BS EN ISO 11137-1:2015+A2:2019 - Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices

BS EN ISO 11137-1:2015+A2:2019

Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices

Status : Current   Published : July 2015

Format
PDF

Format
HARDCOPY






Standard NumberBS EN ISO 11137-1:2015+A2:2019
TitleSterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices
StatusCurrent
Publication Date31 July 2015
Normative References(Required to achieve compliance to this standard)ISO 11737-1:2018, BS EN ISO 11737-2:2020, ISO 11737-2:2019, ISO 11137-2, ISO 13485:2003, ISO 10012-1
Informative References(Provided for Information)ISO 10993-1:2003, ISO 14040:1997, HGB N43.10-2001, ISO 22442-1, IAEA Safety Series No.107, TS 11139:2006, ISO 9000:2005, ISO 11607-1, ISO 22442-2, ISO 11137-3:2006, AAMI ST67:2003, ISO 22442-3, AAMI TIR17:1997, ISO 11607-2, ISO 14001:2004, ISO 9001:2000, ISO 11137:1995, EN 556-1:2001
International RelationshipsEN ISO 11137-1:2015/A2:2019,ISO 11137-1:2006/Amd 2:2018,ISO 11137-1:2006/Amd.2:2018
Amended ByAmendment, November 2019
Draft Superseded By17/30363659 DC
DescriptorsMedical equipment, Records (documents), Radiation measurement, Verification, Maintenance, Process specification, Radiation, Electron beams, Quality assurance, Ionizing radiation, Quality control, Gamma-radiation, Calibration, Medical technology, X-rays, Documents, Sterilization (hygiene), Medical instruments
ICS11.080.01
Title in FrenchStérilisation des produits de santé. Irradiation Exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux
Title in GermanSterilisation von Produkten für die Gesundheitsfürsorge. Strahlen Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte
CommitteeCH/198
ISBN978 0 580 99289 6
PublisherBSI
FormatA4
DeliveryYes
Pages62
File Size2.11 MB
Price£254.00


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