Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
Abstract
ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.
ISO 11737-1:2006-04 (E)
Sterilization of medical devices – Microbiological methods – Part 1: Determination of a
population of microorganisms on products
Contents Page
Foreword ………………………………………………………………………………………………………………………………………iv
Introduction ……………………………………………………………………………………………………………………………………v
1 Scope ……………………………………………………………………………………………………………………………..1
2 Normative references ……………………………………………………………………………………………………..1
3 Terms and definitions ……………………………………………………………………………………………………..2
4 Quality management system elements …………………………………………………………………………….4
4.1 Documentation ……………………………………………………………………………………………………………….4
4.2 Management responsibility ……………………………………………………………………………………………..4
4.3 Product realization ………………………………………………………………………………………………………….4
4.4 Measurement, analysis and improvement — Control of nonconforming product ……………….5
5 Selection of product ………………………………………………………………………………………………………..5
5.1 General …………………………………………………………………………………………………………………………..5
5.2 Sample item portion (SIP) ……………………………………………………………………………………………….5
6 Methods of determination and microbial characterization of bioburden ……………………………6
6.1 Determination of bioburden …………………………………………………………………………………………….6
6.2 Microbial characterization of bioburden …………………………………………………………………………..7
7 Validation of method for determining bioburden ……………………………………………………………..7
8 Routine determination of bioburden and interpretation of data ………………………………………..7
9 Maintenance of the method of determination of bioburden ………………………………………………8
9.1 Changes to the product and/or manufacturing process ……………………………………………………8
9.2 Changes to the method of determination of bioburden …………………………………………………….8
9.3 Revalidation of the method of determination of bioburden ………………………………………………8
Annex A (informative) Guidance on determination of a population of microorganisms on product …..9
Annex B (informative) Guidance on methods of determination of bioburden ………………………………….22
Annex C (informative) Validation of bioburden methods ………………………………………………………………..31
Bibliography …………………………………………………………………………………………………………………………………34