Abstract
Establishes requirements and guidance. Particular attention is drawn to the need for specific testing for safety, quality and efficacy, possibly exceeding the general requirements, which may be necessary for a specific product. Attention is drawn to the existence in some countries of regulations laying down safety requirements for handling ethylene oxide and for premises in which it is used as well as of regulations laying down limits for the level of ethylene oxide residues within medical devices and products.
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Status: WithdrawnPublication date: 1994-01
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Edition: 1Number of pages: 24
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- ICS :
- 11.080.01 Sterilization and disinfection in general
Life cycle
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Now
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00
Preliminary
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10
Proposal
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20
Preparatory
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30
Committee
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40
Enquiry
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50
Approval
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60
Publication
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90
Review
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95
Withdrawal
Corrigenda / Amendments
WithdrawnISO 11135:1994/Cor 1:1994
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00
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Revised by
WithdrawnISO 11135-1:2007
WithdrawnISO/TS 11135-2:2008
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