EN 16602-70-55:2015

Space product assurance - Microbiological examination of flight hardware and cleanrooms

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.

Raumfahrtproduktsicherung - Mikorbiologische Prüfung von Flughardware und Reinräumen

Assurance produit des projets spatiaux - Examen microbiologique des matériels de vol et des salles blanches

Zagotavljanje varnih proizvodov v vesoljski tehniki - Mikrobiološka preiskava letalske strojne opreme in čistih prostorov

Ta standard določa preskusne postopke za kvantitativno in/ali kvalitativno mikrobiološko preiskavo površin letalske strojne opreme in v mikrobiološko nadzorovanih okoljih (npr. površine čistih prostorov, zrak v čistih prostorih, sistemi izolacije). Opisane so naslednje preskusne metode: • vzorčenje površin in zraka ter odkrivanje bioloških onesnaževal z brisi, stičnimi ploščami in vzorčevalniki zraka ter z naknadno kultivacijo za ugotavljanje biološke obremenitve; • vzorčenje bioloških onesnaževal na podlagi analize DNK brisov. Preskusne metode, opisane v tem standardu, se uporabljajo za nadzor mikrobiološke onesnaženosti vesoljskih plovil s posadko ali brez nje, lansirnikov, tovorov, poskusov, podporne opreme na tleh in čistih sob z omejitvami planetarne zaščite. Ta standard se ne nanaša na nadzor molekularne onesnaženosti. Ta standard se ne nanaša na načela in osnovno metodologijo za nadzor čistih sob in povezanih nadziranih okolij z omejitvami glede onesnaženosti z delci.  Ta standard se lahko prilagodi posameznim lastnostim in omejitvam vesoljskega projekta v skladu s standardom ECSS-S-ST-00.

General Information

• Status: Published
• Publication Date: 22-Sep-2015
• Withdrawal Date: 30-Mar-2016
• ICS: 49.140 - Space systems and operations
• Technical Committee: CEN/CLC/TC 5 - Space
• Drafting Committee: CEN/CLC/TC 5 - Space
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 15-Sep-2021
• Mandate: M/496 - Mandate addressed to CEN, CENELEC and ETSI to develop standardisation regarding space industry (Phase 3 of the process)
• Ref Project: SIST EN 16602-70-55:2015 - Space product assurance - Microbiological examination of flight hardware and cleanrooms

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Raumfahrtproduktsicherung - Mikorbiologische Prüfung von Flughardware und ReinräumenAssurance produit des projets spatiaux - Examen microbiologique des matériels de vol et des salles blanchesSpace product assurance - Microbiological examination of flight hardware and cleanrooms49.140Vesoljski sistemi in operacijeSpace systems and operations07.100.99Drugi standardi v zvezi z mikrobiologijoOther standards related to microbiologyICS:Ta slovenski standard je istoveten z:EN 16602-70-55:2015SIST EN 16602-70-55:2015en,fr,de01-november-2015SIST EN 16602-70-55:2015SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16602-70-55
September 2015 ICS 49.140
English version
Space product assurance - Microbiological examination of flight hardware and cleanrooms
Assurance produit des projets spatiaux - Examen microbiologique des matériels de vol et des salles blanches Raumfahrtproduktsicherung - Mikorbiologische Prüfung von Flughardware und Reinräumen This European Standard was approved by CEN on 25 October 2014.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2015 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 16602-70-55:2015 E SIST EN 16602-70-55:2015

Figures Figure 4-1: Microbiological examination process overview . 10 Figure D-1 : Flow chart for the standard swab assay (swab assay 1) . 21 Figure D-2 : Flow chart for swab assay 2. 24 Figure D-3 : Flow chart for swab assay 3. 26 Figure D-4 : Flow chart for swab assay 4. 29 Figure D-5 : Flow chart for swab assay 5 (anaerobic conditions from resuspension onwards) . 31 Figure E-1 : Flow chart for the standard wipe assay (wipe assay 1) . 39 Figure E-2 : Flow chart for wipe assay 2 . 42 Figure E-3 : Flow chart for wipe assay 3 . 44 Figure E-4 : Flow chart for wipe assay 4 . 47 Figure E-5 : Flow chart for wipe assay 5 (anaerobic conditions from resuspension onwards) . 50
Tables Table D-1 : Primers for amplification of 16S rDNA from Archaea, Bacteria and Fungi . 35 Table E-1 : Primers for amplification of 16S rDNA from Archaea, Bacteria and Fungi . 53
“States parties shall pursue studies of outer space, including the Moon and other celestial bodies, and conduct exploration of them so as to avoid their harmful contamination and also adverse changes in the environment of the Earth resulting from the introduction of extraterrestrial matter and, when necessary, adopt appropriate measures for this purpose”.
Harmful contamination in that sense is defined as biological contamination, including organic-constituents, to protect the environment in order to allow future exobiology research. The Committee On Space Research (COSPAR) has established some planetary protection guidelines, based on the Outer Space Treaty. These guidelines impose requirements on spaceflight missions according to target body/mission type combinations.
The objective of this Standard is to ensure that the proper procedures for establishing the microbiological contamination on flight hardware and controlled environments are in place to meet the planetary protection constraints. SIST EN 16602-70-55:2015

This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00. SIST EN 16602-70-55:2015

EN reference Reference in text Title EN 16601-00-01 ECSS-S-ST-00-01 ECSS system – Glossary of terms EN 16602-10-09 ECSS-Q-ST-10-09 Space product assurance – Nonconformance control system EN 16602-20 ECSS-Q-ST-20 Space product assurance - Quality assurance EN 16602-70-01 ECSS-Q-ST-70-01 Space product assurance - Cleanliness and contamination control
Abbreviation Meaning ASTM American Society for Testing and Materials DNA Desoxyribonucleic acid DNase Deoxyribonuclease IEST Institute of Environmental Sciences and Technology IPA Isopropylalcohol ISO International Organization for Standardization PBS Phosphate buffered saline solution PCR Polymerase chain reaction PDA Potato Dextrose Agar SIST EN 16602-70-55:2015

test Work Proposal for microbiological examination (including test specification and procedure (Annex B) Microbiological examination results (including identified deviations, if any)Report for microbiological examination (Annex C) Request for microbiological examination
(Annex A) Customer approvalNCR (if any identified deviation) Figure 4-1: Microb
...