AMS2750 has Been Updated! Revision F out now!

Revision F for AMS2750: Aerospace Material Specification is out. This revision replaces the previous now obsolete revision E. This document covers the pyrometric requirements for equipment used for thermal processing of metallic materials. This specification applies to laboratory furnaces. It covers: temperature sensors, instrumentation, thermal processing equipment, correction factors, instrument offsets, system accuracy tests, and temperature uniformity surveys. This document is not applicable to heating or to intermediate thermal processing.

Steel Mill, Workers, Foundry, Metal, Molten, Hot
Picture by skeeze

What’s New?

This document is a rewrite of the previous standards. There is no tracked changes edition for this document. Technical changes have been made to resolve issues found in revision E. AMS2750 makes updates to the resolution requirements for recording instruments. There are also updates made to demonstrate that the equipment meets the accuracy tolerance when using the percentage instead of numerical tolerance. Other technical adjustments have been made for readability and to accommodate different systems of measurements.

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New Standards on Company Organization And Management In General Including Legal Aspects And Risk Management Q1 of 2020

These are all the changes for documents on Company Organization And Management In General Including Legal Aspects And Risk Management. A complete list of these standards can be found here.

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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!

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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.

IoT Standards

I’ve been attending some of SAE International’s mobility meet-ups lately.  These gatherings are focused on automated vehicles, of interest to many here in Silicon Valley.  As I meet the other attendees, I often hear questions about the state of standardization with regards to IoT, the Internet of Things.  So today I’m providing you with some information on IoT Standards.

IoT Standards actually cover a lot of ground.  These documents provide the connectivity protocols for linking things to the network.  A number of them have been in use for quite some time.  However, the proliferation of devices that gain functionality when connected puts a strain on the standards process.  In order to be universal, standards have to be developed in advance of implementation.  This is the challenge that new technologies bring to our standards processes.

Consortia have often been used to develop standards in emerging technologies.  They tend to be narrowly focused with an urgent need to reach agreement.  One such group operating in this space is the Open Connectivity Foundation (OCF).  Started as the UPnP Forum, this group has expanded it’s mission over time.  They are also of particular interest as they have taken the standards they’ve developed and sent them up into the ISO/IEC system via JTC1 (the Joint Technical Committee 1).

An example of this is the series of IoT standards known as ISO/IEC 29341-30. These documents focus in on the UPnP functionality – Universal Plug and Play.  They are used by many of you, essential for the many home networks for connectivity between devices.  The OCF developed this series first and then used the ISO/IEC adoption protocol for publicly available specifications (PAS) to transform them into international standards.

Needless to say, there are many consortia working in this space.  You’ll also find applicable standards activities happening in the traditional Internet standards spaces (IETF and WC3 for example).  And of course, our more mainstream standards bodies are also busy working on new standards in this space (ETSI, ISO/IEC JTC1, IEEE and so on).

Here is a list of IoT standards that are currently available from ISO/IEC:

  • ISO/IEC 20922:2016
    Information technology – Message Queuing Telemetry Transport (MQTT) v3.1.1
  • ISO/IEC 21823-1:2018 PRV
    Internet of Things (IoT) – Interoperability for IoT systems – Part 1: Framework
  • ISO/IEC TR 22417:2017
    Information technology – Internet of things (IoT) – IoT use cases
  • ISO/IEC 29161:2016
    Information technology – Data structure – Unique identification for the Internet of Things
  • ISO/IEC TR 29181-9:2017
    Information technology – Future Network – Problem statement and requirements – Part 9: Networking of everything
  • ISO/IEC 29341-30-1:2017
    Information technology – UPnP Device Architecture – Part 30-1: IoT management and control device control protocol – IoT management and control architecture overview
  • ISO/IEC 29341-30-2:2017
    Information technology – UPnP Device Architecture – Part 30-2: IoT management and control device control protocol – IoT management and control device
  • ISO/IEC 29341-30-10:2017
    Information technology – UPnP Device Architecture – Part 30-10: IoT management and control device control protocol – Data store service
  • ISO/IEC 29341-30-11:2017
    Information technology – UPnP Device Architecture – Part 30-11: IoT management and control device control protocol – IoT management and control data model service
  • ISO/IEC 29341-30-12:2017
    Information technology – UPnP Device Architecture – Part 30-12: IoT management and control device control protocol – IoT management and control transport generic service
  • ISO/IEC 30118-1:2018
    Information technology – Open Connectivity Foundation (OCF) Specification – Part 1: Core specification
  • ISO/IEC 30118-4:2018
    Information technology – Open Connectivity Foundation (OCF) Specification – Part 4: Resource type specification
  • ISO/IEC 30118-5:2018
    Information technology – Open Connectivity Foundation (OCF) Specification – Part 5: Smart home device specification
  • ISO/IEC 30141:2018
    Internet of Things (IoT) – Reference architecture

You can see they are a mix of IoT standards that have been pushed up, like the ISO/IEC ISO/IEC 29341-30  series, and those that have been developed at the International level itself.

However, there is definitely a need for more standardization and consensus in this space.  Since it is a hot area for product development, we can expect a mix of successful and failed standards.  But as usual, the drive for development of protocols in advance of the investment required for new product will insure that this space will be very active for some time to come.

Should you need any of the above standards, Document Center Inc. is an authorized distributor for ISO and IEC.  In addition, we can assist you with many of your standards challenges.  Our standards collection consists of over 1 million documents.  And since we have been working with standards since 1985, we have a depth of knowledge rare in this area.  Contact us by phone (650-591-7600) or by email (info@document-center.com) for assistance.  We are your Standards Experts!

BSI will remain in CEN/CENELEC after Brexit!

As you probably know, the future of the UK’s involvement in the European Standards system has been in question ever since Brexit became a reality.  So I’m happy to let you know that BSI will remain in CEN/CENELEC after Brexit.  We’ve known for some time that it would take a modification of the rules to allow for this.  On November 23, 2018, a vote was taken.  BSI will be able to remain a full member of both CEN and CENELEC, the European equivalents of ISO and IEC.

BSI had 8 areas of concern that led it to work towards a modification of the rules to allow it to stay involved in CEN/CENELEC should the U.K. withdraw from the European Community.  Here’s the list:

  1. Standards provide a passport to trade.
  2. The European standards system has simplified the market structure in
    Europe through the use of the single national standard model across
    34 countries in the region.
  3. The European standards system is neither owned by nor is it an
    agency of the European Union.
  4. The UK has significant influence in the development of European
    standards.
  5. Maintaining full UK membership of CEN and CENELEC is important
    to the success of business in Europe post-Brexit.
  6. Maintaining full CEN and CENELEC membership also brings benefits
    to consumers and other public interest groups.
  7. BSI must therefore continue as a full member of CEN and CENELEC
    post-Brexit.
  8. Standards will provide a key element underpinning future free trade
    agreements between the UK and non-EU countries.

Apparently, until now the administrative rules governing CEN and CENELEC required membership in the European Union.  This solution has needed a 100% in favor vote from the existing stakeholders.  The positive outcome for BSI represents a political success as well as a pragmatic one.

How does this affect Document Center Inc. customers and other standards users?  BS EN standards will remain valid for use when trading with the European Union.  So any collection of BS EN standards used in your company can be left in place without worry.

Additionally, I would mention that at the recent ISO General Assembly in Geneva, there was much discussion of the role of standards and standardization in continuing the trend towards global free trade in spite of current political rhetoric.  This vote within the European standards bodies reflects the desire of many in our community to foster larger global goals.  After all, some of the most fundamental reasons for standards rest securely in the domain of public safety and well-being.  This development will surely bring a sigh of relief to many.

BSI has a press release and earlier position paper you can review to learn more.  If you have further questions, please get in touch with us.  We can be reached at info@document-center.com or by phone at 650-591-7600.    Should you want to review the status of any of your EN standards, please search on our website www.document-center.com.  We track and sell over a million standards for you.  As you can see, Document Center Inc. is committed not only to providing you with standards, but also the information you need to use your standards collection with confidence.  Make us your Standards Experts!

What’s up with the new EN-IEC standards?

Lately some of the EN IEC adoptions have been renumbered as EN-IEC standards.  Our Document Center customers are asking us why this change is being made.  So when I was in Geneva Switzerland last month, this was one of the questions that I wanted answered by my European colleagues.

To my delight, Elena Santiago, the Director General of CEN and CENELEC, was a featured speaker at our IFAN (the International Federation of Standards Users) General Meeting.  I had a chance to speak with her during a break.  Of course, I had a number of questions for her, and one of them was about the new EN-IEC numbering.

Ms. Santiago explained that the new releases are the culmination of work begun a couple of years ago at the request of the CEN and CENELEC membership.  The mandate is to bring the identical EN adoptions of the IEC standards into line with the protocol for the adoptions of the ISO standards.  So the IEC adoptions are being reissued with a new number scheme that includes the IEC designation.

Why?  “For traceability,” said Ms. Santiago.  CEN and CENELEC members want the same clear acknowledgement of lineage that has always been a part of the ISO adoptions.  So now when you see the EN-IEC standard designation, you know that you are looking at an identical EN adoption of the source IEC document.

Of course, I had more questions than this!  One of them that’s getting a lot of attention from standards users in general is the issue of Brexit.  Ms. Santiago not only discussed this with me, but also touched on it during her presentation.  She is hopeful that during the CEN CENELEC meetings in November a vote can be taken to modify the membership rules of the organizations.  With this change, the U.K. can continue to participate in and use the EN standards system.

I’m sure we’ll all be waiting to see how this particular story ends!  Meantime, I’m glad to be able to shed some light on the new EN-IEC standards designation for you.

If you need to see if an EN standard you use is current and correct, please check in with our Document Center Sales Staff at info@document-center.com.  Or call us at 650-591-7600.  You can also look up any of the standards you use on our website, www.document-center.com.  Any further questions, please ask.  We’re here to help.