EN 71-1 has been amended – Safety of Toys

EN 71-1, Safety of toys – Part 1: Mechanical and physical properties, has just been amended.  It is available now from Document Center Inc. in a number of national editions and formats.  The complete current number is EN 71-1:2014+A1:2018.  Adoption as a harmonized edition for Directive 2009/48/EC (Safety of Toys) is expected.

FYI:  I reviewed the original 2014 Edition for this document in a previous EN 71-1 2014 Updated post.

Now for the important part for most of you – What are the changes?  Well, first of all this is really the 3rd Amendment for the 2014 Edition.  And there are a lot of clauses that have been changed.  To see the complete list, review pages 11 and 12 of the European foreword.  Some highlights include:

  • The addition of flying toys, toy slings, and toy catapults (with projectiles).
  • Requirements for projectiles (kinetic energy density principles, impact resistance, etc.)
  • Requirements for flying toys (includes rotors, propellers, etc.)
  • New requirements for leading parts (including suction cups)
  • New requirements for cords
  • Changes for toys attached to cradles, cots, or carriages (perambulators), including warnings
  • Changes to test methods for scooters

Remember, the EN 71-1 only covers hazards which are not obvious.  You are responsible for things like the inherent instability of a 2 wheel scooter, etc.  You also need to use caution should your product be one that is often given to children inappropriately (a game for older children, but given to younger ones too even though the box is marked for a specific age range).  Luckily, parents and care-givers are still considered to have responsibilities when it comes to the use of toys by their children!

If you need this standard, or any in the EN 71 series, please get in touch with us.  Here is a link to the order page for BS EN 71-1.  Should you need additional assistance, please contact us by phone (650-591-7600) or email (info@document-center.com).  We have been working with standards since 1985.  Make us your Standards Experts!

ISO 19011 2018 Released!

ISO 19011 2018 has just been released.  This standard is titled Guidelines for auditing management systems.  It is the most widely used standard for ISO management system auditors.

I have blogged about this standard before when the 2nd Edition was released back in 2011.  (See ISO 19011 2011 Edition.)  This new 3rd Edition cancels and replaces that previous release.  And it is considered a technical update.

One reason the management system standards are all being updated right now is in response to user requests for a consolidated approach to these many schemes.  With this in mind, it should be obvious that auditors will have to adjust almost every system review to accommodate the new approach.  And if your organization supports more than 1 such scheme, you’ll want to know how your reviews will be affected.

Luckily, the committee has given us a description of the main changes to the document in the Foreword.  These include

  • A risk-based approach to the principles of auditing
  • More guidance on managing the audit program
  • More guidance on conducting the audit itself (especially the audit planning section)
  • Increased generic competence requirements for auditors themselves
  • Removal of the Annex on competence requirements for specific ISO management system standards (now too many to be practical)
  • Expansion of Annex A with guidance on auditing new concepts like virtual audits, compliance and supply chains, and so on.

You may very well have internal auditors in your organization.  If so, you should consider purchasing this new edition of the ISO 19011.  It will help you set up your training material.  Certainly, it should be used for regulatory and other contractual reasons.  And it can also be useful for those of you who self-declare when exporting your products.

Get a copy of this new 2018 Edition now from Document Center Inc.  Here is the link to the order page for ISO 19011 for your convenience.  If you have further questions, please don’t hesitate to get in touch.  You’ll find that we not only sell standards, but we help you become a more effective user of standards.  Make us your Standards Experts!

EN ISO 10993-11 2018 is here!

EN ISO 10993-11 2018 is here!  It’s the European adoption of the ISO-10993-11 issued in 2017.  The title of the standard is Biological evaluation of medical devices. Tests for systemic toxicity.  While the 2009 Edition of this standard is still part of the harmonized lists for 2007/47/EC, 90/385/EEC, and 93/42/EEC,  acceptance of this new 2018 edition is expected.

Changes in the standard reflect the changes in the ISO 10993-11 from 2017.  Here is a list of the guidance on them provided by ISO:

  • Reduction in the group size for chronic toxicity testing (see Table 1)
  • Annex F has been renamed Annex G and a new Annex F has been added
  • Annex H was also added
  • the Bibliography was updated.

Toxicity testing provides evidence that a medical device is safe to use for its intended purpose.  This standard provides you with a framework for conducting a systemic toxicity study.

For this article, I reviewed the BS EN ISO 10993-11 2018 Edition.  Although the European standard references the ZA and ZB Annexes, I don’t find them in this publication.  We may be soon seeing an update to this particular national edition, as the European Annexes provide detailed information on how the standard relates to the 3 medical device directives.

Remember, you do have choices when you purchase EN standards.  The official text is the basis for all national editions.  So you can get the copy that meets your needs the best.  If you have questions on which to purchase, just get in touch with our staff.  We can be reached by phone (650-591-7600) or email (info@document-center.com).  Make Document Center Inc. your Standards Experts!

 

ISO 10045 2nd Edition released – Alpine Skis

Are you going to the snow for the winter holidays?  Guess what!  Standards are going to be there with you if you enjoy many winter sports.  So let’s take a look today at the new 2nd Edition for ISO 10045.  It’s titled Alpine skis – Binding mounting area – Requirements for test screws.  This standard has not been revised since the release of the 1st Edition back in 1991.  It’s a technical update.

What exactly is the ISO 10045 about?  It’s a set of requirements for the use of test screws.  These screws are used for testing the binding mounting area of alpine skis.  The standard makes sure the measurement data can be uniformly compared.  It does this by specifying the dimensions, mechanical properties, and fastening characteristics of the test screws.

The 12 page standard actually has 4 pages of technical material.  These include the usual scope, referenced documents and definition sections.  Section 4 is on designation.  The various requirements, including materials, dimensions, strength,  and characteristics like mounting and fastening are covered in Section 5.   The text is supported by a figure of the test screw itself, showing dimensions, etc.

To get your copy, please head to the Document Center Inc. webstore at www.document-center.com.  We are an authorized distributor of the ISO standards and have been working with these documents since 1982.  Here is a direct link to the order page for ISO 10045 for your convenience.

Need obsolete editions?  Want more delivery options?  Have questions about how to properly use standards?  Get in touch with our staff to get the personalized attention that Document Center Inc. is known for.  You can reach us by phone (650-591-7600) and email (info@document-center.com).

Standards are an essential part of most sports equipment.  If you have any products and want to learn more about the standards that support safety and interconnectivity, let us know.  We’re your Standards Experts!

ASTM F2413 updated for Safety Toe Shoes

ASTM F2413, Standard Specification for Performance Requirements for Protective (Safety) Toe Cap Footwear, has been updated.  The new 2017 Edition replaces the previous 2011 Edition, which is now obsolete.  I reviewed the previous edition in my September 1, 2011 Post on the ASTM F2412 and ASTM F2413.  This is an extensive, technical update to this important foot-safety standard.

The ASTM F2412 and ASTM F2413 replace the ANSI Z41 that was used for over 60 years.  Together, they provide the performance criteria for protective footwear.  These standards play an important role in worker safety in many industries.

The ASTM F2413 itself is on minimum requirements for the performance of shoes that protect against a number of workplace hazards.  This is accomplished by evaluation of shoes for impact and compression resistance, particularly in the toe area, other foot protection, and protection against electrical hazards.

Once you believe that your shoe meets the ASTM requirements, you’ll take samples to an authorized testing lab for verification.  If the shoe passes the various tests, the ASTM label can be printed on your footwear.  Guidelines for the labeling and other identifications are included in the standard.

Changes are extensive and occur throughout the document.  You can find them all in the redline edition available from Document Center Inc.  We are an authorized distributor of the ASTM standards.  You can search for and order them from our webstore at www.document-center.com.  Here is a direct link to the order page for ASTM F2413 for your convenience.  Let us know if you’d like the redline edition or if you need company-wide cloud access to the standard.

We have a number of support services to help your compliance needs for documentation for your organization.  Learn more by reaching out to our staff by phone (650-591-7600) or email (info@document-center.com).  We have been selling standards since 1982.  Learn why so many folks make us their Standards Experts!

ISO 8637 Replaced by ISO 8637-1 on Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators

ISO 8637, the standard for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, has been withdrawn.  It has been replaced with the new ISO 8637-1, Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators.  This is the first of a planned 3-part series for blood purification systems.  It is a technical revision, so you will need to migrate from the old edition to the new one.

What does the ISO 8637-1 cover?  Of course it is for devices used in haemodialysis, haemodiafiltration, haemofiltration and haemoconcentration in humans.  It addresses safety issues and functionality.  Dimensions of blood and other ports are specified.   These design and dimension requirements are intended to reduce the risk of leakage of blood and the intake of air.  The standard does not include information on applicable materials for construction.   You’ll use materials that have been tested for biocompatibility, etc.  Results of this testing should be available upon request.

What are the technical changes?  The committee notes that this is a technical revision.  They also point out that the Figures 1, 2, and 3 have been revised.

What are the other planned parts for the new ISO 8637 series?

ISO 8637-2, Extracorporeal systems for blood purification — Part 2: 
Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

This part is currently at the final draft stage and should be available soon.  It will replace the existing ISO 8638 on the same subject.

ISO 8637-3, Extracorporeal systems for blood purification — Part 3: Plasmafilters

Again, this is currently a final draft, which means publication will occur soon.  This part will replace the current ISO 13960 on the same topic.

Please note:  The ISO 8637 has been adopted by the European Union as EN ISO 8637.  Expect that adoption of the replacement document will happen shortly.  Supersession information will be available as the administrative process of the EU is completed.

Now you’ll want to get your copy of the new standard.  Use Document Center Inc. for your purchase — you’ll find these publications at our webstore, www.document-center.com.  Here is a direct link to the order page for the ISO 8637-1 for your convenience.  Remember, we are an authorized distributor for ISO standards and your purchases from us are in compliance with all copyright laws.

Does your standards supplier notify you when items you’re using are replaced by other standards?  Document Center Inc. does this and more.  To learn about the support services we offer, get in touch with our staff.  You can reach us by phone (650-591-7600) and email (info@document-center.com).  We can help you manage and improve your compliance efforts, so make us your Standards Experts!

AS 9104 Withdrawn in favor of AS 9104/1, AS 9104/2 and AS 9104/3

AS 9104, the SAE Aerospace Standard on Requirements for Aerospace Quality Management System Certification/Registrations Programs, has been withdrawn.  This standard is part of the As 9100 series of Aerospace Quality Management Standards used extensively by the industry.  The replacement documents, the AS 9104/1, AS 9104/2, and AS 9104/3, divide the content of the original AS 9104 into parts.

The last edition of the AS 9104 (Revision B) was released in 2005 and reaffirmed in 2013.  Shortly after the Revision B release, the caretaker organization (the International Aerospace Quality Group – IAQG) decided it was too complex.  Work was undertaken to divide this standard on all aspects of what’s called Industry Controlled Other Party (ICOP) quality management into 3 sections.  These are the superseding parts 1, 2 and 3.

Let’s take a look at the 3 replacement parts:

AS 9104/1, Requirements for Aviation, Space, and Defense Quality Management System Certification Programs

This part was released in 2012.  It is the “keystone” document of the set.  The series is used to insure quality throughout the supply chain.  How?  By creating a methodology for testing and certifying suppliers to the industry that can be accepted internationally.  This overview document provides the general requirements for meeting this scheme.

AS 9104/2, Requirements for Oversight of Aerospace Quality Management System Registration/Certification Programs

This part was originally released in 2007 and updated with Revision A in 2014.  It provides a robust oversight process to ensure conformance to the requirements of the series.  It does so by establishing oversight committees and teams of assessors, and setting requirements for assessments and assessment tools.   Assessment reporting is also standardized here.

AS 9104/3, Requirements for Aerospace Auditor Competency and Training Courses

As this part from 2007 states, an assessment program is only as good as the assessors.  As with many quality auditing systems, need for common requirements for the assessors is a must.  This standard relies on the criteria established by the ISO 19011 section 7 as well as the ISO/IEC Guide 62.  You’ll need to have auditors who meet these specific requirements for competency and have passed the required training courses defined in this Part 3.

To get your copies of these replacement standards, head to the Document Center Inc. webstore at www.document-center.com.  We have been an authorized distributor of SAE standards since the 1980’s.  You’ll be able to purchase your copies in paper format, for pdf download, or as part of our Standards Online cloud enterprise service.  Links to each of the parts are provided in the text above.  All purchases come with our “best-in-class” notification service at no additional charge.

If you need a copy of the cancelled Revision B for the AS 9104 itself, please let us know.  It is available from Document Center Inc.  Just reach out to us by phone (650-591-7600) or email (info@document-center.com).  Find out why so many companies make us their Standards Experts!

 

ISO/IEC 12207 Updated and Renumbered as ISO/IEC/IEEE 12207

ISO/IEC 12207 has been updated.  Along with the technical updates, the document has been issued under a new publication number, ISO/IEC/IEEE 12207.  This new 1st Edition replaces the old number’s 2008 2nd Edition.  The title remains the same, Systems and software engineering – Software life cycle processes.

Confusion over the document’s number is understandable.  This is a standard that originated at IEEE when it was first released.  Over the years, it has moved to the jurisdiction of ISO/IEC’s Joint Technical Committee 1 (JTC1) in cooperation with IEEE.  So both ISO/IEC and IEEE have released this new document at the same time.  To differentiate the 2 separate editions (as well as price correctly and meet our contractual obligations to each organization), we have the item in our system multiple times.  However, each entry is a bit different.

You’ll find the international edition as ISO/IEC/IEEE 12207, in both paper format and for pdf download.  The IEEE edition is available in paper format as IEEE/ISO/IEC 12207.  It is available for pdf download as IEEE/ISO/IEC 12207-P.  The document is also available as part of our Standards Online cloud enterprise solution.  The standard is identical no matter how you get it.  However, the prices will vary.

Why a new edition for the ISO/IEC/IEEE 12207?  The document needed to be harmonized with the ISO/IEC/IEEE 15288 from 2015.  Areas that were creating difficulties were the variations in terminology and the process structure of each.  So this new edition provides a pathway towards a harmonized future, but not forgetting backward compatibility.  It is a technical update and replaces all previous editions.

How will you get your copy of this new update?  Use the Document Center Inc. webstore at www.document-center.com.  Here you can search for and order standards with confidence.  We are an authorized distributor of ISO, IEC, and IEEE publications.  You’ll note that links to the 3 different formats for the publication have already been provided above.

Why use Document Center?  In addition to copyright compliance, we offer a wide spectrum of support services for companies in all sectors.  These range from notifications to reports, from multiple purchasing options to a variety of  ways you can have your standards delivered.  We have been selling standards since 1982 and remain a staunch advocate for compliance.  To learn more, get in touch with us by phone (650-591-7600) or email (info@document-center.com)  Then make us your Standards Experts!

ISO 10006 for Quality Management of Projects Updated

ISO 10006 has just been updated.  The new 3rd Edition is dated November, 2017.  It’s titled Quality management – Guidelines for quality management in projects.  The new 2017 Edition replaces the 2nd Edition from 2003, which has been technically revised.  The ISO 10006 is a supporting standard.  It provides you with guidance and is not a management system standard.

I feel like I’ve been saying this a lot lately, but the new revision was instigated to align this standard with the 2015 Editions of ISO 9000 and ISO 9001.  FYI: the update also supports the 2012 Edition of ISO 21500, on project management.  To help you make the connections between the documents, Annex B is a matrix with the cross references between the ISO 10006, the ISO 9001 and the ISO 21500.

The 42-page ISO 10006 provides you with quality management principles and practices for projects.  You’ll use it for both goals of quality in internal project processes and the quality of the project’s resulting products and/or services.  It doesn’t matter if your organization is small or large.  You’ll just use the level of detail that matches your particular situation.

The document begins with the usual scope, referenced documents, and definition sections.  Clause 4 covers quality management systems in projects.  Next, the management responsibilities for quality are reviewed.  Clauses 6 through 8 provide you with information on other important areas.  These include resource management, product and service realization, and measurement, analysis and on-going improvement.  Annex A is an overview.  Annex B is the matrix we discussed earlier.  And the publication finishes up with a 15-item Bibliography.

To get your copy, you’ll use an authorized ISO distributor like Document Center Inc.  Search for and order the standards you need at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO 10006 for your convenience.  And the standard has been adopted by the European Union as EN ISO 10006.  Expect the EN and its national adoptions to be updated with the new information in the future.

Document Center Inc. has been selling standards since 1982.  We have an extensive collection of standards to support your compliance requirements.  And we offer a range of products and services that will improve the way you manage your documentation as well.  Discuss your needs with our staff.  You can reach us by  phone (650-591-7600) or email (info@document-center.com).  Don’t forget, we’re your Standards Experts!

 

ISO 9564-1 2017 for PIN security

ISO 9564-1 for personal PIN security has been updated.  The new 4th Edition is available from Document Center Inc. in paper format, for pdf download and as part of our enterprise cloud solution, Standards Online.  The full title of the standard is Financial services – Personal Identification Number (PIN) management and security – Part 1: Basic principles and requirements for PINs in card-based systems.  The new 40-page update replaces the previous 3rd Edition with its Amendment 1, which is now obsolete.

Of course, we are all concerned these days with having our credit and debit cards compromised.  A PIN (Personal Identification Number) system is one tool created for cardholder verification. Used correctly, it should be protected throughout the electronic funds transfer (EFT) cycle.  When we use cards that depend on PINs, we are unaware of the process that actually completes the transaction.  However, there are a number of discrete steps that all involve the use and protection of our PIN and other confidential information.

The ISO 9564-1 provides financial technology firms with the requirements for sound key management in these types of transactions.  And it also includes requirements for proper management of PIN information.  It is specifically designed for use in the retail banking industry and those institutions that partner with those banks to convey customer card information.

As to the updates in the new 4th Edition, the committee notes that the revision is a technical update.  However, further guidance is not provided.  I do want to mention that the ISO 9564-1 has been adopted by the European Union and that the 2017 Edition of EN ISO 9564-1 is now released.

Compliance with this standard will be essential for the industry.  Breaches of banking information create not only financial losses, but also the loss of consumer confidence. No institution should find itself out of compliance with the best practices that the 4th Edition of ISO 9564-1 represents.

That’s where Document Center Inc. comes in.  As an authorized distributor of the ISO standards, we can supply you with copies of the latest editions in a format that best suits your needs. And all purchases come with our “best-in-class” notification service, so you’ll always know when your standards are updated.

Use our webstore www.document-center.com to search for and order the standards you need.  Here is a direct link to the order page for ISO 9564-1 for your convenience.  We also have a number of other support services to aid your document control function.  To learn more, check in with our staff by phone (650-591-7600) or email (info@document-center.com).  Learn why so many companies make us their Standards Experts!