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UNE-EN ISO 17511:2022 UNE
Status: Vigente/ 2022-03-02
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
UNE-EN ISO 11737-1:2018/A1:2022 UNE
Status: Vigente/ 2022-02-16
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
UNE-EN ISO 11737-2:2020 UNE
Status: Vigente/ 2020-12-16
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
UNE-EN 1659:1997 UNE
Status: Vigente/ 2019-03-14
In vitro diagnostic systems - Culture media for microbiology - Terms and definitions
UNE-EN 12322:1999 UNE
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
UNE-EN ISO 11737-1:2018 UNE
Status: Vigente/ 2018-12-26
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
UNE-EN ISO 18153:2004 UNE
Status: Vigente/ 2014-02-28
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
UNE-EN 12322/A1:2002 UNE
Status: Vigente/ 2002-04-30
In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media.
ISO 11737-3:2023 ISO
Status: Published/ 2023-06-26
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
ISO 11737-1:2018/Amd 1:2021 ISO
Status: Published/ 2021-05-19
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
ISO/TS 22456:2021 ISO
Status: Published/ 2021-03-19
Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
ISO 11737-2:2019 ISO
Status: Published/ 2019-12-02
Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2018 ISO
Status: Published/ 2018-01-12
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
UNE-EN ISO 17511:2004 UNE
Status: Anulada/ 2024-07-01
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
UNE-EN ISO 11737-2:2010 UNE
Status: Anulada/ 2020-12-16
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
UNE-EN ISO 11737-1:2007 UNE
Status: Anulada/ 2018-12-26
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
UNE-EN ISO 11737-1:2007/AC:2009 UNE
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006/Cor 1:2007)
UNE-EN ISO 11737-2:2000 UNE
Status: Anulada/ 2010-05-05
STERILIZATION OF MEDICAL DEVICES. MICROBIOLOGICAL METHODS. PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS. (ISO 11737-2:1998)
UNE-EN ISO 11737-2:2000 ERRATUM:2007 UNE
Sterilization of medical devices. Microbiological methods. Part 2: Tests of sterility performed in the validation of a sterilization process. (ISO 11737-2:1998)
UNE-EN 1174-1:1996 UNE
Status: Anulada/ 2006-11-01
STERILIZATION OF MEDICAL DEVICES. ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT. PART 1: REQUIREMENTS.
UNE-EN 1174-2:1997 UNE
STERILIZATION OF MEDICAL DEVICES. ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT. PART 2: GUIDANCE.
UNE-EN 1174-3:1997 UNE
STERILIZATION OF MEDICAL DEVICES. ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT. PART 3: GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES.
UNE-EN ISO 11737-1:2006 UNE
Status: Anulada/ 2007-03-14
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) (Endorsed by AENOR in October of 2006.)
ISO 11737-2:2009 ISO
Status: Withdrawn/ 2009-11-06
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/Cor 1:2007 ISO
Status: Withdrawn/ 2007-05-11
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Technical Corrigendum 1
ISO 11737-1:2006 ISO
Status: Withdrawn/ 2006-03-20
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
ISO 11737-3:2004 ISO
Status: Withdrawn/ 2004-07-13
Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data
ISO 11737-2:1998 ISO
Status: Withdrawn/ 1998-07-09
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process
ISO 11737-1:1995 ISO
Status: Withdrawn/ 1995-11-30
Sterilization of medical devices — Microbiological methods — Part 1: Estimation of population of microorganisms on products
