Summary

This issue we are going to focus on the 60601-1 series of standards based on the 3^rd edition of 60601-1 and the MDD & AIMDD, including the Amendment 2007/47/EC for the MDD. First we are presenting an audio conference on the Marking and Labeling requirements for IEC 60601-1 which will be on November 18^th. Please come and join in the audio conference. Next we summarize the issues discussed on the CENELEC FAQ web page dealing with EN 60601-1, 3^rd edition questions that apply to the MDD and AIMDD. Then we discuss the big changes coming down the line for the draft EMC Standards IEC 60601-1-2, 4^th edition & the new IEC 6XXXX, 1^st edition. This is a must read article for any electrical medical device manufacturer. Lastly, we remind you that there are less than 5 months left til the MDD Amendment requirements come into play. One way to deal with this is to use our MDD Amendment Toolkit, which is only $249.00.

We hope you enjoy the third edition of our newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

• Summary
• $50 off IEC 60601-1 3rd Ed. Marking & Labeling Audio Conf.
• EN60601 Series in Relation to EU MDD & AIMDD
• Big Changes for EMC Standards IEC 60601-1-2, 4th Ed. & IEC 6XXXX, 1st Ed.
• Are You Prepared For The MDD Amendment Changes?

$50 off IEC 60601-1 3^rd Edition Marking & Labeling Audio Conference -- Only $199

This audio conference titled “How to Mark & Label Devices Under IEC 60601-1, 3^rd Edition” is hosted by FX Conferences and the material will be presented by Leo Eisner of Eisner Safety Consultants. The audio conference will be on Wednesday November 18, 2009 from 1 – 2PM Eastern.

To get a $50 discount for this event use the special promotion code AF2009EIS when you sign up at the FX conferences website. Continue reading more information on this audio conference.

EN 60601 Series in Relation to the EU MDD & AIMDD

Good news! A clarification FAQ page has been posted on the CENELEC website, on 9 October 2009, in regard to the EN 60601 series of standards. It helps clarify some of the questions that have been circulating on EN 60601 standards and when transition periods will occur based on your situation as a manufacturer.

Below is a summary of most of the issues discussed on the FAQ page on the CENELEC website:

  1. If the general standard applies to your product without any particular standards (e.g. EN 60601-2-XX) to your device you can use EN 60601-1:1990 (2^nd edition) + amendments + applicable collaterals (e.g. EN 60601-1-XX) up til 31 May 2012. On 1 June 2012 you must meet the requirements of EN 60601-1:2006 (3^rd edition) + corrigendums + applicable collaterals. This decision was confirmed by the CENELEC Technical Board (decision D135/C228) early October 2009. Publication in the Official Journal of the EU, necessary for this decision to enter into force, is expected later in 2009. Note that the foreword of the related standards will be amended: the date of 12 September 2009 will be deleted

2. If your product falls under one or more particular standards (part 2 standards) then you need to look to the part 2 standard(s) that apply and see what is the earliest transition date. So, if the product under question is a radiotherapy simulator EN 60601-2-29 applies and the date of cessation of presumption of conformity of the superseded standard (DOCOPOCOSS) is 1 November 2011 so this would mean to CE mark your product you will need to meet this standard prior to the transition date for EN 60601-1. Note, that if the part 2 that applies has a DOCOPOCOSS later than the EN 60601-1:2006 than you will want to use the transition date of EN 60601-1:2006 as your date you need to be in compliance with the applicable EN 60601-1:2006 standards.

3. You will need to use the collateral and particular standards that are aligned with the edition of the general standard EN 60601-1. So, if you are using the EN 60601-1:1990 + Amendments then you need to use the collateral and particular standards that are aligned with EN 60601-1:1990. Mixing and matching will not work in this case.

To access the link for the CENELEC website with the FAQ page click here.

Big Changes Coming For EMC Standards IEC 60601-1-2, Draft 4^th Edition & IEC 6XXXX, 1^st Edition

Are you aware of the proposals for drafts of IEC 60601-1-2, 4^th edition, “Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic phenomena – Requirements and tests” and IEC 6XXXX, 1^st edition “Medical electrical equipment – Electromagnetic compatibility and safety with regard to electromagnetic disturbances – requirements and tests”?

The IEC 6XXXX standard will have significant impact on many electrical medical device designs and could mean a redesign of many products. In the proposed IEC 6XXXX standard there are new or significantly increased immunity levels. Also, there are new EMC requirements and tests for Medical Electrical Equipment and Systems for performance, including performance that may not be Basic Safety or Essential Performance but that the user or purchaser can reasonably expect (i.e. the performance for which the equipment or system was purchased). One of the goals of the proposal was to address functional performance as required by ISO 16142 Essential Principle A.3, MDD Essential Requirement I.3, and other national regulatory requirements for effectiveness of medical devices. For IEC 60601-1-2, 4^thedition will only require doing the tests related to essential performance.

It is strongly recommend that you voice your opinion based on a review of these proposals. To be able to do such you need to either be a TC62A member or if not you may want to consider becoming a National TAG (Technical Advisory Group) member for your country for TC62A.

Are You Prepared For The MDD Amendment Changes?
Less Than 5 Months Left to Get Ready!

We have the solution to help you get thru the transition with our MDD Amendment Toolkit to help meet the MDD Amendment 2007/47/EC – It is only $249.00. The changes to the current EC Medical Device Directive (MDD) 93/42/EEC become mandatory on March 21, 2010. All manufacturers of CE marked medical devices must be in compliance by that date. There is no transition date for the amendment 2007/47/EC. Eisner Safety Consultants in conjunction with Roberts Consulting & Engineering is offering a package for device manufacturers to assist them in complying with the changes. Click here to order the package.

The package contains useful resources to make your job easier in meeting the new changes in a timely and efficient manner. We e-mail the package to you typically within a few hours.

This exciting new package is now available for sale on the Eisner Safety Consultants website for $249.00. You can order with a credit card or a Paypal account.