BS EN ISO 11137-2 Sterilization of health care products. Radiation. Establishing the sterilization dose
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BS EN ISO 11137-2:2007

Sterilization of health care products. Radiation. Establishing the sterilization dose

Status : Revised, Withdrawn   Published : June 2007 Replaced By : BS EN ISO 11137-2:2012

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What is BS EN ISO 11137-2:2007?

BS EN ISO 11137-2 was developed to establish the right sterilisation dose for medical equipment. This international standard takes an in-depth look at the methods aligned with the two approaches in ISO 11137-1:2008, including dose setting to get a product specific dose; and dose substantiation to confirm a preselected dose of 25kG or 15kGy. These methods are based on a probability model that demonstrates the inactivation of microbial populations after radiation – such as gamma and ionising radiation – and involve performance tests of sterility on medical instruments.

How does it work?

BS EN ISO 11137-2 helps the user to choose and test their medical equipment for the verification of sterilisation doses. It also looks at the manner of sampling to ensure quality control, as well as microbiological testing. This standard includes various procedures for dose setting using bioburden information (Method 1), and dose setting using fraction positive information from incremental dosing (Method 2).

Who should buy it?

  • Laboratories
  • Manufacturers of medical equipment
  • Quality assurers
  • Persons responsible for sterilising medical equipment
  • Regulatory bodies

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Standard NumberBS EN ISO 11137-2:2007
TitleSterilization of health care products. Radiation. Establishing the sterilization dose
StatusRevised, Withdrawn
Publication Date29 June 2007
Withdrawn Date30 June 2012
Normative References(Required to achieve compliance to this standard)BS EN ISO 11737-2:2020, ISO 11737-2:2019, ISO 11737-1:2018, ISO 13485, ISO 11137-1:2006
Informative References(Provided for Information)98/79/EC, 90/385/EEC, 93/42/EEC, ANSI/AAMI ST32:1991, ISO 14971, AAMI RS:1984, ISO/TS 11139:2006, ISO 11137-3:2006, AAMI TIR27:2001, ISO 11137:1995
Replaced ByBS EN ISO 11137-2:2012
ReplacesBS EN 552:1994
International RelationshipsISO 11137-2:2006/COR 1:2009,EN ISO 11137-2:2007/AC:2009
Amended ByCorrigendum, October 2009
DescriptorsRadiation measurement, Quality assurance, Verification, Mathematical calculations, Medical technology, X-rays, Electron beams, Ionizing radiation, Sterile equipment, Sterilization (hygiene), Radiation, Gamma-radiation, Medical equipment, Quality control, Medical instruments
ICS11.080.01
Title in FrenchStérilisation des produits de santé. Irradiation. Établissement de la dose stérilisante
Title in GermanSterilisation von Produkten für die Gesundheitsfürsorge. Strahlen. Festlegung der Sterilisationsdosis
CommitteeCH/198
ISBN978 0 580 67501 0
PublisherBSI
FormatA4
DeliveryNo
Pages72
File Size979 KB
Price£280.00


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