ISO 15883: What if my washer doesn't disinfect?

[AOIRA]

Hi All,

Before I spend $167 U.S. on it, does anyone know if ISO 15883-1 applies not only to medical washer-disinfectors but also to just medical washers? Our washer is used to automate the flushing of debris from reusable, ophthalmic devices (such as Phaco handpiece) prior to their sterilization. In no way is our device intended to disinfect. Thanks!

David

[Stijloor]

In Reply to Parent Post by AOIRA

Hi All,

Before I spend $167 U.S. on it, does anyone know if ISO 15883-1 applies not only to medical washer-disinfectors but also to just medical washers? Our washer is used to automate the flushing of debris from reusable, ophthalmic devices (such as Phaco handpiece) prior to their sterilization. In no way is our device intended to disinfect. Thanks!

David

Hello David,

It's the Fourth of July week; Holiday and vacation time.
Someone will respond..just be patient with us..

Stijloor, Forum Moderator.

[sorin]

I really have no idea, but the answer to your question is not in this para?

ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.

The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of ISO 15883. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply.

ISO 15883-1:2006 does not specify requirements intended for machines for use for laundry or general catering purposes.

ISO 15883-1:2006 does not include requirements for machines which are intended to sterilize the load, or which are designated as "sterilizers", these are specified in other standards e.g. EN 285.

The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

ISO 15883-1:2006 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of ISO 15883-1:2006 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme also is given.

from: http://www.iso.org/iso/catalogue_det...csnumber=41076

[AOIRA]

Maybe I should have asked a different question. What I'm really looking for is a consensus standard that specifies the methods and criteria for challenging the cleaning efficiency of my medical washer. There is a draft FDA guidance document that applies to both washers and washer-disinfectors, but it's just a draft, and only national. Also, while it does state what should be included in design control records, it does not specify methods and criteria.

Thanks!

[AOIRA]

I'm just going to buy ISO 15883 and take my chances. Cleaning and disinfecting are two distinct steps, so I figure that a standard for a washer-disinfector should have one set of methods and criteria for cleaning (what I need) and another for disinfecting. I'll let you know if my gamble pays off.

[AOIRA]

Several testing labs saved me the $167 by posting white papers with all of the methods and criteria I could ever ask for. God bless the internet!

[sorin]

In Reply to Parent Post by AOIRA

Several testing labs saved me the $167 by posting white papers with all of the methods and criteria I could ever ask for. God bless the internet!

Heh..that proves again that one test is worth a thousand experts opinions