DSF/PREN ISO 11138-1
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO/DIS 11138-1:2015)
pending
| Organization: | DS |
| Status: | pending |
| Page Count: | 50 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
1.1 General 1.1.1 This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. 1.1.2 This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies. NOTE National or regional regulations can apply.
Document History
April 4, 2017
Sterilization of health care products – Biological indicators – Part 1: General requirements (ISO 11138-1:2017)
ISO 11119-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and...
July 14, 2006
Sterilization of health care products – Biological indicators – Part 1: General requirements
1.1 General 1.1.1 This part of ISO 11138 provides general requirements for production, labeling, test methods and performance characteristics of biological indicator systems, including inoculated...
DSF/PREN ISO 11138-1
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO/DIS 11138-1:2015)
1.1 General 1.1.1 This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers...