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Checklist for Auditing Sterilization with Radiation Mobile App

The Checklist for Auditing Sterilization with Radiation mobile app serves for the evaluation of audit results. Every audit requirement should be evaluated separately. This checklist shall be used for assessment of operators of the corresponding sterilization facilities. Where sterile products are to be included in the company’s product spectrum, a sterilization assessment (including assessment of design and validation of sterilization processes) must be carried out based on at least one product file of a sterile product. For sterile products of risk class III, the documentation of design and validation must be examined. Where an assessment of sterilization procedures validation is necessary as a part of the QM assessment for medical products, the present checklist should be applied in case of radiation used as the sterilizing agent.

  • Lendlease
  • The Cooperative
  • PG&E
  • oxy
  • Red Bull
  • Mirvac

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Take a peek inside the Checklist for Auditing Sterilization with Radiation Mobile App

Included Features

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Included Fields

Customize to add, remove, or edit any of the fields below.

  • Ico textbox

    Ref:

  • Ico textbox

    Device:

  • Ico date

    Date:

  • Ico textbox

    Manufacturer:

  • Ico textbox

    Auditor:

  • Ico signature

    Signature:

  • Ico statictext

    Documentation

  • Ico statictext

    Have procedures for the design, validation, routine control and product release from sterilizatio...

  • Ico statictext

    Are all documents and records that are necessary according to ISO 11137-1 reviewed, approved and ...

  • Ico statictext

    Management Responsibility

  • Ico checkbox

    Are responsibilities and authorities for all the requirements of ISO 11137-1 specified and assign...

  • Ico checkbox

    Is there a contract agreement about the responsibilities and authorities, in case several organiz...

  • Ico statictext

    Product Realization

  • Ico checkbox

    Are procedures for purchasing, identification*) and traceability*) specified?

  • Ico checkbox

    Is a system for calibration of all equipment and testing instruments specified**)?

  • Ico checkbox

    Is the metrological aspect of the dosimetry traceable to national or international standards and ...

  • Ico statictext

    Measurement, Analysis and Improvement — Control Of Nonconforming Product

  • Ico checkbox

    Are procedures for the control of nonconforming products, corrections, corrective actions and pre...

  • Ico statictext

    (*) respective applicable parts of ISO 13485

  • Ico statictext

    (**) respective applicable parts of ISO 13485 or ISO 10012-1

  • Ico multiline

    Comments

  • Ico multiline

    Corrective Actions

  • Ico statictext

    Sterilizing Agent

  • Ico checkbox

    Has the type of radiation to be used been specified?

  • Ico checkbox

    For electrons or X-rays: has the energy of electrons been specified?

  • Ico checkbox

    Is the electron beam energy >10 MeV (accelerated electrons) resp.

  • Ico statictext

    Microbicidal Effectiveness

  • Ico checkbox

    (No normative requirements)

  • ...and More!

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