ONORM EN ISO 10993-7 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
13-10-2022
12-01-2013
Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
4.1 General
4.2 Categorization of devices
4.3 Allowable limits
4.3.1 Permanent contact devices
4.3.2 Prolonged exposure devices
4.3.3 Limited exposure devices
4.3.4 Special situations
4.4 Determination of EO and ECH residuals
4.4.1 Safety considerations
4.4.2 Determination of residue
4.4.3 Product sampling
4.4.4 Sample/fluid ratios
4.4.5 Extraction time and conditions
4.4.6 Product extraction
4.4.7 Data analysis and interpretation
5 Product release
5.1 Release of products without dissipation curve
data
5.2 Procedure for product release using residue
dissipation curves
Annexes
A Evaluation of gas chromatograms
B Gas chromatographic determination for EO and ECH
C Factors influencing product residuals
D Extraction conditions for determination of
residual EO
E Rationale
F Bibliography
ZA Normative references to international publications
with their relevant European publications
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