You might think that if certain rules apply to all companies of an industry that those rules should be freely available. Like law. Law texts are freely available. That makes sense. Because everyone in a country must comply with the law. And it’s easier to comply with the law if you can read it for free.
When it comes to Medical Devices, companies are also expected to comply with the law and applicable standards. The standards, however, are not freely available. They must be purchased from weird web shops for three-digit-prices.
Why? I don’t know. The weird web shop people could probably come up with a plausible explanation like “we need that crazy cash to fund important standard committee gatherings to write down important future versions of the standard, also we need to build our death star”.
Frankly, I don’t care. If something is a rule and people in a society must follow it, then it must be freely available.
Interestingly, there isn’t even one central web shop which sells them. Among others, there’s iso.org, the IEC webstore and beuth.de which is focused on Germany. It’s amusing that they all have differing prices. It’s like their interpretation of a not-so-free-market economy: “Let’s come up with random three-digit prices! It won’t matter anyway because our customers are companies, and they’re clueless!”
And those prices are still insane. For the IEC 62304:2006 with the 2015 amendment (which you need), you’ll pay a whopping 515€ at beuth.de! When I hinted at this insanity towards an auditor, he referred to them as the “standardisation mafia”. I don’t know if I would go that far, but then again, he’s an auditor, so that means he’s always right.
Accessing ISO / IEC Standards For Less Than 30€
Luckily, there’s one no-nonsense country on this planet which seems to prioritize innovation, and better yet, it’s in favor of using new technology like the internet: Estonia.
The Estonian Centre for Standardisation also sells the same standards, for much less money. They have their
own versions of them, prefixed with EVS-EN which generally is just the English version with an Estonian
translation.
Their prices are around an order of magnitude lower, ranging from 20€ - 50€. Not quite free, but it’s a start and you’ve got to give them credit for that.
Below is a overview over prices for the most common standards at iso.org, beuth.de and evs.ee. The links lead to the relevant product page.
Very Important Note: You Shall Buy the Multi-User License
One thing which I nearly forgot: On evs.ee, you should buy the multi-user license. Because if you purchase the single-user license (which is cheaper), you need to install some shady ransomware PDF plugin on your computer which ensures that only your computer can open the PDF. Not worth it. Pay some extra money for the multi-user license (e.g. for the minimum of 2 users) and get a normal PDF file instead.
The table below lists the multi-user license price for 2 users.
| Standard | iso.org | beuth.de | evs.ee |
|---|---|---|---|
| ISO 13485:2016 | 147.23€ | 171.30€ | 34.29€ |
| ISO 14971:2019 | 147.23€ | 171.30€ | 28.74€ |
| IEC 62304:2006 | 517.16€* | 515€* | 44.67€* |
| IEC 62366-1:2015 | 260.91€ | 214.60€ | 30.49€ |
Notes
* Includes 2015 amendment. At iso.org and beuth.de, it must be purchased separately (!). At evs.ee, it’s included in the original price.
Prices from July 25th 2020. Swiss Franc prices from iso.org were converted to Euro.
Do You Have to Read Those Standards?
You might wonder: Do you have to read those standards or can you leave it up to your consultants? Read my answer to that question here.