Tag: IEC 62304

IEC 62304 and it’s new amendment

IEC 62304, “Medical device software – Software life cycle processes,” has just been amended.  This new amendment 1 can be purchased from Document Center Inc. in two ways — As part of a consolidated Edition 1.1 or as a stand-alone Amendment 1.  Let’s talk about the pros and cons of these two formats and the changes that the new amendment makes to this important medical device standard.

First, if you purchase the amendment by itself, the cost is far less ($ 285.00) than getting the consolidated edition ($728.00).  You’ll have the changes clearly identified as they will be the only content of the document.  This makes your gap analysis safer, as you can be sure that you’ve addressed all modifications that have been made to the document.  However, with the extensive changes that have been made to the standard, it will be difficult to compile the data into one usable document once your analysis is complete.

The consolidated Edition 1.1 includes those same changes, with the document divided into two parts.  The first half of the publication is a Redline Edition, with changes identified by the use of a line in the margin and red typeface for all updates.   That’s followed by a Final Edition with the new text in full.  This will be easier to use once the gap analysis is complete, that’s for sure.

Now for the significance of the revisions.  Amendment 1 for IEC 62304 was developed to  address the issue of legacy software, that is medical device software designed prior to 2006 when the Edition 1.0 was released.  Why?  Because manufacturers need help to prove compliance with various European Directives.  Wouldn’t you know it — that means clarification of requirements and updating the classification to include a risk-based approach.

It’s taken a joint working group of subcommittee IEC TC62A, IEC TC62, ISO TC210, and ISO/IEC JTC 1/SC7 to write this update.  You’ll find there are significant and extensive changes to the document.  The amendment 1 alone consists of 46 pages of corrections.  Since the consolidated final edition is a total of 82 pages, you can see what I mean.  Changes occur in almost every section of the standard.  Some are simple corrections like those to a referenced document number to reflect the correct year of the current edition.  Others are major modifications, as to the update for Clause 4.3 on software safety classification.

How much time do you have to make the transition from the Edition 1.0 to the Edition 1.1 or Edition 1.0 with the Amendment 1?  The committee states in the introductory material that you have 3 years to make the required changes to your affected products.

What does the future hold for IEC 62304?  The committee is working on an Edition 2.0 right now to further refine the document to meet the challenge of the changes in the understanding of risk-management that is affecting many European medical device standards right now.

IEC reminds you to be sure you’ve purchased your copy from an authorized dealer and Document Center Inc. is the one you’ll want to use.  We offer the IEC 62304 in both paper and pdf format, and you can get multi-user access by including it in your Standards Online subscription service as well.  Order online at our webstore, www.document-center.com.  Or go direct to the link for either the IEC 62304 order page or the IEC 62304 Amendment 1 order page.  And if you need a personal touch, contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

Why use Document Center Inc.?  We’ve been working with folks like you since 1982, have the best notification service in the business, and go out of our way to help you make the best use of your standards purchases.  We’re a woman-owned business located in Silicon Valley, here to offer you a wide range of products and services to improve the way you purchase and use standards.  Make us your Standards Experts!

IEC 62304, Medical device software – Software life cycle processes, is a critical part of many medical device technology requirements

Software is often an integral part of medical device technology. Establishing the safety and effectiveness of a medical device containing software requires knowledge of what the software is intended to do and demonstration that the use of the software fulfills those intentions without causing any unacceptable risks.

IEC 62304 provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software. The standard provides requirements for each life cycle process. Each life cycle process is further divided into a set of activities, with most activities then further divided into a set of tasks.

As a basic foundation the standard assumes that medical device software is developed and maintained within a quality management system and a risk management system. The medical device risk management system is already covered by ISO 14971.  So IEC 62304 references the ISO 14971 throughout the standard.  However, some minor additional risk management requirements are needed for software, especially in the area of identification of contributing software factors related to hazards.  These are covered by IEC 62304.

Whether software is a contributing factor to a hazard is determined as an activity of the risk management process.  Hazards that could be indirectly caused by software (for example, by providing misleading information that could cause inappropriate treatment to be administered) need to be considered. The decision to use software to control risk is made during the risk control activity.  Then the software risk management process required in this standard has to be embedded in the device according to ISO 14971.

Because many incidents in the field related to service or maintenance of medical device systems include inappropriate software updates and upgrades, the software maintenance process is considered to be as important as the software development process.  So maintenance is covered by the standard as well.

These documents, and all IEC and ISO Standards, can be purchased from Document Center Inc. at our website, www.document-center.com.  Or order by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Your questions and comments are welcome.