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This Malaysian Standard 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.
This Malaysian Standard 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 may apply.
Primary Item Type:
Malaysian Standard
Identifiers:
Standard Number MS ISO 11138-1:2010
ICS 11.080.01
ISC ISC R - Medical Devices and Facilities for Healthcare
Language:
English
Subject Keywords:
Medical device; Sterilization; Biological indicators