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    I.S. EN ISO 10993-7:2008+AC:2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-02-2022

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Product release
    Annex A (normative) Evaluation of gas chromatograms
    Annex B (informative) Gas chromatographic determination for EO and ECH
    Annex C (informative) Flowchart and guidance for the application of this part of ISO 10993 series of standards to the determination of EO and ECH residuals in medical devices
    Annex D (informative) Factors influencing product residual
    Annex E (informative) Extraction conditions for determination of residual EO
    Annex F (informative) Rationale for the provisions of this part of ISO 10993
    Annex G (informative) Establishment of allowable limits for EO
    Annex H (informative) Establishment of allowable limits for ECH
    Annex I (informative) Establishment of allowable limits for EG
    Annex J (informative) Preparation of EO and ECH standards
    Annex K (informative) Ethylene oxide residue measuring methods
    Bibliography

    Abstract - (Show below) - (Hide below)

    This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released.

    General Product Information - (Show below) - (Hide below)

    Committee TC 194
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes
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