BS EN ISO 10993-7:2008
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices Ethylene oxide sterilization residuals
Hardcopy , PDF
01-26-2022
English
07-31-2010
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CH/194
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| DevelopmentNote |
Supersedes 93/500349 DC. (11/2005) Supersedes 06/30097290 DC. (12/2008)
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| DocumentType |
Standard
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| Pages |
98
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| PublisherName |
British Standards Institution
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| Status |
Withdrawn
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| Supersedes |
This part of ISO10993 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, are also included in the informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO10993.
NOTE This part of ISO10993 does not specify limits for ethylene glycol (EG).
| Standards | Relationship |
| ONORM EN ISO 10993-7 : 2010 | Identical |
| UNE-EN ISO 10993-7:2009 | Identical |
| NS EN ISO 10993-7 : 2008 AC 2009 | Identical |
| SN EN ISO 10993-7 : 2008 CORR 2009 | Identical |
| UNI EN ISO 10993-7 : 2009 | Identical |
| NF EN ISO 10993-7 : 2008 | Identical |
| 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 |
| I.S. EN ISO 10993-7:2008 | Identical |
| ISO 10993-7:2008/Cor 1:2009 | Identical |
| EN ISO 10993-7:2008/AC:2009 | Identical |
| BS EN 1283:1996 | Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits |
| 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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