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Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a…
Description
Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a…1 Scope This International Standard specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single use medical devices comprising, in whole or in part, materials of animal origin. This International Standard covers the control of risks arising from contamination with bacteria and fungi by
BS EN 13267 discusses surface-active agents
cylindrical
The correlation between the measured parameters by the proposed method and a relevant product performance parameter must be established for every application
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This standard part shall be used in conjunction with EN 4710‑06 and EN 4710‑07 as described in EN 4710‑02
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ISO 15661 on determining the total chlorine content is relevant to:
It takes into account that software developers and software users are members of the same scientific-technical community and offers means and measures for a transparent and open communication between them
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