements in this new A17.1 Code.

These new documents and all ASME standards may be purchased 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).  Any questions you might have on these or any standards will be welcomed.

JESD47 New Revision H on Stress-Test-Driven Qualification of Integrated Circuits released February, 2011

JESD47, Stress-Test-Driven Qualification of Integrated Circuits, has just been released as the new Revision H dated 2/2011.  The standard describes a baseline set of acceptance tests for use in qualifying electronic components as new products, a product family, or as products in a process which is being changed.

This qualification standard is not aimed at extreme use conditions such as military applications, automotive under-the-hood applications, or uncontrolled avionics environments, nor does it address 2nd level reliability considerations, which are addressed in JEP150.

Tables in the standard list qualification requirements not only for new components but also for a qualification family or category of change.  It is expected that the IC sampling lot will pass all appropriate qualification tests derived from these tables.

The new JESD47 Revision H and all JEDEC standards can be purchased from Document Center Inc. at our website, www.document-center.com.  Or call (650-591-7600), fax (650-591-7617) or email us (info@document-center.com).  We’re happy to help you with your procurement needs or with any standards questions you might have.

Japanese earthquake reminds us how Building Codes save lives

With the news today of the devastating earthquake in Northern Japan, I find myself reminded of our San Francisco earthquake in 1988.  The difference in the magnitude of the two quakes is significant and gives us a moment to be thankful for all the hard work the Japanese have done over the years to improve the seismic requirements of the Building Standard Law of Japan.

Living in an earthquake area means preparing for the inevitable.  There is never a question about “If” but only “When.”  One cannot turn a blind eye to the kind of damage caused by this phenomena if one cares about human life and suffering.

The Japanese starting thinking about seismic requirements for buildings back in the 1920’s, with the revision of Law Enforcement Regulations in 1924.  This was the first time the Japanese building codes included seismic design forces.

After World War II, with massive rebuilding necessary in the country, the modern structure of the building code was developed.  It includes references to standards from both the Architectural Institute of Japan and the Japan Concrete Institute.

There have been two significant seismic design code revisions to the Building Standard Law of Japan.  The first occurred in 1981, when a two-phase earthquake design was introduced. Then a second revision in 2000 allowed for performance based requirements and verification relying on accurate earthquake response and limit states of a building.

There is no doubt that the attention paid to earthquake vulnerability of buildings has saved countless lives in the current massive earthquake off the shores of Japan.  Our hearts go out to the victims but our hats are off to a country that has worked so hard to minimize the devastation that this natural phenomena brings.

Contact us with standards questions and comments at info@document-center.com.

New 2011 Edition of the NBS HDBK 44 on weighting and measuring devices is now available

NBS HDBK 44, Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices, is now available in the 2011 Edition.  The 479 page standard was adopted by the 95th National Conference on Weights and Measures (NCWM) in 2010.

Handbook 44 was first published in 1949, having been preceded by similar handbooks of various designations and in several forms, beginning in 1918.  It is reviewed annually by the NCWM.

The handbook conforms to the concept of primary use of SI (metric) measurements recommended in the Omnibus Trade and Competitiveness Act of 1988.  In some cases, however, trade practice is currently restricted to the use of inch-pound units; therefore, some requirements continue to specify only inch-pound units until the NCWM achieves a broad consensus on the permitted SI units.

The purpose of Handbook 44 is to prevent the use of weights and measures and weighing and measuring devices that give readings that are false,  faulty (that is, that are not reasonably permanent in their adjustment or will not repeat their indications correctly), or that facilitate the perpetration of fraud.

It has been designed to be a working tool for federal, state, and local weights and measures officials, the equipment manufacturers, installers, and service agencies/agents.  Many organizations cite the Handbook in calibration or quality documentation.

This NBS Handbook, and other standards on calibration and measurement,  is available from Document Center Inc.’s website, www.document-center.com.  You can also order by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  If you have any questions about this standard, please get in touch.

BS EN ISO 14155 2011 Edition on Human Clinical Trials for Medical Devices just released

BS EN ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice, has just been released for public distribution.  The ISO 14155:2011 standard is adopted by the European Union for meeting the requirements of the Medical Device Directive (93/42/EEC).

BS EN ISO 14155 is the standard that specifies the general requirements intended to:

  • Protect the rights, safety and well-being of human subjects
  • Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results
  • Define the responsibilities of the sponsor and principal investigator
  • Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

It does not apply to in vitro diagnostic medical devices.

The document is identical to ISO 14155:2011, but does contain 2 informative annexes that are part of the EN administrative information regarding the adoption of the ISO standard.  These 2 annexes are:

Annex ZA:  Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices and

Annex ZB:  Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EECon active implantable medical devices

The principles set forth in BS EN ISO 14155 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

The document withdraws and replaces two documents, BS EN ISO 14155-1 and BS EN ISO 14155-2, which are now obsolete.

The new BS EN ISO 14155 can be purchased on Document Center’s website, www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Should you have any questions about this document or any other standard, please get in touch.  Our expert staff is available to help you during business hours (8 am to 5 pm California time).

New SAE AMS 2418 H on Copper Plating released 2/18/2011

AMS 2418 new Revision H on Copper Plating was just released on 2/18/2011.  This Aerospace Material Specification covers the requirements for electrodeposition of copper on metals and the properties of the deposit.

This process has been used typically to provide an anti-seize surface, to prevent carburizing of surfaces on which carburizing is neither required nor permitted, to prevent decarburization, to enhance solderability, or to provide a source of copper for furnace brazing, but usage is not limited to such applications.

The standard is one of the primary plating spec standards in use all over the world.

It is available from Document Center Inc. at our website, www.document-center.com, via phone at 650-591-7600, fax 650-591-7617, and email info@document-center.com.  Any questions are welcome.

Food safety management standards from ISO

With all the recent interest in food safety for cross-border food supply chains, a review of the Food Safety Management Standards developed by ISO, the International Organization for Standards, seems appropriate.

The ISO 22000 series has been developed expressly for the purpose of helping organizations set up a good safety management system viable for international trade.

The ISO 22000 international standard is derived from  ISO-9001. It specifies the requirements for a food safety management system that involves interactive communication, system management, prerequisite programs, and HACCP (Hazard Analysis Critical Control Point) principles.

The documents in the series are:

ISO-22000:2005, Food safety management systems — Requirements for any organization in the food chain

ISO/TS-22004:2005, Food safety management systems — Guidance on the application of ISO 22000:2005

ISO/TS-22003:2007, Food safety management systems — Requirements for bodies providing audit and certification of food safety management systems

ISO-22006:2009, Quality management systems — Guidelines for the application of ISO 9001:2008 to crop production

ISO/TS-22002-1:2009, Prerequisite programmes on food safety — Part 1: Food manufacturing

Here is the abstract for the ISO-22000:

ISO 22000:2005 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2005 can be accomplished through the use of internal and/or external resources.

ISO 22000:2005 specifies requirements to enable an organization

— to plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer,

— to demonstrate compliance with applicable statutory and regulatory food safety requirements,

— to evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction,

— to effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain,

— to ensure that the organization conforms to its stated food safety policy,

— to demonstrate such conformity to relevant interested parties, and

— to seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to ISO 22000:2005.

The ISO-22004 is a generic guidance document for the ISO-22000.

For the ISO-22003, the abstract is as follows:

ISO/TS 22003:2007 defines the rules applicable for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000:2005 (or other sets of specified FSMS requirements), and provides the necessary information and confidence to customers about the way certification of their suppliers has been granted.

FSMS certification does not attest to the safety or fitness of the products of an organization within the food chain. However, ISO 22000:2005 requires an organization to meet all applicable food-safety-related statutory and regulatory requirements through its management system.

And for the ISO-22006, the abstract states:

ISO 22006:2009 gives guidelines to assist crop producers in the adoption of ISO 9001:2008 for crop production processes. The term “crop” includes seasonal crops (such as grains, pulses, oilseeds, spices, fruit and vegetables), row-planted crops that are cultivated, perennial crops that are managed over a period of time, and wild crops that are not formally planted or managed. Horticultural crops provide an even broader range of types from annual and perennial fruits, vegetables, and ornamental flowering plants to perennial shrubs and trees, and root crops. These diverse crops require a broad range of planting, cultivating, pest control, and harvesting methods and practices. Decisions regarding planting, growing, and harvesting activities can be similar, although specific steps can be quite different when considering the range of crops.

ISO 22006:2009 gives guidelines on the use and application of ISO 9001:2008 to the establishment and management of a quality management system (QMS) by an organization involved in crop production.

ISO 22006:2009 is not intended to change, add or reduce the requirements of ISO 9001:2008, nor is it intended for certification.

Further down the supply chain, in manufacturing processes, the language of ISO 9001:2008, ISO 15161 or ISO 22000 is considered more appropriate. The need for an ISO 9001:2008-based system containing agricultural terminology became apparent due to difficulties in the interpretation of the language of ISO 9001:2008 for crop production applications.

Lastly, for the ISO-22002-1, more information follows:

ISO/TS 22002-1:2009 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards.

ISO/TS 22002-1:2009 is applicable to all organizations, regardless of size or complexity, which are involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the requirements specified in ISO 22000:2005, Clause 7.

ISO/TS 22002-1:2009 is neither designed nor intended for use in other parts of the food supply chain.

Food manufacturing operations are diverse in nature and not all of the requirements specified in ISO/TS 22002-1:2009 apply to an individual establishment or process.

Where exclusions are made or alternative measures implemented, these need to be justified and documented by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted should not affect the ability of the organization to comply with these requirements. Examples of such exclusions include the additional aspects relevant to manufacturing operations listed under 1), 2), 3), 4), and 5) below.

ISO/TS 22002-1:2009 specifies detailed requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3: a) construction and layout of buildings and associated utilities; b) layout of premises, including workspace and employee facilities; c) supplies of air, water, energy, and other utilities; d) supporting services, including waste and sewage disposal; e) suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance; f) management of purchased materials; g) measures for the prevention of cross-contamination; h) cleaning and sanitizing; i) pest control; j) personnel hygiene.

In addition, ISO/TS 22002-1:2009 adds other aspects which are considered relevant to manufacturing operations: 1) rework; 2) product recall procedures; 3) warehousing; 4) product information and consumer awareness; 5) food defence, biovigilance, and bioterrorism.

For additional information on these standards, to purchase them, or to talk with a standards expert on any other standards question, please contact us at info@document-center.com, by phone (650-591-7600) or fax (650-591-7617).  You can also use our website at www.document-center.com to search for any standards you’re interested in.

The Benefits of using Standards when Marketing Medical Devices

In order to sell Medical Devices in the U.S., companies must submit a premarket application (i.e., Premarket Notification (510(k)), Investigational Device Exemptions application (IDE), Premarket Approval application (PMA), Humanitarian Device Exemption application (HDE), or Product Development Protocol (PDP)).  These applications provide the information that’s required by law (and regulations) to allow FDA to make an appropriate decision regarding the marketing of the device.

One way to simplify and speed up the process is to use standards. Conformance with standards can satisfy these premarket review requirements.  The FDA states that “conformance with recognized consensus standards can support a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices.”

You’ll need to use FDA-recognized consensus standards.  They are particularly useful when they serve as a complete performance standard for a specific medical device. In these cases, the standard may include specific acceptance criteria that describe the relevant performance characteristics for a specific medical device. Conformity can minimize the amount of data and documentation needed in the 510(k) submission, but such standards are rare.

However, conformance to other more general vertical standards (i.e., device specific standards that may not encompass all aspects of device performance) can also serve as a means to streamline the premarket review process. Using any recognized consensus standard that clearly spells out acceptance criteria is a very effective use of this type of document in the premarket process. This means the use of FDA recognized standards can reduce the amount of documentation to submit and may reduce the FDA’s review time as well.

At this time, there are actually 813 standards that are accepted by the FDA.  Compliance is confirmed by a declaration of conformity which is included with the premarket application submission.  With adequate justification for the acceptance criteria and for any deviations from the standard, FDA can usually accept a declaration of conformance without the need to review test protocols and analyze the raw data.

For a list of the Recognized Consensus Standards, or for any other question on Medical Device standards, please contact us at info@document-center.com or by phone (650-591-7600) or fax (650-591-7617).  Medical Device standards can be purchased on our website, www.document-center.com.

ASTM releases new standard on fungal growths in buildings

If you’ve got an interest in mold assessment in any building, ASTM’s new standard ASTM D7338 will be of interest.  Titled Guide for the Assessment of Fungal Growth in Building, the document provides the user with options for a systematic assessment of fungal growth in buildings.  This standard is available from Document Center Inc. now.

The guide describes minimum steps and procedures for collecting background information on a building in question, procedures for evaluating the potential for moisture infiltration or collection, procedures for inspection for suspect fungal growth, and procedures beyond the scope of a basic survey that may be useful for specific problems.

However, ASTM D7338 does not describe a set of uniform steps that will always be performed during an assessment, as would a standard practice.  The user of the guide must decide which steps are appropriate for a given situation or building.

This standard is one of four planned on the topic by the D22 committee of ASTM International.  Already released ASTM D7391,
Standard Test Method for Categorization and Quantification of Airborne Fungal Structures in an Inertial Impaction Sample by Optical Microscopy, covers procedures for categorizing and enumerating fungal structures by morphological type.  The other two planned standards will cover the Examination of Fungal Structures on Tape Lift Samples by Optical Microscopy and the  Collection of Total Airborne Fungal Spores via Inertial Impaction Methodology.

Why produce these particular standards?  The lack of consensus standards in the fungal sampling and analysis practice was the driving force for the ASTM D22 committee.  Anyone who has an interest in indoor air quality or mold/fungal assessment, remediation and analysis should find these four standards essential.

All ASTM International standards are available in paper or pdf format from Document Center Inc. at our website, www.document-center.com.  Orders and questions are always welcome by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com).