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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
July 2013
Why does it take so long to get a medical device standard?
2 min reading time

As originally asked by Joerg Schulze-Clewing.

Friday I quickly needed info about susceptibility standards for pacemakers. Quickly as in “right now”. So I went to the AAMI web site, found the respective standard, whipped out my credit card but then decided to call first, just to make sure. What I heard almost let me fall off the chair: I was told that it would take 3-5 days (!) to release the PDF copy after my credit card authorization goes through. Needless to say, I was no longer interested and obtained the required information elsewhere (but legally, of course).

What’s going on there? Is there a more expedient way to obtain standards? In this example it was ANSI/AAMI/ISO 14117:2012.


John Abbott
Consultant, Medical Devices & Regulatory Affairs
Sadly, banking technology is still caught in the 20th century in some ways. It CAN sometimes take 3-5 days for the vendor to receive the money from the credit card company particularly if the card is from a small local bank or international. That said, I have NEVER encountered ANY delay in downloading any kind of electronically purchased documentation. Clearly the person you spoke to at AAMI either misunderstood your question, was trying to cover ALL possible cases (like if their library database were off-line for maintenance or other technical issue) or was just misinformed. Don’t worry about it.

Joerg Schulze-Clewing
Electronics Design Consultant
But why on earth does any vendor need a “safe window” for a PDF download? Maybe they assume that electrons are transported by horse and buggy out here 🙂

Radha Arichandran
QARA Consultant at AQARAM Limited
Even though the pdf version is available immediately after payment, they generally have a safe window period suggesting will be available within 3-5 working days.

Wilhelm Ye
CEO at Jimsar Industries Limited
Right, they provide pdf download link ater paymnet. It’s strange that you need to wait for days.

Joerg Schulze-Clewing
Electronics Design Consultant
It’s possible that they gave me wrong info, but when I couldn’t believe it and asked whether that was really true I was told “Yes”. Maybe some sort of new policy? Next time I’ll call them again, see what they say then 🙂

Joshua Patton
E-Commerce and Digital Marketing Management
That’s strange, I have never had this issue. Are you sure the person didn’t give you bad information? Their downloads have always been available right after purchase for me, I would recommend calling them back, you should be able to get it immediately. Good luck!

Joerg Schulze-Clewing
Electronics Design Consultant
That’s what I had hoped for. But when I called them they told me that even then it’ll take 3-5 days until I get permission to download.

Joshua Patton, MBA
E-Commerce and Digital Marketing Management
Once you purchase the document if you select to purchase it in PDF format it is immediately available for download.

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Posted by Joe Hage
Asked on July 18, 2013 7:19 am
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