Sterilizacija proizvoda za zaštitu zdravlja — Hemijski indikatori — Deo 1: Opšti zahtevi

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

Ovaj deo standarda utvrđuje opšte zahteve i metode ispitivanja za indikatore koji se izlažu procesima sterilizacije u smislu fizičkih i/ili hemijskih promena supstanci i koji se koriste za praćenje dostizanja jedne ili više promenljivih zahtevanih u procesu proizvodnje.

ISO 11140-1:2005 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism. The requirements and test methods of ISO 11140-1:2005 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.

SRPS EN ISO 11140-1:2015 zamenjuje SRPS EN ISO 11140-1:2011 - 22.06.2015

SRPS EN ISO 11140-1:2011 zamenjuje SRPS EN ISO 11140-1:2009 - 31.05.2011

hemijski indikatori, oprema, etilen-oksid, formaldehid, indikatori, medicinska sredstva, sterilizatori