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Ethylene oxide in medical devices

Reliable quality control of medical devices is a precondition for production in accordance with international standards and for successful product marketing. EN ISO 10993-7 regulates the quality control of these medical devices.

A new version of the EN ISO 10993-7 standard has been in force since October 2008 and contains important changes to allowable limits.

Manufacturers of medical devices are obliged to perform analytical tests on residue from sterilisation procedures in accordance with international standards. The task of analytics is to establish whether the prescribed limits are being adhered to.

The essential changes refer to allowable limits for ethylene oxide and ethylene chlorohydrin. New specifications have been issued for various special products. The revised standard also provides information on tolerable doses for products that come into contact with body surface areas. A wide range of special cases are also explicitly regulated.

The following table provides an overview of changes to allowable limits:

 

Revision 1995Revision 2008
Permanent contact devices
ETO: 0.1mg average daily doseETO: 0.1mg average daily dose
ETO: 20mg in the first 24hETO: 4mg in the first 24h
ETO: 60mg in the first 30 daysETO: 60mg in the first 30 days
ETO: 2.5g in a life-timeETO: 2.5g in a life-time
ECH: 2mg average daily doseECH: 0.4mg average daily dose
ECH: 12mg in the first 24hECH: 9mg in the first 24h
ECH: 60mg in the first 30 daysECH: 60mg in the first 30 days
ECH: 50g in a life-timeECH: 10g in a life-time
Prolonged exposure devices
ETO: 2mg average daily doseETO: 2mg average daily dose
ETO: 20mg in the first 24hETO: 4mg in the first 24h
ETO: 60mg in the first 30 daysETO: 60mg in the first 30 days
ECH: 2mg average daily doseECH: 2mg average daily dose
ECH: 12mg in the first 24hECH: 9mg in the first 24h
ECH: 60mg in the first 30 daysECH: 60mg in the first 30 days
Limited exposure devices
ETO: 20mg average daily doseETO: 4mg average daily dose
ECH: 12mg average daily doseECH: 9mg average daily dose
Tolerable contact limits for surface contacting devic
ETO: ---ETO: 10 µg/cm2
ECH: ---ECH: 5 µg/cm2
Special situations
Intraocular lenses
ETO: 0.5µg per lens per dayETO: 0.5µg per lens per day
ETO: 1.25µg per lensETO: 1.25µg per lens
Blood cell separators (blood collection)
ETO: 60mg average daily doseETO: 10 mg
ECH: ---ECH: 22 mg
Blood oxygenators and blood separators
ETO: 60mg average daily doseETO: 60 mg
ECH: ---ECH: 45 mg
Devices for cardiopulmonary bypass procedures
ETO: ---ETO: 20 mg
ECH: ---ECH: 9 mg
Extracorporeal blood purification devices
ETO: diverseETO: 4.6 mg
ECH: diverseECH: 4.6 mg
ETO: allowable dose for a lifetime may be exceededETO: allowable dose for a lifetime may be exceeded
ECH: allowable dose for a lifetime may be exceededECH: allowable dose for a lifetime may be exceeded

 

UFAG LABORATORIEN has optimised the analytical procedure to determine ethylene oxide residue in medical devices and, in addition to analytical services, also provides consultancy on this standard.

Rückstandsanalytik: Extraktion von Ethylenoxid aus Spritzen
Residue analysis: extraction of ethylene oxide from syringes
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