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For older standards, please access the Public Review Draft Archives.

Public Review Proposed Withdrawal

Deadline for comments: 30-May-08
AAMI/ American National Standard
AAMI/CDV-1 11737-03-Reaff, Proposed withdrawal of ANSI/AAMI/ISO 11737-3:2004, Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data. See more information

Public Review Proposed Reaffirmation

Deadline for comments: 02-May-08
AAMI/ American National Standard
AAMI/DS-1 BE78-Reaff, Proposed reaffirmation of ANSI/AAMI BE78:2002, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity.    See more information

Deadline for comments: 16-Jun-08
AAMI/ American National Standard
IAAMI/CDV-1 PB70-Reaff, Proposed reaffirmation of ANSI/AAMI PB70:2003, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.    See more information 

Deadline for comments: 16-Jun-08
AAMI/CDV-1 ST55-Reaff, Proposed reaffirmation of ANSI/AAMI ST55:2003, Table-top steam sterilizers.  See more information 

Deadline for comments: 16-Jun-08
AAMI/CDV-1 ST67-Reaff, Proposed reaffirmation of ANSI/AAMI ST67:2003, Sterilization of health care products - Requirements for products labeled 'sterile'.   See more information 

Public Review Draft

Deadline for comments: 16-Jun-08
AAMI/ American National Standard
AAMI/CDV-1 13408-02 (ISO 13408-2:2003), Aseptic processing of health care products - Part 2: Filtration  See more information 

Deadline for comments: 16-Jun-08
AAMI/ American National Standard
AAMI/CDV-1 13408-03 (ISO 13408-2:2006), Aseptic processing of health care products - Part 3: Lyophilization.   See more information 

Deadline for comments: 16-Jun-08
AAMI/ American National Standard
AAMI/CDV-1 13408-04 (ISO 13408-4:2005), Aseptic processing of health care products - Part 4: Clean-in-place technologies.     See more information 

Deadline for comments: 16-Jun-08
AAMI/ American National Standard
AAMI/CDV-1 13408-05 (ISO 13408-5:2005), Aseptic processing of health care products - Part 5: Sterilization in place     See more information 

Deadline for comments: 16-Jun-08
AAMI/ American National Standard
AAMI/CDV-1 13408-06 (ISO 13408-6:2005), Aseptic processing of health care products - Part 6: Isolator systems.       See more information 

Deadline for comments: 16-Jun-08
AAMI/ American National Standard
AAMI/CDV-1 14160, Sterilization of HC products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, devel, valid, and routine control of a sterilization process for med devices.       See more information 

Deadline for comments: 16-Jun-08
International Standard
ISO/CD-V-1 14160 (ISO/CD 14160), Sterilization of HC products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, devel, valid, and routine control of a sterilization process for med devices.     See more information 

Deadline for comments: 10-Jul-08
AAMI/ American National Standard
AAMI/CDV-2 15225, Nomenclature - Specification for a nomenclature system for medical devices for the purposes of regulatory data exchange. See more information 

Deadline for comments: 10-Jul-08
AAMI/ American National Standard
AAMI/CDV-3 15223-02, Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Development, selection and validation.   See more information 

Deadline for comments: 10-Jul-08
International Standard
SO/DIS-1 15223-02, Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Development, selection and validation.     See more information 

Deadline for comments: 10-Jul-08
International Standard
ISO/DIS-1 15225, Nomenclature - Medical device nomenclature data structure.   See more information 

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