ISO 14160:2011 PDF
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 sterilization process for medical devices
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 sterilization process for medical devices
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 34
- Дата публикации:
- 1 июля 2011 г.
- Издание:
- ISO IS 14160 edition 2 version 1
- ICS:
- 11.080.01
ISO 14160:2011 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. ISO 14160:2011 covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms need to be assessed. ISO 14160:2011 is not applicable to material of human origin. ISO 14160:2011 does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopath (TSE) agents. ISO 14160:2011 does not describe methods for validation of the inactivation, elimination, or elimination and inactivation of protozoa and parasites. The requirements for validation and routine control described in ISO 14160:2011 are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps. ISO 14160:2011 does not specify tests to establish the effects of any chosen sterilization method upon the fitness for use of the medical device. ISO 14160:2011 does not cover the level of residual sterilizing agent within medical devices. ISO 14160:2011 does not describe a quality management system for the control of all stages of manufacture.
Технические детали
- Технический комитет
- ISO/TC 198 - Sterilization of health care products
- SKU
- ISO 14160:2011
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