Some time ago, Intertek offered some webinars on the changes of the new edition of IEC 60601-1. Now they published a “white paper” resuming the subject, which can be obtained in the following link resumido sobre o assunto que pode ser baixado a seguir: IEC 60601-1: Changes from 2nd to 3rd Edition.

It´s a good start for people not aware of the changes.

The NPL (National Physical Laboratory) from England put online a guida to power measurement of medical ultrasonic equipment (based on IEC 61161) . It´s very detailed and will surely help people making these kind of measurements.

Link: http://www.npl.co.uk/server.php?show=ConWebDoc.2282

The navigation is a littleweird (each one of : Introduction | Radiation Force Balances | Measurement | Additional Information | Further Reading has various pages)

The second edition of “IEC 60601-2-31 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source” has been recently published by the IEC> The main chage was the alignment with the new editio of the new standard IEC 60601-1:2005. Some technical comments were maed during the drafting but they were postponed for a future amendment if needed.

Canada is one of the first countries to officialy establish a transition period to the third edition of IEC 60601. In truth, they have already adopted the new versions of IEC 60601-1 and IEC 60601-1-2, removing the previous editions from the Health Canada List of Recognized Standards. This meant that only the new versions could be used. But this position was reviewed due to the difficult in the implementaion of the new standard (the main problem is the requirement for a risk management process based on ISO 14971), so they reinserted the older editions in the list. This means that, until December 15, 2008, the old or the new version can be used for regulatory purposes. After that, only the new edition. It´s a short period, but will surely help manufacturers in the adaptation process.

More information on the original link: Inclusion of Second and Third Editions of IEC 60601-1 and IEC 60601-2 on TDP List of Recognized Standards

Thanks for Dmitry from the Elsmar Cove Forum for the tip.

- IEC 62366 Ed. 1.0 - Medical devices - Application of usability engineering to medical devices

This standard is the best example of the regulatory trend to require the use of usability engineering (also know as human factors engineering) to demonstrante conformance to the Essential Principles of Safety and Performance of Medical Devices (to understand what i´m saying about the regulatory trend, take a look at the FDA Human Factors Program at the CDRH website, where you can download human factors guidance documents such as Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, Write It Right: Recommendations for Developing User Instruction Manuals for Medical Devices used in Home Health Care. Also take a look at Do It By Design - An Introduction to Human Factors in Medical Devices).

Standard IEC 60601-1-6, on medical electrical equipment usability was the basis for this new standard, which expands the scope to all medical devices.

This standard specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use.

The standard is totally based on risk management and, therefore, is best used integrated in a risk management process and system based on ISO 14971.

More information on the IEC Webstore.

- IEC 60601-2-39 Ed. 2.0 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

The new version of the standard for peritoneal dialysis equipment is already aligned with the third edition of IEC 60601-1 . The technical change made was the addition of a list of essential performance requirements contained in the standard - this list will be a feature of all the new particular standards; this was added to facilitate the understanding of the concept of essential performance of medical electrical equipment.

More info on the IEC Webstore.

- IEC 60601-1-3 Ed. 2.0 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

The new version of colateral standard IEC 60601-1-3 is also aligned with the new edition of the general standard, and also has some technical modifications (which i won´t detail here because x-ray equipment are not my business….yet :-))

More info about the standard on the link da IEC Webstore.

Howdy, folks,it´s been a long time…

No updates here for some.. hum… six months? Wow, only time can tell.

Anyway, it´s been a busy end-of-one-year-beginning-of-another. I´ve been mostly warming things for my consulting practice - i´m planning to put it rock`n`rollling this year - and working on some projects, one of which is the implementation of tests based on IEC 60601-1:2005 at the Technological Research Institute in Brazil. We will be the first lab in the country to be able to execute the tests. Sweet.

But right now i´m more focused on risk management and management in general. And thanks to some discussion groups (mainly Elsmar Cove; i´ve returned, after some time, to the EBME forum, these are two that i really like) and A LOT of reading and studying, i think that now i have a deeper understanding of the ways things happen in the medical device regulatory affairs sector worldwide and the impact of risk management on all that (two must-read documents are Medical device regulations : global overview and guiding principles from the World Health Organization and Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety by G.R Higson - this last one made a high impact on my views of the medical device regulatory sector. Oh, and it can be read on Crcnetbase, but only those who subscribe.

We´ll, in the time i was away, some things happened in the medical device standards arena. A lot of things are related to the new edition of IEC 60601 and the work of TC 62 from IEC on the harmonization of all the standards in the series with the general one. The general standard itself changed a bit, with the release of another corrigendum and a soon to be released Interpretation Sheet (more info in a future post!).

Well, i´ll try to update the site regularly again, but won´t promise anything.

As always, if you have news or topics that you want to see posted on the blog, contact me using the contact form or leave a response on a post.

Oh, and happy new 2008! Better late than never…

Just to confirm the trend in guidance documents for end-users, on the same week that IEC published the guidance document for output tests and mantainance for ultrasound therapy equipment it published another document on mantainance, this time a general one.

IEC 62353 - “Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment” provides guidance to mantainance tests and tests to be made after the repairing of medical electrical equipment.

But why these tests have to be made? This is a concept that not everyone understands.

When a medical electrical equipment is designed, it usually (by means of regulatory requirements) conforms to IEC 60601 series of standards. The problem is, after the equipment is sold (meaning post-marketing) it still has to comply with the standards. For the end-user to verify this, it´s generally agreeded that some tests are necessary (and the IEC series has documentation requirements for these tests to be declared by the manufacturer).

For the general standard, these tests are usually tests regarding electrical safety (leakage current, earthing and dielectric strenght to test insulation). It can be argued that these tests do not verify 100 % conformance with the standard, an the surely don´t, but to do that would require tests of the full standard, and this would certainly destrou the equipment :-). This problem is dealt with in IEC 62353, as the standard do not asks for the destructive dielectric strenght tests, but instead asks for insulation resistance tests which is a good way, and not a destructive one, to test the insulation.

I think this document (and the US one) are real trend in the safety assurance of medical devices. No other document of this type is being drafted on the IEC but i think they´ll be required in the future, at least for the most problematic types of devices (IEC has already published some documents of this type, for example the ones related to electrosurgical units and guidance for staff on the handling of medical equipment).

The following link has a preview (you can also buy the standard there too): http://webstore.iec.ch/Webstore/webstore.nsf/0/1A42D899896A37C8C12572DD000B92CE

Ultrasound physioterapy systems have a known and stablished problem regarding ouput measurement and calibration (see for example the three consecutive projects of PTB, TNO, NPL and others on the development of standards for US therapy equipment, funded by the EC Growth program [1], [2]. [3]). It affects both manufacturers and end-users. Guidance for manufacturers are already in place in international standard bodies and regulatory schemes.

Now it´s the time for the end-users. IEC published last week IEC/TS 62462 - Ultrasonics - Output Test - Guide for the maintenance of ultrasound physiotherapy systems
. This technical specification details methos for output measurement of US therapy equipment in the end-user (for example, hospital) setting, and also has guidance on stablishing a mantainance program for such equipment. The methods described are easy-to-use (in comparison with the appopriate methos used to characterise output, which are described in IEC 61689 and are expensive difficult to perform in a hospital setting).

This is not really the first of theses documents. This IEC document is based on an australian standard (i don´t remember the reference right now) and there´s also an IPEM report the same subject [4]. But this is the first international agreeded document on the subject.

The following link has a preview (you can also buy the standard there too): http://webstore.iec.ch/Webstore/webstore.nsf/0/D53F4042496E9127C12572DD000B93C3

[1]Hekkenberg RT
Characterising ultrasonic physiotherapy systems by performance and safety now internationally agreed.
Ultrasonics 1998 Feb; 36(1-5) :713-20.

[2] Hekkenberg RT, Beissner K, Zeqiri B, et al.
Validated ultrasonic power measurements up to 20 W.
Ultrasound Med Biol 2001 Mar; 27(3) :427-38.

[3]Hekkenberg RT, Richards A, Beissner K, et al.
Transfer standard device to improve the traceable calibration of physiotherapy ultrasound machines. Ultrasound Med Biol 2006 Sep; 32(9) :1423-9.

[4]IPEM Report 84 - ‘Guidelines for the Testing and Calibration of Physiotherapy Ultrasound Machines’, Bajram Zeqiri and Steve Pye

Standard IEC 62366, “Medical Devices – Application of Usability Engineering to Medical Devices,” has a scheduled release date in october or november 2007. But the new blog , Medical Devices Today, has an inside scoop on the standard with views from FDA personal. A must read (even thought it´s no a full article): New Usability Standard Aims To Help Firms Institute Human Factors Programs

The International Organization for Standardization (ISO) published last month the new verison of the risk management standard for medical devices, ISO 14971:2007 - Medical devices - Application of risk management to medical devices. From the site:

ISO 14971:2006 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 14971:2006 are applicable to all stages of the life-cycle of a medical device.

The development of this second edition used the experience gained from the application of the previous edition. One of the main problems identified, for example, was that users of the standard failed to understando the principles of risk management applied to the safety of medical devices. This has been dealt with in an extensive annex. Another annex provide real-life examples of hazard and hazardous situations.

This standard is the most important one in the field of medical device safety, simply because the majority of the certification and conformity assessment systems in the world are based on risk management. Even safety standards (for example, the new IEC 60601-1:2005) are being developed inside a risk management framework.