Claudia Bach

New BS EN 14127 on Non-destructive testing, Ultrasonic thickness measurement, now released for use in sales to Europe

The new BS EN 14127:2011 standard, titled “Non-destructive testing. Ultrasonic thickness measurement,” was released on March 31st of this year. It replaces the BS EN 14127:2004 edition, which is now obsolete.

This document specifies the principles for ultrasonic thickness measurement of metallic and non-metallic materials by direct contact, based on measurement of time-of-flight of ultrasonic pulses only.

It is the official English language edition of the EN 14127:2011, which is not available as a stand-alone document. All EN Standards are only available as reprints furnished by each country in Europe as they are adopted for use within that particular state. The official German language edition is the DIN-EN-14127:2011 and the official French language edition is the AFNOR-EN-14127:2011.

The standard, and all BS EN documents, 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). Your questions and comments are always welcome.

Document Center recommends Standard MSA, Measurement Systems Analysis, for assessing the quality of a measurement system

MSA, “Measurement Analysis System,” is the widely referenced standard for measurement system quality. Generated by the automotive industry, the standard presents guidelines for assessing the quality of a measurement system. Currently it’s the 4th Edition, released in June of 2010, with an errata from the same month.

Its primary focus is measurement systems where the readings can be replicated on each part. The standard helps the user analyze the collection of equipment, operations, procedures, software and personnel that affects the assignment of a number to a measurement characteristic.

If you need to plan and prepare a Measurement System Analysis (MSA) program and understand process variation and its impact, this standard is for you. It will provide insight into organizational applications, categories of measurement system variation, and gage repeatability and reproducibility.

MSA has direct application to ISO/TS 16949:2002, “Quality management systems – Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations,” as well. So if you’re certifying to the ISO document, the MSA can provide practical information for meeting your requirements.

The MSA and ISO standards can be purchased from Document Center Inc. at our website, www.document-center.com. Or call us (650-591-7600), fax us (650-591-7617) or email us (info@document-center.com) your request. We’re here to help you with your standards needs.

New ISO/IEC 20000-1:2011 provides guidance on Service management system requirements

ISO/IEC 20000-1:2011, titled “Information technology — Service management — Part 1: Service management system requirements,” has been issued as the new 2nd Edition. The new revision specifies requirements for a service provider to plan, establish, implement, operate, monitor, review, maintain and improve a service management system (SMS). The requirements include the design, transition, delivery and improvement of services to fulfil agreed service requirements.

The types of companies that may find this standard helpful are

organizations seeking services from service providers and requiring assurance that their service requirements will be fulfilled;
organizations requiring a consistent approach by all service providers, including those in a supply chain;
service providers intending to demonstrate capability for the design, transition, delivery and improvement of services that fulfil service requirements;
service providers needing to monitor, measure and review service management processes and services;
service providers wishing to improve the design, transition, delivery and improvement of services through the effective implementation and operation of the SMS;
and assessors or auditors as the basis for conformity assessments of service providers’ SMS to the requirements of the standard.

The standard is a joint release from both ISO and IEC due to the fact that it was developed by JTC1, the Joint Technical Committee of both ISO and IEC on Information Technology. It was published by the Subcommittee 7, on software and systems engineering.

It is another standard that reflects the growing trend towards the development of management standards, aimed at providing a framework for business management processes. This is based on the success of the ISO 9000 quality standards series.

All ISO and IEC standards, including those mentioned above, may be purchased from Document Center Inc. at our webstore, www.document-center.com. Or call us (650-591-7600), fax us (650-591-7617) or contact us by email (info@document-center.com). We’re happy to help you with all your standards requirements.

New ASTM E1742/E1742M 2011 Edition released on Radiographic Examination

ASTM E1742/E1742M, 2011 Edition, titled “Standard Practice for Radiographic Examination” has just been released and is available now from Document Center Inc. This practice establishes the basic parameters for the application and control of the radiographic method. The standard is written so it can be specified on the engineering drawing, specification, or contract.

E1742/E1742M establishes the minimum requirements for radiographic examination for metallic and nonmetallic materials. The criteria presented for the radiographic examination are applicable to all types of metallic and nonmetallic materials. However, the standard is intended to control the quality of the radiographic images and not to establish acceptance criteria for parts and materials.

It is not a detailed how-to procedure to be used by a non-destructive test (NDT) facility and so must be supplemented by a detailed procedure. ASTM Test Methods E1030, E1032, and E1416 contain information to help develop detailed technique/procedure requirements.

Again, because the number of the standard has both the E1742 and E1742M included, the values are stated in either SI units or inch-pound units. They are to be regarded separately as standard because the values stated in each may not be exact equivalents. Therefore, each system needs to be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

This ASTM Standard, and all ASTM documents, may be purchased from Document Center Inc. through our website, www.document-center.com. Or call us at 650-591-7600, send us a fax at 650-591-7617, or email us at info@document-center.com. Staff is ready to assist you with your orders and questions.

BS EN 60601-1, Medical electrical equipment, General requirements for basic safety and essential performance, one of the essential Medical Device Standards

BS EN 60601-1:2006 is one of the essential standards to meet the requirements of the Medical Device Directive for sales of Medical Devices in the European Union. Entitled “Medical electrical equipment. General requirements for basic safety and essential performance,” the standard is identical in content to the IEC 60601-1 Edition 3.0 from 2005.

BS EN 60601-1 is for intended for use by manufacturers, regulation bodies, independent certification bodies and professional users and beneficiaries of medical electrical equipment.

The standard applies to medical electrical equipment intended to be used in the diagnosis, treatment, or monitoring of a patient. It focuses on the basic safety and essential performance of medical electrical equipment and medical electrical systems.

The standard is one of a group of standards in the 60601 series. For a complete listing of the IEC 60601 series documents, here is our Document Center page with the complete listing – http://www.document-center.com/iec_60601.cfm.

And here is a link to our page on all the documents that are part of the harmonized standards list for the Medical Device Directive.

You’ll find both pages useful in identifying the documents you need in order to meet Medical Device regulations globally. The standards are all available from Document Center Inc. on our website, www.document-center.com. Or call us (650-591-7600), fax us (650-591-7617) or send us an email (info@document-center.com). Your questions and comments are always welcome.

AAMI TIR12 2010 Edition, for Reusable Medical Devices, is a top-seller at Document Center Inc.

AAMI TIR12, 2010 Edition, titled “Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers,” is one of the best selling new releases here at Document Center Inc.

This technical information report (TIR) covers design considerations that medical device manufacturers need to consider when developing products that need to be safely and effectively reprocessed. It also provides information on decontamination, cleaning, disinfection, and sterilization processes commonly used in health care facilities. This means that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided in the TIR, as well as a bibliography and other informative annexes.

Please note: An AAMI TIR like this one is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board.

The document, and all AAMI publications, are available from Document Center Inc. at our website, www.document-center.com. Or contact us via phone (650-591-7600), fax (650-591-7617), or email (info@document-center.com). We’ll be happy to help you with all your standards requirements.

New EIA 649 Revision B, “National Consensus Standard for Configuration Management”

The new EIA-649 Revision B titled “National Consensus Standard for Configuration Management” has just been released by TechAmerica, the organization previously known as GEIA (Government Electronics Industry Association).

Configuration Management (CM) focuses on establishing and maintaining consistency of a system or product’s performance and its functional and physical attributes with its requirements, design, and operational information throughout its life.

This standard defines five CM functions and their underlying principles. The functions are detailed in Section 5. The principles, highlighted in text boxes, are designed to individually identify the essence of the related CM function, and can be used to collectively create a checklist of criteria to evaluate a CM program.

In describing each CM function and its principles, this standard utilizes neutral Configuration Management terminology, while also providing equivalent terms, that have historically been used in various product environments. There is no intent to express preference for any particular set of terminology.

Similarly, this standard uses a neutral set of names for the phases of a product’s life cycle, which are generic enough to be easily mapped to the myriad of different life cycle models in use. Table 1 illustrates some of the aliases for each phase name and identifies characteristics that apply in each one.

Regardless of the titles chosen for these phases, or whether the product is a facility, software, an airplane or a machine screw, at some time in its history a product will go through all or most of these phases. The phases can have considerable overlap, or the sequence of the phases might change or be repeated, e.g., for product improvements and enhancements. Approved configurations of a product can be in the build, distribution, operation, and disposal phases simultaneously, and changes to those configurations may occur during all life cycle phases.

Appropriate application of CM functions enables a user of this standard to plan and implement a CM program for a product, project, or enterprise. The degree to which each of the CM principles applies to a product varies over the product’s life cycle. Some principles do not apply during every phase of the product’s life cycle, e.g., configuration verification and audit principles are not applicable in the conception or definition phases. The degree of rigor and techniques used in implementing CM is commensurate with the type of product and its application environment as defined by program requirements.

The EIA-649 Revision B and all TechAmerica standards are available from Document Center Inc. at our website, www.document-center.com. You can also order via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Questions are always welcome.

ICS (International Classification for Standards) Codes can help you identify the standards you need

The ICS (International Classification for Standards) Codes are intended to serve as a structure for cataloging standards by subject area. It is similar to the Dewey Decimal system for books in the library. They’re used by standards bodies at the International Level (ISO and IEC), the regional level (CEN and CENELEC in Europe) and at the national level (ASTM International for example). Understanding the ICS schema can help you find the standards you need to maintain the use of best practices in your organization.

The scheme is made up of 3 levels, each divided by a period. The first level is a two digit number that specifies one of forty specific areas of standardization. Some examples are 11 (for Health Care Technology), 25 (for Manufacturing Engineering) and 29 (Electrical Engineering).

Each of these area is then divided into 392 groups for level 2, this time a three digit number. So for Health Care Technology, the 11.040 covers Medical Equipment, 11.060 is for Dentistry, and 11.080 is for Sterilization and disinfection. For section 25, 25.040 is Industrial automation systems, 25.060 is Machine tool systems, and 25.200 is Heat treatment. And in section 29, 29.020 is Electrical engineering in general, 29.030 is Magnetic materials, and 29.045 is Semiconducting materials.

Many of these level two designations still are rather broad, so there is a possible level three (for 144 of the 392 level two groups), again separated by a period. Some examples would be 11.040.40, Implants for surgery, 25.040.30, Industrial robots, Manipulators, or 29.060.01, Electrical wires and cables in general.

You can find the documents you need by drilling down using the links to StandardsCatalog.com above which direct you to lists sorted by the ICS Code numbers. Or you can use the references in StandardsCatalog.com to specific documents like ASTM B633 and use the link found towards the bottom of the page in the section “To find similar documents by classification.” In the case of ASTM B633, the ICS Code is 25.220.40 (Metallic coatings).

Should you find documents you like to purchase, they are available from us at our www.document-center.com website. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Remember, we’re happy to answer any questions you might have about this or any standards-related topic.

New ASTM A484/A484M 2011 Edition for Stainless Steel is now available

The new 2011 Edition of ASTM A484/A484M is now available from Document Center Inc. Titled “Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings,” the specification is widely used for bars, shapes, forgings, and billets or other semi-finished materials, except wire, for forging.

It covers stainless steel in the following conditions: (1) hot-worked; (2) hot-worked and annealed; (3) hot-worked, annealed and cold-worked; or (4) hot-worked, annealed, and heat-treated. Product analysis tolerances are required to conform to the required chemical compositions of carbon, manganese, phosphorus, sulfur, silicon, chromium, nickel, molybdenum, titanium, cobalt, columbium, tantalum, copper, aluminum, nitrogen, tungsten, vanadium, and selenium.

The materials covered are heat treated and austenitic stainless steels and austenitic-ferritic grades. It is expected that they will be furnished in the solution annealed condition. Additionally, conformance to the required values of temperature, permitted annealing procedure, quenching, and rapid cooling are specified.

The following ASTM metal standards are referenced in this document:

ASTM-A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels

ASTM A276, Standard Specification for Stainless Steel Bars and Shapes

ASTM A314, Standard Specification for Stainless Steel Billets and Bars for Forging

ASTM A370 Test Methods and Definitions for Mechanical Testing of Steel Products

ASTM A473, Standard Specification for Stainless Steel Forging

ASTM A479/A479M, Standard Specification for Stainless Steel Bars and Shapes for Use in Boilers and Other Pressure Vessels

ASTM A480/A480M Specification for General Requirements for Flat-Rolled Stainless and Heat-Resisting Steel Plate, Sheet, and Strip

ASTM A555/A555M Specification for General Requirements for Stainless Steel Wire and Wire Rods

ASTM A564/A564M, Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes

ASTM A565/A565M, Standard Specification for Martensitic Stainless Steel Bars for High-Temperature Service

ASTM A582/A582M, Standard Specification for Free-Machining Stainless Steel Bars

ASTM A638/A638M, Standard Specification for Precipitation Hardening Iron Base Superalloy Bars, Forgings, and Forging Stock for High-Temperature Service

ASTM A700 Practices for Packaging, Marking, and Loading Methods for Steel Products for Shipment

ASTM A705/A705M, Standard Specification for Age-Hardening Stainless Steel Forgings

ASTM A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products

ASTM A831/A831M, Standard Specification for Austenitic and Martensitic Stainless Steel Bars, Billets, and Forgings for Liquid Metal Cooled Reactor Core Components (Withdrawn 2005)

ASTM E112 Test Methods for Determining Average Grain Size

ASTM E139 Test Methods for Conducting Creep, Creep-Rupture, and Stress-Rupture Tests of Metallic Materials

The ASTM A484/A484M and all ASTM standards can be purchased from Document Center Inc. at 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). Comments and questions are welcomed.