ISO-14971 Archives - Document Center's Standards Forum

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

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!

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.

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

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.

New ISO/TR 24971 provides guidance for ISO 14971

The new ISO/TR 24971, “Medical devices – Guidance on the application of ISO 14971,” has been released. The ISO/TR 24971 was written to address the difficulties that some folks have in implementing particular clauses of the ISO 14971. It supplements the guidance already found in the ISO 14971, so if you’re using that ISO standard you may want to get a copy of this new Technical Report.

Guidance on the following particular areas are addressed in the new Technical Report:

The role of international product safety and process standards in risk management,
Policy development for risk acceptability criteria,
Integrating production and post-production feedback loops into risk management,
How to differentiate information for safety as a risk control measure vs. the disclosure of residual risk, and
Evaluation of overall residual risk.

ISO/TR 24971 also suggests some alternative approaches for implementing and maintaining a risk management system for ISO 14971.

All this stems from the fact that the use of ISO 14971 sets a acceptable risk threshold for hazards and hazardous situations unless there is objective evidence to the contrary. This means a medical device company has to document how they identified those hazards/hazardous situations and also monitor potential “evidence to the contrary.”

ISO/TR 24971 provides the user with 12 pages of detailed questions to review, decision flow charts, and discussions of the factors listed above. It will surely assist medical device manufacturers meet the issues recently identified in the informational annexes of the European adoptions of ISO 14971.

Document Center Inc. has been providing customers with copies of the ISO standards under license agreement since the 1980’s. You can purchase your copies at our web store, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Some territorial restrictions may apply.

You’ll also be happy to know that each purchase comes with our free regular notification service. Your list of standards is reviewed against our database every two to three weeks and if there are changes, you’re automatically notified by email. We even have premium services that check on a nightly basis.

If you’re in the Medical Device business, you need to know about the changes to the standards you use. But you also need to know about new releases like the ISO/TR 24971. That’s why you should be using Document Center — We’re Your Standards Experts!

New ISO/TR 15499 standard available on Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process

ISO/TR 15499:2012, “Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process,” has just been released and is now available from Document Center Inc. The new Technical Report provides guidance on conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1.

This document can be used to better understand the requirements of ISO 10993-1 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 10993-1. Biological evaluation is a design verification activity which is set in the context of broader risk management processes. This means ISO/TR 15499 includes guidance on the application of ISO 10993-1 in the context of risk management processes conducted according to the requirements of ISO 14971.

Guidance contained in this Technical Report can also be useful as background information for those representing risk management process assessors, conformity assessment bodies and regulatory enforcement bodies.

ISO standards are sold by Document Center Inc. under license agreement at our webstore, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We can assist you with the standards questions and requirements that affect your business.

ISO 15223 Series on Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

ISO 15223 has been around since 1998, but in 2007 it was split into 2 parts covering two distinct topics. We often sell this set here at Document Center Inc. so I thought you might appreciate a brief synopsis of the two documents.

ISO 15223-1:2007 is titled “Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.” Note the English spelling for labeling. All ISO standards are published using the English spelling, not the American. The standard is not complete without Amendment 1, ISO 15223-1:2007/Amd 1:2008. So be sure to order both items when you purchase the standard.

ISO 15223-1:2007 identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices. It also lists symbols that satisfy it’s requirements.

ISO 15223-1:2007 is limited to symbols applicable to a broad spectrum of devices that may be marketed globally. These symbols may be used on the device itself or its package or in the associated documentation.

ISO 15223-2:2010, titled “Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation,” specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.

The purpose of ISO 15223-2 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

These standards, and all ISO and IEC documents, are available from Document Center Inc. at our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re happy to answer any questions you may have about these publications.

There’s a new standard EP23 available for Laboratory Quality Control Based on Risk Management

CLSI has released a new standard, EP23, titled “Laboratory Quality Control Based on Risk Management; Approved Guideline.” The document, available through Document Center Inc., provides guidance based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.

CLSI, formerly known as NCCLS, is a global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the health care community.

The new guideline EP23 compliments the ISO 14971, “Medical devices — Application of risk management to medical devices,” ISO 10993-1, “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process,” and ISO 20993, “Biological evaluation of medical devices — Guidance on a risk-management process.” It shows the increasing emphasis on risk management as a component of quality control in the health care industry.

All standards mentioned can be purchased from Document Center Inc. through our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We can assist you in the challenge of compiling and maintaining your standards documentation.

Human Factors for Medical Devices – IEC 62366 and ANSI/AAMI HE75

Do you need help in finding the best practices guidance in medical device human factors engineering? With the focus of good design being expanded to the entire product life cycle, the issue of insuring adequate medical device usability has taken on new importance. Here at Document Center Inc. our customers have been relying on two standards for this – ANSI/AAMI 75 and IEC 62366.

Human Factors Engineering (HFE) is a new and separate discipline within the medical device industry. It has evolved due to the high concentration of medical device incident reports and recalls involving use error. HFE includes all aspects of a device that users interact with when operating the product. It considers the interaction with the device by operators, maintainers, cleaners, caregivers, and patients. By providing adequate labeling, instruction, and ease of use, manufacturers can reduce use-associated risk.

IEC 62366 Edition 1.0 from 2007, “Medical devices – Application of usability engineering to medical devices,” focuses on the process of analysis, evaluation, and testing methods for developing safe and usable medical devices. It aims to improve usability by reducing design-induced error. Simply stated, IEC 62366 covers human factors design process — what needs to be done and when.

One important aspect in using the standard is the presumption of reduction of risk as defined in ISO 14971. If the usability engineering process detailed in the standard and the acceptance criteria documented in the usability validation plan have both been met, then the residual risks associated with usability of a medical device are considered to be acceptable, unless there is objective evidence to the contrary.

It is my understanding that if you already meet the IEC 60601-1-6, you have most of the requirements of the IEC 62366 already achieved. The document has been adopted for use in Europe as EN 62366: 2008.

ANSI/AAMI HE75-2009, “Human Factors Engineering—Design of Medical Devices,” covers the principles of HFE. The standard provides detailed human factors engineering design guidance, examples, checklists, and case studies. With 445 pages, and extensive illustrations, it is considered an encyclopedia of HFE for specific situations. It covers all aspect of design, from basic human skills and abilities to post-market issues. The standard is a powerful tool in all stages of the design life cycle.

These standards can all be purchased from Document Center Inc. at our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). As always, questions and comments are welcome.

New BS EN ISO 14971 Medical devices. Application of risk management to medical devices Corregendum 1 for 2009 Edition

BS EN ISO 14971:2009 has been reissued with a new Corrigendum 1 as of February 2011. The document is titled “Medical devices. Application of risk management to medical devices.” It’s available for purchase from Document Center Inc.

The EN Corrigenda are corrections that are interfiled directly into the standard they modify. For example, the Corrigendum 1 for the BS EN ISO 14971:2009 corrects the pagination of the document. So, there is no page within the document that describes the change. It is just included by correcting the way the pages are numbered.

The EN ISO 14971 is a major European medical devices standard. The BS EN ISO 14971 is the official English language edition. It continues to adopt the ISO-14971:2007 Edition.

The standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 and its various adoptions are applicable to all stages of the life-cycle of a medical device.

The EN ISO 14971 is one of the “harmonised” standards for the Medical Devices Directive (93/42/eec), which means that by meeting the requirements of the standard there is the presumption of conformity with the essential requirements of the directive.

Both ISO 14971 and BS EN ISO 14971 are available for purchase from Document Center Inc. Check out our website at www.document-center.com or send us an email at info@document-center.com, phone us at 650-591-7600 or send a fax to 650-591-7617. We’re happy to help you with all your Standards Requirements.

Advice from the Pros regarding the use of ISO and EN-ISO standards for certification

I recently sent emails to a number of quality professionals asking the question: Is the use of the equivalent ISO document acceptable in the place of the EN-ISO adoption of the same standard?

I got back a wide variety of responses and am culling the best suggestions here for you!

As one consultant put it, “The bottom line [is that it] will ultimately be a decision made by the registrar.” Or, as another expert wrote, “The only issue would be if the Notified Body is BSI… they may ‘prefer’ the client using the BS[-EN version].”

However, there was a response from a Regulatory Compliance Specialist who works for a major international medical devices company that did provide a rationale for the use of the EN documentation, and a suggestion on how to keep from having to purchase multiple copies of the same material.

He notes that auditors will require the use of the EN editions because they are specifically called out in the supporting harmonised lists for specific directives. However, he has found that the original source documents can be substituted if the organization being registered will take the time to do the following steps:

1. Provide a reason for choosing a different document than the EN Edition.

2. Provide written justification that the ISO documents are identical to the EN adoptions. (Document Center Inc. can provide you with documentation that this is so.)

3. For those EN adoptions that have a conflicting date due to the addition of the annexes, provide documentation that shows that the differences do not affect your product. (Again, Document Center Inc. can help you with this.)

I also asked if there were other jurisdictions that presented similar documentation issues. Here’s some of the feedback:

1. Canada – Note that CSA has lists of recognized standards, similar to the lists issued by the EU. However, they not only list the CSA National publications but also the source ISO documents when applicable — they are more flexible in their published approach.

2. There are countries like Japan and China that will not recognize certain ISO standards.

3. Certification in the U.S. is more flexible than EU certification, with more acceptance of the various national adoptions.

And in a phone conversion, it was pointed out that an EN standard with the same number as an ISO document, but without the ISO as part of the number, is not an equivalent standard. So the above suggestions for gaining acceptance of the ISO original for EN certification will only apply to EN documents that are identical.

All comments will be appreciated. And if you’d like to get in touch directly, contact us at info@document-center.com, to my attention, Claudia Bach.