ISO 10993-7:2008 ✓ Most Recent

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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.

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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

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Product Details

Edition:

2nd

Published:

10/15/2008

Number of Pages:

94

File Size:

1 file

Same As:

BS EN ISO 10993-7:2008, DIN EN ISO 10993-7

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus