Iso 11139 Pdf
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This standard contributes to the following Sustainable Development Goal: 3 Good Health and Well-being Buy this standard en Format Language std 1 40 PDF + ePub English French std 2 40 Paper English French CHF40 Buy Buy this standard Life cycle Previously Withdrawn ISO/TS 11139:2006 Now Published ISO 11139:2018 Stage: 60.60 00 Preliminary 10 Proposal 10.99 2014-03-07 New project approved 20 Preparatory 30 Committee 30.00 2016-02-10 Committee draft (CD) registered 30.20 2016-07-13 CD study initiated 30.60 2016-09-09 Close of comment period 30.92 2017-02-13 CD referred back to Working Group 30.20 2017-02-14 CD study initiated 30.60 2017-04-13 Close of comment period 30.99 2017-05-10 CD approved for registration as DIS 40 Enquiry 40.00 2017-06-15 DIS registered 40.20 2017-08-17 DIS ballot initiated: 12 weeks 40.60 2017-11-10 Close of voting 40.99 2018-03-01 Full report circulated: DIS approved for registration as FDIS 50 Approval 50.00 2018-03-02 Final text received or FDIS registered for formal approval 50.20 2018-04-19 Proof sent to secretariat or FDIS ballot initiated: 8 weeks 50.60 2018-05-18 Close of voting. Proof returned by secretariat 60 Publication 60.00 2018-05-18 International Standard under publication 60.60 2018-08-03 International Standard published 90 Review 90.20 International Standard under systematic review 90.60 Close of review 95 Withdrawal Corrigenda / Amendments Under development ISO 11139:2018/DAmd 1 Got a question?Check out our FAQs
The aseptic processing sector of the healthcare industry sterilizes many components feeding into aseptic processes. The term SAL is appropriately applied to these components. In addition, the aseptic processing sector has used the more intuitive term probability of a non-sterile unit, PNSU, synonymously with SAL. Interestingly, the term PNSU is not in the ISO 11139 vocabulary document. The Parenteral Drug Association, PDA,12 defined PNSU in a way that also only applies after a sterilization process, 2b1af7f3a8