AAMI 11138-5

AAM 11138-5 2006-JAN-01 Sterlzaton of health care products—Bologcal ndcators—Part 5 Bologcal ndcators for low-temperature steam and formaldehyde sterlzaton processes

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This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.

NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.

NOTE 2 Requirements for work place safety may be provided by national or regional regulations.

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