ISO/IEC 17788 and ISO/IEC 17789 – Standards for Cloud Computing

October 21st, 2014

You know it had to happen!  Cloud computing is the “hot” technology area and here come the standards!  However, if you’re responsible for developing contracts or fulfilling them, you’re glad of it.  And the new standards I’ll review today cover the basics you need.  ISO/IEC 17788, “Information technology – Cloud computing – Overview and vocabulary,” puts everyone on the same page with regards to concepts and terminology.  ISO/IEC 17789, “Information technology – Cloud computing – Reference architecture,” shows you how the functional layers are structured.  We’ll cover ISO/IEC 17788 and ISO/IEC 17789 separately.

ISO/IEC 17788 (also published as ITU-T-Y.3500) was developed by JTC1′s subcommittee on distributed application platforms and services.  The first half of the document provides you with a list of definitions for 44 terms, as well as other acronyms (FYI: some definitions are taken from other standards).  Then the balance of the standard gives you a review of what cloud computing is, the key characteristics, various roles and activities, and cloud service types.  OK, I thought we’re primarily talking about SaaS (Software as a Service).  But, hey, there’s all sorts of things that can be put on the cloud!  I may be in trouble since Management as a Service is also included (I think that’s my job…)

ISO/IEC 17789 also has been published as an ITU document (ITU-T-Y.3502). There is a brief definitions section followed by Clause 5 on conventions.   Next, cloud computing reference architecture goals and objectives are covered.  Then the standard dives into the heart of the matter, providing you with detailed descriptions and charts to model the user view and the corresponding functional view.  Discussion in Clauses 7 through 10 covers various activities, relationships, and so on.

Annex A delves further into these two views with sections on the relationships between:

  • Customer and service provider
  • Provider and provider (aka “inter-cloud”)
  • Cloud service developer and cloud service provider and
  • Cloud service provider and auditor

A short bibliography of 6 additional standards for further review rounds out this publication.

Now you’ll want to get copies of these two standards.  Head to Document Center’s webstore at www.document-center.com.  Here you can order the standards you need in both paper format and for pdf download.  Want multi-user access?  Ask our staff about our Standards Online subscription service.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping folks like you since 1982.  Make Document Center your Standards Experts!

New ASTM A480/A480M and ASTM A484/A484M – Subscription Service Available!

October 20th, 2014

ASTM A480/A480M and ASTM A484/A484M are two examples of ASTM standards that are frequently revised.  So Document Center Inc. would like to suggest that if you use either or both of these publications, you may want to consider purchasing them from us as multi-user licensed subscription standards.  And now is the perfect opportunity, since both documents have again been updated.

FYI: The ASTM A480/A480M, “Standard Specification for General Requirements for Flat-Rolled Stainless and Heat-Resisting Steel Plate, Sheet, and Strip,” is now updated to the 2014b Edition for $62.00.  The ASTM A484/A484M, “Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings,” is now the 2014a Edition for $49.00.

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The other important benefit of the Standards Online subscription service for ASTM standards is the automatic updating feature.  This means that when your standard changes during the period the subscription is in force, your copy is automatically changed to the newest edition at no additional cost to you.  You no longer have to be concerned with frequent updates to these ASTM standards.  They will be processed for you automatically.

The Standards Online service is an annual subscription service which needs to be renewed once a year.  However, the overall costs to you for these ASTM standards that are updating more frequently will be a reduction in cost, an increase in user access, and the reduction of risk posed by out-of-date documentation.

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New EN 1672-1 – Safety Requirements for Food Processing Machinery

October 17th, 2014

Standards pervade the world around us, in ways that we might not be aware of.  Food and food processing is such an area.  Now there’s a new standard for the safety requirements for food processing machinery.  It’s the EN 1672-1 and it’s just been released.  Titled “Food processing machinery. Basic concepts. Safety requirements,” the document provides guidance for the eurozone.  However, many manufacturers of such equipment will want to take note if they sell product into this market.

EN 1672-1 deals with the significant hazards, hazardous situations and events relevant to commercial and industrial food processing machines.  You’ll need to be concerned with situations where your equipment is used as intended and also  under conditions of misuse which should have reasonably been foreseen.  These events can occur during transport, assembly and installation, commissioning, setting, teaching, programming, process changeover, operation, cleaning, fault finding and maintenance.

The standard deals with those risks which occur commonly in food processing machines.  It is expected that common technical requirements can be set which can be applied to all (or most) machines which have that defined  hazard.

Remember, this is not geared for the domestic use product, but for commercial equipment.  And it will also not address packaging machines.

If you need a copy, you can purchase it online at the Document Center webstore (www.document-center.com).  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have been providing standards to industry since 1982 from our Silicon Valley location.  Make us your Standards Experts!

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.

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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.

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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.

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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!