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 |
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 |