UNE-EN ISO 11137-1:2015
Current
Current
The latest, up-to-date edition.
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
16-09-2015
Publisher
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 552. (05/2009)
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Current
|
| SupersededBy | |
| Supersedes |
| 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 |
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