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

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).

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.

Committee	ACE/68
DocumentType	Standard
Pages	64
PublisherName	British Standards Institution
Status	Current

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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BS EN 16602-70-55:2015

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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