ISO 13485 ISO 13488 vs. EN 4600 EN 4601 Series

[Roger Eastin]

Where can I get copies of EN46001 & ISO13485?

Global Engineering Documents, they have an easy to navigate website, and they have everything you can imagine. I'm not sure what the exact address is but plug it in to webcrawler or another search engine and I'm sure you will find it.

[Marc]

I'm not sure how big their library is, but another possible source is:

<a href="http://www.doccenter.com" target=blank> Document Center </a>

The SAE also has tons of specs:

<a href="http://www.sae.org/" target=blank> Society of Automotive Engineers </a> (Go to the Bookstore)

Global (Christian's post) has long been a 'standard'. I've used them in the past - expensive, but fast.

[This message has been edited by Marc Smith.]

[Marc]

Subject: Re: EN46000 /Andrews/Meron/Moore
Date: Tue, 23 Nov 1999 16:09:43 -0600
From: ISO Standards Discussion <jennejohnn@UWSTOUT.EDU>

From: JackTQM@aol.com

To All,

Just for your early information...

At the 1999 Global Harmonization Task Force Meeting in Bethesda, Maryland the European attendees indicated that the EN46000 sereies of standards are in discussion to be "phased out" in favor of the "almost the same standard series" ISO13485/ISO13488.

In addition, the current ISO13485/ISO13488 are also not stand alone standards (just like EN 46001/EN 46002) and they are structured with heavy references to ISO 9001 and ISO 9002.

With the current changes afoot with ISO 9000:2000, including Customer Satisfaction and Continuous Improvement there are concerns from the government regulators regarding future references to ISO 9000:2000 in conjunction with Medical Device Quality Systems Standards (ISO13485/88 and EN46001/2). The government regulators indicated that they are not responsible nor do they want to be responsible for auditing compliance to customer satisfaction and continuous improvement standards requirements.

(IMHO) The bottom line is that we will see a "Stand Alone" Medical Device Quality System Standard in the near future without references to ISO 9000:2000 (how near is uncertain).

Jack Moore

[Aaron Lupo]

Does anyone know the status of ISO13485, I know it is currently under review, but I was wondering if it is in th DIS, FDIS stage? If anyone knows could you please let me know.

Thanks
ISO GUY

[Marc]

What's the title of it?

[Aaron Lupo]

The title is medical devices- Particular requirements for the application of ISO 9001.

[Marc]

Also see:

http://elsmar.com/Forums/showthread.php?t=6513