UNE-EN ISO 11137-2:2015
Current
Current
The latest, up-to-date edition.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Amended by
Available format(s)
Hardcopy , PDF
Language(s)
Spanish, Castilian, English
Published date
16-09-2015
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 552. (05/2009)
|
| DocumentType |
Standard
|
| Pages |
86
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 11137-2 : 2015 | Identical |
| ISO 11137-2:2013 | Identical |
| NF EN ISO 11137-2 : 2015 | Identical |
| NBN EN ISO 11137-2 : 2015 | Identical |
| NEN EN ISO 11137-2 : 2015 | Identical |
| NS EN ISO 11137-2 : 2015 | Identical |
| I.S. EN ISO 11137-2:2015 | Identical |
| SN EN ISO 11137-2:2015 | Identical |
| UNI EN ISO 11137-2 : 2013 | Identical |
| BS EN ISO 11137-2:2015 | Identical |
| EN ISO 11137-2:2015 | Identical |
| DIN EN ISO 11137-2:2015-11 | Identical |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| 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 |
| AAMI TIR27 : 1ED 2001 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE - METHOD VD MAX |
| AAMI ST32 : 1991 | GUIDELINE FOR GAMMA RADIATION 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 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
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