ISO/IEC 19988 Core Business Vocabulary Standard Updated

ISO/IEC 19988, the Core Business Vocabulary Standard, has just been updated.  It is the definition document underlying the use of EPCIS for trading partner information exchange.  The new 2nd Edition available now from Document Center Inc.  It replaces the previous 1st Edition from 2015 and is a technical revision.

The ISO/IEC 19988 is the international adoption of the GS1 CBV Core Business Vocabulary Standard.  The 2nd Edition is identical to the CBV Version 1.2 from September 2016.  Changes include the following:

  • New terms for EPCIS error declaration reason identifiers
  • Requirements for the URI structure for EPCIS event identifiers
  • New business step values dispensing and voidShipping
  • New disposition values dispensed and partially_dispensed
  • A new section for trade item master data attributes
  • Expansion of the section on location and party master data attributes

At this point, if you’re not familiar with this standard you’re probably wonder what the heck it’s all about!  EPCIS is a standard used to share trading partner information as products move through the supply chain.  CBV is the definitions document used for common implementation of EPCIS.

These standards underline the increasing reliance on trading partner relationships in order to produce and distribute goods as the global economy takes off.  The need for consumer and regulatory information throughout the product lifecycle is helping to fuel the development of these standards.  And traceability remains a critical issue, as seen in the recent disclosure of sub-standard material shipments of aluminum recently.

You’ll need a copy of this new revision and you’ll want to use an authorized ISO/IEC distributor like Document Center Inc.  Use our web store to place your order at www.document-center.com.  Here is a direct link to the order page for  ISO/IEC 19988 for your convenience.

Many of you need visibility of your standards collection throughout your organization.  We suggest using our Standards Online cloud access service.  It provides your entire organization with a way to use the latest editions of the documents critical to your success.  Contact us by phone (650-591-7600) or email (info@document-center.com) to learn more.  Find out why so many companies make us their Standards Experts!

ISO 13485 Handbook Released

ISO has just published an ISO 13485 handbook and it’s available now from Document Center Inc.  This new guidance document is titled ISO 13485:2016 – Medical devices – A practical guide.  It was developed by members of the committee to assist you in implementing this important quality standard.  It contains their best advise for success!

ISO 13485 Medical Devices – A Practical Guide addresses the challenges faced by those of you in the medical device industry using the ISO 13485.  This is the requirements document for regulatory Quality Management Systems (QMS).  The handbook is therefore divided into mirror sections for the structure of the ISO 13485.  And, like many other guidance documents, each comments area is prefaced by the actual text of the 13485 standard.

As you move through the handbook, you’ll find an ISO 13485 clause, a paragraph on the intent of the clause, and then the guidance.  Whenever possible, actual examples are used.  So for the 13485 clause on human resources, there is discussion on the processes you’ll need to identify training needs.  And for this, an example of a professional extrusion specialist’s need for additional training is given.  After all, the improper operation of an extrusion machine might negatively affect your medical devices’ safety and performance.

This ISO 13485 Handbook is 220 pages of detailed information on using the ISO 13485:2016 Edition.  This will prove to be an invaluable tool for industry, as implementation of the ISO medical device standards has been impacted by recent changes in the documents themselves.

You’ll want to get your copies from an authorized ISO distributor like Document Center Inc.  Just order at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO 13485 Medical Devices – A Practical Guide for your convenience.  And you can find the order page for the ISO 13485 here.

When picking a format for using the ISO standards, you have a number of choices with Document Center Inc.  Of course, we have the usual paper copy and pdf download options.  But your organization may prefer cloud access.  You can talk with our staff about our Standards Online subscription services.  Many of our medical device customers find this an excellent solution to the stringent document control requirements for regulatory certification.

Learn more by reaching out to us by phone (650-591-7600) or email (info@document-center.com).  We have been working with standards since 1982 and recognize the needs that standards users have beyond just purchasing documents.  Our services range from reporting to notifying to delivery and maintenance of your compliance documents.  Make us your Standards Experts!

ASTM A380/A380M 2017 – Cleaning and Corrosion Protection for Stainless Steels

ASTM A380/A380M has just been revised.  The new 2017 Edition is available now from Document Center Inc.  The title is Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems.  It’s a best-seller here at Document Center.

Passivation is the chemical treatment of stainless steel using a mild oxidant.  During this process, a “film” layer is created that protects the steel against corrosion.  Descaling and cleaning are used prior to passivation to remove surface contaminants which cause corrosion.

ASTM A380/A380M specifically addresses these processes for new stainless steel parts, equipment, and installed systems.  They should not be used for decontamination or cleaning equipment or systems that have been in use.  And they are not appropriate for passivation of materials at the mill.

This new 2017 Edition replaces the previous 2013 Edition that I blogged about when it was released (New ASTM A380/A380M 2013 Edition…)  It is a technical update, with a number of changes that are summarized at the end of the publication.  Here are the highlights:

  • References to FED-STD-209 have been replaced by ISO 14644-1 and ISO 1464402.
  • Precleaning in sections 5.2.2 and 6.2.11 are now a requirement.
  • Updates were made to Section 5.2.2, including a new Section 5.2.3.
  • Same for Section 6.2.11, with a new 6.2.12.
  • Contents of 7.2.5 are now in 7.2.1.1.
  • Sections 6.2.5.1 and 5.2.5.3 were updated.
  • Duplex grades were added to tables A1.1. and A2.1.
  • Requirements in A1.5 and A2.10 are changed.
  • Time spans in Table A2.1 Part II are updated.

For a complete analysis of the revisions, purchase the redline edition.  You’ll get a clean copy of the new Revision and a “marked-up” copy of the old one.

To get your new update, make your purchase with an authorized ASTM distributor like Document Center Inc.  You can order all ASTM standards (including many obsolete editions if needed) at our website, www.document-center.com.  Here is a direct link to the order page for ASTM A380/A380M for your convenience.

Should you want company-wide access to any ASTM standard, choose our Standards Online cloud based service.  Talk to our staff about setting up a subscription for your company.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  We have a wide range of options for you to make sure you meet your compliance requirements.  We’re your Standards Experts!

IPC A 610 G due at the end of the month!

IPC A 610, Acceptability of Electronic Assemblies, is on path for release at the end of this month/the beginning of next.  The IPC J STD 001 G, Requirements for Soldered Electrical and Electronic Assemblies, will be released concurrently.  The two standards are widely used in the electronics industry.  Changes will be made throughout the publications.

The IPC A 610 is one of Document Center’s biggest sellers over the years.  It is used by companies large and small.  Changes to this new Revision G vary from Section to Section.  Some modifications are small — like renumbering in Section 1.  Other areas have extensive changes.

For example, Section 6 has significant updates throughout.  This includes Sections 6.6 on lead/wire placement, general requirements and 6.7 on general requirements for solder.

One thing that you will notice in this new Revision G for IPC A 610 is that it’s not necessary to redesign your boards just to meet the new requirements.  The committee recommends using the new Revision G for new design, of course.  But for previously existing designs, upgrade to this document can wait until either enforced by contract or is part of the usual design review process.  In other words, updating your board designs should not solely be based on the fact that there’s a new revision of the IPC A 610 available.

IPC is changing how its standards are available to the public.  You can still purchase the hardcopy edition.  However, the use of CD Rom format is being phased out.  So for electronic delivery, you’ll be ordering a non-printing pdf copy.  Normally, folks choose the single user option.  However, site licenses are available.

Head to Document Center Inc.’s webstore to preorder your copies now.  It can be found at www.document-center.com.  Here is a direct link to the order page for IPC A 610 paper format and the IPC A 610 pdf format.  For your convenience, here are the links for the J STD 001 paper edition and the J STD 001 single user pdf format as well.

Document Center Inc. is an authorized distributor of the IPC standards.  You’ll be purchasing with confidence knowing copyright laws are being met.  And you’ll get our best-in-class notification service with each standards purchase at Document Center.  To learn more about the wide range of services for compliance available from us, contact our staff by  phone (650-591-7600) or email (info@document-center.com).  We’re your Standards Experts!

IEC 61558-1 for Transformer Safety Requirements Updated!

IEC 61558-1 covers the safety requirements for transformers.  It has been recently revised with the release of Edition 3.0.  The title of this standard is Safety of transformers, reactors, power supply units and combinations thereof – Part 1: General requirements and tests.  This new Edition is a technical update and replaces all previous editions (which are now obsolete). You can purchase your copies now from Document Center Inc.

IEC 61558-1 provides you with a set of requirements and tests.  These are applicable to most types of transformers.  Additional, more specific, information can be found in the IEC 61558-2 series.

Coverage is for independent or association stationary and portable types of transformers.  These include dry-type transformers, power supply units (including switch mode power supply units), reactors, and combinations.  Windings can be either encapsulated or non-encapsulated.

It goes without saying that the IEC 61558-1 is widely used.  For those of you impacted by changes to this standard, the committee has compiled a list of changes in the introductory material.  These include:

  • fully insulated winding wires (FIW), new tables and aging tests for FIW constructions,
  • overvoltage categories 1, 2, 3 and 4 for clearances and dielectric strength tests (new tables) are included,
  • new symbols for overvoltage categories, symbol for maximum altitudes if higher than 2 000 m, symbol for plug in power supply units if the pins are damaged (tumbling barrel test), and symbol for minimum temperature (even during the transportation),
  • alternative temperature measurement, simulated load and back to back method according to IEC 60076-11,
  • short circuit and overload protection, simulated load and back to back method according to IEC 60076-11,
  • Table 2 temperature adjustments,
  • establishing partial discharge test above 750 V for FIW constructions,
  • requirements for toroidal core constructions, division for basic and for supplementary isolation,
  • modification of protection indexes for enclosures (IP-code),
  • dimensioning of rectangular cross section connectors for transformers,
  • repetition test, 80 % of required dielectric strength test voltage of Table 14,
  • vibration test for vehicles and railway applications, and
  • two Y1 Capacitors for working voltages above 250 V and not exceeding 500 V with overvoltage category 3.

This new Edition is available from Document Center Inc. in paper format, for pdf download and as part of our Standards Online company-wide cloud access service.  You can order on the web at www.document-center.com.  Here is a direct link to the order page for IEC 61558-1 for your convenience.  We are authorized distributors for IEC, so you can order with confidence.

Should you have additional questions or concerns, please get in touch.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  Find out why so many organizations make Document Center their Standards Experts!

AAMI ST90 – QMS for Processing Health Care Products

AAMI ST90 has just been released.  It’s titled Processing of health care products – Quality management systems for processing in health care facilities.  The new 50 page standard was developed by a group that included industry, practitioners (including nursing representatives), academia, government, affiliated organizations, and other interested parties.  It is focused on guidelines for hospitals and other healthcare facilities.  You’ll use it to set up procedures and guidelines supporting quality management systems (QMS) for processing medical devices (sterilization).

The hospital and health care facilities industry is fast adopting processes used by quality professions for many years.  These protocols are helping this industry improve outcomes, with an increased focus on systematic process improvement using a range of quality tools.    The AAMI ST90 is based on ANSI/AAMI/ISO 13485 and follows its format.  However, you can use this document even if you are not implementing the 13485.

The standard is to be used for the sterilization processing of medical devices.  With the knowledge that many adverse effects are in fact caused by human error, creating a QMS for effective and consistent processing during sterilization is a reasonable goal.  So you’ll find information in this standard for setting your objectives, creating a document trail, management responsibilities, resource management, and of course, measurement, analysis, and improvement.

The AAMI ST90 is then arranged to support this.  It begins with the usual scope, referenced documents, and definitions sections.  Next follow sections on QMS, management, resources, product realization, and the measurement, analysis and improvement process.  Four Annexes cover document and record retention, risk management, product QA testing for steam sterilization, and the six major steps in creating a QMS.  A 30-item bibliography completes the text.

Now you’ll want to get a copy of this new standard.  Choose Document Center Inc., an authorized distributor of the AAMI standards.  You can order them on our website at www.document-center.com in paper format or for pdf download.  Here is a direct link to the order page for AAMI ST90 for your convenience.

It’s also possible to purchase AAMI standards as part of our Standards Online company-wide cloud access service.  For more information about this, please get in touch by phone (650-591-7600) or email (info@document-center.com). We’ve been working with standards since 1982.  We’re your “one-stop shop” for all your standards needs.  Make us your Standards Experts!

SAE J2931/7 Released – Plug-In Vehicle Communication Security

SAE J2931/7, Security for Plug-In Electric Vehicle Communications, has just been released.  This is a new addition to the J2931 set of ground vehicle standards focused on plug-in vehicles.  They center on the intersection of data communications, vehicles, and the “smart” energy grid.

The 65-page SAE J2931/7 sets security requirements for digital communication between Plug-in Electric Vehicles (PEV), the Electric Vehicle Supply Equipment (EVSE) and electric grid components.  These include the utility supplier, the Energy Service Interface (ESI), the Advanced Metering Infrastructure (AMI) and/or the Home Area Network (HAN).  (Boy oh boy, more acronyms!)  Communications may be via wire or wireless, and may be point-to-point or internet-enabled.

The standard begins with the usual scope, referenced documents, and definitions sections.  Next, logical architecture and the available interfaces for plug-in electric vehicles are reviewed.  Section 5 provides you with requirements.  These range from basic assumptions to authentication, authorization, privacy, and data integrity.  Attention is given to the various interest areas: vehicle owner, vehicle operator, vehicle maintenance providers, passengers, energy services and providers, and so on.

Section 6 covers Use Cases.  These include such things as charging locations, payments and the like.  Sections 7 and 8 delve into communication issues.  Section 7 is on the network and 8 is for software vulnerabilities.  A brief Section 9 touches on emerging technologies.

There are a lot of interesting developments in the area of electric vehicles.  Standards provide the structural support necessary for developing the new infrastructure requirements for implementing these technologies.  SAE and its membership recognize the benefits of “smart” cars and a “smart” power grid.  Creating the background protocols for effective and secure communication between electric vehicles and the energy grid is essential.  This work is just another example of the developing inter-reliance between industry sectors not seen in the past.

To get your copy of this SAE ground vehicle standard (or any SAE document), head to the Document Center Inc. webstore.  You’ll find it at www.document-center.com.  Here is a direct link to the order page for SAE J2931/7 for your convenience.  And remember, you have purchasing options with Document Center Inc.  SAE Standards are available in paper format, for pdf download, and as part of our Standards Online company-wide cloud access service.

To learn more about how we can help you improve your document control system for standards, get in touch.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  We’ve been working with standards since 1982 and understand the challenges you face.  Make us your Standards Experts!

AS 13001 Updated – Supplier Self Release Training

AS 13001 has just been updated.  The new Revision A has a change in the title.  It’s now Delegated Product Release Verification Training Requirements.  You may be more familiar with this as Supplier Self Release verification training.  The new Revision A is available from Document Center Inc. in paper format, for pdf download, and as part of our Standards Online cloud access service.  The revision is a technical update, primarily intended to bring this standard in line with the new Edition of AS 9117.

The AS 13001 is an Aerospace Standard and reflects the industry’s use of a delegated product release verification system.  This is where a supplier is authorized to ship product directly to the end-use customer without oversight by the contracting organization.  It is essential that the duties that might have previously been performed by a company representative be correctly performed by supplier personnel.  Thus, the need for training.

The 8-page standard begins with the usual scope, referenced documents, and terms and definitions sections.  The core of the technical information is found in the requirements section 4.  This provides an overview, delegating organization training requirements, supplier training requirements and records retention.  Appendix A covers the relationship between this and other SAE standards on the topic. Links are provided to pertinent websites for further assistance.

Normally, an updated standard like this would have black lines in the margins to help you spot the technical changes.  However, they are not provided in this new Revision A.  This is because the changes are so extensive.   The previous original release was only 3 pages in length compared to the 8 pages in this revision.  And, as noted, even the title of the standard has been changed…

To get your copy, please choose Document Center Inc., an authorized distributor of SAE standards.  You can order them at our webstore, www.document-center.com.  Here is a direct link to the order page for the AS 13001 for your convenience.

Document Center Inc. has been working with standards since 1982. We have a wide range of support services to help maintain your document control requirements.  Ask us for more information by contacting us by phone (650-591-7600) or email (info@document-center.com).  We are your Standards Experts!

ANSI A117.1 for Building Accessibility Updated

ANSI A117.1, Accessible and Usable Buildings and Facilities, has been updated.  This important standard provides guidance on correctly meeting requirements for facilities accessibility for people with mobility and other issues.  It is referenced in the laws of many jurisdictions here in the U.S.  The new 2017 Edition is now available from Document Center Inc.

The details of properly making buildings accessible are to be found within the ANSI A117.1.  The publication covers issues ranging from parking spaces to hallways and routes to room spaces.  Even communication features like alarms and ATM access are addressed.  Both construction and facility companies rely on this standard for the details needed to meet the needs of all.

The new 2017 Edition has a wide range of updates.  They include new dimensions for clear and turning spaces due to increased use of motorized wheelchairs.  New requirements exist for exterior access, like curb cuts, passenger drop offs, and parking.  Issues surrounding hearing disabilities are also updated.  Acoustic requirements for classrooms now allow for improved communication, particularly for those reliant on sign language.

The ANSI A117.1 is written with a number of regulations in mind.  These include the Fair House Accessibility Guidelines (FHAG) and the 2010 Standard for Accessible Design (referenced by the ADA, Americans with Disabilities Act, and the ABA, Architectural Barriers Act).

To get your copy of this new update, use our Document Center Inc. webstore at www.document-center.com.  Here is a direct link to the order page for the ANSI A117.1 for your convenience.  The standard is covered by copyright, so you will need to purchase an authorized copy.

Document Center Inc. will provide you with our no-charge notification service with your purchase.  This means that when the standard is updated in the future, you’ll get an email alerting you to the change.  Many people rely on Document Center for all their compliance documentation requirements.  Contact us by phone (650-591-7600) or email (info@document-center.com) to learn more.  And then make us your Standards Experts!