BS EN 16602-70-55:2015
Current
The latest, up-to-date edition.
Space product assurance. Microbiological examination of flight hardware and cleanrooms
Hardcopy , PDF
English
30-09-2015
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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
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).
| Committee |
ACE/68
|
| DocumentType |
Standard
|
| Pages |
64
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
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.
| Standards | Relationship |
| EN 16602-70-55:2015 | Identical |
| 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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