DIN EN 16602-70-55-2015 Space product assurance - Microbiological examination of flight hardware and cleanrooms English version EN 16602-70-55 2015《航天产品保证 飞行硬件和洁净室的微生物学检查 英文版本EN 16.pdf

1、Dezember 2015DEUTSCHE NORM Preisgruppe 22DIN Deutsches Institut fr Normung e. V. Jede Art der Vervielfltigung, auch auszugsweise, nur mit Genehmigung des DIN Deutsches Institut fr Normung e. V., Berlin, gestattet.ICS 49.140!%FF“2353527www.din.deDIN EN 16602-70-55Raumfahrtproduktsicherung Mikrobiolog

2、ische Prfung von Flughardware und Reinrumen;Englische Fassung EN 166027055:2015Space product assurance Microbiological examination of flight hardware and cleanrooms;English version EN 166027055:2015Assurance produit des projets spatiaux Examen microbiologique des matriels de vol et des salles blanch

3、es;Version anglaise EN 166027055:2015Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 Berlin www.beuth.deGesamtumfang 64 SeitenDDIN-Normenausschuss Luft- und Raumfahrt (NL)DIN EN 16602-70-55:2015-12 2 Nationales Vorwort Dieses Dokument (EN 16602-70-55:2015) wurde vom Technischen Komitee CEN/C

4、LC/TC 5 Raumfahrt“ erarbeitet, dessen Sekretariat vom DIN (Deutschland) gehalten wird. Das zustndige deutsche Normungsgremium ist der Arbeitsausschuss NA 131-06-02 AA Interoperabilitt von Informations-, Kommunikations- und Navigationssystemen“ im DIN-Normenausschuss Luft- und Raumfahrt (NL). Dieses

5、Dokument (EN 16602-70-55:2015) basiert auf ECSS-Q-ST-70-55C. Dieses Dokument enthlt unter Bercksichtigung des DIN-Prsidialbeschlusses 1/2004 nur die englische Originalfassung von EN 16602-70-55:2015. Dieses Dokument wurde speziell zur Behandlung von Raumfahrtsystemen erarbeitet und hat daher Vorrang

6、 vor jeglicher Europischer Norm, da es denselben Anwendungsbereich hat, jedoch ber einen greren Geltungsbereich (z. B. Luft- und Raumfahrt) verfgt. DIN EN 16602-70-55:2015-12 3 Nationaler Anhang NA (informativ) 3 Begriffe und Abkrzungen 3.1 Begriffe aus anderen Normen Fr die Anwendung dieser Norm ge

7、lten die Begriffe nach ECSS-S-ST-00-01. 3.2 Fr diese Norm spezifische Begriffe 3.2.1 Keimbelastung Menge lebensfhiger Mikroorganismen, gemessen mithilfe eines festgelegten Assays 3.2.2 Biodiversitt Identifizierung der Art der Mikroorganismen, gemessen mithilfe festgelegter Assays 3.2.3 anaerob Gas m

8、it 40 ppm O23.3 Abkrzungen Fr die Anwendung dieser Norm gelten die Abkrzungen in ECSS-S-ST-00-01 und die folgenden Abkrzungen: Abkrzung Bedeutung ASTM Amerikanische Gesellschaft fr Materialprfung (en: American Society for Testing and Materials) DNA Desoxyribonukleinsure (en: Desoxyribonucleic acid)

9、DNase Desoxyribonuklease (en: Deoxyribonuclease) IEST Institut fr Umweltwissenschaften und Technologie (en: Institute of Environmental Sciences and Technology) IPA Isopropylalkohol (en: Isopropylalcohol) ISO Internationale Organisation fr Normung (en: International Organization for Standardization)

10、PBS phosphatgepufferte Salzlsung (en: Phosphate buffered saline solution) PCR Polymerase-Kettenreaktion (en: Polymerase chain reaction) PDA Kartoffel-Dextrose-Agar (en: Potato Dextrose Agar) DIN EN 16602-70-55:2015-12 4 Abkrzung Bedeutung R2A ein nhrstoff-reduziertes bakterielles Agar-Medium (en: a

11、low nutrient bacterial medium with agar) rDNA Ribosomale DNA (en: Ribosomal DNA) RNase Ribonuklease (en: Ribonuclease) S Svedberg-Einheit (en: Svedberg unit) TE Tris-EDTA, Tris(hydroxymethyl)aminomethan-Ethylendiamintetraacetat (en: Tris-EDTA, 2-Amino-2-(hydroxymethyl)propane-1,3-diol ethylenediamin

12、etetraacetic acid) TSA Trypticase-Soja-Agar (en: Trypticase Soy Agar) TGA Thioglycolat-Agar (en: Thioglycollate Agar) EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16602-70-55 September 2015 ICS 49.140 English version Space product assurance - Microbiological examination of flight hardware an

13、d cleanrooms Assurance produit des projets spatiaux - Examen microbiologique des matriels de vol et des salles blanchesRaumfahrtproduktsicherung - Mikorbiologische Prfung von Flughardware und Reinrumen This European Standard was approved by CEN on 25 October 2014. CEN and CENELEC members are bound t

14、o 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-C

15、ENELEC 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-CENELE

16、C 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, Franc

17、e, 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

18、 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 EEN 16602-70-55:2015 (E) 2 Table of contents European foreword 4 Introduction 4 1 Scope . 6 2 Normative references . 7 3 Terms, definitions and abbre

19、viated terms 8 3.1 Terms defined in other standards . 8 3.2 Terms specific to the present standard . 8 3.3 Abbreviated terms. 8 4 Principles 10 5 Requirements 11 5.1 Specifying test 11 5.1.1 General provision 11 5.1.2 Specifying the test means . 11 5.1.3 Specifying the test procedure 12 5.2 Validati

20、on 13 5.3 Preparing and performing the microbiological examination . 13 5.3.1 General . 13 5.3.2 Preparing microbiological assays 13 5.3.3 Performing microbiological assays 13 5.3.4 Personnel 14 5.4 Recording and reporting the test results . 14 5.4.1 Test records 14 5.4.2 Test report 15 5.4.3 Accept

21、ance criteria and nonconformance . 15 Annex A (normative) Request for microbiological examination - DRD 16 Annex B (normative) Microbiological examination test specifications and procedures (Work Proposal) - DRD . 17 Annex C (normative) Microbiological examination test report - DRD 19 DIN EN 16602-7

22、0-55:2015-12 EN 16602-70-55:2015 (E) 3 Annex D (informative) Procedures for swab assays 21 Annex E (informative) Procedures for wipe assays . 38 Annex F (informative) Procedures for contact plates 56 Annex G (informative) Procedure for active air sampling . 58 Bibliography . 60 Figures Figure 4-1: M

23、icrobiological 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 (anaer

24、obic 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 (an

25、aerobic 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 DIN EN 16602-70-55:2015-12 EN 16602-70-55:2015 (E) 4 European foreword T

26、his document (EN 16602-70-55:2015) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-70-55:2015) originates from ECSS-Q-ST-70-55C. This European Standard shall be given the status of a national standard, either by publicat

27、ion of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be withdrawn at the latest by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall n

28、ot be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. This document has been developed to cover specifically space systems and has therefore precedence ove

29、r any EN covering the same scope but with a wider domain of applicability (e.g. : aerospace). According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus,

30、 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 the United Ki

31、ngdom. DIN EN 16602-70-55:2015-12 EN 16602-70-55:2015 (E) 5 Introduction The UN Outer Space Treaty of 1967 sets up the general principles applicable to the exploration and use of outer space. Article IX of the Outer Space Treaty constitutes the primary statement of international law: “States parties

32、 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, ado

33、pt 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 prot

34、ection 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 har

35、dware and controlled environments are in place to meet the planetary protection constraints. DIN EN 16602-70-55:2015-12 EN 16602-70-55:2015 (E) 6 1 Scope This standard defines test procedures for quantitative and/or qualitative microbiological examination of surfaces of flight hardware and in microb

36、iologically 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 determ

37、ination. 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

38、 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

39、 tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00. DIN EN 16602-70-55:2015-12 EN 16602-70-55:2015 (E) 7 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions

40、of this ECSS Standard. For dated references, subsequent amendments to, or revision of any of these publications do not apply, However, parties to agreements based on this ECSS Standard are encouraged to investigate the possibility of applying the more recent editions of the normative documents indic

41、ated below. For undated references, the latest edition of the publication referred to applies. 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-

42、20 Space product assurance - Quality assurance EN 16602-70-01 ECSS-Q-ST-70-01 Space product assurance - Cleanliness and contamination control DIN EN 16602-70-55:2015-12 EN 16602-70-55:2015 (E) 8 3 Terms, definitions and abbreviated terms 3.1 Terms defined in other standards For the purpose of this S

43、tandard, the terms and definitions from ECSS-S-ST-00-01 apply. 3.2 Terms specific to the present standard 3.2.1 bioburden quantity of viable microorganisms measured with a specified assay 3.2.2 biodiversity identification of type of microorganism, measured with specified assays 3.2.3 anaerobic gas w

44、ith 40 ppm O2 3.3 Abbreviated terms For the purpose of this Standard, the abbreviated terms from ECSS-S-ST-00-01 and the following apply: Abbreviation Meaning ASTM American Society for Testing and Materials DNA Desoxyribonucleic acid DNase Deoxyribonuclease IEST Institute of Environmental Sciences a

45、nd Technology IPA Isopropylalcohol ISO International Organization for Standardization PBS Phosphate buffered saline solution PCR Polymerase chain reaction PDA Potato Dextrose Agar DIN EN 16602-70-55:2015-12 EN 16602-70-55:2015 (E) 9 R2A A low nutrient bacterial medium with agar rDNA Ribosomal DNA RN

46、ase Ribonuclease S Svedberg unit TE Tris-EDTA, 2-Amino-2-(hydroxymethyl)propane-1,3-diol ethylenediaminetetraacetic acid TSA Trypticase Soy Agar TGA Thioglycollate Agar DIN EN 16602-70-55:2015-12 EN 16602-70-55:2015 (E) 10 4 Principles The activities related to microbial examination requirements, sp

47、ecifications, procedures and reports are described in Figure 4-1, and the related standardization requirements are captured in clause 5. Specifying test Preparing and performing testQuality RequirementsRecording and reporting test Work Proposal for microbiological examination (including test specifi

48、cation 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: Microbiological examination pro

49、cess overview Clause 5.1 provides the test specification. Clause 5.2 and 5.4 provide the requirements for preparing, performing, recording and reporting microbiological examination. The methods for bioburden determination are used to obtain an indication of the overall bioburden, but not for a general assessment of all microorganisms present in a sample. DIN EN 16602-70-55:2015-12 EN 16602-70-55:2015 (E) 11 5 Requirements 5.1 Specifying test 5.1.1 General provision a. The customer shall provide a request for microbiological