BS EN ISO 11137-2:2015 Sterilization of health care products. Radiation. Establishing the sterilization dose

BS EN ISO 11137-2:2015

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

Status : Current, Work in hand   Published : June 2015
Conformity to regulation : Designated



What is this standard about?

BS EN ISO 11137-2:2015 outlines methods for determining the minimum dose needed to achieve a specified requirement for sterility of health care products.

Who is this standard for?

  • Sterilization equipment manufacturers
  • Sterilization service providers
  • Infection control professionals
  • Other professionals responsible for sterilization
  • Healthcare facilities/hospitals

Why should you use this standard? 

This standard contains guidelines to specify the methods that can be used to determine the minimum sterilisation dose.  It also outlines methods relating to gamma sterilization – substantiating the use of 25 kGy (KiloGrays) or 15 kGy, to achieve a sterility assurance level SAL of <10–6.

This part of ISO 11137 specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. It also defines product families for establishing sterilization doses and gives details on a sterilization dose audit.

It complements BS EN ISO 11137-1:2015 Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices and BS EN ISO 11137-3:2015  Sterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control.

What’s changed since the last update?

The standard has been systematically reviewed by experts to ensure its continued market relevance and adherence to clinical best practice and now includes significant technical changes such as: 

  • A correction of the language used to describe the requirements for interpretations of results during a verification dose experiment
  • Amendments to methods of dose establishment and means of substantiation
  • Changes to the incremental increases in the bioburden values have been included in Table 6

Standard NumberBS EN ISO 11137-2:2015
TitleSterilization of health care products. Radiation. Establishing the sterilization dose
StatusCurrent, Work in hand
Publication Date30 June 2015
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)ISO 11737-1:2018, BS EN ISO 11737-2:2020, ISO 11737-2:2019, ISO 11137-1:2006
Informative References(Provided for Information)98/79/EC, NHB 5340.1A:1968, AAMI TIR 27:2001, ISO/TS 11139:2006, AAMI RS:1984, ISO 14971, 93/42/EEC, ANSI/AAMI ST32:1991, 90/385/EEC, ISO 13485, ISO 11137-3:2006, ISO 11137:1995
ReplacesBS EN ISO 11137-2:2013
International RelationshipsEN ISO 11137-2:2015,ISO 11137-2:2013
DescriptorsRadiation measurement, X-rays, Sterile equipment, Quality control, Gamma-radiation, Medical equipment, Medical instruments, Radiation, Medical technology, Sterilization (hygiene), Electron beams, Mathematical calculations, Ionizing radiation, Quality assurance, Verification
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
ISBN978 0 580 90759 3
File Size1.741 MB

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