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What do you have to put in place for Sterile Procedure Packs? MDD Article 12
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What do you have to put in place for Sterile Procedure Packs? MDD Article 12
What do you have to put in place for Sterile Procedure Packs? MDD Article 12
What do you have to put in place for Sterile Procedure Packs? MDD Article 12
What do you have to put in place for Sterile Procedure Packs? MDD Article 12
What do you have to put in place for Sterile Procedure Packs? MDD Article 12
What do you have to put in place for Sterile Procedure Packs? MDD Article 12
What do you have to put in place for Sterile Procedure Packs? MDD Article 12
What do you have to put in place for Sterile Procedure Packs? MDD Article 12
What do you have to put in place for Sterile Procedure Packs? MDD Article 12
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  Post Number #1  
Old 24th June 2012, 09:45 AM
ISO 13485 - Medical

 
 
Total Posts: 60
Question What do you have to put in place for Sterile Procedure Packs? MDD Article 12

to meet article 12 of the MDD, what do you have to put in place for Sterile Procedure Packs??

Thanks in Advance

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  Post Number #2  
Old 25th June 2012, 03:06 AM
Ronen E

 
 
Total Posts: 3,736
Re: What do you have to put in place for Sterile Procedure Packs? MDD Article 12

Quote:
In Reply to Parent Post by ISO 13485 - Medical View Post

to meet article 12 of the MDD, what do you have to put in place for Sterile Procedure Packs??

Thanks in Advance
From MDD Article 12 (emphasis added):

Quote:
3. Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.
This is on top of any requirements applicable to procedure packs in general, as detailed in sections 2 & 4, Article 12.
Thank You to Ronen E for your informative Post and/or Attachment!
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