IS 18243 : 2023 ( ISO/TS 19930 : 2017)    

Guidance on Aspects of a Risk- Based Approach to Assuring Sterility of Terminally Sterilized, Single-Use Health Care Product that is Unable to Withstand Processing to Achieve Maximally a Sterility Assurance Level of 10-6

Technical Committee : MHD 12

Status : Active