1、BSI Standards PublicationBS EN 16602-70-56:2015Space product assurance Vapour Phase BioburdenReduction for Flight HardwareBS EN 16602-70-56:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN16602-70-56:2015.The UK participation in its preparation was entrusted
2、 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 correctapplication. The B
3、ritish Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 86643 2ICS 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 Septemb
4、er 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 16602-70-56:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16602-70-56 September 2015 ICS 49.140 English version Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware Assurance
5、produit des projets spatiaux - Rduction en phase gazeuse de la charge microbienne des matriels de vol Raumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei Dampfphase fr Flughardware This European Standard was approved by CEN on 16 November 2014. CEN and CENELEC members are bound to comply wi
6、th 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 Mana
7、gement 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 Managemen
8、t 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,
9、 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
10、exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 16602-70-56:2015 EBS EN 16602-70-56:2015EN 16602-70-56:2015 (E) 2 Table of contents European foreword 3 Introduction 3 1 Scope . 5 2 Normative references . 6 3 Terms and abbrevi
11、ated terms 7 3.1 Terms from other standards 7 3.2 Terms specific to the present standard . 7 3.3 Abbreviated terms. 8 3.4 Nomenclature . 9 4 Principles 10 5 Requirements 12 5.1 General requirements . 12 5.2 Product requirements . 12 5.2.1 Product compatibility with process 12 5.2.2 Product cleanline
12、ss . 12 5.2.3 Product packaging 13 5.2.4 Product release . 13 5.3 Process requirements . 14 5.3.1 Procedure requirements 14 5.3.2 Bioburden reduction cycle requirements . 15 5.4 Equipment requirements . 15 Annex A (normative) Hydrogen peroxide bioburden reduction specification - DRD 17 Annex B (norm
13、ative) Hydrogen peroxide bioburden reduction proposal - DRD 19 Annex C (normative) Hydrogen peroxide bioburden reduction report - DRD . 21 Bibliography . 23 Figures Figure 4-1: Hydrogen peroxide bioburden reduction process overview . 11 BS EN 16602-70-56:2015EN 16602-70-56:2015 (E) 3 European forewo
14、rd This document (EN 16602-70-56:2015) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-70-56:2015) originates from ECSS-Q-ST-70-56C. This European Standard shall be given the status of a national standard, either by publ
15、ication 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 sha
16、ll not 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
17、 over 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, Cyp
18、rus, 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 Unite
19、d Kingdom. BS EN 16602-70-56:2015EN 16602-70-56:2015 (E) 4 Introduction 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 sh
20、all pursue studies of outer space, including the Moonand other celestial bodies, and conduct exploration of them so as to avoidtheir harmful contamination and also adverse changes in the environmentof the Earth resulting from the introduction of extraterrestrial matterand, when necessary, adopt appr
21、opriate measures for this purpose.” Harmful contamination in that 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 gui
22、delines, based on the Outer SpaceTreaty. These guidelines impose requirements on spaceflight missionsaccording to target body/mission type combinations. The objective of this Standard is to ensure that proper procedures for reducingthe microbiological contamination on flight hardware are in place to
23、 meet theplanetary protection constraints. 5 1 Scope This standard specifies procedures for the reduction of microbiologicalcontamination of flight hardware using hydrogen peroxide vapour. The procedures specified in this standard cover: Reduction of microbiological contamination on exposed surfaces
24、. Reduction of microbiological contamination in controlled ambient andvacuum environments. This standard also specifies requirements for the conditioning of the flighthardware, bioburden reduction cycle development, and equipment to be usedfor applying a bioburden reduction procedure. This standard
25、may be tailored for the specific characteristics and constraints of aspace project in conformance with ECSS-S-ST-00C. BS EN 16602-70-56:2015EN 16602-70-56:2015 (E) BS EN 16602-70-56:2015EN 16602-70-56:2015 (E) 6 2 Normative references The following normative documents contain provisions which, throu
26、ghreference in this text, constitute provisions of this ECSS Standard. For datedreferences, subsequent amendments to, or revision of any of these publicationsdo not apply. However, parties to agreements based on this ECSS Standard areencouraged to investigate the possibility of applying the more rec
27、ent editions ofthe normative documents indicated below. For undated references, the latestedition 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 16601-40 ECSS-M-ST-40 Space project management - Configurat
28、ion and information management EN 16602-10-09 ECSS-Q-ST-10-09 Space product assurance - Nonconformance control system EN 16602-70-53 ECSS-Q-ST-70-53 Space product assurance - Materials and hardware compatibility tests for sterilization processes EN 16602-70-55 ECSS-Q-ST-70-55 Space product assurance
29、 - Microbial examination offlight hardware and cleanrooms EN 16602-70-58 ECSS-Q-ST-70-58 Space product assurance - Bioburden control of cleanrooms IEST-STD-CC1246D Institute of environmental science and technology - product cleanliness levels and contamination control program 7 3 Terms and abbreviat
30、ed terms 3.1 Terms from other standards For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01apply. For the purpose of this Standard, the terms and definitions from ECSS-M-ST-40,ECSS-Q-ST-70-01, ECSS-Q-ST-70-55 and ECSS-Q-ST-70-58 apply, and inparticular the following: Bio
31、burdenBioburden reductionCleanliness levelProduct item 3.2 Terms specific to the present standard 3.2.1 biological indicators viable microorganisms providing a defined resistance to a specific process NOTE The process is a hydrogen peroxide bioburdenreduction. 3.2.2 controlled ambient conditions 100
32、0 hPa pressure, temperature from 25 C to 45 C and relative humidity from3 % to 50 %, as measured at 35 C 3.2.3 controlled vacuum conditions temperature from 25 C to 45 C and pressure from 1,3 hPa to 13,3 hPa 3.2.4 cycle sequence of individual steps NOTE For the purpose of this standard, the individu
33、alsteps are preconditioning, bioburden reductionCt-value and venting. Each step has associatedcontrol and monitoring parameters like timeand hydrogen peroxide vapour concentration. BS EN 16602-70-56:2015EN 16602-70-56:2015 (E) BS EN 16602-70-56:2015EN 16602-70-56:2015 (E) 8 3.2.5 exposed surfaces in
34、ternal and external surfaces free for gas exchange NOTE Examples: Free for gas exchange are e.g.,exterior surfaces, interior surfaces of boxes withventing holes, surfaces of honeycomb cells,surfaces of the outer and inner plies of multi-layer insulation, open cell foam. 3.2.6 overkill equivalent to
35、a 12 order of magnitude bioburden reduction 3.2.7 parametric release declaration that a product is at a certain bioburden level, based on recordsdemonstrating that the process parameters were delivered within specifiedtolerances NOTE Parametric release can be used for achievingbioburden reduction wi
36、th heat (temperatureand time record sufficient, no need forbiological test) but is not acceptable forbioburden reduction using chemicals(biological test for process monitoring ismandatory). 3.2.8 positive control testing the viability of biological indicators and the quality of the culturemedium 3.3
37、 Abbreviated terms For the purpose of this Standard, the abbreviated terms from ECSS-S-ST-00-01and the following apply: Abbreviation Meaning BIs biological indicators cfu colony forming unit COSPAR Committee on Space Research Ct time integrated (hydrogen peroxide) concentration ESD electrostatic dis
38、charge L litre (volume in controlled environment) mg milligram (hydrogen peroxide) NCR nonconformance report sec seconds 9 3.4 Nomenclature The following nomenclature apply throughout this document: a. The word “shall” is used in this standard to express requirements. All therequirements are express
39、ed with the word “shall”. b. The word “should” is used in this standard to express recommendations.All the recommendations are expressed with the word “should”. NOTE It is expected that, during tailoring, all therecommendations in this document are eitherconverted into requirements or tailored out.
40、c. The words “may” and “need not” are used in this standard to expresspositive and negative permissions respectively. All the positivepermissions are expressed with the word “may”. All the negativepermissions are expressed with the words “need not”. d. The word “can” is used in this standard to expr
41、ess capabilities orpossibilities, and therefore, if not accompanied by one of the previouswords, it implies descriptive text. NOTE In ECSS “may” and “can” have a completedifferent meaning: “may” is normative(permission) and “can” is descriptive. e. The present and past tense are used in this standar
42、d to express statementof fact, and therefore they imply descriptive text. BS EN 16602-70-56:2015EN 16602-70-56:2015 (E) BS EN 16602-70-56:2015EN 16602-70-56:2015 (E) 10 4 Principles It is expected that every project specifies the high level planetary protectionrequirements (as needed). NOTE For exam
43、ple: for all ESA projects, thoserequirements are specified in ESSB-ST-U-001. The following series of ECSS standards describe the processes and proceduresto respond to those bioburden requirements: ECSS-Q-ST-70-57 together with the present standard describe thecurrently approved bioburden reduction p
44、rocesses, i.e. dry heat andvapour hydrogen peroxide, respectively. ECSS-Q-ST-70-58 describes how to operate a bioburden controlledenvironment, like a cleanroom, for the assembly and testing of bioburdencontrolled flight hardware. ECSS-Q-ST-70-55 describes how to measure the biological contaminationo
45、n flight hardware and in bioburden controlled environments. ECSS-Q-ST-70-53 describes how to evaluate the material compatibilitywith different bioburden reduction processes. The activities related to hydrogen peroxide bioburden reduction are shown inFigure 4-1. The related requirements are captured
46、in clause 5. The process canbe summarized as follows: The customer issues a “bioburden reduction specification” used as aninput for the supplier “work proposal for bioburden reduction”. Subject for customer approval the supplier prepares and performs theprocess taking as inputs the hardware requirin
47、g bioburden reduction, thequality requirements and the work proposal (output of the previousactivity). Then the supplier will record and produce a report by comparing theresults against the work proposal for bioburden reduction. Background information for using biological indicators can be found in
48、ISO11138. 11 Specifyingprocess Preparing andperforming processQuality RequirementsRecording andreporting process Work Proposal for the bioburden reductionincluding process description (Annex B) Bioburden reduction results(including identified deviations, if any)Bioburden reductionreport (Annex C) Bi
49、oburden reductionspecification (Annex A) Customer approvalNCR (if any identifieddeviation)HardwareBioburden reducedhardwareTask nInput to Task nOutput from Task n(and possible input to next Task)ActorNecessaryconditionLegend:SupplierSupplierSupplierSpecifyingbioburden requirementsCustomerFigure 4-1: Hydrogen peroxide bioburden reduction process overview BS EN 16602-70-56:2015EN 16602-70-56:2015 (E) BS EN 16602-70-56:2015EN 16602-70-56:2015 (E) 12 5 Requirements 5.1 General requirements a. The bioburden reduction agent shall be hydrogen peroxide vapour. b. The
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