BS EN ISO 18472:2006 - Sterilization of health care products. Biological and chemical indicators. Test equipment and methods – BSI British Standards

BS EN ISO 18472:2006

Sterilization of health care products. Biological and chemical indicators. Test equipment and methods

Status : Superseded, Withdrawn   Published : June 2006 Replaced By : BS EN ISO 18472:2018

WITHDRAWN TITLE
*To ask about withdrawn titles contact the
Customer Relations
cservices@bsigroup.com, +44 345 086 9001


To test the performance of chemical and biological indicators, specific test equipment is required. BS EN ISO 18472 specifies the performance requirements for the test equipment to be used in order to establish the response of chemical and biological indicators to critical process variables. This standard does not apply to test equipment for irradiation indicators or low temperature steam and formaldehyde indicators.

Resistometers constitute test equipment designed to create precise and repeatable sterilizing environments, allowing the evaluation of their effect on biological inactivation kinetics, chemical reactions, material degradation and product bioburden. Resistometers allow precise variation of the environmental conditions and cycle sequences in order to produce controlled physical studies. When used with the defined test methods given in ISO 11138 for biological indicators and ISO 11140 for chemical indicators, the results of these studies can be used to demonstrate conformance of biological indicators and chemical indicators to these standards.

Resistometers differ from conventional sterilizers. Instrumentation selection and control requirements for resistometers are based upon mathematical models in which rates of reaction, measurement accuracy and process control requirements are evaluated to quantify the effects induced by test equipment-controlled variables. The requirements for accurate measurement, precise control, and rapid rates of change approach limits of commercially available process control and calibration instrumentation accuracy. The measurement and control requirements often prohibit practical validation of a resistometer using procedures that might be employed in a conventional heat or chemical sterilization system. Resistometers are considered test equipment rather than sterilizers; therefore, an understanding of instrumentation and process design is critical in clarifying requirements on precision and accuracy.

Practical design has to consider the following:

  • achievable measurement and control
  • acceptable equipment induced variation in test results
  • economic design (utilizing tight process controls only where required)
  • test method correlation with intended us
  • historical knowledge applied to test procedures and an understanding of micro-environmental physical phenomena
  • testing and analysis alternatives, when accurate quantitative determinations exceed physical measurement/control limits.

BS EN ISO 18472:2006 specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140-1 for chemical indicators, or the requirements given in the ISO 11138 series for biological indicators. This International Standard also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing.

This International Standard does not address the methods used to demonstrate compliance of biological or chemical indicators to ISO 11138 and ISO 11140, as these are covered in the appropriate parts of these standards. Indicators used with combination processes, such as washer-disinfection, are not covered by this International Standard.




Standard NumberBS EN ISO 18472:2006
TitleSterilization of health care products. Biological and chemical indicators. Test equipment and methods
StatusSuperseded, Withdrawn
Publication Date30 June 2006
Withdrawn Date19 September 2018
Normative References(Required to achieve compliance to this standard)ISO 11138-3:2017, ISO 17665-1, ISO 11138-2:2017, IEC 60751:1983, ISO 11138-4, IEC 60584, ISO 11140-1, ISO 11140-4
Informative References(Provided for Information)ISO 11140-3, ISO 11140-5, ISO 10013:1995, ISO 11138-5:2017
Replaced ByBS EN ISO 18472:2018
International RelationshipsEN ISO 18472:2006,ISO 18472:2006
DescriptorsBiological analysis and testing, Chemical reagents, Sterilization (hygiene), Sterilizers, Sterile equipment, Test equipment, Performance testing, Medical equipment, Chemical indicators
ICS11.080.01
Title in FrenchSterilisation des produits de sante. Indicateurs biologiques et chimiques. Appareillage d'essai
Title in GermanSterilisation von Produkten fuer die Gesundheitsfuersorge. Biologische und chemische Indikatoren. Pruefausruestung
CommitteeCH/198
ISBN0 580 48454 8
PublisherBSI
FormatA4
DeliveryYes
Pages40
File Size513 KB
Price£214.00


WITHDRAWN TITLE
*To ask about withdrawn titles contact the
Customer Relations
cservices@bsigroup.com, +44 345 086 9001
 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Develop a PAS

Develop a fast-track standardization document in 9-12 months


BSOL

The faster, easier way to work with standards