ISO 11737:2018
ISO 11737:2018 Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products
CDN $364.00
Description
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‚Äë3, 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.
Edition
3
Published Date
2018-01-12
Status
PUBLISHED
Pages
48
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
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‚Äë3, 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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 24096:2024 Technical product documentation (TPD) – Classification of requirements – Part 2: Classification based on severity and susceptibility
CDN $251.00 Add to cart -
ISO 20560:2024 Safety information for the content of piping systems and tanks – Part 1: Piping systems
CDN $251.00 Add to cart -
ISO 16972:2020 Respiratory protective devices – Vocabulary and graphical symbols
CDN $82.00 Add to cart -
ISO 17097:2024 3-D human body scan data – Methods for the processing of human body scan data
CDN $186.00 Add to cart
