Sterilization of health care products - Microbiological methods -
Part 1: Determination of a population of microorganisms on products
1 Scope
This document 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.
This document 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.
This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 13,485 Medical devices - Quality management systems - Requirements for regulatory purposes
Note: YY/T 0287-2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
——IEC Electropedia: available at http://www.electropedia.org/;
——ISO Online browsing platform: available at http://www.iso.org/obp.
3.1
batch
defined quantity of a product intended or purported to be uniform in character and quality, which has been produced during a defined cycle of manufacture
[Source: ISO 11139: 2018, 3.21]
3.2
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[Source: ISO 11139: 2018, 3.23]
3.3
bioburden correction factor
numerical value applied to a viable count to compensate for incomplete removal of microorganisms from a product and/or failure to culture microorganisms
[Source: ISO 11139: 2018, 3.24]
3.4
bioburden estimate
value established by applying a bioburden correction factor to a bioburden count
[Source: ISO 11139: 2018, 3.25]
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Selection of products
6 Methods of determination and microbial characterization of bioburden
7 Validation of the method for determining bioburden
8 Routine determination of bioburden and interpretation of data
9 Maintenance of the method for determining bioburden
Annex A (Informative) Guidance on the determination of a population of microorganisms on products
Annex B (Informative) Guidance on methods to determine bioburden
Annex C (Informative) Validation of bioburden recovery efficiency
Annex D (Informative) Typical assignment of responsibilities
Bibliography
