2015 IATA Dangerous Goods Regulations is here!

October 16th, 2014

The IATA, International Air Transport Association, publishes the Dangerous Goods Regulations (DGR).  It’s updated each year at this time, so for folks who ship products that are classified as hazardous, it’s essential to keep up with the changes.  If you use this manual, you’ll want to purchase the new 56th Edition and you can get your copy from Document Center!  It will be in effect as of January 1, 2015 and includes all changes of the ICAO, International Civil Aviation Organization, for the upcoming year.  And it also contains the IATA’s operational requirements for airlines as well.

What kinds of changes will you find in the Dangerous Goods Regulations 56th Edition?  Here’s a partial list:

  • The GHS (Globally Harmonized System for classification and labeling of chemicals) has been added.
  • Lithium metal batteries are now prohibited from passenger aircraft.
  • There’s new provisions for adsorbed gases.
  • Various terms for restraint systems like air bag modules or inflators have been renamed “safety devices,” electrically initiated or pyrotechnic.
  • If your shipment of environmentally hazardous substances is less the 5 kg per receptacle, it’s no longer subject to regulations.
  • Some restrictions for overpacks have been removed (for cargo aircraft only).
  • Provisions for radioactive materials have been updated in response to the 2012 edition of the IAEA (International Atomic Energy Agency) Regulations for the Safe Transport of Radioactive Material.

You’ll use the DGR to determine if your shipment is considered dangerous.  And if so, you’ll find complete information on the regulations that apply to your products.  With the issue of the safe transport of hazardous material by air in the news, you’ll want to make sure that you’re using the latest information to protect your shipment and those responsible for it during transit.

Order your copy online at the Document Center Inc. webstore, 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 find we have a wide range of additional services that will help you procure and maintain your compliance information collection.  Make us your Standards Experts!

IEC/TR 62354, Guidance for Medical Electrical Equipment Testing, Updated

October 15th, 2014

For those of you who use IEC 60601-1 in your business, you know that the IEC/TR 62354, provides you with information on testing for meeting those requirements.  Now the technical report, titled “General testing procedures for medical electrical equipment,” has been updated.  The new 3rd Edition of the publication is available from Document Center now, in paper format or for pdf download.  And it can be included in your multi-user access online subscription service as well.

The IEC/TR 62354 is intended to provide guidance on general testing procedures according to the IEC 60601-1.  So it’s no surprise that it has been updated to align the guidance with the modifications made to the IEC 60601-1 by the Amendment 1 released in 2012.  For this reason, the 3rd Edition of the IEC/TR 62354 is a technical update, withdrawing and replacing the previous 2nd Edition.

What’s new in this revision?  The changes are centered in Section 13, procedures for testing, including particular conditions.

For Clause 13.2, Tests to be performed by inspection, you should particularly review Sections 13.2.1 (risk management), 13.2.4 (durability and legibility of marking), 13.2.5 (battery markings), 13.2.8 (potential equalization terminal) and 13.2.14 (usability of medical electrical equipment).

For Clause 13.3, Measurements and tests performed on non-energized equipment, you’ll need to look at Sections 13.3.1 (humidity preconditioning), 13.3.2 (impedance of PE [protective-earth] connection), 13.3.7 (creepage distances and air clearances), 13.3.12 (instability), 13.3.13 (castors and wheels), 13.3.14 (safety catch evaluation), 13.3.17 (overflow), 13.3.18 (spillage), 13.3.23 (impact), 13.3.24 (drop impact), 13.3.25 (rough handling), 13.3.27 (actuating parts of controls) and 13.3.28 (construction of transformers).

For Clause 13.4, Measurements and tests for equipment that is operating, please review sections 13.4.1 (essential performance – functional), 13.4.3 (voltage mismatch), 13.4.4 (limitation of voltage, current or energy), 13.4.5 (defibrillation-proof applied part protection), 13.4.6 (energy reduction), 13.4.7 (earth leakage current), 13.4.9 (patient leakage current), 13.4.14 (sound pressure level measurements), and 13.4.16 (X-radiation measurement).

You’ll note that some of these sections are new, while others have been revised.

Now to get your copy of this new revision.  Head to Document Center’s webstore at www.document-center.com.  It’s easy to order the publications you need from our collection of over 500, 000 unique titles of specifications and standards from around the world.  Need to talk to an expert before you make your purchase?  Just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping folks like you from our Silicon Valley location since 1982.  Make us your Standards Experts!

New FDA Guidance for Medical Device Cybersecurity

October 14th, 2014

Medical Device Cybersecurity has been a hot topic as medical information is increasingly being exchanged electronically, including medical device monitoring.  The FDA has been issuing guidance ever since 1998, when the organization first addressed the issue of software in medical devices.  Now, a new guideline has been released.  Titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” it’s the final publication for a draft that was issued in 2013.  You’ll use it to review how you reduce the risk that your device functionality will be compromised by inadequate software security issues.

The new guidance is intended to supplement the information that’s found in 2 previous FDA guidance documents:  ”Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software” and “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”  It’s divided into various clauses, beginning with an introduction and then a scope paragraph.

Next is a definitions section, Clause 3, which relies heavily on terms and definitions found in ANSI/AAMI/ISO 14971.  Following this, Clause 4 provides you with the general principles that the FDA uses in assessing the cybersecurity controls a given developer or manufacturer uses in their products.

Section 5 covers cybersecurity functions, the mantra of identify, protect, detect, respond and recover.  Here you’ll find the detailed suggestions for how to provide limited access to software by trusted users only, ensuring trusted content, and so on.

Section 6 is particularly useful, as it provides the recommendations of the agency for the type of documentation they expect to see in your premarket submission.  Of course, the recommendations expect that you’ll have support for the implementation and management of this issue as part of your quality system as defined in the Quality System Regulation (including Design Controls).

The new publication concludes with a list of FDA recognized consensus standards that deal with IT (information technology) and software security for medical devices.  Of the 6 referenced standards, five have IEC as the source organization and one has been developed by CLSI.

If software, including any networked components, is part of your medical device, you’ll want to get a copy of this new guidance on medical device cybersecurity.  Head to Document Center’s webstore at www.document-center.com.  There you can pick up a copy in either paper format or for pdf download.  You can even add it to your Standards Online multi-user subscription service.

Benefits?  When the document is updated, you’ll be notified.  And you’ll have the support of our team of experts here at Document Center.  You can register on our site and easily review the status of all standards purchased from us at any time.  And there’s loads of other services offered by Document Center Inc. that can make it far easier to maintain and control your collection of compliance documentation.  Thousands have made Document Center their preferred standards source.  Do the same and make us your Standards Experts!

New ISO 8124-4 Update – Toy Safety for Swings and Slides

October 13th, 2014

I spent Saturday afternoon at a birthday party for our two-year-old nephew (cute kid, I must say!)  And how did the birthday boy spend his party time?  On the slide that’s part of the new landscaping his parents put at the end of the summer!  Like many other types of toys, there’s an ISO safety standard for family use slides and swings, and it’s just been updated.  The new ISO 8124-4 2nd edition, “Safety of toys – Part 4: Swings, slides and similar activity toys for indoor and outdoor family domestic use,” is available now from Document Center Inc.

This new update extends the types of toys covered by the standard.  The requirements section now includes inflatable activity toys and paddling pools.  The warnings and labeling clause 5 has also been expanded to include a new clause 5.4 specifically on warnings.  This is in part a response to the added dangers of the new types of toys introduced in this edition.

The expansion of the requirements clause 4 means that the clause 6 for test methods has also been lengthened.  As you might expect, the new sections are 6.9 on the deflation of inflatable activity toys and 6.10 for the static load test for paddling pools with non-inflatable walls.

Users of ISO 8124-4 will also be interested to find that the Annexes have been extended.  In additional to Annex A on Rationale and Annex B on playground surfacing material consumer information sheets, there’s a new Annex C.  This new Annex addresses safety labeling guidelines for certain types of activity toys.  What kinds of guidelines does it include?  Information on label definition and location for hazards introduced by inflatable toys and those that may accumulate water are in this section.  And so is information on providing the customer with warnings of the dangers posed by connection tubes for inflating activity toys as well as the possibility of friction burns.

If you need copies of this or any ISO standard, you can order it online at the Document Center website, www.document-center.com.  You’ll have over 500,000 unique titles to choose from!  You can specify delivery in paper format or for pdf download, and you can even include them in your Standards Online multi-user subscription service.  Want help from our staff?  Contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing standards to customers like you since 1982.  Make us your Standards Experts!

New AAMI TIR34 – Water for reprocessing Medical Devices

October 10th, 2014

AAMI, the Association for the Advancement of Medical Devices, has two main roles in standardization here in the U.S.  First, it acts as the Technical Advisory Group (TAG) for medical device standardization at the international level.  And secondly, it provides guidance for U.S. companies when international standardization has not yet taken place.  One of these AAMI Technical Reports, AAMI TIR34, has just been updated.  Document Center has the new 2014 Edition now so you can purchase it in paper format or for pdf download.

Titled “Water for the reprocessing of medical devices,” AAMI TIR34 covers the complete range of issues involved in what is basically sterilization of medical devices using water.  You’ll learn why water quality is important, the categories of both medical devices and of water for the reprocessing function, what types of water treatment you’ll need to consider, and the stages of medical device reprocessing where water quality is a factor.

Of course, in order to set up an effective water treatment process you’ll need to know about the various water treatment systems available and what will work best in your situation.  The standard covers this, down to the issues of the physical layout of the water purification system to distribution and storage.  You’ll also get complete guidance on how to monitor the water quality in your system, both in clause 7 and in Annex B.  Concluding sections cover strategies for bacterial control, personnel considerations, and quality concerns.

You’ll also be pleased to know that there are 7 Annexes that review the various issues in detail — from the monitoring issues noted above to thermal disinfection, water treatment using filtration and the typical presentation of quality issues during reprocessing.

What’s new in this edition?  Of course, there are many updates and organization enhancements throughout the document.  But the committee also brings the fact that the water categories have been reduced to two from the previous four that were specified in the 2007 Edition.

How do you get a copy?  Due to copyright considerations, you’ll want to make sure you purchase your copy from an authorized dealer.  Document Center Inc. is such a source.  You can order any standards you need at our web store, www.document-center.com.  Or feel free to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Interested in multi-user online subscription access?  We have that too!  Remember, Document Center has been providing standards to folks like you since 1982.  Make us your Standards Experts!

ISO 22400-1 released – KPI’s for Manufacturing

October 9th, 2014

Key Performance Indicators (KPIs) are a valuable tool for the management of manufacturing operations.  By choosing a few measurements, and perhaps manipulating them into monitoring values, an organization can better realize it’s objectives.  The ISO 22400 series has been developed on this very topic and the Part 1, ISO 22400-1, has just been released.  Titled “Automation systems and integration — Key performance indicators (KPIs) for manufacturing operations management — Part 1: Overview, concepts and terminology,” it’s a great introduction to KPI and the value it brings to any business.

The ISO 22400-1 was specifically developed for MOM (Manufacturing Operations Management).  The KPI’s generated will be from data from the control domain with an eye to providing decision support information.  However, you’ll find it a relevant document if you need to understand the concepts and data flows used for generating and using KPI’s in general.

The beginning of the standard is fairly routine, with a scope clause, then terms and definitions, as well as an abbreviated terms section that’s so helpful if you’re new to the field.  Then the document delves into the basic concepts of KPI’s in general.  You’ll learn what criteria to use, what types of KPI’s are available, the categories of KPI’s by purpose, generating KPI’s from measurements and so on.

Section 5 is titled “Definitions and descriptions.”  It really provides you with concrete information on KPI’s themselves.  Here you’ll find a table with the basic structure of a KPI, how to present effect model diagrams, and more.

Section 6 on exchange and use provides guidance for taking the KPI data and moving it between one MOM application and another.  And Section 7 discusses relationships and dependencies.  This is visually defined with the presentation of Table 2, a model of relationships and dependencies.  Here you’ll see how the data can flow throughout the organization, and how that data is then modeled into the various KPI’s you choose to focus on.  You’ll also get computational support for verifying the effectiveness of your KPI’s.

Annex A brings the KPI primer back to the context of MOM, so you’ll be able to review the benefits, etc., of KPI’s specifically within this environment.  A 6-item bibliography completes the document.

FYI:  There’s also the ISO 22400-2 available, “Automation systems and integration – Key performance indicators (KPIs) for manufacturing operations management – Part 2: Definitions and descriptions.”  It was released at the beginning of the year.  And 2 additional parts are currently in the works — Part 3: Exchange and use and Part 4: Relationships and dependencies.

If you need a methodology for structuring the use of KPI’s in your manufacturing environment, you’ll want a copy of this new standard.  Head to the Document Center webstore at www.document-center.com and order your copy now.  It comes in both paper format and for pdf download, and you can include it in your multi-user online subscription service too!  If you’d prefer to work with our staff, you can contact them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping folks improve their operations by using standards effectively since 1982.  Make us your Standards Experts!

AS 9102 updated for First Article Inspection

October 8th, 2014

There are a number of quality standards developed specifically for the Aerospace Industry, and AS 9102 is among the most important of these.  Titled “Aerospace First Article Inspection Requirement,” the document has just been revised.  The new Revision B is available now from Document Center Inc. in both paper format and for pdf download.  It’s the first update of the standard since 2004.

AS 9102 provides the user with the baseline requirements for First Article Inspection (FAI), so necessary in ensuring that the item produced is the item as specified in both the contract and engineering specifications.  You’ll normally use it for a part that is representative of the first production run.  The process assures that all engineering design and specification requirements are understood and verified.

What’s new in the Revision B?  Here’s the list from SAE:

  • The new update emphasizes the value of the First Article Inspection (FAI) process to an organization
  • It separates and enhances the planning and evaluation activities
  • There’s a definition of Digital Product Definition (DPD) and its relationship to the FAI process
  • Other updates have been made in response to user comments

Over the years, the aerospace industry has come to rely on the AS 9102 not only for the guidance it provides, but also for the various forms that are included in the document.  You’ll find forms for Part Number Accountability, Product Accountability, and Characteristic Accountability included.  And instructions on how to use the forms are also part of this standard.

Why use Document Center Inc. for your purchase of this new edition?  We have options for both the delivery and purchasing methods.  Our superior notification service is included at no charge.  And our expert staff can help you maximize your use of the standard with a variety of support services.  Just go to our webstore at www.document-center.com to order.  Or contact our staff by phone (650-591-7600), email (info@document-center.com) or fax (650-591-7617).  We’ve been helping folks like you since 1982.  Make us your Standards Experts!

New IEC/TR 62511 – Power System Guidelines

October 7th, 2014

In recent years, the question of the reliability of the power grid has loomed large.  The new IEC technical report, IEC/TR 62511 provides users with design guidelines for interconnected power systems (IPS).  It is anticipated that the user of this technical report will find system reliability will be enhanced, primarily in when part of the system is down or unintentially separated.

Titled “Guidelines for the design of interconnected power systems,” IEC/TR 62511 is intended for high voltage transmission systems (generally more than 50kV).  You’ll use the guidelines during your assessment phase as well as in the reliability testing of your transmission system.  This will help you determine the elements of IPS needed for enhanced design.  Then the report gives you all the considerations to take into account as you proceed.

After the usual scope, referenced documents and definitions sections, the IEC/TR 62511 covers the complete range of issues for your review.  They include:

  • General Principles
  • Resource adequacy
  • Modeling and assessments
  • IPS design guidelines

A short 3-item bibliography rounds out the document.

Failure of the power grid has turned out to be an unpleasant consequence of increased inter-connectivity and unanticipated loads.  You’ll find that this guide will help you identify those areas where you’ll need to do an assessment of how your power grid components will behave in adverse conditions.  And it will give you an overview of how to design your system (including existing components) to minimize the risk of cascading failures when one part of the grid goes down.

If this document will assist you to meet your requirements for a high level of reliability in your integrated power system, you’ll need to get a copy.  Head to Document Center’s webstore at www.document-center.com.  There you can purchase an authorized copy in either paper or pdf format.  Or you can request to have it added to your multi-user online subscription service.  If you’d like more information, just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

We’ve been providing our customers with standards from our Silicon Valley location since 1982.  Make Document Center Inc. you Standards Experts!

New Service PPAP Supplement available

October 6th, 2014

AIAG, the Automotive Industry Action Group, has just issued a new Service PPAP Supplement for the popular PPAP 4th Edition standard, “Production Part Approval Process.”  This new PPAP Supplement is title “Service Production Part Approval Process (Service PPAP)” and is available from Document Center now.  It’s been written to clarify requirements for service part production.

AIAG notes that Service PPAP:

  • Provides PPAP expectations for serviceable components as opposed to top level assemblies
  • Clarifies service unique PPAP requirements for low volume service vs. production parts
  • Gives you guidance on applying Advanced Product Quality Planning (APQP) to service part processing
  • Outlines adequate visual aids and operator instructions needed for service processing, including routing, inspection, packaging, and labeling

Of course you may be wondering if the supplement has additional requirements you’ll need to meet.  Actually the supplement provides clarification only.  But if this is an area that applies to your operations, you’ll be pleased that the document does identify all requirements specific to your applications.

What kind of situations are covered by Service PPAP?  You’ll use it if you’re affected by remanufactured parts, service unique chemicals, third party packagers, and service software requirements.  The document allows for evidence that required customer engineering design records and specification requirements are being met by a service part supplier.  And it allows you to confirm that a supplier’s manufacturing process will produce consistent product.

Now you’ll need a copy of the new Service PPAP.  Head to Document Center’s webstore at www.document-center.com and order your copy there.  Or you can contact our staff by phone (650-591-7600), email (info@document-center.com) or fax (650-591-7617).  We’ve been providing our customers with standards since 1982 from our Silicon Valley location.  Make us your Standards Experts!

New ISO/DIS 14644-2 – Cleanroom Monitoring

October 3rd, 2014

In tandem with the release of ISO/DIS 14644-1 (reviewed in Wednesday’s StandardsForum.com blog), there’s been the release of ISO/DIS 14644-2.  It’s a proposed revision of ISO 14644-2 to be titled “Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.”  You’ll get the draft to take a look at possible changes to the document and to allow for comments that you might want to make to the committee regarding these proposed updates.

The difference between ISO 14644-1 and ISO 14644-2 is that the Part 2 provides you with information on air cleanliness over time, rather than just a one-time at-rest reading.  Developing a strategy for this type of monitoring allows for more effective risk analysis, with potential for reduction of operational and product losses.

Some of the things you’ll notice that are different in this proposed 2nd edition are the expansion of the requirements from Section 3 on terms and definitions and Section 4 on demonstration of continued compliance.  In the draft, there are 3 areas of requirements:

  • Section 3 on terms and definitions
  • Section 4 on creating, implementing and maintaining a monitoring plan
  • Section 5 on periodic classification of air cleanliness using particle concentration (ACP)

The informative Annexes have also been revised.  Now Annex A covers matters to consider when developing your monitoring plan.  Annex B provides you with considerations for setting alert and action levels.

As you can see, use of the document over time has resulted in a different slant to the content of the standard.  Since this is a draft, the changes are not yet authorized.  However, many folks do find it helpful to understand the direction of future requirements.  If you’d like to review the new document, you’ll need a copy.  You can order yours at the Document Center website, www.document-center.com.  Or you can contact our staff by phone (650-591-7600), email (info@document-center.com) or even by fax (650-591-7617).

Since comments are due by November, this gives you some time to reflect and possibly contact the committee with your opinions.  And if you need a resource that not only provides you with standards but also provides you with additional services to make them easier to use, you’ll be glad you’ve chosen Document Center.  We’ve been supporting standards users like you since 1982.  Make us your Standards Experts!