An Amendment for IEC 62366-1 has Been Released. Get Yours today!

An amendment for IEC 62366-1, Medical devices – Part 1: Application of usability engineering to medical devices, has been released. Get your copy today! We offer this amendment in both paper and pdf format. You can also add this document to your standards online subscription. If you need the complete document, you can find it with the amendment interfiled inour shop in both formats.

Image by Thomas Breher from Pixabay

What’s New in this Amendment?

According to the publisher, this amendment was released to correct inaccuracies found in the 2015 release. Since then, a total of 22 inacuracies have been identified. You will need this amendment in order to remain complaint with projects that require use of IEC 62366-1.

The amendment not only covers safety-related aspects of user interfaces, but also offers more detailed descriptions of usability engineering methods. A technical tutorial has been added from IEC 62366-2 to assist manufacturers. Both documents can be purchased as a bundle. Get your copy of the amendment today!

Standards Online Service Available!

The amendment and its source document are available for our standards online service. All IEC documents are available for this service.

Our Standards Online service is a yearly subscription plan that we offer at Document Center inc. You choose the standards you want and the number of sites you need them for. We upload these standards to your site and you and your team can access them anytime from any computer. There is no limit to the amount of users. You can print these documents, save them on your personal device, and even upload them to a shared server. It doesn’t get any easier. We will also make sure that your document stays current at no extra cost to you. Updated documents will be uploaded to your site the day they come out so you don’t have to worry about your next audit.

Check out other services that we offer to help you stay on top of your standards. Let us worry about your standards so you can focus on the next big innovation!

The New IEC 61000-4-11 is out now!

The new IEC 61000-4-11: Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement techniques – Voltage dips, short interruptions and voltage variations immunity tests for equipment with input current up to 16 A per phase, is now in edition 3.0 and replaces the previous 2.1 edition. This section of IEC 61000 defines the immunity test method and range of preferred test levels for electrical and electronic equipment connected to low-voltage power supply networks for voltage dips, short interruptions, and voltage variations.

This applies to electrical/electronic equipment with a rated input current not exceeding 16A/phase, for 50 Hz or 60Hz networks. This document aims to establish a common reference for evaluating the immunity of electrical and electronic equipment when subjected to voltage dips. This document makes references to IEC 61000-2-8.

So What Changed?

Aside from some formatting changes, there are a few technical changes that have been made. Some sections that were optional in the previous editions are now required. Some sections were also taken out of this edition entirely. The biggest change is the addition of Appendix D which talks about the generator specification requirements for voltage, rise and fall time, and inrush current capability. to easily see the changes between editions make sure you grab the red-line edition here. Redline editions come pre-marked from the publisher and clearly show the changes that were made this time around.

To purchase the regular unmarked version, you can get your copy here. This copy is available for our standards online subscription service. For a yearly fee, we will add this and any other standard you need to a personalized website that you and your team will have access to anywhere at anytime Stop buying multiple copies or sharing the one copy. Have everything readily and easily accessible on one website when you need it. Standards purchased in this way will be automatically updated at no extra cost as long as your subscription is active. For more information on this service, read about it here or ask us today!

Make sure you follow us for more news on all things standards.

New Standards on Properties Of Surfaces for Q1 of 2020

This is a list of standards on properties of surfaces that were updated in the first quarter of 2020. If you would like to view a complete list on the subject, check it out here. To search other standards by ICS or subject, check out our complete list here. Please note that links for standards that have been replaced or renumbered will take you directly to the most recent replacement.

Most of these standards will be available for purchase through our standards online service. This service is especially great if you have a big team that needs to share a standard. Instead of buying multiple copies for a team, you will only need to pay for one site. Add as many people as you like and they can access it anywhere anytime. For more on this service, check out a complete description here or ask us today!

Don’t forget to follow us for regular updates on everything standards!

New Standards on Environmental Economics Including Sustainable Development for Q1 of 2020

Here is list of standards on Environmental Economics Including Sustainable Development that were updated in the first quarter of 2020. For a complete list of standards got here.

You can search other standards by subject and ics code here. Don’t forget to follow us for updates on all things quality standards.

Ask about our Other services

We offer multiple services to make it easy for you to stay current so that you can focus on your projects. We will check your library and help you update the standards you use every day and even send you real time updates when they are released. For a complete list of what we have to offer, check us out here.

Don’t forget to ask us about our subscription service. With out subscription service, you don’t have to worry about:

  • knowing when to update the standard, we will do it for you
  • losing your copy, you can access it anytime any where on a personalized site we provide for you
  • buying multiple copies for your time, we will give your whole team access to this site

We are able to offer most standards through this service. Our subscription service truly is the best and easiest way to build a standards library. To learn more and try it out, please visit our site.

New Standards on Anaesthetic, Respiratory And Reanimation Equipment Including Medical Gas Installations Q1 of 2020

This is a list of all the standards that were updated in the first quarter of 2020. The list is alphabetical. Documents that have been replaced will link to its replacement. A complete list on the subject can be found here.

Some of these standards are available for our subscription service. Documents purchased this way are uploaded to a personalized website so you and your team can access the standards you need anywhere. For more information, read here. For all our other services to help you keep compliant, check out a full list here.

To search up other standards by ICS subject check here.

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.

Get your copy today!

You can get the latest edition of this document here. This document is also available for our subscription service. Instead of buying multiple copies of this document, it is uploaded to a personalized site where you and your team will have accessible anywhere from any computer. For more information on this service, go here. We offer various other service to make it easy for you to stay complaint with all of your future projects, a list of which can be found here.

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.

If you would like to search other standards by subject, go here

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!

To search other standards by subject, go here!

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

To Search other standards by subject, go here

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!