Standard for "Simulating Long Term Effects on Materials / Thermal Disinfecion" needed

[temujin]

hi,

I´m about to conduct tests where our medical devices will be subject to thermal disinfection in a Washer/Disinfector. Goal is to evaluate the different detergents influence on different materials.

I´m quite sure I have read somewhere that there exist an ISO Standard for this (e.g. stating that I should use 10x normal concentration to simulate long term effects etc ), but I am not sure which one.

Can anyone direct me in the right direction?


best regards
t.

 

[harry]

Re: Standard for "Simulating Long Term Effects on Materials / Thermal Disinfecion" ne

Any takers for this??

 

[Jim Wynne]

Re: Standard for "Simulating Long Term Effects on Materials / Thermal Disinfecion" ne

Any takers for this??

The third hit from a Google search for Thermal Disinfection Test:
http://www.infectioncontroltoday.com/articles/551inside.html

From the abstract:

The efficacy of the cleaning and disinfection obtained by automatic washer/disinfector machines, in running programs with different times and temperatures determined by the different official agencies, was validated according to recommendations from International Organization for Standarization (ISO) Standard 15.883-1/1999 and HTM 2O3O (NHS States, 1997) for the determining of the minimum lethality and disinfection assurance level (DAL), both theoretically and through the use of thermocouples.

 

[Ajit Basrur]

Re: Standard for "Simulating Long Term Effects on Materials / Thermal Disinfecion" ne

hi,

I´m about to conduct tests where our medical devices will be subject to thermal disinfection in a Washer/Disinfector. Goal is to evaluate the different detergents influence on different materials.

I´m quite sure I have read somewhere that there exist an ISO Standard for this (e.g. stating that I should use 10x normal concentration to simulate long term effects etc ), but I am not sure which one.

Can anyone direct me in the right direction?

best regards
t.

Are you referring to ISO 15883 - 1:2006 ?

There are 4 associated parts within this standard viz.

Washer-disinfectors -- Part 1: General requirements, terms and definitions and tests

Washer-disinfectors -- Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.

Washer-disinfectors -- Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers

Washer-disinfectors -- Part 5: Test soils and methods for demonstrating cleaning efficacy

Refer this site for buying the standard -http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=41076

Also take a look at the FDA website - http://www.fda.gov/cdrh/ode/guidance/1252.html

Refer to the Guidelines (draft) for Validation and Routine Monitoring of Process Steps in Automated Cleaning Processes with Thermal Disinfection for Heat-Resistant Medical Devices as per prEN ISO 15883-1 and prEN ISO 15883-2 on http://www.uni-duesseldorf.de/awmf/ll/075-001e.htm