ISO 11737-1:2018
2018-01
Abstract
ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.
ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
General information
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Status: PublishedPublication date: 2018-01Stage: International Standard to be revised [90.92]
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Edition: 3Number of pages: 48
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Technical Committee :ISO/TC 198
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Amendments
Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.
Amendment 1
Edition 2021
Life cycle
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Previously
WithdrawnISO 11737-1:2006
WithdrawnISO 11737-1:2006/Cor 1:2007
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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
Amendments
Provide additional content; Available for purchase; Not included in the text of the existing standard.PublishedISO 11737-1:2018/Amd 1:2021
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00
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Will be replaced by
Under developmentISO/CD 11737-1
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