AAMI 10993 7 2008 RA 2012
$140.32
ANSI/AAMI/ISO 10993-7:2008/(R)2012 – Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
| Published By | Publication Date | Number of Pages |
| AAMI | 2008 | 114 |
ANSI/AAMI/ISO 10993-7 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 this document is applied, is also included in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this standard.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 10993-7:2008/(R)2012, Biological evaluationof medical devices—Part 7: Ethylene oxide sterilization residuals |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 11 | Background of AAMI adoption of ISO 10993-7:2008 |
| 12 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 2 Normative references 3 Terms and definitions |
| 16 | 4 Requirements 4.1 General 4.2 Categorization of devices |
| 17 | 4.3 Allowable limits 4.3.1 General 4.3.2 Permanent contact devices |
| 18 | 4.3.3 Prolonged exposure devices 4.3.4 Limited exposure devices 4.3.5 Tolerable contact limits for surface contacting devices and implants 4.3.5.1 Overview 4.3.5.2 Tolerable contact limit for EO 4.3.5.3 Tolerable contact limit for ECH for surface contacting devices 4.3.6 Special situations |
| 19 | 4.4 Determination of EO and ECH residuals 4.4.1 General 4.4.1.1 Procedure 4.4.1.2 Ethylene oxide |
| 20 | 4.4.1.3 Ethylene chlorohydrin 4.4.2 Determination of residue 4.4.3 Product sampling and sample “blank” 4.4.3.1 Product sampling |
| 21 | 4.4.3.2 Sample “blank” 4.4.4 Sample/fluid ratios 4.4.5 Extraction time and conditions 4.4.6 Product extraction 4.4.6.1 Overview |
| 22 | 4.4.6.2 Simulated-use extraction (reference method) |
| 23 | 4.4.6.3 Exhaustive extraction (acceptable alternative method) 4.4.6.3.1 Overview 4.4.6.3.2 Residual ethylene oxide 4.4.6.3.3 Residual ethylene chlorohydrin |
| 24 | 4.4.7 Data analysis and interpretation 4.4.7.1 Calculation of amount of residue extracted 4.4.7.2 Calculation of average delivered dose, Madd, for comparison to allowable limits in 4.3 |
| 25 | 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 |
| 28 | Annex A Evaluation of gas chromatograms A.1 General A.2 Background A.3 Symbols A.4 Minimum requirements |
| 30 | A.5 Chromatographic baseline A.6 Resources |
| 32 | Annex B Gas chromatographic determination for EO and ECH B.1 Chromatographic procedures B.1.1 Preparation of standards B.1.2 General B.2 Criteria for validating gas chromatographic methods B.2.1 General overview |
| 33 | B.2.2 Accuracy B.2.3 Precision B.2.3.1 Overview B.2.3.2 Repeatability |
| 34 | B.2.3.3 Intermediate precision B.2.3.4 Ruggedness/reproducibility B.2.4 Linearity B.2.5 Method detection limit (MDL) B.2.5.1 Overview B.2.5.2 MDL based on signal-to-noise |
| 35 | B.2.5.3 MDL based on the standard deviation of the response B.2.6 Quantitation limit (QL) B.2.6.1 Overview B.2.6.2 QL based on signal-to-noise B.2.6.3 QL based on the standard deviation of the response |
| 36 | Annex C Flowchart and guidance for the application of this part of ISO 10993 series of standards to the determination of EO and ECH residualsin medical devices C.1 Background |
| 37 | C.2 Guidance |
| 39 | C.3 Simulated-use extraction procedure C.3.1 Extraction fluid C.3.2 Extraction temperature C.3.3 Extraction time |
| 40 | C.3.4 Extraction of device C.3.5 Grouping of devices C.3.6 Device kits and trays |
| 44 | Annex D Factors influencing product residual D.1 Sterilization process parameters D.1.1 General overview D.1.2 Material composition D.1.3 Packaging D.1.4 Ethylene oxide sterilization cycle D.1.5 Aeration |
| 45 | D.1.6 Sample retrieval D.2 Controlling variables |
| 46 | Annex E Extraction conditions for determination of residual EO |
| 47 | Annex F Rationale for the provisions of this part of ISO 10993 F.1 General F.2 Rationale for special situations F.2.1 General F.2.2 Intraocular lens limits |
| 48 | F.2.3 Blood cell separators used in donor or patient blood collection F.2.4 Blood oxygenators and blood separators |
| 49 | F.2.5 Devices used in cardiopulmonary bypass procedures F.2.6 Extracorporeal blood purification devices |
| 50 | F.2.7 Drapes contacting intact skin F.3 Rationale for 4.4 F.3.1 General F.3.2 Product extraction F.3.3 Analytical methods F.3.3.1 Stability of EO in solution |
| 51 | F.3.3.2 Stability of ECH in solution F.3.3.3 Linearity of standard curve F.3.4 Rationale for 4.4.7.1, data analysis and interpretation |
| 52 | Annex G Establishment of allowable limits for EO G.1 General G.2 Introduction |
| 53 | G.3 Methods G.3.1 General G.3.2 Route-to-route extrapolation of dose G.3.3 Non-cancer risk assessment approach |
| 54 | G.3.4 Cancer risk assessment approach G.3.5 Effects not considered in deriving TI values for EO G.4 Non-cancer-based TI values for EO G.4.1 Overview G.4.2 Selection of critical studies G.4.2.1 Limited/prolonged exposure category |
| 55 | G.4.2.2 Permanent exposure category |
| 56 | G.4.3 Selection of uncertainty factors for non-cancer effects G.4.3.1 Inter-individual variability (UF1) G.4.3.1.1 Overview |
| 57 | G.4.3.1.2 Polymorphism of EO detoxification enzymes G.4.3.1.2.1 General considerations G.4.3.1.2.2 Role of GSTT1 polymorphism in the variability of the response of the human population to EO |
| 58 | G.4.3.1.2.3 Role of EH polymorphism in the variability of the response of the human population to EO G.4.3.1.3 Inhibition of EO detoxification enzymes G.4.3.1.3.1 Inhibition in disease states |
| 59 | G.4.3.1.3.2 Inhibition by drugs and other compounds G.4.3.1.4 Glutathione levels G.4.3.1.5 Polymorphism of DNA repair capacity |
| 60 | G.4.3.2 Inter-species differences (UF2) G.4.3.2.1 Overview |
| 61 | G.4.3.2.2 Results of PBPK modeling G.4.3.2.3 Species differences in DNA repair rates |
| 62 | G.4.3.3 Quality and relevance of experimental data (UF3) G.4.4 Derivation of non-cancer TI values for EO |
| 63 | G.5 Cancer-based TI values for EO G.5.1 General overview G.5.2 Approach 1: Linear extrapolation from human data |
| 64 | G.5.3 Approach 2: Linear extrapolation from animal data G.5.4 Approach 3: Uncertainty factor approach G.5.5 Approach 4: Linear dose-response modeling of human data G.5.6 Comparison of cancer-based TI value |
| 65 | G.5.7 Comparison of TI values for EO |
| 66 | G.6 Calculation of tolerable exposure (TE) levels G.6.1 Tolerable exposure TE G.6.2 Limited exposure TE G.6.3 Prolonged exposure TE G.6.4 Permanent exposure TE |
| 67 | G.6.5 Calculation of Tolerable Contact Limit (TCL) G.6.5.1 Rationale G.6.5.2 Selection of critical studies |
| 68 | G.6.5.3 Selection of uncertainty factors for TCL derivation G.6.5.4 Inter-individual variability (UF4) G.6.5.5 Inter-species differences (UF5) G.6.5.6 Data deficiencies |
| 69 | G.7 Calculation of allowable limits G.8 Calculation of device limits G.8.1 General considerations G.8.2 Limited contact devices |
| 70 | G.8.3 Prolonged contact devices G.8.4 Permanent contact devices G.8.5 Limit based on TCL value |
| 71 | Annex H Establishment of allowable limits for ECH H.1 General H.2 Introduction H.3 Methods H.3.1 Overview |
| 72 | H.3.2 Route-to-route extrapolation of dose H.3.3 Non-cancer risk assessment approach H.3.4 Cancer risk assessment approach H.3.5 Effects not considered in deriving TI values for ECH H.4 Non-cancer-based TI values for ECH H.4.1 Selection of critical studies H.4.1.1 Limited exposure limit |
| 74 | H.4.1.2 Prolonged exposure limit |
| 76 | H.4.1.3 Permanent exposure limit |
| 78 | H.4.2 Selection of uncertainty factors for non-cancer effects |
| 79 | H.5 Calculation of Tolerable Contact Limit (TCL) |
| 81 | Annex I Establishment of allowable limits for EG I.1 Background I.2 General considerations I.2.1 Overview I.2.2 Limited exposure |
| 82 | I.2.3 Prolonged exposure |
| 84 | I.2.4 Permanent exposure |
| 85 | I.2.5 Tolerable contact limit (TCL) |
| 86 | Annex J Preparation of EO and ECH standards J.1 Preparation of EO standards J.1.1 Collection of EO gas |
| 87 | J.1.2 EO standard dilutions for headspace methods |
| 88 | J.1.3 EO standard dilutions for solvent methods |
| 89 | J.2 Preparation of ECH standards |
| 90 | Annex K Ethylene oxide residue measuring methods K.1 Results of interlaboratory evaluation of methods K.1.1 EO methods K.1.2 ECH methods |
| 91 | K.2 Apparatus and reagents K.2.1 Apparatus |
| 92 | K.2.2 Reagents K.3 Standard preparation K.3.1 Preparation of ethylene oxide standards K.3.2 Preparation of ethylene chlorohydrin standards K.3.3 Preparation of propylene oxide (PO) standards K.4 Product extraction K.4.1 General |
| 93 | K.4.2 Extraction to simulate product use K.4.3 Exhaustive procedure using thermal extraction |
| 94 | K.4.4 Exhaustive extraction with ethanol followed by headspace gas analysis of the ethanol extract K.4.4.1 Calibration standards K.4.4.2 Analysis procedure |
| 95 | K.4.5 Exhaustive extraction with solvent |
| 96 | K.4.6 Exhaustive extraction with ethanol followed by preparation of the bromohydrin derivative and chromatography using a gas chromatograph equipped with an ECD K.4.6.1 Calibration standards K.4.6.2 Analysis procedure |
| 97 | K.4.7 Simulated-use extraction for ethylene chlorohydrin using water K.4.8 Exhaustive extraction for ethylene chlorohydrin using water K.5 Gas chromatography K.5.1 General K.5.2 Extraction to simulate product use for the determination of EO or ECH K.5.3 Exhaustive procedure using thermal extraction K.5.4 Exhaustive extraction with ethanol followed by headspace gas analysis of the ethanol extract |
| 98 | K.5.5 Exhaustive extraction with ethanol followed by preparation of the bromohydrin derivative and chromatography using a gas chromatograph equipped with an ECD |
| 99 | Bibliography |
| 113 | Errata – ANSI/AAMI/ISO 10993-7:2008 |
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