Document Center's Standards Forum - Page 145 of 154 - A Review of New Standards and Questions Standards Users Have

New ISO 14997 2011 Edition released on Test methods for surface imperfections of optical elements

ISO 14997:2011, titled “Optics and photonics — Test methods for surface imperfections of optical elements,” has just been released. It is the second edition of the standard and replaces the first edition, ISO 14997:2003.

ISO 14997:2011 establishes the physical principles and practical means for the implementation of methods for measuring surface imperfections. This method evaluates the surface area obscured or affected by the imperfections.

ISO has released this new revision of ISO 14997 in order to adjust the standard to ISO 10110-7:2008 (“Optics and photonics – Preparation of drawings for optical elements and systems – Part 7: Surface imperfection tolerances”).

These documents, and all ISO standards, are available from Document Center Inc. at our website www.document-center.com. Or call us (650-591-7600), fax us (650-591-7600), or email us (info@document-center.com) with your orders, questions and comments. We appreciate hearing from you.

IEC 62304, Medical device software – Software life cycle processes, is a critical part of many medical device technology requirements

Software is often an integral part of medical device technology. Establishing the safety and effectiveness of a medical device containing software requires knowledge of what the software is intended to do and demonstration that the use of the software fulfills those intentions without causing any unacceptable risks.

IEC 62304 provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software. The standard provides requirements for each life cycle process. Each life cycle process is further divided into a set of activities, with most activities then further divided into a set of tasks.

As a basic foundation the standard assumes that medical device software is developed and maintained within a quality management system and a risk management system. The medical device risk management system is already covered by ISO 14971. So IEC 62304 references the ISO 14971 throughout the standard. However, some minor additional risk management requirements are needed for software, especially in the area of identification of contributing software factors related to hazards. These are covered by IEC 62304.

Whether software is a contributing factor to a hazard is determined as an activity of the risk management process. Hazards that could be indirectly caused by software (for example, by providing misleading information that could cause inappropriate treatment to be administered) need to be considered. The decision to use software to control risk is made during the risk control activity. Then the software risk management process required in this standard has to be embedded in the device according to ISO 14971.

Because many incidents in the field related to service or maintenance of medical device systems include inappropriate software updates and upgrades, the software maintenance process is considered to be as important as the software development process. So maintenance is covered by the standard as well.

These documents, and all IEC and ISO Standards, can be purchased from Document Center Inc. at our website, www.document-center.com. Or order by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Your questions and comments are welcome.

New API 616 5th Edition covers Gas Turbines for the Petroleum Industry

There’s a new API 616 5th Edition available from Document Center Inc., titled “Gas Turbines for the Petroleum, Chemical, and Gas Industry Services.” The document is 180 pages in length and was issued in 2011.

This standard covers the minimum requirements for open, simple, and regenerative-cycle combustion gas turbine units for services of mechanical drive, generator drive, or process gas generation. All auxiliary equipment required for operating, starting, controlling, and protecting gas turbine units are either discussed directly in this standard or referred to in this standard through references to other publications. Additionally, gas turbine units that are capable of firing gas or liquid or both are included.

API 616 covers both industrial and aeroderivative gas turbines. For gas turbine applications in the oil and gas sector, API 616 is the foundation for almost all purchase specifications.

This standard, and all API 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). Your questions and comments are welcome.

What ever happened to MIL-STD-45662?

MIL-STD-45662 was one of Document Center’s all time best selling standards, bar none. It was the quality standard for calibration until Mil Spec reform took over in the mid-90’s. So what ever happened to the standard and what should you be using now?

MIL-STD-45662A was cancelled by Cancellation Notice 2 on Feb 27, 1995. The cancellation notice provided superseding information for the standard, so there are 2 documents which can be used instead of the now obsolete MIL-STD-45662.

First is ISO-10012, “Measurement management systems — Requirements for measurement processes and measuring equipment.” In 1995, the document was divided into 2 parts, ISO-10012-1 and ISO-10012-2. The ISO-10012-1 was the first replacement for MIL-STD-45662, but is now obsolete due to the cancellation of this document in 2003 with the release of the replacement ISO-10012.

The story is much the same for the second replacement document, ANSI-Z540.1,” Calibration Laboratories and Measuring and Test Equipment – General Requirements.” The document was revamped in 2006 as ANSI-Z540.3, “Requirements for the Calibration of Measuring and Test Equipment”, and officially superseded by the new standard in 2008. So you’ll need to use ANSI-Z540.3 now.

One of the sad results of Mil Spec reform is the fact that expensive industry standards, like the two documents above, have replaced the inexpensive (or free) military documents that companies around the U.S. used to reference extensively. Because of the high cost of industry standards, many of our customers have reduced or eliminated standards from their business practices. We’re a big supporter of standards and the standards process, so if you have some suggestions on how to get these companies back into standards, please send me a comment!

The obsolete standards referenced above, and the current quality standards for calibration, can be purchased from Document Center Inc. at our website www.document-center.com. Please note: you’ll have to get a quote first for all obsolete documents so that we can confirm that you really want a cancelled item before the order is processed.

Feel free to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) as well for ordering or any questions you might have about this posting. We appreciate your feedback.

New TAPPI TIP 0304-08 provides answers on Gel Temperatures for Corrugating Adhesives

TAPPI has just released a new TAPPI TIP 0304-08, titled “Questions and Answers on Gel Temperatures and on the Gel Temperature Test for Corrugating Adhesives,” for use by the paper and pulp industry.

TAPPI TIPs, Technical Information Papers, are documents containing specialized information (e.g., data, software, calculations) used in the manufacture, evaluation and description of pulp, paper, and related products, written in a readily accessible standardized format.

This particular TIP addresses common questions on gel temperatures and temperature tests for corrugating adhesives. The gel temperature is the temperature at which a water-starch mixture changes from a liquid slurry to a gelatin-like solid. It is the point at which the material begins to function as an adhesive.

All TAPPI TIPs and Standards are available from Document Center Inc. on our website, www.document-center.com. Or call (650-591-7600), fax (650-591-7617) or email (info@document-center.com) us with your orders or questions. We’ve been your standards experts since 1982.

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.