Category: Hot Docs – New Standard Releases

New Standards on Health Care Technology for Q1 of 2020

Here is a list of all the updates for standards on health care technology for the first quarter this year. Follow us for more updates!

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New Standards on Lubrication, Industrial Oils and Related Products 1st Quarter of 2020

You can grab your copies of the new standards on lubrication, industrial oils and related products from us today! Order now

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It’s Finally Here! ISO/TR 24971

The wait is finally over! ISO has finally released the long awaited companion standard for ISO 14971:2019. Get your copy of ISO/TR 24971 here.

Photo by Jan Friml from FreeImages

As per the publisher, this technical report provides guidance to help manufacturers develop, implement, and maintain the risk management process described in ISO 14971:2019. It includes medical devices such as active, non-active, implantable, non implantable, in vitro diagnostic medical devices as well as software used as medical devices. If you need a little more information about this document, please look at our previous post on the topic found here.

So What’s New?

The new edition of ISO/TR 24971 cancels and replaces the 1st Edition of the report. If you would like to remain compliant, this document will be needed. Aside from some format changes for readability, here are some of the changes of note according to the publisher:

  • Clauses and annexes have been merged, restructured, technically revised and supplemented with additional guidance
  • Some structural changes for readability
  • Addition of informative annexes for additional guidance on specific aspects of rist management

Get your copy of ISO/TR 24971:2020 this companion standard today. You can also get yourself a copy of ISO 14971 while you are there if you need one. This document is also available for our standards subscription service. Add this document to a personalized site where you and your team can access it on any device at any time. Stop being limited by a shared single copy. Stop buying multiple copies of the same document. to learn more or try a demo, click here!

If you would like to keep up to date on new releases, ask us about our notification services. Get emails about updates on all the standards you need as soon as they come out. No more guess work or having to do research. With a simple email, you never have to worry about not being ready for your next audit. Ask us today!

ISO 14971 (2019) Released

If you haven’t heard by now, you should know that ISO-14971, Medical devices — Application of risk management to medical devices, has released its 3rd edition, which you can purchase here. We also offer a redline edition of the document available here.

14971 goes over the principles and processes for risk management specifically those pertaining to medical devices and in vitro diagnostic medical devices. Specifically, this will help you identify, control, and monitor the risks and effectiveness of the controls. For more details on the subject, I would suggest checking out our previous posts on the standards easily accessible here and here.

Companion Standard

Photo by Angel Norris from FreeImages

ISO 24971 is also now available for purchase! It has been long awaited but it is finally made it out of committee review. You can grab your own copy here! Don’t for get to ask us about out subscription service.

So What’s New?

Aside from a few new terms and some format changes for accessibility, there a few fundamental changes made to the document. Some of these changes include as per the publisher:

  • a clause on normative references to respect requirements for fixed ISO/IEC directives
  • terms have been updated to match up with ISO/IEC Guide 63:2019
  • Definitions of certain terms such as benefit, state of the art have been added
  • More attention to the benefits of use of medical devices. Benefit-risk analysis has been aligned with terminology used in some regulations.
  • The process descruved can be used for managing risk
  • Requirements to disclose residual risks have been merged into one requirement
  • Results of reviews is now risk management report
  • Requirements for production and post production activities have been restructured and clarified.
  • Several annexes moved to guidance of ISO/TR 24971

If you would like a more detailed representation of the differences between editions, check out the redline edition available here. This is a great option if you want to easily see what was changed without having to spend any time comparing it with the older edition. Change are clearly marked for viability. Ordering redline editions will give you access to both marked and unmarked editions for convenience. You can find an unmarked edition here.

This document is part of our yearly subscription service, StandardsOnline. We make it easy for you and your team to access the same document without the hassle of buying multiple copies. If you would like to learn more about this service, go here.

Medical Device Regulation and a Hard Brexit

The U.K. Government released information today on Medical Device Regulation and a Hard Brexit.  Here is the link to the relevant page:  https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal.

As noted before, the U.K. and BSI in particular are trying to keep a hard Brexit from negatively impacting public health and welfare.  To this end, participation in EU standards activities and maintaining regulatory consistency short term are top priorities.  I know many of our Document Center Inc. customers and other medical device manufacturers have been concerned.  You will all appreciate this official information which provides the beginning of clarity on this worse-case scenario.

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!