New ISO 8828 2nd Edition – Handling Orthopedic Implants

November 21st, 2014

Extreme care is taken during the production and shipment of medical implants — but what happens after delivery?  Setting up protocols to insure that implants are free from contamination or damage prior to surgical insertion is another critical link in the chain.  Guess what?  There is an ISO standard for this and it’s just been revised.  It’s ISO 8828, “Implants for surgery – Guidance on care and handling of orthopaedic implants,” and the new 2nd edition is available from Document Center now.

Yes, this standard has been written for all personnel involved in receiving and handling implants, including surgical staff (surgeons).  Nothing is more difficult as a patient than going through a surgery only to have an implant fail due to contamination.  So all staff members involved in receiving, storing, transporting, handling, cleaning and sterilizing implants need to be well trained in these recommended procedures.

What does this new revision cover?  After the usual scope and definition sections, the document reviews general guidance on such topics as the manufacturer’s instuctions, stock records and rotation, storage, modification and so on.  Then there are sections with additional guidance for polymeric implants, ceramic components, and products with rough surfaces or intrinsic porosity.  The bibliography provides you with information on 4 additional standards for more detailed data.

This is a technical revision of the ISO 8828 1st Edition from 1988, which is now withdrawn.

You’ll want to get a copy if your staff handles surgical implants.  Head off to the Document Center webstore at www.document-center.com and order it in either paper format or for pdf download.  You can also opt for multi-user licensed access using our Standards Online service.  Just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.

Standards like the ISO 8828 can help you set up procedures and processes to improve outcomes in what-ever line of business you’re in.  Rely on Document Center to help you identify and maintain your collection of this type of conformance information.  We’re your Standards Experts!

New AAMI TIR51 – Human Factors for Medical Devices

November 20th, 2014

For Medical Device developers and other healthcare professionals, one challenge is to understand how people interact with their products in a “real world” context.  Now AAMI has provided you with guidance for this challenge - AAMI TIR51, “Human factors engineering – Guidance for contextual inquiry.”  If you’re in the healthcare business, this new Technical Information Report can help you design devices, systems or instructions in a more informed manner.  Here’s more details about this new document.

The goal of this report is to help you expand your concept of human factors from an interview-based methodology to a broader process based on both interviews and observation.  This will help you bridge the gap between what people say they do and their actual actions.  The protocol is intended to help you develop a deeper understanding of both users and the environments the device will be used in.  You’ll also be using this system to spot problems with existing design.  And you’ll also be getting insight into both the viewpoint of users as well as their capabilities and limitations.

Sections in AAMI TIR51 cover research methodology, data analysis, and reporting (including the use of video).   It also covers how to integrate your analysis into the design of devices, facilities and/or processes.  It covers troubleshooting, since the process is different from market research, for example.  And it also has a sample story board format for this type of process from the University of Cincinnati.  A 15-item bibliography finishes up the document.

This new publication is available from Document Center Inc. in both paper format and for pdf download.  You’ll be able to order the AAMI TIR51 (and all current AAMI standards) at our webstore, www.document-center.com.  Need more information?  Check in with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping people like you with standards and standards questions since 1982.  Make us your Standards Experts!

ISO/IEC/TS 17021-7 – Auditors for Road Traffic Safety Systems

November 17th, 2014

The ISO/IEC 17021 series of standards provides guidance for those who do conformity assessment services.  Now there’s a new ISO/IEC/TS 17021-7, “Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 7: Competence requirements for auditing and certification of road traffic safety management systems.”  It’s used to provide the requirements for auditors for compliance to ISO 39001, “Road traffic safety (RTS) management systems – Requirements with guidance for use.”

ISO 39001 was released almost exactly 2 years ago.  It provides any organization with the requirements necessary to set up and maintain an RTS system as a way to improve road safety and reduce transportation-related injuries and deaths.  But with this type of standard — a management system conformity publication — there’s the need for qualified certification.

The ISO/IEC 17021 series provides the requirements for auditors and auditing bodies for a variety of ISO certification schemes.  This means that those who provide these services should be expected to meet the applicable series documentation.  As a customer, you’ll use the standards to insure that the organization you hire is up to snuff.

So far, there’s seven parts to the series.  Here’s the list:

  • ISO/IEC 17021 (will be renumbered ISO/IEC 17021-1 with the next revision), Conformity assessment — Requirements for bodies providing audit and certification of management systems
  • ISO/IEC/TS 17021-2, Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 2: Competence requirements for auditing and certification of environmental management systems
  • ISO/IEC/TS 17021-3, Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 3: Competence requirements for auditing and certification of quality management systems
  • ISO/IEC/TS 17021-4, Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 4: Competence requirements for auditing and certification of event sustainability management systems
  • ISO/IEC/TS 17021-5, Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 5: Competence requirements for auditing and certification of asset management systems
  • ISO/IEC/TS 17021-6, (not yet released), Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 6: Competence requirements for auditing and certification of business continuity management systems
  • ISO/IEC/TS 17021-7, Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 7: Competence requirements for auditing and certification of road traffic safety management systems

The series is essential for any organization that provides certification to various ISO standards, so you need to be aware of them and their requirements if you use a third-party service for ISO conformity certification.

And you’ll need to get your authorized copies of the standards themselves as well.  Choose Document Center Inc., a distributor of ISO standards since the 1980′s.  You’ll order on our webstore at www.document-center.com or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

You’ll have options:  delivery in paper format, for pdf download or as part of our multi-user subscription service, Standards Online.  If you’re in the U.S. you can use a PO# on a net 30 basis or a credit card for your order.  There’s a number of different notification possibilities, from the free emails that come with the purchase of any standard to a nightly check provided by our premium service Standards Alert.  Our reporting services help you review the status of your collection and newly released standards in areas of interest to you.  And our Standards Audit can verify that your current collection is up-to-date.

Remember:  Here at Document Center Inc., we’re your Standards Experts!

FF-S-92 New Rev C – Machine Screws

November 14th, 2014

Have you ever wondered how come you can go to any hardware store and get the specific screw you need for the job or part you’re working on?  For those of us in the specifications business, it’s simple.  Standards!  But these types of publications can come from many sources.  Of course, industry trade groups have actually started to develop such standards for specific applications in their fields.  But another major source of these types of specifications is our U.S. government.  So the new FF-S-92, Revision C, “Screw, Machine, Slotted, Cross-Recessed or Hexagon Head,” is a good example of this.

First of all, you’re probably wondering why the title is so garbled!  This goes back many long years ago when the catalogs of standards were only available in paper format (yes, there was a time before the internet!).  There were indeed many government publications used for federal procurement, including the Department of Defense.  And finding the right specification or standard to call out in your contract was a challenge for government procurement agents.

There were two tools used to correctly find documents in those days.  The first was the catalog that indexed specifications according to the FSC (Federal Supply Classification) numbers.  You can do a similar search on the Document Center website in the left hand pull down menu.  The second was the alphabetical index.  Of course, finding screws based on a regularly written title would be challenging (the FF-S-92 would have read “Slotted, Cross-Recessed or Hexagon Head Machine Screw).  By putting the title basically backwards, the words move from the most general (screw) to most specific (slotted, cross-recessed or hexagon).  Thus, the mixed up title protocol was born!

A document like the FF-S-92 will have regularized sections, first the scope paragraph and then reference documents.  In this case, the requirements section comes next.  This will provide you with the details of the materials available, including a table showing you the mechanical properties of non-ferrous machine screws. This links the material with the applicable document, composition or class, condition, and so on.

Section 5 covers quality assurance requirements.  This reminds us that we’re looking at a specification used in procurement, where verification of quality for parts is an essential part of every transaction.  The document finishes off with packaging requirements and notes.  Here we learn that the changes from the previous edition (Revision B) are so extensive that lines have not been added to the margins where changes have been made.

Now you’ll want to get a copy.  You can go to the Document Center webstore at www.document-center.com and order it in paper format, for pdf download or as part of our multi-user Standards Online subscription service.  And if you have questions, you are always welcome to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

New SAE J383 and J384 – Seat Belt Anchors

November 13th, 2014

When it comes to automobile safety, there’s one organization you’ll turn to — SAE International (formerly the Society of Automotive Engineers).  Now there’s two new updates for the J Standards on seat belt anchors – SAE J383, “Motor Vehicle Seat Belt Anchorages – Design Recommendations,” and SAE J384, “Motor Vehicle Seat Belt Anchorages – Test Procedures.”  They’re available from Document Center Inc. in both paper format and for pdf download.

These documents were both stabilized in 2013 and were not expected to be updated at all, let alone so soon.  However, as is sometimes the case, the act of putting a standard to bed causes last minute alerts to errors!  So both these documents have been updated to be compatible with FMVSS (Federal Motor Vehicle Safety Standards) requirements.  Changes to the SAE J384 also include the addition of the provisions of SAE J385, which has been cancelled as of July of this year.

The SAE J383 provides you with design recommendations for the location of seat belt assembly anchorages.  These locations are intended to properly transfer of occupant restraint forces on the strongest parts of the human anatomy to the vehicle or seat structure.

The companion document, SAE J384, specifies performance requirements and test procedures for the strength and location of seat belt assembly anchorages. It applies to seat belt anchorages attached to vehicle body structure or to seat assemblies in the vehicle.

Now to get your copies of these new revisions.  Head to the Document Center webstore at www.document-center.com.  You can search our database of over 500,000 different documents (and many more editions) easily and securely.  Order the items you need in the format you want.  If you have any questions, just get in touch with our staff.  We’ve been providing our customers with standards from our Silicon Valley location since 1982.  Make us your Standards Experts!

New AAMI TIR58 – Hemodialysis Water Testing

November 12th, 2014

ISO 13959 (aka ANSI/AAMI/ISO 13959) provides you with the allowable limits for chemical contaminants in water used for hemodialysis.  And FYI: both editions of this standard have been recently revised.  Still, you may need more information on the actual testing you should use.  Now the AAMI TIR58, “Water testing methodologies,” gives you up-to-date information on a variety of topics that will improve your facility’s ability to test the water used in this process.

What types of processes does this new Technical Information Report cover?  The AAMI TIR58 will provide you with information on:

  • maximum allowable levels of various contaminants
  • clinical symptoms in dialysis patients exposed to specific contaminants
  • toxic levels for these contaminants when available
  • substances that can interfere with testing results
  • how various contaminants can affect your equipment
  • new proven tests and techniques that have been developed more recently

The information is presented in the usual format at the beginning of the publication, the usual scope, applicability and use, and definitions sections.  But the bulk of the document is a table of the water testing methodologies themselves.  Section 4 provides you with a guide to using this table.

This lengthy Table 1 is set up in 5 columns:  Chemical element or contaminant, maximum allowable levels, clinical symptoms associated with exposure, effect of the contaminant of dialysis systems, and test methodologies.  These are all supported by a 95-item list of cited references, so you’ll have the various resources at your fingertips for the tests, etc., that are included in the table.  A two-page bibliography finishes up the document.

Since AAMI TIR58 is a copyright document, you’ll need to purchase a copy from an authorized dealer.  Choose Document Center and order yours at our webstore, www.document-center.com.  Or feel free to work with our staff personally by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll be able to choose delivery in paper format, as a pdf download, or as part of our multi-user annual subscription platform, Standards Online.  Make us your Standards Experts!

Does Anyone in China Pay Attention to Standards?

November 11th, 2014

Today I have a guest blogger, Dr. Tim Rodgers, who asks the question:  ”Does Anyone in China Pay Attention to Standards?

Over the past several years there’s been a growing number of high-profile incidents involving quality problems with Chinese suppliers and contract manufacturers. Earlier this year the venerable British car company Aston Martin announced a recall of 75% of the cars built since 2008 after discovering a Chinese supplier used fake materials in an accelerator pedal that was implicated in field failures. Incidents like this have plagued both small businesses with limited staffs as well as large multinational corporations with strong reputations and extended supplier management teams. Many companies are shifting production away from China to locations with higher labor cost in order to get better control over quality.

As someone who has lived and worked in China at a leading electronics manufacturing service for almost two years, I know from experience how hard it can be to maintain quality standards in that part of the world. I’m not convinced that this problem is unique to China, but it may seem worse because of the sheer number of suppliers competing on price with extremely small profit margins and very little loyalty on either side of the purchasing relationship. In this Darwinian setting, suppliers will look for any way to reduce their costs, and unfortunately that means some will violate standards, substitute materials, and skip testing or inspection.

Some people will look at this seemingly lawless environment and ask whether anyone cares about standards, and whether they should even bother communicating standards to their suppliers. If no one’s paying attention, what’s the point?

Do we still need standards? Of course we do. Let’s not confuse supplier performance problems with the value of setting clear expectations. Standards still provide a clear and unambiguous way to specify product requirements, testing procedures, and acceptance criteria. Regulatory agencies and review committees made up of your industry’s leading experts create standards that give you a proven, technically-sound basis for assuring reliable and safe products. They specify not just the quality characteristics of the supplier’s output, but in many cases also how that output should be produced.

Standards tell the supplier how you will measure their performance, and establish the criteria you will use to accept or reject their deliverables. Your supplier should already be familiar with your industry’s standards, and if they’re not, then they’re probably not the right supplier for you.

However, simply communicating the standard to your supplier is not enough to assure compliance. Purchasing customers have a responsibility here as well. You need to “trust but verify,” and regularly audit suppliers, which can include sampling incoming parts and inspecting the production factory and supporting processes. Suppliers need to understand that there are consequences for failures to meet standards, such as financial penalties and loss of business, and suppliers need to know that you’re monitoring their performance.

Yes, it’s frustrating when you discover a quality problem that can be traced to your supply chain, but that shouldn’t lead you to abandon standards. It can sometimes seem like the Wild West where anything goes, but without standards that clearly define your requirements and expectations you’re just contributing to the chaos.

Author:  Dr. Tim Rodgers

Editor’s Note:

Tim Rodgers, Ph.D., MBA, SSBB, PMP, is a senior engineering manager with many years of experience leading new product development, supply chain management, and quality engineering teams at large multinational firms, including Lockheed-Martin, Hewlett-Packard, and Eastman Kodak. Tim is currently in-transition, looking for an opportunity to join a growing firm with an entrepreneurial culture. He writes regularly on management and quality issues at his own blog “Managing in the 2000s” at http://timrodgers.wordpress.com

New ISO 37500 – Guidance for Outsourcing

November 10th, 2014

Standardization is sometimes used to help define professionalism in emerging industries.  ISO 37500, “Guidance on outsourcing,” is a good example of this type of document.  As the concept of outsourcing has become integrated into many organizations, specialists in this field have joined together and formed the International Association of Outsourcing Professionals (IAOP).  This group has developed a methodology for certifying professionals in this discipline.  Now the ISO 37500 provides a counterbalance to their efforts.  It has been written for organizations to help manage the outsourcing life cycle.

The primary national players in the development of this standard have come from Europe and India.  The goal is to provide terms and concepts that will create a good practice model.  You’ll be able to use ISO 37500 before, during and after your outsourcing decision is made.  And it will be the foundation of a beneficial relationship between you and your partnering organization.

The generous 80 page document begins with the usual scope, referenced documents and definitions sections.  Then Section 4 gives you introductory material and various models (shown in lovely colored figures) that define the life cycle phases.  Section 5 is titled Governance and provides you with an overview of leadership and cultural issues.

The next four sections cover each of the four life cycle phases in detail.  You’ll get in depth information on your outsourcing strategy analysis, the initiation and selection process, transitioning from the in-house to outsourced model, and how to insure that outsourcing delivers value.  Nine Annexes provide you with checklists and other information that will help you turn the requirements into reality.

Are you an Outsourcing Professional interested in learning how to improve your individual competencies?  Consider joining IAOP or reviewing their publication, “Outsourcing Professional Body of Knowledge.”

Meantime, you’ll want to get yourself a copy of the new ISO 37500.  Use Document Center’s webstore at www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to help you collect and maintain your standards collection — as well as answer your questions about them!  Make us your Standards Experts!

New IEC 61082-1 – Rules for electrotechnology documents

November 7th, 2014

The IEC 61082-1, “Preparation of documents used in electrotechnology – Part 1: Rules,” was developed for use by the various committees that prepare standards and other documents within IEC.  Now there’s a new 3rd Edition for the document, available from Document Center Inc.   You may not be part of an IEC committee, but you may find the standard to be helpful if you are responsible for technical documentation.  Here’s more about the new update.

The IEC 61082 series was a set of 5 publications, Parts 1, 2, 3, 4, and 6.  Only the Part 1 remains current — the balance of the set has been withdrawn.  It sets down the general rules and guidelines for the presentation of information in documents, specifically rules for diagrams, drawings and tables used in electrotechnology.

There are a number of other IEC standards that address this topic, covering designation, symbols, documentation rules, preparation of documentation (where this document falls), and data organization.  These are considered to be on the topic of the presentation of data.

This new 3rd edition is a technical revision, which means that it cancels and replaces the previous edition from 2006.  The main changes are in the following areas:

  • New presentation rules for wireless interconnections,
  • A description of exceptional cases for the application of the rules for positioning reference designations in diagrams,
  • Modifications to the various referenced documents, and
  • Harmonization of the definitions with regards to the other standards it references.

IEC has provided a redline edition for this document, which will make it a lot easier for you to find all these changes.  The IEC 61082-1 Redline Edition provides you with a copy of the old second edition with all the changes that have been made for the new 3rd edition marked in red.  It’s a breeze to see every single change that’s been made.

Where will you get your copy of the new standard?  Try Document Center Inc., an authorized dealer of the IEC standards since the 1980′s.  You can order on our webstore at www.document-center.com.  IEC standards are available in paper format, for pdf download or as part of our multi-user access subscription service, Standards Online.  Questions?  Contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

New EN 10088-1 -2 and -3 on Stainless Steels

November 6th, 2014

ASTM standards are the go-to resource for information on the chemical composition of various metals.  But there are alternatives and one of the most important for stainless steels is the EN 10088 series.  There have been recent updates to 3 of the standards in this group:  EN 10088-1, EN 10088-2, and EN 10088-3.  All are available from Document Center Inc.  We’ll review them in the BS EN editions.  The DIN EN and SS EN editions should update shortly as well.

BS EN 10088-1, 2014 Edition, Stainless steels. List of stainless steels

This European Standard lists the chemical composition of stainless steels.  These steels are subdivided in accordance with their main properties into corrosion resisting steels, heat resisting steels and creep resisting steels.  You’ll find them specified in the European Standards given in Table 1.  Reference data on some physical properties are given in Tables E.1 to E.8.

BS EN 10088-2, 2014 Edition, Stainless steels. Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes

Part 2 specifies the technical delivery conditions for hot or cold rolled sheet/plate and strip of standard grades.  It also covers special grades of corrosion resisting stainless steels for general purposes.

BS EN 10088-3, 2014 Edition, Stainless steels. Technical delivery conditions for semi-finished products, bars, rods, wire, sections and bright products of corrosion resisting steels for general purposes

The new edition for Part 3 specifies the technical delivery conditions for semi-finished products, hot or cold formed bars, rods, wire, sections and bright products of standard grades, as well as special grades of corrosion resisting stainless steels for general purposes.  This does include the use of stainless steels in contact with foodstuffs.

BS EN 10088-4 and BS EN 10088-5 remain stable at the 2009 Edition level as of this writing.

Now you’ll need to get your copies.  Order on the Document Center website at www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re able to assist you with any questions you may have.  Make us your Standards Experts!