Medical Device External Standards Control and Monitoring

N

NT Bregman

#1
:confused:
I recently started working at a new company and was given a job of creating a current external standards list which we will monitor for revisions.

I was given several lists of standards used by the different departments. I have the following questions:

1. Are technical reports (such as AAMI TIR 33:2005) considered a standard? What status do technical information reports have?

2. When they list something like ANSI/AAMI/ISO 11137-1:2006/(R)2010, what does the (R) stand for? Are we supposed to have a 2006 and a 2010 revision of this same document?

Thank you for your assistance.
 
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Jim Wynne

Leader
Admin
#2
Re: External Standards Control and Monitoring

I can't help with #1, but for #2, all ANSI standards are periodically reviewed with one of three results--they are revised, withdrawn, or reaffirmed. "R" designates reaffirmation--a finding that the standard is still adequate for use, and no changes are made. So for the one you cite, 2006/(R) 2010 would refer to one document.
 
M

MIREGMGR

#3
1. Are technical reports (such as AAMI TIR 33:2005) considered a standard? What status do technical information reports have?
A "technical information report" is a guidance document on how to interpret and use a standard.

For your company's purposes, guidances (TIRs, and other guidances from US FDA, EUMED, MEDDEV, others) should be managed in the same manner as standards. Your product/process developers, engineers, regulators, marketers and managers need to have accurate information on current and future versions of such documents, and the time schedules for transitions from current to future versions.
 
N

NT Bregman

#4
Thank you for your help!

I may have more questions later as I establish some ground rules for this system.:)
 
G

GPjeri

#5
I head up the standards committee at our company, so for what it's worth, here's my advice: 1) survey each functional area as to the standards they use 2) make an applicable ( to your product/company) subset list of the EU Harmonized, US FDA Concensus, and Health Canada Recognized standards. This will give you a shorter list and keep you in the good graces of any Notified Body, FDA, or HC reviewer. 3) use a service such as techstreet to take your list and send you notifications when one of the standards is revised 4) create a system to review and write up a gap analyis citing the impact to your company's products (customer/patient too of course) and follow with an implemenatation plan if any actions are required such as re-testing, if nothing's required make sure you have a good system for archiving your assessments for audit purposes 5) train your organization on standards, how to use them, when to use them, drive home the point that just saying you generally comply is not good enough, you must be able to cite which subpart you have actually tested to,etc. 6) Lastly, the people in your company are responsible for knowing and using the current rev of a standard. In an audit you'd be nicked for citing an outdated rev.
 
N

NT Bregman

#6
I have another question. We have developed and implemented a system for the monitoring and evaluation of standards.

Now we are updating our standards list but our document control reviewer needs additional clarification. Originally we were buying the EN or ISO standards. Now that we are referencing the harmonized standards list, we are trying to buy the same one referenced on the list but that is not always possible. There are so many versions out there but they have the same content. I have included two examples below:

1. The harmonized standards list includes EN 556-1:2001. If you try to purchase EN 556-1 on techstreet, you only see DIN EN 556-1 or BS EN 556-1. Which should we purchase? Are they the same as EN 556-1?

2. We are in compliance with ISO 13485:2003. Our external standards reviewer saw that there was a new standard out - BS EN ISO 13485:2012 and she purchased it so that we can review it. The result was that the 2012 version was the same as the 2003 one. Which version should we be buying and referencing in our system? We have essentially paid money for the exact same standard.

We are trying to stay in compliance but these prefixes (BS, DIN, EN, ISO) make it very confusing. Any clarification to the standards process would be much appreciated. Thank you.
 

Marcelo

Inactive Registered Visitor
#7
1. The harmonized standards list includes EN 556-1:2001. If you try to purchase EN 556-1 on techstreet, you only see DIN EN 556-1 or BS EN 556-1. Which should we purchase? Are they the same as EN 556-1?
You have to check the year/version, but yes, they will be the same. EN standards are pure European, and don't always exist in published form (they exist in a way as to be enable national versions to be published).


2. We are in compliance with ISO 13485:2003. Our external standards reviewer saw that there was a new standard out - BS EN ISO 13485:2012 and she purchased it so that we can review it. The result was that the 2012 version was the same as the 2003 one. Which version should we be buying and referencing in our system? We have essentially paid money for the exact same standard.

It depends on which standard you use and for what. If you are using 13485 to gain conformity with the directives, you cannot use the ISo one, you have to use the EN one. In this example, when EN 1385:2012 is harmonized, it will be the only standard giving presumption of conformity in this area.

You can take a llok at this thread - EN ISO 13485:2012 vs. ISO 13485:2003 - Confusion? for some extra explanations.
 

Marcelo

Inactive Registered Visitor
#8
Oh, and a great way to keep up to date on standards (and regulations) is to participate in standards development groups in ISO, IEC or regional such as CEN or CENELEC.
 

Ronen E

Problem Solver
Moderator
#9
Oh, and a great way to keep up to date on standards (and regulations) is to participate in standards development groups in ISO, IEC or regional such as CEN or CENELEC.
What is the procedure for becoming a participant in such standards development groups in ISO, IEC etc.?

:thanx:
Ronen.
 
T

Terese

#10
Hi NT Bregman,

In response to your question regarding EN standards, I manage the external standards at my organization, so I am well aware of your confusion. EN standards are European Norms (standards) created by or adopted by CEN. When they become official (published the European Journal Eurlex), member states have up to 9 months to adopt them; hence, the DIN EN, BS EN, SS EN, etc. Once the standards become official, they are no longer available for purchase as simply EN standards (and I am not certain that they are available for purchase at all until they have been adopted and published by a member state).

Regarding the differences, if the standard is a harmonized ISO standard (e.g., EN ISO 13485), the content of the adopted standard does not change (only ISO can change the primary content because ISO owns the standard), but changes can be made to the foreward and informational annexes that are added to demonstrate compliance to the Medical Device Directives (this is what 'harmonizes' standards). This is why the publication dates can be different between an ISO original standard and an adopted standard.

To ensure that we have current standards at our company, we subscribe to a standards subscription service and a standards tracking service. When populating our subscription portal, I make sure that we include the harmonized adoption of any standard that we require.

If you really want to learn more about the whole process of origination and adoption, do a Goolge search for the CENELEC Standards Primer--it's a great and informative read. It will answer most of your questions and then some.
 
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