BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007

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arios

Your Mexican Amigo
#2
Re: BS EN ISO 14971:2009 What new!

Wow!, it is then time now to buy the new std.

On BSI website I found this detail:

"BS EN ISO 14971 Medical devices. Application of risk management to medical devices has been revised and now contains three additional informative annexes, to ensure conformity with a means of conforming to the Essential Requirements of the EU Directives 93/42/EEC (medical devices), 90/385/EEC (active implantable medical devices) and 98/79/EC (in vitro diagnostic devices)."

and

"BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007, which has been withdrawn"

Thanks for sharing!
Alberto
 
D

DRDDO

#3
Re: BS EN ISO 14971:2009 What new!

Wow!, it is then time now to buy the new std.

On BSI website I found this detail:

"BS EN ISO 14971 Medical devices. Application of risk management to medical devices has been revised and now contains three additional informative annexes, to ensure conformity with a means of conforming to the Essential Requirements of the EU Directives 93/42/EEC (medical devices), 90/385/EEC (active implantable medical devices) and 98/79/EC (in vitro diagnostic devices)."

and

"BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007, which has been withdrawn"


Thanks for sharing!
Alberto

Thanks Alberto
I agree with you it's time to pay the money
DRDDO
 

SteveK

Trusted Information Resource
#4
Re: BS EN ISO 14971:2009 What new!

I've not done a total word for word check, but in the main text all the clauses appear to be identical between 2007 and 2009 versions.

There is some text changes in Annex ZA - relationship between the standard and medical device directives - but not anything significant. There is an addition of Annex ZB - links to 90/385/EEC (Active Implantable Medical Devices) and Annex ZC with links to 98/79/EC (IVD devices). The text of each annex is essentially the same - just referrencing the specific directives. The Annex ZA now just covers 93/42/EEC i.e. 3 seperate pages when 1 was OK before!:2cents:
 

liuyy

Involved In Discussions
#5
Re: BS EN ISO 14971:2009 What new!

Wow!, it is then time now to buy the new std.

On BSI website I found this detail:

"BS EN ISO 14971 Medical devices. Application of risk management to medical devices has been revised and now contains three additional informative annexes, to ensure conformity with a means of conforming to the Essential Requirements of the EU Directives 93/42/EEC (medical devices), 90/385/EEC (active implantable medical devices) and 98/79/EC (in vitro diagnostic devices)."

and

"BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007, which has been withdrawn"

Thanks for sharing!
Alberto
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices
Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical DevicesAnnex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on In Vitro Diagnostic Devices
 

SteveK

Trusted Information Resource
#6
Re: BS EN ISO 14971:2009 What new!

Additional

Bottom of page 3 of new standard.

Endorsement notice

The text of ISO 14971:2007, Corrected version 2007-10-01 has been approved by CEN as EN ISO 14971:2009 without any modification.

Money for old rope!
 
D

DRDDO

#7
Re: BS EN ISO 14971:2009 What new!

Additional

Bottom of page 3 of new standard.

Endorsement notice

The text of ISO 14971:2007, Corrected version 2007-10-01 has been approved by CEN as EN ISO 14971:2009 without any modification.

Money for old rope!
Thanks all,
No money for old rope!
:agree1:
DRDDR
 
D

DRDDO

#9
this standard was not harmonized yet -

http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html

Date of cessation of presumption of conformity of superseded ISO 14971:2000 is March 31, 2010
frankly, You will agree with me ISO 14971:2007 is good Standard but not easy to implement,
after I read it, I make decision that ISO 14971:2007 is product Risk management, nothing about manufacturing Risk management nor Non-manufacturing risk management.
so when I heard BS EN ISO 13485:2009, I imagin with hope it will be more clearly or more details or more example.
But It disappointed me.
If you or anyone have good sample of Risk management, please present!
Not only me is waiting,
:whip:
DRDDO
 

bio_subbu

Super Moderator
#10
Last edited:
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