BS EN ISO 11137-3:2017 Sterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control

BS EN ISO 11137-3:2017

Sterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control

Status : Current   Published : August 2017

Format
PDF

Format
HARDCOPY



What is this standard about?

Dose measurement is an integral part of radiation sterilization. This standard provides guidance on the application of dose measurements (dosimetry) during all stages of the sterilization process.

Who is this standard for?

  • Sterilization equipment manufacturers
  • Sterilization service providers
  • Infection control professionals
  • Other professionals responsible for sterilization

Why should you use this standard?

It gives guidance on dosimetry procedures relating to the development, validation and routine control of radiation sterilization processes as described in:

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

It also provides explanations and methods regarded as suitable for complying with requirements.

What’s changed since the last update?

The revised standard:

  • Includes much more guidance on dose measurement uncertainty to help with meeting the dosimetric requirements in BS EN ISO 11137-1 and BS EN ISO 11137-2
  • Introduces and formally defines the ideas of ‘direct’ and ‘indirect’ measurement

Provides guidance on target doses based on measurement uncertainty considerations and process variability




Standard NumberBS EN ISO 11137-3:2017
TitleSterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control
StatusCurrent
Publication Date23 August 2017
Normative References(Required to achieve compliance to this standard)ISO 13485:2016, ISO/TS 13004:2013, ISO 11137-2:2006, ISO 11137-1:2006
Informative References(Provided for Information)ISO/ASTM 51261:2013, ISO/ASTM 51608:2015, ISO/ASTM 51631:2013, ISO/ASTM 51205:2017, ISO 11462-2:2010, ISO/ASTM 51401:2013, ISO/ASTM 51607:2013, ISO/ASTM 51276:2012, ISO/ASTM 52701:2013, ISO/ASTM 51275:2013, ISO/ASTM 51650:2013, ISO/ASTM 52303:2015, ISO 14253-1:2013, ISO/ASTM 51707:2002, ISO/ASTM 51538:2017, ISO/ASTM 51649:2015, ASTM E2232 - 16, ISO/IEC 17025:2005, ISO 14971:2007, ISO/ASTM 52628:2013, ISO 10012:2003, ISO/ASTM 51818:2013
ReplacesBS EN ISO 11137-3:2006
International RelationshipsEN ISO 11137-3:2017,ISO 11137-3:2017
Draft Superseded By15/30282559 DC
DescriptorsMaintenance, Gamma-radiation, Verification, Calibration, Sterilization (hygiene), Medical instruments, Quality assurance, Medical equipment, Quality control, Medical technology, Radiation measurement, Electron beams, Process specification, Ionizing radiation, Radiation, X-rays
ICS11.080.01
Title in FrenchStérilisation des produits de santé. Irradiation Directives relatives aux aspects dosimétriques de développement, la validation et le contrôle de routine
Title in GermanSterilisation von Produkten für die Gesundheitsfürsorge. Strahlen Anleitung zu dosimetrischen Aspekten der Entwicklung, Validierung und Lenkung der Anwendung
CommitteeCH/198
ISBN978 0 580 82896 6
PublisherBSI
FormatA4
DeliveryYes
Pages50
File Size2.145 MB
Price£240.00


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