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ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

standard by International Organization for Standardization , 10/15/2008

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Full Description

ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes.

EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.

 

Product Details

Edition:
2nd
Published:
10/15/2008
Number of Pages:
94
File Size:
1 file , 1.8 MB
Same As:
BS EN ISO 10993-7:2008, DIN EN ISO 10993-7
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 10993-7:2008

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    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

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  2. ISO 10993-7:1995


    Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

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Amendments, rulings, supplements, and errata

  1. ISO 10993-7:2008/Amd1:2019


    - Amendment 1: Applicability of allowable limits for neonates and infants

  2. ISO 10993-7/Cor1:2009

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    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Corrigendum 1