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EN 16602-70-55:2015

Current

Current

The latest, up-to-date edition.

Space product assurance - Microbiological examination of flight hardware and cleanrooms

Published date

23-09-2015

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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

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 environmentswith 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.

Committee
CEN/CLC/JTC 5
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

BS EN 16602-70-56:2015 Space product assurance. Vapour Phase Bioburden Reduction for Flight Hardware
I.S. EN 16602-70-58:2015 SPACE PRODUCT ASSURANCE - BIOBURDEN CONTROL OF CLEANROOMS
I.S. EN 16602-70-01:2014 SPACE PRODUCT ASSURANCE - CLEANLINESS AND CONTAMINATION CONTROL
BS EN 16602-70-58:2015 Space product assurance. Bioburden control of cleanrooms
I.S. EN 16602-70-53:2015 SPACE PRODUCT ASSURANCE - MATERIALS AND HARDWARE COMPATIBILITY TESTS FOR STERILIZATION PROCESSES
BS EN 16602-70-01:2014 Space product assurance. Cleanliness and contamination control
BS EN 16602-70-53:2015 Space product assurance. Materials and hardware compatibility tests for sterilization processes
EN 16602-70-53:2015 Space product assurance - Materials and hardware compatibility tests for sterilization processes
BS EN 16602-70-57:2015 Space product assurance. Dry Heat Bioburden Reduction for Flight Hardware
I.S. EN 16602-70-57:2015 SPACE PRODUCT ASSURANCE - DRY HEAT BIOBURDEN REDUCTION FOR FLIGHT HARDWARE
EN 16602-70-57:2015 Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware
EN 16602-70-58:2015 Space product assurance - Bioburden control of cleanrooms
EN 16602-70-56:2015 Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware
EN 16602-70-01:2014 Space product assurance - Cleanliness and contamination control
I.S. EN 16602-70-56:2015 SPACE PRODUCT ASSURANCE - VAPOUR PHASE BIOBURDEN REDUCTION FOR FLIGHT HARDWARE

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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