Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

09-16-2015

Publisher

Asociacion Espanola de Normalizacion

Committee	CTN 111
DevelopmentNote	Supersedes UNE EN 552. (05/2009)
DocumentType	Standard
Pages	52
PublisherName	Asociacion Espanola de Normalizacion
Status	Current
Supersedes	UNE-EN ISO 11137-1:2007/A1:2014 UNE-EN ISO 11137-1:2007

Standards	Relationship
NBN EN ISO 11137-1 : 2015	Identical
UNI EN ISO 11137-1 : 2013	Identical
EN ISO 11137-1:2015	Identical
SN EN ISO 11137-1 : 2015	Identical
BS EN ISO 11137-1:2015	Identical
DIN EN ISO 11137-1:2015-11	Identical
ISO 11137-1:2006	Identical
NF EN ISO 11137-1 : 2016	Identical
NS EN ISO 11137-1 : 2015	Identical
I.S. EN ISO 11137-1:2015	Identical
NEN EN ISO 11137-1 : 2015	Identical

ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ANSI N43.10 : 2001(R2010)	SAFE DESIGN AND USE OF PANORAMIC, WET SOURCE STORAGE GAMMA IRRADIATORS (CATEGORY 4) AND DRY SOURCE STORAGE GAMMA IRRADIATORS (CATEGORY 2)
ISO 11737-2:2009	Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2006	Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 22442-1:2015	Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
ISO/IEC Guide 99:2007	International vocabulary of metrology Basic and general concepts and associated terms (VIM)
AAMI TIR17 : 2008	COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 11137-3:2017	Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 11137-2:2013	Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 14001:2015	Environmental management systems — Requirements with guidance for use
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9001:2015	Quality management systems — Requirements
ISO 22442-2:2015	Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 22442-3:2007	Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11137:1995	Sterilization of health care products Requirements for validation and routine control Radiation sterilization
ISO 14040:2006	Environmental management Life cycle assessment Principles and framework
ISO 10012-1:1992	Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment