CSA ISO 10993-7 : 1998
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
01-01-2007
01-09-2009
1 Scope
2 Normative references
3 Definitions
4 Requirements
4.1 General
4.2 Categorization of devices
4.3 Allowable limits
4.4 Determination of ED and ECH residuals
5 Product release
5.1 Release of products without dissipation curve
data
5.2 Procedure for product release using residue
dissipation can
Annexes
A Evaluation of gas chromatograms
Specifies limits allowable for residual ethylene oxide and ethylene chlorohydrin in individual sterilized medical devices, methods of determining compliance and procedures for the measurement of ethylene chlorohydrin and ethylene oxide are covered.
| DocumentType |
Standard
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ISO 10993-7:2008 | Identical |