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BS EN ISO 11737-1:2018+A1:2021

BS EN ISO 11737-1:2018+A1:2021

$198.66

Sterilization of health care products. Microbiological methods – Determination of a population of microorganisms on products

Published By Publication Date Number of Pages
BSI 2021 70
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 European foreword
7 Anchor 5
Foreword to amendment A1
9 Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
11 Annex ZB (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
13 Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices [OJ L 331] aimed to be covered
16 Foreword
18 Introduction
21 1 Scope
2 Normative references
3 Terms and definitions
24 4 General
25 5 Selection of products
5.1 General
5.2 Sample item portion (SIP)
26 6 Methods of determination and microbial characterization of bioburden
6.1 Determination of bioburden
6.1.1 Selection of an appropriate method
6.1.2 Neutralization of inhibitory substances
6.1.3 Removal of microorganisms
27 6.1.4 Culturing of microorganisms
6.1.5 Enumeration of microorganisms
6.2 Microbial characterization of bioburden
7 Validation of the method for determining bioburden
7.1 General
7.2 Validation
28 8 Routine determination of bioburden and interpretation of data
8.1 General
8.2 Limits of detection and plate counting
8.3 Microbial characterization
8.4 Bioburden data for extent of treatment
8.5 Bioburden spikes
8.6 Bioburden levels
8.7 Data analysis
8.8 Statistical methods
29 9 Maintenance of the method for determining bioburden
9.1 Changes to the product and/or manufacturing process
9.2 Changes to the method for determining bioburden
9.3 Requalification of the method for determining bioburden
30 Annex A (informative) Guidance on the determination of a population of microorganisms on products
47 Annex B (informative) Guidance on methods to determine bioburden
57 Annex C (informative) Validation of bioburden recovery efficiency
65 Annex D (informative) Typical assignment of responsibilities
67 Bibliography

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BS EN ISO 11737-1:2018+A1:2021
$198.66