DIN EN ISO 10993-7/A1:2018-08
Superseded Draft amendment
Historical

DIN EN ISO 10993-7/A1:2018-08

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7:2008/DAM 1:2018); German and English version EN ISO 10993-7:2008/prA1:2018
Most recent standard

Summary

When the risk analysis indicates that the device may be used in special populations, the appropriate patient body mass shall be used for the derivation of the allowable limits. For example, if the device is intended to be used in premature neonates, neonates or children, the allowable limits shall be derived using the abovementioned limits and diminished by the pro rata of the appropriate body mass. The appropriate default body mass used for each category of special patient population should be justified and documented.

Notes

Prévu comme amendement à DIN EN ISO 10993-7 (2009-02).

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 08/01/2018
Page Count 26
EAN ---
ISBN ---
Weight (in grams) ---
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Previous versions

DIN EN ISO 10993-7:2024-08

DIN EN ISO 10993-7:2024-08

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024
01/08/2024
Active
Most Recent
DIN EN ISO 10993-7:2022-09

DIN EN ISO 10993-7:2022-09

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
01/09/2022
Active , Under review
Most Recent
DIN EN ISO 10993-7/A1:2018-08

DIN EN ISO 10993-7/A1:2018-08

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7:2008/DAM 1:2018); German and English version EN ISO 10993-7:2008/prA1:2018
01/08/2018
Superseded
Historical
DIN EN ISO 10993-7 Berichtigung 1:2011-06

DIN EN ISO 10993-7 Berichtigung 1:2011-06

Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène (ISO 10993-7:2008); Version allemande EN ISO 10993-7:2008, Corrigendum à DIN EN ISO 10993-7:2009-02, Version allemande EN ISO 10993-7:2008/AC:2009
01/06/2011
Superseded
Historical
DIN EN ISO 10993-7:2009-02

DIN EN ISO 10993-7:2009-02

Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène (ISO 10993-7:2008); Version allemande EN ISO 10993-7:2008
01/02/2009
Superseded
Historical
DIN EN ISO 10993-7:2006-11

DIN EN ISO 10993-7:2006-11

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2006); German version prEN ISO 10993-7:2006
01/11/2006
Superseded
Historical
DIN EN ISO 10993-7:1995-11

DIN EN ISO 10993-7:1995-11

Evaluation biologiques des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène (ISO 10993-7:1995); version allemande EN ISO 10993-7:1995
01/11/1995
Superseded
Historical
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