EN 16602-70-55-2015 en Space product assurance - Microbiological examination of flight hardware and cleanrooms《航天产品保证 飞行硬件和洁净室微生物学检验》.pdf

1、BSI Standards PublicationBS EN 16602-70-55:2015Space product assurance Microbiological examinationof flight hardware andcleanroomsBS EN 16602-70-55:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN16602-70-55:2015.The UK participation in its preparation was e

2、ntrusted to TechnicalCommittee ACE/68, Space systems and operations.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplicatio

3、n. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 86591 6ICS 49.140Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30

4、 September 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 16602-70-55:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16602-70-55 September 2015 ICS 49.140 English version Space product assurance - Microbiological examination of flight hardware and clea

5、nrooms 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 to comp

6、ly 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

7、 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 Mana

8、gement 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, Ger

9、many, 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 right

10、s 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 EBS EN 16602-70-55:2015EN 16602-70-55:2015 (E) 2 Table of contents European foreword 4 Introduction 4 1 Scope . 6 2 Normative references . 7 3 Terms, defin

11、itions and abbreviated 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、 12 5.2 Validation 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

13、 15 5.4.3 Acceptance criteria and nonconformance . 15 Annex A (normative) Request for microbiological examination - DRD 16 Annex B (normative) Microbiological examination test specifications andprocedures (Work Proposal) - DRD . 17 Annex C (normative) Microbiological examination test report - DRD 19

14、 BS EN 16602-70-55:2015EN 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 Fig

15、ure 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 assa

16、y 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 a

17、ssay 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 BS EN 16602-70-55:2015EN 16602-70-55:2015 (E) 4 European forew

18、ord This document (EN 16602-70-55:2015) has been prepared by TechnicalCommittee 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, eitherby publi

19、cation of an identical text or by endorsement, at the latest by March2016, and conflicting national standards shall be withdrawn at the latest byMarch 2016. Attention is drawn to the possibility that some of the elements of this documentmay be the subject of patent rights. CEN and/or CENELEC shall n

20、ot be heldresponsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by theEuropean Commission and the European Free Trade Association. This document has been developed to cover specifically space systems and hastherefore precedence over a

21、ny EN covering the same scope but with a widerdomain of applicability (e.g. : aerospace). According to the CEN-CENELEC Internal Regulations, the national standardsorganizations of the following countries are bound to implement this EuropeanStandard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech

22、 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 UnitedKingdom. 5 In

23、troduction The UN Outer Space Treaty of 1967 sets up the general principles applicable tothe exploration and use of outer space. Article IX of the Outer Space Treatyconstitutes the primary statement of international law: “States parties shall pursue studies of outer space, including the Moonand othe

24、r celestial bodies, and conduct exploration of them so as to avoidtheir harmful contamination and also adverse changes in theenvironment of the Earth resulting from the introduction ofextraterrestrial matter and, when necessary, adopt appropriate measuresfor this purpose”. Harmful contamination in t

25、hat sense is defined as biological contamination,including organic-constituents, to protect the environment in order to allowfuture exobiology research. The Committee On Space Research (COSPAR) hasestablished some planetary protection guidelines, based on the Outer SpaceTreaty. These guidelines impo

26、se requirements on spaceflight missionsaccording to target body/mission type combinations. The objective of this Standard is to ensure that the proper procedures forestablishing the microbiological contamination on flight hardware andcontrolled environments are in place to meet the planetary protect

27、ionconstraints. BS EN 16602-70-55:2015EN 16602-70-55:2015 (E) BS EN 16602-70-55:2015EN 16602-70-55:2015 (E) 6 1 Scope This standard defines test procedures for quantitative and/or qualitativemicrobiological examination of surfaces of flight hardware and inmicrobiologically controlled environments (e

28、.g. cleanroom surfaces, cleanroomair, isolator systems). The following test methods are described: Surface and air sampling and detection of biological contaminants withswabs, wipes, contact plates and air samplers, followed by cultivation forbioburden determination. Sampling of biological contamina

29、nts by DNA analysis from swabs andwipes. The test methods described in this standard apply to controlling themicrobiological contamination on all manned and unmanned spacecraft,launchers, payloads, experiments, ground support equipment, and cleanroomswith planetary protection constraints. This stand

30、ard does not address molecular contamination control. This standard does not address the principles and basic methodology forcontrolling cleanrooms and associated controlled environments withconstraints on particulate contamination. This standard may be tailored for the specific characteristic and c

31、onstrains of aspace project in conformance with ECSS-S-ST-00. 7 2 Normative references The following normative documents contain provisions which, throughreference in this text, constitute provisions of this ECSS Standard. For datedreferences, subsequent amendments to, or revision of any of these pu

32、blicationsdo not apply, However, parties to agreements based on this ECSS Standard areencouraged to investigate the possibility of applying the more recent editions ofthe normative documents indicated below. For undated references, the latestedition of the publication referred to applies. EN referen

33、ce 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 - C

34、leanliness and contamination control BS EN 16602-70-55:2015EN 16602-70-55:2015 (E) BS EN 16602-70-55:2015EN 16602-70-55:2015 (E) 8 3 Terms, definitions and abbreviated terms 3.1 Terms defined in other standards For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01apply. 3.

35、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 with 40 ppm O2 3.3 Abbreviated terms For the purpose of this Stand

36、ard, the abbreviated terms from ECSS-S-ST-00-01and the following apply: Abbreviation Meaning ASTM American Society for Testing and Materials DNA Desoxyribonucleic acid DNase Deoxyribonuclease IESTInstitute of Environmental Sciences and Technology IPA Isopropylalcohol ISO International Organization f

37、or Standardization PBS Phosphate buffered saline solution PCR Polymerase chain reaction PDA Potato Dextrose Agar 9 R2A A low nutrient bacterial medium with agar rDNA Ribosomal DNA RNase Ribonuclease S Svedberg unit TE Tris-EDTA, 2-Amino-2-(hydroxymethyl)propane-1,3-diol ethylenediaminetetraacetic ac

38、id TSA Trypticase Soy Agar TGA Thioglycollate Agar BS EN 16602-70-55:2015EN 16602-70-55:2015 (E) BS EN 16602-70-55:2015EN 16602-70-55:2015 (E) 10 4 Principles The activities related to microbial examination requirements, specifications,procedures and reports are described in Figure 4-1, and the rela

39、tedstandardization requirements are captured in clause 5. Specifying test Preparing andperforming testQuality RequirementsRecording andreporting test Work Proposal for microbiological examination(including test specification and procedure (Annex B) Microbiological examination results(including ident

40、ified deviations, if any)Report for microbiologicalexamination (Annex C) Request for microbiologicalexamination (Annex A) Customer approvalNCR (if anyidentified deviation)Figure 4-1: Microbiological examination process overview Clause 5.1 provides the test specification. Clause 5.2 and 5.4 provide t

41、he requirements for preparing, performing,recording and reporting microbiological examination. The methods for bioburden determination are used to obtain an indication ofthe overall bioburden, but not for a general assessment of all microorganismspresent in a sample. 11 5 Requirements 5.1 Specifying

42、 test 5.1.1 General provision a. The customer shall provide a request for microbiological examination inconformance with Annex A DRD. b. ECSS-Q-ST-20 shall be made applicable in the request for microbiologicalexamination. c. ECSS-Q-ST-10-09 shall be made applicable in the request formicrobiological

43、examination. d. For safety and security, the test centre shall comply with the “Safety andsecurity” requirements of ECSS-Q-ST-20-07. NOTE Examples of safety issues are hazard and health. Example of security issues is access control. e. Cleanliness and contamination control requirements according to

44、ECSS-Q-ST-70-01 shall be applied for space hardware. f. The supplier shall provide a microbiological examination proposal inconformance with Annex B DRD. NOTE 1 Quality standards for microbiological laboratoriesshould follow ISO 17025. NOTE 2 Additional specific requirements (e.g. avoidance ofcertai

45、n chemical functionalities) can be imposed bythe mission objectives. 5.1.2 Specifying the test means 5.1.2.1 Facilities a. The work area shall comply to the rules and guidelines of goodlaboratory practice. b. The ambient conditions for the process and work areas shall be(22 3) C with a relative humi

46、dity of (55 10) % unless otherwise stated. BS EN 16602-70-55:2015EN 16602-70-55:2015 (E) BS EN 16602-70-55:2015EN 16602-70-55:2015 (E) 12 5.1.2.2 Equipment, reagents and consumables a. The supplier shall identify and specify the list of the equipment, reagentsand consumables necessary to set up and

47、run the approved testprocedures. NOTE If the test procedures proposed in Annex D - Annex G are executed by the supplier, thecorresponding equipment, reagents andconsumables specification is described therein. 5.1.3 Specifying the test procedure 5.1.3.1 Test procedures a. Surfaces with an area of max

48、imal 25 cm2shall be sampled with swabsand surfaces with an area of maximal 1 m2shall be sampled with wipes. NOTE Multiple swabs and wipes can be used to sample alarger surface area. b. Bioburden shall be determined with assays for quantification of aerobicmesophilic bacteria. NOTE 1 Example procedur

49、es are given in Annex D.1, D.2., E.1 and E.2. NOTE 2 This sampling is only appropriate for materialsand material combinations (e.g. electrochemicalcompatibility, see ECSS-Q-ST-70-71) that cantolerate sample collection using damp materials. c. Biodiversity shall be determined with assays for determination of thetype of micro-organism. NOTE 1 Example procedures are given in Annexe D.2 to D.5 (swabs) and Annexes E.2 to E.5 (wipes). NOTE 2 In addition, non-culture-based methods are usedfor the molecular analysis of non-cultivablemicroorganisms with example procedures inAn