Claudia Bach

New ASTM F899 2011 Edition on Wrought Stainless Steels for Surgical Instruments

New ASTM F899:2011, “Standard Specification for Wrought Stainless Steels for Surgical Instruments,” has just been released. The document covers the chemistry requirements for wrought stainless steels used for the manufacture of surgical instruments.

Classes of stainless steels covered are Class 3 (austenitic stainless steel), Class 4 (martensitic stainless steel), Class 5 (precipitation hardening stainless steel), and Class 6 (ferritic stainless steel). The data contained in this specification are for reference only and include typical hardness values, common heat treating cycles, and examples of selected stainless steels that have been used for surgical instruments. Mechanical property, heat treatment, hardness, and all other requirements except for chemical composition, are governed by the appropriate material standards as specified or as agreed upon between purchaser and supplier.

Previous editions of ASTM-F899 include ASTM F899:2010, ASTM F899:2009(e1), ASTM F899:2009, ASTM F899:2007, ASTM F899:2002, ASTM F899:1995, ASTM F899:1994, ASTM F899:1984. All these editions, and all ASTM standards, can be purchased from Document Center Inc. 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). We’re happy to assist you with all your standards needs.

New MIL-HDBK-115 Revision B released on Reverse Engineering

MIL-HDBK-115, “U.S. Army Reverse Engineering Handbook (Guidelines and Procedures),” has just been released as the new Revision B dated 4/27/2011. This 78 page handbook provides guidelines and procedures for reverse engineering, and can be employed by in-house personnel, engineering services contractors, and manufacturing contractors performing reverse engineering.

The primary objective of reverse engineering as presented in this handbook is the development of unrestricted technical data, adequate for competitive procurement, through engineering evaluations of existing hardware. The nominal reverse engineering process is covered in Figure 1. Detailed procedures are described as well. In Process Reviews are expected to be performed at the end of each principal phase of the reverse engineering process to assure compliance to the process and to evaluate the need for continuing reverse engineering on the item.

The material is presented as a handbook, rather than a standard, as it has been developed for guidance only and is not applicable for inclusion in any government procurement contract. MIL-HDBK-115 was created using knowledge gained during a trial program from July 1985 to April 1987, and is based on experiences obtained from both military and industry participants.

This Handbook, and all U.S. military publicly distributed publications, are available from Document Center Inc. on our website, www.document-center.com. Or you may prefer to call us (650-591-7600), fax us (650-591-7617) or email us (info@document-center.com). We will be happy to help you with any of your standards requirements.

Newly released Revision B for JESD9, Inspection criteria for microelectronic packages and covers

Document Center Inc. announces the availability of a new JEDEC Standard, JESD-9 Revision B dated 5/1/2011. Titled “Inspection criteria for microelectronic packages and covers,” the standard’s purpose is to verify the workmanship and requirements of microelectronic packages and covers (lids) used in fabricating hybrid microelectronic circuits/microcircuits.

This standard establishes the general requirements and quality assurance provisions that can be specified and met in procuring microelectronics packages and covers, manufactured from matched seal with and without high thermal conductivity base materials, intended for use in fabricating hybrid microelectronics circuits. This document details those minimum requirements necessary for metal and ceramics packages’ use.

The previous edition, JESD 9 Revision A, covered only metal packages and JESD 27 covered ceramic ones. However the new Revision B covers both and so replaces JESD 27, Ceramic Package Specification for Microelectronic Packages. The new edition is meant to be used in conjunction with MIL-STD-883, Test Method 2009: External Visual.

JESD-9 is applicable for use by the package manufacturer (i.e., package components) and the microcircuit manufacturer (i.e., from incoming inspection of package components through final inspection of the completed microcircuit).

These JESD standards, and all standards from JEDEC, can be purchased at Document Center Inc.’s website, www.document-center.com. Or phone us (650-591-7600), fax us (650-591-7617) or email us (info@document-center.com). We’re happy to assist you with all your standards requirements.

CAN/CGSB/CSA-Z1610-11, A new Canadian national standard for protecting first responders

There’s a new national standard available from Canada, CAN/CGSB/CSA-Z1610-11 – Protection of first responders from chemical, biological, radiological, and nuclear (CBRN) events. The document is standard is specifically targeted to fire, police, and medical first responders/receivers in the front line of the response.

CSA-Z1610 specifies requirements for the selection, use, and care of personal protective equipment (PPE) for first responders to a deliberate chemical, biological, radiological, or nuclear (CBRN) incident, including releases and contagious outbreak events. It takes a systems approach in identifying the requirements for whole-body protective system performance (respiratory, ocular, and dermal), including integration with other equipment. It also provides guidance on the capabilities and limitations of CBRN PPE and on how to enhance the protection provided by, and interoperability of CBRN PPE.

Within the Canadian legislative framework, a variety of regulations apply to the first responder. But now, for the first time, first responders in Canada have a national standard, recognized across jurisdictions, to help protect them in their vital work.

This Canadian Standard, and all CSA standards, may 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 orders and queries. We appreciate your business.

MIL-PRF-38804, Preparation of Time Compliance Technical Orders

MIL-PRF-38804 Revision C with Amendment 1 is titled “Time Compliance Technical Order, Preparation of.” It’s one of the military’s TMSS specifications, on Technical Manual Specifications and Standards. I used to write a column on changes to these documents for the Society for Technical Communication and find that folks still have questions about this particular military document.

The first thing people need to know is the definition of Time Compliance Technical Order (TCTO). The answer can be found in TO 00-5-15, “Air Force Time Compliance Technical Order Process.”

It states “TCTOs provide instructions to modify military systems or commodities within speciﬁed time limits, initiate special ‘onetime’ inspections, or impose temporary restrictions and track conﬁguration on systems or equipment.”

TCTO’s are similar to Service Letters or Service Bulletins, a technical update that has a specific time value assigned to it. Some examples are Immediate action, Urgent action and Routine action. TCTO’s are frequently used for Air Force aircraft, for example.

The MIL-PRF-38804 covers the general style and format requirements for creating TCTO’s and TCTO supplements. These type of Technical Orders need to be developed according to this performance specification and also to those requirements specified by the acquiring activity. In addition to delivery in paper format, MIL-PRF-38804 provides for electronic delivery of data using the specified Document Type Definitions (DTD), if required.

This Mil Spec, and all publicly distributed DOD specifications and standards, are available from Document Center Inc. at our website, www.document-center.com. We’ve been supplying industry with these documents since 1982.

Or call us (650-591-7600), fax us (650-591-7617) or send us an email (info@document-center.com) with any questions or comments. We appreciate hearing from you.

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.