Reference number
ISO 11137:1995
ISO 11137:1995
© ISO 2024
ISO 11137:1995
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
Edition 1
1995-03
1995-03
Withdrawn
Abstract
Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator. Does not cover facility design, licensing, operator training, factors related to radiation safety, the assessment of the suitability of the product for its intended use.
General information
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Status: WithdrawnPublication date: 1995-03Stage: Withdrawal of International Standard [95.99]
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Edition: 1Number of pages: 61
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Technical Committee :ISO/TC 198ICS :11.080.01
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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
Correct the current edition; free; not included in the text of the existing standard.WithdrawnISO 11137:1995/Cor 1:1997
Amendments
Provide additional content; available for purchase; not included in the text of the existing standard.WithdrawnISO 11137:1995/Amd 1:2001
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00
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Revised by