標準號：BS EN ISO 14160-2011
中文標準名稱：醫療保健產品的無菌加工.動物組織及其衍生產品制單次使用醫療器械用液體化學消毒劑.醫療器械滅菌工藝的特性描述,開發,確認和常規控制要求
英文標準名稱：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 proc
標準類型：C10
發布日期：2011/7/31 12:00:00
實施日期：2011/7/31 12:00:00
中國標準分類號：C10
國際標準分類號：11.080.01
引用標準：ISO 10012;ISO 10993-1;ISO 10993-17;ISO 11737-1;ISO 13408;ISO 13485-2003;ISO 22442-2
適用范圍：This International Standard specifies requirements for the characterization of a liquid chemical sterilizing agentand for the development, validation, process control and monitoring of sterilization by liquid chemicalsterilizing 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 byapplication of a liquid chemical sterilization process. Risks associated with other microorganisms can beassessed using other methods (see ).This International Standard is not applicable to material of human origin.This International Standard does not describe methods for the validation of the inactivation of viruses andtransmissible spongiform encephalopathy (TSE) agents (see Note 2).This International Standard does not describe methods for validation of the inactivation or elimination ofprotozoa and parasites.The requirements for validation and routine control described in this International Standard are only applicableto 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 (see Note 4).This International Standard does not specify tests to establish the effects of any chosen sterilization processupon the fitness for use of the medical device (see Note 5).This International Standard does not cover the level of residual sterilizing agent within medical devices (seeNote 6).This International Standard does not describe a quality management system for the control of all stages ofmanufacture (see Note 7). The prior application of risk management principles to medical devices utilizing animal tissues, as described inISO 22442-1, is important.NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might notbe effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie.Satisfactory validation in accordance with this International Standard does not necessarily demonstrate inactivation ofinfective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described inISO 22442-2.NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents isdescribed in ISO 22442-3.NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure tochemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process,a medical device is exposed to a defined sterilization process.NOTE 5 Such testing is a crucial part of the design and development of a medical device.NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages ofmanufacture including the sterilization process.