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steam sterilization

  1. S

    EN 285:2006 and EN 285:2015 - Can we test according to EN 285 ourself?

    Hello everybody. Does anybody knows can we testing according to EN 285 standard ourselfs? (With calibrated measuring instruments, created tests etc.) Medical device for testing is steam sterilizer. Or that testing, and issuing test report and certificate must be conducted from external...
  2. H

    Max and Min Load Determination for Steam Sterilization of Liquds

    Hello all. We're developping a new medical device and it requires to be sterilized by steam. Me or neither my company only have experience on EO and irridation sterilization. Now we're preparing the protocol for validation and try to determine the load configuration. Iknow that minimum...
  3. J

    EU countries and steam sterilisation protocol

    Hi everyone, Does anyone can indicate me the preconised recognized steam sterilization protocols for reusable medical instruments per countries? As I know: - France: 134°C - 18 minutes - UK: 134°C - 3 minutes - Germany: 134 °C - 4 minutes - Denmark, Norway, Sweden: 134°C - 5 minutes 30 sec ...
  4. R

    Does an Outside Steam Generator need to be Registered in the EU?

    Hi All, Do we need to register steam generator as medical device? Confusion is that some large sterilizers approved in EU have integrated small steam generator but in our case it is placed outside of premises and steam is then transported to sterilizer (small, large, stations). Steam is...
  5. E

    Class II Implant Steam Sterilizer Validation

    Hi, We make Class II implants that we will be sterilized by a new steam sterilizer. The new sterilizer was calibrated and validated by an external lab. Upon reviewing the validation, I'm wondering how others have handled such results: I think it's standard to use 121?C for X minutes and during...
  6. S

    Steam Sanitization Requirements for Parts for Medical Device Manufacturing

    Hello All: Are there any ISO or comparable requirements/standards for steam sanitization of parts used in the manufacture of medical devices? If it means anything, the parts are not components of the device but they do come into direct contact with components that comprise what the site...
  7. S

    ETO ISO 11135-1 & ISO 17665-2 - Purity and Quality of Steam (Humidity)

    The equipment characterization for EtO sterilization required specification for purity and quality of steam. Does it means that this steam must be tested to ISO 17665-2 according to steam sterilization? Or is there any means to determine the purity and quality of steam (humidity) used in EtO gas...
  8. L

    Steam Sterilization Validation per ANSI ST 79

    Hello every one,:bigwave: I hope this is the correct spot to ask this question. I am preparing the steam sterilization validation. We plan to label the device with 132℃, 4min steam sterilization parameter per ANSI ST 79. But now I am confused with ISO 17665 about the approach to achieve SAL...
  9. ScottK

    Card used to indicate Sterilization Status - Australian Medical Device Question

    I have a card that is used to indicate sterilization status and a customer in Australia that wants some. So I’m looking into what it takes to sell them there. Here’s the gist…The cards are attached to trays to be sterilized. There are two swatches on the card. One turns color when the card...
  10. V

    SPC for Continuous Steam Sterilization Unit

    Hello everyone, I am working on continuous steam sterilization unit. We have one 8 ft long square chamber where we heat product (Powder) by transferring heat form the augar (Screw) which also push product form on end (Starting point) to other (Downstream). we also introduce steam in to the...
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