New BS EN ISO 14971 Medical devices. Application of risk management to medical devices Corregendum 1 for 2009 Edition

BS EN ISO 14971:2009 has been reissued with a new Corrigendum 1 as of February 2011.  The document is titled “Medical devices. Application of risk management to medical devices.”  It’s available for purchase from Document Center Inc.

The EN Corrigenda are corrections that are interfiled directly into the standard they modify.  For example, the Corrigendum 1 for  the BS EN ISO 14971:2009 corrects the pagination of the document.  So, there is no page within the document that describes the change.  It is just included by correcting the way the pages are numbered.

The EN ISO 14971 is a major European medical devices standard.  The BS EN ISO 14971 is the official English language edition.  It continues to adopt the ISO-14971:2007 Edition.

The standard 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 14971:2007 and its various adoptions are applicable to all stages of the life-cycle of a medical device.

The EN ISO 14971 is one of the “harmonised” standards for the Medical Devices Directive (93/42/eec), which means that by meeting the requirements of the standard there is the presumption of conformity with the essential requirements of the directive.

Both ISO 14971 and BS EN ISO 14971 are available for purchase from Document Center Inc.  Check out our website at www.document-center.com or send us an email at info@document-center.com, phone us at 650-591-7600 or send a fax to 650-591-7617.  We’re happy to help you with all your Standards Requirements.

Administrative Changes to Standards — What does it all mean?

One of our customers called today just to ask us what some of those odd changes to Standards actually mean.

Since purchasing standards can be expensive, it’s best to know what you’re going to be getting before you plunge ahead.  So let’s review some kinds of changes that can happen to standards and discuss if they should signal a buying opportunity for you or not.

First up: Reapproval, Reaffirmation and Validation.  All three terms mean the same thing — the standard has been reviewed and is still wonderful just the way it was.  If the standard’s still great, why issue this notice or republication?

For the folks who oversee standards, there is a need to prove to the public that the documents are being maintained.  So good standards practice suggests reviewing every standard you’re responsible for (caretaker of) every five years.  The issuing of a notice or the republication of a standard with a reapproval or reaffirmation date is a way to permanently confirm that good practices have been met.  And this periodic review is mandatory for compliance with the rules of  adoption for American National Standards Institute (ANSI) documents.

FYI:  The validation notice states that a document is still valid for U.S. Department of Defense (DOD) procurement.  It is issued by the DOD and reminds us that the mil-spec system is basically support for military purchases.

Next on the list: Editorial Changes.  Most notably used by ASTM International (formerly the American Society for Testing and Materials), an editorial change modifies the document but doesn’t affect the technical content.  You’ll see them as part of the  revision level information in the document number, i.e., ASTM-B899-09e1.  This is the document ASTM B899, 2009 Edition with 1 editorial change.

What could be an editorial change?  Perhaps an association was mentioned in the standard and the address of the association has changed.  Perhaps a phone number was included and the phone number has changed.  Remember, the change will not affect the technical content, so its going to be a non-essential piece of information.

How about a Non-Current or Inactive notification?  Both mean the same thing — The standard is good to use for replacement purposes but is not authorized for new design.  That is, if you have an existing product to maintain, it’s OK to use the standard.  But if you’re going to design something new, use something else.  With luck, the notification will point you to a replacement.  But not always…

A Cancellation Notices is another kind of notice that you may or may not need.  It will be issued for two reasons.  It presents an authorized notification that a standard has been withdrawn and is no longer valid.  And it may provide the caretaker with a way to direct users to a replacement document or to let them know the standard has no superseding document.

All of the changes above are primarily administrative in nature.  They do not make technical changes to the document.  Are they necessary to purchase?

My answer is always, “It depends on the situation.”  For reaffirmations, reapprovals and validations — not necessary unless you have an auditor coming in.  If you use the document for compliance, you’ll want every little thing every time.  If not, then these items are not so critical.

For editorial changes, it’s very much the same situation.  The information can certainly be useful, but if money’s tight it’s not essential.

Cancellation notices are often notated in databases and catalogs.  So unless you need a paper trail (or again, you’re getting audited), it may not be necessary.  But if you have a customer who thinks you should be using an obsolete document, then a cancellation notice or cancellation revision can support your case about as strongly as you would ever want!

There’s a couple more kinds of notices that do cause confusion.  The first is the technical corrigendum.  This is just a fancy name for a change notice.  Don’t let this one go by — It’s got corrections to the document that you will want to know about.  Errata are the same, document corrections that you need to have (usually printing errors to tell you the truth).

Amendments and change notices are in the same category but usually are longer and may offer new information to add to the standard.  Again, don’t leave home without it.

Do you have any questions about the many little things that can be called out to accompany a standard that you’re using or that you need?  Check in with us at Document Center (www.document-center.com) by email at info@document-center.com or give us a call at 650-591-7600.  We’ll be happy to answer your questions and perhaps it will even be included in this posting or a new one!