INFORMATION SHEET

ISO 11137

TESTING

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 dened 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 dened by EN 556 is 10-6, that is equivilant to one
surviving microorganism per million products.

ISO 11137 - part 2

TEST

FREQUENCY

Bioburden analysis

Quarterly*/ ***
Monthly**/***

ANNUAL
TOTAL

QUANTITY (UNITS)
REQUIRED
3 samples per
quarter ***
3 samples per month
***

Environmental monitoring
(contact & settle plates)

Quarterly
Monthly**

Dose establishment (VDmax, Once

Method 1 or Method 2)

Dose audit
(VDmax, method 1 or
method 2)

Quarterly
(for initial 12
months, can be
scaled back
after if no
failures)

Single batch VDmax study

Each batch

Single batch Method 1 study Each batch

Dependant on size of Dependant on size of

cleanroom /
cleanroom /
manufacturing area
manufacturing area
1 providing dose 40 for VDmax****
audits are completed
and nothing changes 130 for Method 1****
with manufacturer
process or components
3 (plus one study)
20 for VDmax
110 for Method 1

25 samples
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.

Telephone: +44 (0) 8456 88 99 77

Email: assistance@synergyhealthplc.com

www.synergyhealthplc.com/sterilisation