{"id":592017,"date":"2024-11-05T21:22:50","date_gmt":"2024-11-05T21:22:50","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-141602011\/"},"modified":"2024-11-05T21:22:50","modified_gmt":"2024-11-05T21:22:50","slug":"iso-141602011","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-141602011\/","title":{"rendered":"ISO 14160:2011"},"content":{"rendered":"

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.<\/p>\n

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. <\/p>\n

ISO 14160:2011 is not applicable to material of human origin.<\/p>\n

ISO 14160:2011 does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopath (TSE) agents. <\/p>\n

ISO 14160:2011 does not describe methods for validation of the inactivation, elimination, or elimination and inactivation of protozoa and parasites.<\/p>\n

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.<\/p>\n

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.<\/p>\n

ISO 14160:2011 does not cover the level of residual sterilizing agent within medical devices.<\/p>\n

ISO 14160:2011 does not describe a quality management system for the control of all stages of manufacture.<\/p>\n","protected":false},"excerpt":{"rendered":"

Sterilization of health care products \u2014 Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives \u2014 Requirements for characterization, development, validation and routine control of a sterilization process for medical devices<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ISO<\/b><\/a><\/td>\n2011-07<\/td>\n42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":592034,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2634],"product_tag":[],"class_list":{"0":"post-592017","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","7":"product_cat-iso","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/592017","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/592034"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=592017"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=592017"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=592017"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}