STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2006, IDT)
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.
Published
• (none) / (none) / (none)
PDF
04/05/2020
48
NSC 18 - Medical Devices and Facilities for Healthcare
