• BS EN 16602-70-55:2015

    Current The latest, up-to-date edition.

    Space product assurance. Microbiological examination of flight hardware and cleanrooms

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-09-2015

    Publisher:  British Standards Institution

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

    European foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms, definitions and abbreviated terms
    4 Principles
    5 Requirements
    Annex A (normative) - Request for microbiological
            examination - DRD
    Annex B (normative) - Microbiological examination
            test specifications and procedures (Work Proposal)
            - DRD
    Annex C (normative) - Microbiological examination test
            report - DRD
    Annex D (informative) - Procedures for swab assays
    Annex E (informative) - Procedures for wipe assays
    Annex F (informative) - Procedures for contact plates
    Annex G (informative) - Procedure for active air sampling
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies test procedures for quantitative and/or qualitative microbiological examination of surfaces of flight hardware and in microbiologically controlled environments (e.g. cleanroom surfaces, cleanroom air, isolator systems).

    Scope - (Show below) - (Hide below)

    This standard defines test procedures for quantitative and/or qualitative microbiological examination of surfaces of flight hardware and in microbiologically controlled environments (e.g. cleanroom surfaces, cleanroom air, isolator systems).

    The following test methods are described:

    • Surface and air sampling and detection of biological contaminants with swabs, wipes, contact plates and air samplers, followed by cultivation for bioburden determination.

    • Sampling of biological contaminants by DNA analysis from swabs and wipes.

    The test methods described in this standard apply to controlling the microbiological contamination on all manned and unmanned spacecraft, launchers, payloads, experiments, ground support equipment, and cleanrooms with planetary protection constraints.

    This standard does not address molecular contamination control.

    This standard does not address the principles and basic methodology for controlling cleanrooms and associated controlled environments with constraints on particulate contamination.

    This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00.

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

    Committee ACE/68
    Document Type Standard
    Publisher British Standards Institution
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    ISO 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
    EN 16602-70-71:2016 Space product assurance - Materials, processes and their data selection
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    EN 16602-70-58:2015 Space product assurance - Bioburden control of cleanrooms
    EN 16601-00-01:2015 Space systems - Glossary of terms
    EN 16602-10-09:2014 Space product assurance - Nonconformance control system
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    EN 16602-70-53:2015 Space product assurance - Materials and hardware compatibility tests for sterilization processes
    EN 16602-70-01:2014 Space product assurance - Cleanliness and contamination control
    EN 16602-20:2014 Space product assurance - Quality assurance
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