Get the New 3rd Edition of ISO 14155

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice, is now in it’s third edition. You can pick up your copy from our website in either Paper of PDF format. This standards is eligible for our Standards Online Subscription Service. Ask for your quote today.

This document is a good reference for the conduct, design, recording and reporting of clinical investigation. It can be used to asses the performance, effectiveness, or safety of medical devices. This standard addresses a few specific general requirements with the intention to:

  • protect the rights, safety, and well being of the patient
  • it ensures the scientific conduct of clinical investigation in a credible manor
  • defines the responsibilities of investigator
  • aids investigators or other regulatory authorities in the conformity assessment of medical devices
Image by Pasi Mäenpää from Pixabay

Note: Please check to see if there are other standards that apply to your the investigation, other documents might be more relevant than this one. This document does not apply to in vitro devices, unless otherwise specified. This document does not apply to in vitro devices, unless otherwise specified. This document also makes references to ISO 14971

The Changes

This document completely replaces the second edition. According to the publisher, the changes to this document include the following

  • summary section of GCP principles
  • references of registration of the clinical investigation in a publicly accessible database
  • clinical quality management
  • risk based-monitoring
  • statistical considerations
  • guidance for ethics committees
  • risk management throughout the process of a clinical investigation
  • clarification of applicability of this document
  • guidance on clinical investigations audits

You can grab your copy from our web store. We offer both printed and pdf format. This document is also available for on our Standards Online Subscription service. You can read more about our Standards Online Service on a previous post. We offer a 14 day trial so that you can determine if this service is right for you. Ask us today!

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!

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.

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.

ISO 15223-1 Medical Device Labeling Update!

For the first time since 2012, ISO 15223-1 has been updated.  The full title of this document is “Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General Requirements”.  This document will lay out for you all the requirements for a wide variety of medical device label symbols.  As I’m sure many of you current users of ISO 15223-1 already know, this standard is an important one.  If medical devices are your game, you’ll want to pick this one up ASAP.  It’s available now from Document Center as a paper copy or for PDF download.

Certain information must be conveyed when presenting a new medical device.  Much of this information is vitally important to the proper and safe use of the device.  It is also mandated by regulation in the US, EU, Canada, and many more. This can pose a problem when marketing a device that must be presented in various geographic locations and languages.  The solution to this problem?  Create a series of internationally recognized symbols, detailed within ISO 15223-1 2016 Edition.  This document was designed to take the confusion out of labeling medical devices in different languages.  In doing so, it helps to ensure the safe use of the products that it applies to.

Detailed within this text you’ll find a discussion of the scope of the document and who it applies to.  Requirements for usage of the medical device labels that are presented are covered.  Following this is an extensive “Symbols” section.  This includes a 16-page series of tables showing the symbols themselves.  It also provides their titles, descriptions, requirements, and informative notes.

The document finishes with two informative annexes.   Annex A gives practical examples of how each symbol is used to convey information.  Some examples are manufacturing location, use-by date, and batch code.  Annex B provides guidance on general prohibition and negation symbols.

Do you need a copy of ISO 15223-1 2016?  Contact us at Document Center.  Here’s a link to the order page for ISO 15223-1. If you need to provide a document for multiple users, make sure to ask about our site-wide subscriptions.  You can also visit our website (www.document-center.com) and browse our standards library.

If you have questions regarding ISO 15223-1 or other standards, just give us a call (650-591-7600) or send us an email (info@document-center.com).  We’ve been an authorized distributor of ISO standards for thirty years.  Make us your Standards Experts!

 

The ISO 10993 Series on Biological evaluation of medical devices

The ISO-10993 Series on Biological Evaluation of Medical Devices is an essential part of every Medical Device company’s standards collection.  They are among Document Center’s all-time best selling Medical Device Standards.

The ISO-10993 Parts cover a broad range of principles and tests for the biological evaluation of medical devices within a risk management process.  Medical devices are categorized by the nature and duration of the contact of the device with the body.  The series helps the user identify and evaluate existing relevant data, identify gaps using risk analysis, identify where further information is necessary, and provides guidance on needed testing.  It is a must-have series for medical device manufacturers, researchers, laboratories, and regulators.

New releases in this  series (dated in 2010) are the Corrigendum 1 (Correction Sheet) for the ISO-10993-1, the ISO-10993-10:2010, the ISO-10993-13:2010, and the ISO-10993-16:2010.

Here’s the complete list of 10993 Standards.

  • ISO 10993-1 – Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
  • ISO 10993-2 – Biological evaluation of medical devices Part 2: Animal welfare requirements
  • ISO 10993-3 – Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-4 and Amd 1 – Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
  • ISO 10993-5 – Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-6 – Biological evaluation of medical devices Part 6: Tests for local effects after implantation
  • ISO 10993-7 – Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
  • ISO 10993-8Withdrawn – Biological evaluation of medical devices Part 8: Selection and qualification of reference materials for biological tests
  • ISO 10993-9 – Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
  • ISO 10993-10 – Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
  • ISO 10993-11 – Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • ISO 10993-12 – Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
  • ISO 10993-13 – Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993-14 – Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
  • ISO 10993-15 – Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
  • ISO 10993-16 – Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
  • ISO 10993-17 – Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
  • ISO 10993-18 – Biological evaluation of medical devices Part 18: Chemical characterization of materials
  • ISO/TS 10993-19 – Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
  • ISO/TS 10993-20 – Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices

The complete set can be purchased as a package as well (ISO-10993-Package).  Contact Document Center Inc. at 650-591-7600 or on our website at www.document-center.com.