Norm

NEN-EN-ISO 11140-1:2014 en

Sterilisatie van producten voor de gezondheidszorg - Chemische indicatoren - Deel 1: Algemene eisen

124,99

Over deze norm

Status Definitief
Aantal pagina's 31
Gepubliceerd op 01-11-2014
Taal Engels
NEN-EN-ISO 11140-1 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 process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism. NOTE 1 Biological test systems are regarded as those test systems which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138- series for biological indicators (BIs). The requirements and test methods of this part of ISO 11140 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. Relevant test equipment is described in ISO 18472.

Details

ICS-code 11.080.01
Nederlandse titel Sterilisatie van producten voor de gezondheidszorg - Chemische indicatoren - Deel 1: Algemene eisen
Engelse titel Sterilization of health care products - Chemical indicators - Part 1: General requirements
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

Winkelwagen

Subtotaal:

Ga naar winkelwagen