Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - AMENDMENT 1

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
ISO 11737-1/AMD 1
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Amendment Revision
ICS code(s):
11.080.01
07.100.10
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

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.  

This is the first amendment for the third edition of ISO 11737-1:2018 and it covers amendments to clauses: 4.1, 4.2, B.3.3.4 and Bibliography.

Project need:

To maintain alignment with international requirements on sterilization of health care products and microbiological methods.

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