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Standards Around Sterile Medical Device on the Move
Standards around sterile medical devices are in the move.
After a long time without changes, following standards are already or will be replaced soon:
| Hitherto | New | Content |
| DIN EN 550:1994 | DIN ISO 11135-1 & -2:2007-06 (?)* | Sterilisatsion mit Ethylenoxid |
| DIN EN 552:2001 | DIN EN ISO 11137-1 bis -3:2006 | Sterilisation mit Strahlen |
| DIN EN 554:1994 | DIN EN ISO 17665-1:2006 | Sterilisation mit feuchter Hitze |
| DIN EN 868-1:1997 | DIN EN ISO 11607-1:2006** | Verpackungen - Teil 1 |
| DIN EN 868-2:1999 | DIN EN ISO 11607-2:2006 | Verpackungen - Teil 2 |
* FDIS of ISO 11135-1 has been agreed on March 14, 2007;
** DIN EN ISO 11607-1 issued in Juli 2006, will be changed soon (expected in May 2007) due to failures.
The new standards will include major changes and new requirements, compared to the hitherto valid standards, which may lead to discussions within audits or conformity assessments in cooperation with Notified Bodies.
FDIS/ISO 11135:2007 for example, does contain new chapters regarding "Tolerable contact limit for EO" and "Tolerable contact limit for ECH for surface contacting devices". Further the new draft of ISO 10993-7 (2006-11) contians lower limits for EO and ECH.
The new standard for sterilization by radiation does contain inter alia the VDmax25 method, which has hitherto been described in AAMI TIR 27. This method can reduce the effort of the validation as solely 10 parts out of three production batches are needed for the evaluation of the bioburden and further 10 parts from one batch for radiation, instead of hunderts of parts (depending on the sort of validation performed).
As standards are considered to be state-of-the-art right after their publication, manufacturers should consider to fulfill the new requirements as soon as possible, even though a transitional period is given for the standard to be replaced.