ISO-11737-1 › Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
The following bibliographic material is provided to assist you with your purchasing decision:
Included in this current edition are the following subparts:
FOR 3RD EDITION AMENDMENT 1 SEE - May 1, 2021
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.
To find similar documents by classification:
07.100.10 (Medical microbiology Laboratory medicine, see 11.100)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-D4169Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM-F88
Standard Test Method for Seal Strength of Flexible Barrier Materials
ISO-10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Document Number
ISO 11737-1:2018
Revision Level
3RD EDITION
Status
Current
Publication Date
Jan. 1, 2018
Committee Number
ISO/TC 198