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ASTM F 2475 : 2011 : REDLINE

ASTM F 2475 : 2011 : REDLINE

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

Available format(s)

PDF

Superseded date

06-04-2020

Language(s)

English

Published date

01-04-2011

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 15.09, 2015 Gives information to determine the appropriate testing for biocompatibility of materials (or packaging materials) in sterile barrier systems used to contain a medical device.

1.1 This guide provides information to determine the appropriate testing for biocompatibility of materials (or packaging materials) in sterile barrier systems used to contain a medical device.

1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

Committee
F 02
DocumentType
Redline
Pages
4
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM F 99 : 2007 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
ASTM F 2559/F2559M : 2006 : R2010 : EDT 1 Standard Guide for Writing a Specification for Sterilizable Peel Pouches
ASTM F 99 : 2007 : R2011 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
ASTM F 99 : 2007 : R2015 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
ASTM F 2559 : 2006 Standard Guide for Writing a Specification for Sterilizable Peel Pouches
ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
ASTM F 2559/F2559M : 2006 : R2015 Standard Guide for Writing a Specification for Sterilizable Peel Pouches
ASTM F 2097 : 2016 : REDLINE Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
AAMI ISO 11607 : 2ED 2000 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES

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