I.S. EN ISO 10993-7:2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008)
Hardcopy , PDF
10-07-2020
English
01-01-2008
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Categorization of devices
4.3 Allowable limits
4.4 Determination of EO and ECH residuals
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
Annex A (normative) Evaluation of gas chromatograms
Annex B (informative) Gas chromatographic determination
for EO and ECH
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
Annex D (informative) Factors influencing product residual
Annex E (informative) Extraction conditions for
determination of residual EO
Annex F (informative) Rationale for the provisions of this
part of ISO 10993
Annex G (informative) Establishment of allowable limits for
EO
Annex H (informative) Establishment of allowable limits for
ECH
Annex I (informative) Establishment of allowable limits for
EG
Annex J (informative) Preparation of EO and ECH standards
Annex K (informative) Ethylene oxide residue measuring
methods
Annex ZA (informative) Relationship between this International
Standard and the Essential Requirements of EU
Directive 93/42/EEC Medical devices
Annex ZB (informative) Relationship between this International
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable Medical Devices
Bibliography
Describes 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.
| DocumentType |
Standard
|
| Pages |
102
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 10993-7:2009-02 | Identical |
| NEN EN ISO 10993-7 : 2008 C1 2009 | Identical |
| EN ISO 10993-7 : 2008 COR 2009 | Identical |
| NBN EN ISO 10993-7 : 2008 COR 2009 | Identical |
| UNE-EN ISO 10993-7:2009 | Identical |
| ISO 10993-7:2008 | Identical |
| NS EN ISO 10993-7 : 2008 AC 2009 | Identical |
| SN EN ISO 10993-7 : 2008 CORR 2009 | Identical |
| BS EN ISO 10993-7:2008 | Identical |
| UNI EN ISO 10993-7 : 2009 | Identical |
| NF EN ISO 10993-7 : 2008 | Identical |
| ONORM EN ISO 10993-7 : 2010 | Identical |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| AAMI ST30 : 1989 | DETERMINING RESIDUAL ETHYLENE CHLOROHYDRIN AND ETHYLENE GLYCOL IN MEDICAL DEVICES |
| AAMI ST29 : 1988 | DETERMINING RESIDUAL ETHYLENE OXIDE IN MEDICAL DEVICES |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| AAMI ST43 : 3ED 93 | GOOD HOSPITAL PRACTICE: ETHYLENE OXIDE GAS - VENTILATION RECOMMENDATIONS AND SAFE USE |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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