Searching for applicable Standards for a Medical Device using electronics, software

S

SteveK

#11
Re: Searching for applicable Standards for a Medical Device using electronics, softwa

Hi Sherwood,

Don't forget (if you had not found it yet/considered) the IEC/EN 60601-1 series. Also have a look at http://www.meddev.info/_documents/R2_2-4_rev5.pdf for software essentials.

You mention pneumatics - I suppose this could possibly take in electrical medical suction - EN ISO 10079-1.:2cents:

Steve
 
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#12
Re: Searching for applicable Standards for a Medical Device using electronics, softwa

Hum, can you explain how exactly you can get all this information? I´ve ried to use the nando database search sometimes but have never had useful answers, so maybe the problem is really with me.
Go to NANDO website... Choose directive link on the left. Directives will be listed, choose the related directive. A page with all the standards will be opened in most directives (now you have the most -up-to-date standard list); but you are asked to pick up a product group in some cases, then you have to pick one to go on. When you click on the standard, NB lists will be displayed. Choose an NB, and click the related directive again in the NB's scope page, there you will see the certification system for that standard.

However, before doing those above, just read,

1. Scope of the directive,
2. The certification procedure section of the directive,

to get an idea on,

1. If your product is covered or not,
2. What is the applicable certification procedure if your product is covered.

(2) Because, in some cases, your product may be object to self declaration (module A, system 4, class I non-sterile etc...).
 
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