What’s it about:  The FDA published its draft guidance on Design Considerations for Devices Intended for Home Use in December of 2012, as part of an initiative started back in April 2010 “to support the safe use of medical devices in the home.” The guidance document is a significant step forward helping manufacturers understand the design criteria, user environments to consider, environmental considerations, and labeling issues. It also looks at other standards and FDA guidance manufacturers should consider, as well as post-market considerations, and other vital aspects of designing and developing devices that are intended to make the devices safer and easier to use.

Join us for this timely and informative audio conference presentation as our speaker takes attendees on a guided tour of the draft guidance. The presentation reviews the key points of the document as it relates to the IEC 60601-1-11 standard (Home Use Medical Electrical Equipment), human factors and usability (user environment), environmental considerations, labeling, and design controls (including risk management).

This audio conference will cover:

• Variations in the definition of home-use device under FDA and IEC 60601-1-11
• How the draft guidance relates to FDA’s Medical Device Home Use Initiative
• Environmental considerations discussed in the draft guidance
• User environments to be considered
• Key elements to keep in mind when designing home-use devices
• Labeling considerations
• Post-market considerations
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

It’s just under one week away from this big presentation.  I (Leo) have been working tirelessly to get the presentation in tip top shape and there will be lots of helpful information in the PowerPoint presentation.  So, sign-up now to take away a really useful summary document of the more important changes to IEC 60601-1 under Amendment 1 changes.

What’s it about:  Amendment 1 (A1) to IEC 60601-1, 3rd edition was published 13 July 2012 to help reduce the confusion surrounding the use of IEC 60601-1, 3rd ed.  A1 is a significant improvement to the standard and clarifies the use of new concepts in the 3rd Edition such as more detailed information on how to implement the risk management process and the process for identifying what is essential performance. It also helps resolve issues in some of the test requirements.

Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the significant A1 changes to the 3rd Edition!
This audio conference will cover:

• Changes to risk management requirements under Amendment 1
• Changes to essential performance and examples of essential performance
• Changes to test requirements
• Additional labeling issues, including changes to electronic labeling requirements
• Best documents to use to understand the differences between 60601-1, 3rd Edition and 60601-1, 3rd edition A1:2012
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users” at an FX Conferences event on May 2, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).  You don’t have to leave your office to join in on the presentation and as a special thank you for visiting us at Eisner Safety Consultants you can get a $50.00 discount.

What’s it about:  Amendment 1 (A1) to IEC 60601-1, 3rd edition was published 13 July 2012 to help reduce the confusion surrounding the use of IEC 60601-1, 3rd ed.  A1 is a significant improvement to the standard and clarifies the use of new concepts in the 3rd Edition such as more detailed information on how to implement the risk management process and the process for identifying what is essential performance. It also helps resolve issues in some of the test requirements.
Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the significant A1 changes to the 3rd Edition!
This audio conference will cover:

• Changes to risk management requirements under Amendment 1
• Changes to essential performance and examples of essential performance
• Changes to test requirements
• Additional labeling issues, including changes to electronic labeling requirements
• Best documents to use to understand the differences between 60601-1, 3rd Edition and 60601-1, 3rd edition A1:2012
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

What’s it about:  Amendment 1 (A1) to IEC 60601-1, 3rd edition was published 13 July 2012 to help reduce the confusion surrounding the use of IEC 60601-1, 3rd ed.  A1 is a significant improvement to the standard and clarifies the use of new concepts in the 3rd Edition such as more detailed information on how to implement the risk management process and the process for identifying what is essential performance. It also helps resolve issues in some of the test requirements.
Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the significant A1 changes to the 3rd Edition!
This audio conference will cover:

• Changes to risk management requirements under Amendment 1
• Changes to essential performance and examples of essential performance
• Changes to test requirements
• Additional labeling issues, including changes to electronic labeling requirements
• Best documents to use to understand the differences between 60601-1, 3rd Edition and 60601-1, 3rd edition A1:2012
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

Either way this is a great resource and is useful to get a grip on the breadth of changes made for A1 and also if you are still getting your feet wet with 3^rd ed. of IEC 60601-1 (many companies are still just starting along this process) there are still items that were in 1st ed. of IEC 62348 that are still of great resource to you.  

With the release of A1 of IEC 60601-1 on July 13, ‘12 (consolidated edition 3.1 published Aug 20, ’12) & the US National Version ANSI/AAMI ES 60601-1:2005/A1:2012 there were a significant number of changes made to the 60601-1, 3^rd edition.  There were 182 identified issues and a total of 496 discrete changes to the 3^rd ed. of 60601-1, which included some significant changes, moderate changes, and some minor typos, as well.  Each of the 496 changes that A1 made were accessed by the developers of the standard to determine the impact on the users of 60601-1.  Many of the changes are only editorial corrections or clarifications so many of the changes (413 changes) were accessed as having minimal or no impact on the application of the standard.  But there were 83 changes that were accessed as having a moderate to significant impact on the users of the standard.  So, IEC TR 62348 “Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition” (here forward will only refer to IEC version as ANSI/AAMI/IEC TIR 62348:12 is the same as no technical changes to the document, just US national version introductory page changes) was updated for the 2^nd edition to add in the Assessment of the impact of these 83 changes, as noted in the title of the standard, and still keep the comparison between 2^nd to 3^rd ed. of IEC 60601-1.  The A1 assessment portion of the Technical Report is split into 2 parts based on the Significant (Table 1) or Moderate (Table 2) Impact on the users of the standard.  This assessment is based on the likelihood that some alterations to the design documentation, testing, the product itself, or its accompanying documents will be required because of the change to a requirement in the A1.  Further within each table the impact is sliced a bit thinner by considering if the issue will Impact many users or impact only particular users like a mechanical requirement that a chunk of devices may not be impacted by.  As these assessments are subjective users of the standard (IEC 60601-1:05 + A1:12) are highly encouraged to review the contents of the A1 and determine its impact on the sections that are relevant to their products.   The easiest way to read the A1 document is the consolidated A1 by IEC as the changes that can be shown are identified in a different color.  The IEC version of the consolidated version (edition 3.1) of IEC 60601-1:2005 + A1:2012 standard can be obtained thru TechStreet.  For the AAMI pdf go to the AAMI standards store and for the print version click here.

The first edition of IEC TR 62348 was originally set up to compare 2^nd to 3^rd ed. of IEC 60601-1 so for those going from 2^nd to 3^rd ed. the document was accessible to any that wanted to learn what type of changes were made and what clauses changed, stayed the same or similar, were new or disappeared.  Also, this document used to be free on the IEC website.  As of the 2^nd edition publication the document isn’t free anymore.  You can purchase the 2^nd ed. of IEC TR 62348:212 or AAMI/IEC TIR 62348:12 from various sources such as TechStreet or AAMI.