Iso 11137 Testing Requirements
2
“Sterile” is an absolute term, but the assurance that any given item is sterile is a probability function. The Sterility Assurance Level (SAL) of a product is defined as the probability of any given unit being non-sterile after exposure to a validated sterilization process. For a CE marked medical device to be labelled sterile, it needs to conform to the European Standard EN 556. The SAL defined by EN 556 is 10 -6 , that is equivilant to one surviving microorganism per million products. INFORMATION SHEET ISO 11137 TESTING
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Transcript of Iso 11137 Testing Requirements
“Sterile” is an absolute term, but the assurance that any given item is sterile is a probability function. The Sterility Assurance Level (SAL) of a product is defi ned as the probability of any given unit being non-sterile after exposure to a validated sterilization process.
For a CE marked medical device to be labelled sterile, it needs to conform to the European Standard EN 556. The SAL defi ned by EN 556 is 10-6, that is equivilant to one surviving microorganism per million products.
INFORMATION SHEET
ISO 11137TESTING
Telephone: +44 (0) 8456 88 99 77Email: [email protected]
www.synergyhealthplc.com/sterilisation
TEST FREQUENCY ANNUAL TOTAL
QUANTITY (UNITS)REQUIRED
Bioburden analysis Quarterly*/ ***
Monthly**/***3 samples per quarter ***
3 samples per month ***
Environmental monitoring (contact & settle plates)
QuarterlyMonthly**
Dependant on size of cleanroom / manufacturing area
Dependant on size of cleanroom / manufacturing area
Dose establishment (VDmax, Method 1 or Method 2)
Once 1 – providing dose audits are completed and nothing changes with manufacturer process or components
40 for VDmax****
130 for Method 1****
Dose audit (VDmax, method 1 or method 2)
Quarterly (for initial 12 months, can be scaled back after if no failures)
3 (plus one study) 20 for VDmax
110 for Method 1
Single batch VDmax study Each batch 25 samples
Single batch Method 1 study Each batch 110 samples
Notes:* Minimum requirements to be compliant with the standard.** Recommended test frequency for products manufactured on a regular basis.*** Determined by manufacturing frequency or level of bioburden.**** 5-10 extra samples should where possible to be used for method validation and development. Additional samples are required for B&F testing or as part of the bioburden validation.
Single batch options are available for those companies producing infrequently and with limited product numbers.
ISO 11137 - part 2
