ISO 10993:2008
ISO 10993:2008 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
CDN $442.00
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.
Edition
2
Published Date
2008-10-13
Status
PUBLISHED
Pages
86
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 20560:2024 Safety information for the content of piping systems and tanks – Part 1: Piping systems
CDN $263.00 Add to cart -
ISO 4125:1991 Dry fruits and dried fruits – Definitions and nomenclature
CDN $86.00 Add to cart -
ISO 20537:2025 Footwear – Identification of defects during visual inspection – Vocabulary
CDN $310.00 Add to cart -
ISO 7176:2007 Wheelchairs – Part 26: Vocabulary
CDN $352.00 Add to cart
