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BS EN ISO 10993-7:2008+A1:2022 – TC

$280.87

Tracked Changes. Biological evaluation of medical devices – Ethylene oxide sterilization residuals

Published By Publication Date Number of Pages
BSI 2022 246
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PDF Catalog

PDF Pages PDF Title
1 30455191
149 A-30355037
150 National foreword
154 European foreword
155 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC Medical devices
156 Annex ZB (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices
158 Foreword
159 1 Scope
2 Normative references
3 Terms and definitions
160 4 Requirements
4.1 General
4.2 Categorization of devices
161 4.3 Allowable limits
4.3.1 General
4.3.2 Permanent contact devices
4.3.3 Prolonged exposure devices
162 4.3.4 Limited exposure devices
4.3.5 Tolerable contact limits for surface contacting devices and implants
4.3.6 Special situations
163 4.4 Determination of EO and ECH residuals
4.4.1 General
4.4.2 Determination of residue
164 4.4.3 Product sampling and sample “blank”
165 4.4.4 Sample/fluid ratios
4.4.5 Extraction time and conditions
4.4.6 Product extraction
167 4.4.7 Data analysis and interpretation
168 5 Product release
5.1 General
5.2 Release of products without dissipation curve data
5.3 Procedure for product release using residue dissipation curves
170 Bibliography
182 Annex A (normative) Evaluation of gas chromatograms
185 Annex B (informative) Gas chromatographic determination for EO and ECH
189 Annex C (informative) Flowchart and guidance for the application of this part of ISO 10993 series of standards to the determination of EO and ECH residuals in medical devices
196 Annex D (informative) Factors influencing product residual
198 Annex E (informative) Extraction conditions for determination of residual EO
199 Annex F (informative) Rationale for the provisions of this part of ISO 10993
203 Annex G (informative) Establishment of allowable limits for EO
220 Annex H (informative) Establishment of allowable limits for ECH
229 Annex I (informative) Establishment of allowable limits for EG
233 Annex J (informative) Preparation of EO and ECH standards
237 Annex K (informative) Ethylene oxide residue measuring methods
BS EN ISO 10993-7:2008+A1:2022 - TC
$280.87