BS EN 16602-70-57-2015 Space product assurance Dry Heat Bioburden Reduction for Flight Hardware《航天产品保证 飞行硬件的干热微生物减少》.pdf

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1、BSI Standards PublicationBS EN 16602-70-57:2015Space product assurance DryHeat Bioburden Reduction forFlight HardwareBS EN 16602-70-57:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN16602-70-57:2015.The UK participation in its preparation was entrusted to T

2、echnicalCommittee 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 Britis

3、h Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 86648 7ICS 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 September 20

4、15.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 16602-70-57:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16602-70-57 September 2015 ICS 49.140 English version Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware Assurance produit d

5、es projets spatiaux - Rduction par chaleur sche de la charge microbienne des matriels de vol Raumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei trockener Hitze fr Flughardware This European Standard was approved by CEN on 16 November 2014. CEN and CENELEC members are bound to comply with t

6、he 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 Manageme

7、nt 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 Ce

8、ntre 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, Gre

9、ece, 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 expl

10、oitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 16602-70-57:2015 EBS EN 16602-70-57:2015EN 16602-70-57:2015 (E) 2 Table of contents European foreword 4 Introduction 4 1 Scope . 6 2 Normative references . 7 3 Terms and abbreviated

11、 terms 8 3.1 Terms from other standards 8 3.2 Terms specific to the present standard . 8 3.3 Abbreviated terms. 10 3.4 Nomenclature . 10 4 Principles 11 5 Requirements 13 5.1 General requirements . 13 5.2 Product requirements . 13 5.2.1 Product compatibility with process 13 5.2.2 Product cleanliness

12、 . 13 5.2.3 Product packaging 14 5.2.4 Product release . 14 5.3 Process requirements . 14 5.3.1 Procedure requirements 14 5.3.2 Bioburden reduction cycle requirements . 17 5.4 Equipment requirements . 17 Annex A (normative) Dry heat bioburden reduction specification - DRD 19 Annex B (normative) Dry

13、heat bioburden reduction proposal - DRD . 21 Annex C (normative) Dry heat bioburden reduction report - DRD 23 Annex D (informative) D-values for 2 to 3 orders of magnitude reduction 25 Annex E (informative) Effective D-values for 4 to 6 orders of magnitude reduction 27 BS EN 16602-70-57:2015EN 16602

14、-70-57:2015 (E) 3 Bibliography . 29 Figures Figure 4-1: Dry heat bioburden reduction process overview . 12 Figure D-1 : D-values for 2 to 3 orders of magnitude reduction. 25 Figure E-1 : Effective D-values for 4 to 6 orders of magnitude surface reduction 27 Tables Table D-1 : D-values for 2 to 3 ord

15、ers of magnitude reduction 26 Table E-1 : Effective D-values for 4 to 6 orders of magnitude surface reduction . 28 BS EN 16602-70-57:2015EN 16602-70-57:2015 (E) 4 European foreword This document (EN 16602-70-57:2015) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of w

16、hich is held by DIN. This standard (EN 16602-70-57:2015) originates from ECSS-Q-ST-70-57C. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be w

17、ithdrawn 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 not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate

18、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 over any EN covering the same scope but with a wider domain of applicability (e.g. : aerospace). According to the CEN-CEN

19、ELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, I

20、celand, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16602-70-57:2015EN 16602-70-57:2015 (E) 5 Introduction The UN Outer Space Treaty of 1967 sets up the gene

21、ral 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 shall pursue studies of outer space, including the Moon and other celestial bodies, and conduct exploration of them so as

22、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, incl

23、uding 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

24、to target body/mission type combinations. The objective of this Standard is to ensure that proper procedures for reducing the microbiological contamination on flight hardware are in place to meet the planetary protection constraints. BS EN 16602-70-57:2015EN 16602-70-57:2015 (E) 6 1 Scope This stand

25、ard defines procedures for the reduction of microbiological contamination of flight hardware using heat. The procedures described in this standard cover: Reduction of microbiological contamination on exposed surfaces, mated surfaces and encapsulated in materials. Reduction of microbiological contami

26、nation in dry, ambient and uncontrolled humidity environments. This standard also sets requirements for the conditioning of the flight hardware, bioburden reduction cycle development, and equipment to be used for applying a bioburden reduction procedure. This standard may be tailored for the specifi

27、c characteristics and constraints of a space project in conformance with ECSS-S-ST-00. BS EN 16602-70-57:2015EN 16602-70-57:2015 (E) 7 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this ECSS Standard. For d

28、ated 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 indicated below. For undated refe

29、rences, 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 16601-40 ECSS-M-ST-40 Space project management - Configuration and information management EN 16602-10-09 ECSS-Q-ST-10-09 Space pro

30、duct assurance - Nonconformances control system EN 16602-70-01 ECSS-Q-ST-70-01 Space product assurance - Cleanliness and contamination control 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-70-5

31、5 Space product assurance - Microbial examination of flight 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 progr

32、am BS EN 16602-70-57:2015EN 16602-70-57:2015 (E) 8 3 Terms and abbreviated terms 3.1 Terms from other standards For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01 apply. For the purpose of this Standard, the terms and definitions from ECSS-M-ST-40, ECSS-Q-ST-70-01, ECSS

33、-Q-ST-70-55 and ECSS-Q-ST-70-58 apply, and in particular the following: Bioburden Bioburden reduction Cleanliness level Product item 3.2 Terms specific to the present standard 3.2.1 ambient humidity absolute humidity of no more than 12 g/m3NOTE This is equivalent to 70 % relative humidity at 20 C an

34、d 1000 hPa pressure. 3.2.2 cycle sequence of individual steps NOTE For the purpose of this standard, the individual steps are preconditioning, heat-up, bioburden reduction as defined by the selected procedure, cool-down. Each steps has associated control and monitoring parameters like time and tempe

35、rature. 3.2.3 D-value time required to achieve inactivation of 90 % of a population of the test microorganisms under stated conditions BS EN 16602-70-57:2015EN 16602-70-57:2015 (E) 9 3.2.4 dry humidity absolute humidity of no more than 1,2 g/m3NOTE This is equivalent to 25 % relative humidity at 0 C

36、 and 1000 hPa pressure or to 7 % relative humidity at 20 C and 1000 hPa pressure 3.2.5 effective D-value used for bioburden reduction of 4 orders of magnitudes NOTE 1 Example: One effective D-value is 4 orders of magnitude reduction, 2 times effective D-value is 5 order of magnitude reduction, 3 tim

37、es effective D-value is 6 order of magnitude reduction. NOTE 2 Attention: There is a substantial difference in the time required between 3 orders of magnitude reduction and 4 orders of magnitude reduction. NOTE 3 Reason for the longer time period necessary for 4 orders of magnitude reduction is a su

38、b-population of typical cleanroom bioburden that is more resistant to heat than the average population. 3.2.6 encapsulated bioburden bioburden inside bulk non-metallic materials NOTE Examples: bioburden inside of paints, coatings, adhesives, inserts, ablative material. 3.2.7 exposed surfaces interna

39、l and external surfaces free for gas exchange NOTE Examples: Free for gas exchange are e.g., exterior surfaces, interior surfaces of boxes with venting holes, surfaces of honeycomb cells, surfaces of the outer and inner plies of multi-layer insulation, open cell foam. 3.2.8 mated bioburden surfaces

40、joined by fasteners rather than by adhesives 3.2.9 parametric release declaration that a product is at a certain bioburden level, based on records demonstrating that the process parameters were delivered within specified tolerances NOTE Parametric release can be used for achieving bioburden reductio

41、n with heat (temperature and time record sufficient, no need for biological test) but is not acceptable for BS EN 16602-70-57:2015EN 16602-70-57:2015 (E) 10 bioburden reduction using chemicals (biological test for process monitoring is mandatory). 3.2.10 uncontrolled humidity humidity level that is

42、either not measured or does not conform to ambient humidity or dry humidity 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 COSPAR Committee on Space Research ESD electrostatic discharge 3.4 Nomenclature

43、 The following nomenclature apply throughout this document: a. The word “shall” is used in this standard to express requirements. All the requirements are expressed with the word “shall”. b. The word “should” is used in this standard to express recommendations. All the recommendations are expressed

44、with the word “should”. NOTE It is expected that, during tailoring, all the recommendations in this document are either converted into requirements or tailored out. c. The words “may” and “need not” are used in this standard to express positive and negative permissions respectively. All the positive

45、 permissions are expressed with the word “may”. All the negative permissions are expressed with the words “need not”. d. The word “can” is used in this standard to express capabilities or possibilities, and therefore, if not accompanied by one of the previous words, it implies descriptive text. NOTE

46、 In ECSS “may” and “can” have a complete different meaning: “may” is normative (permission) and “can” is descriptive. e. The present and past tense are used in this standard to express statement of fact, and therefore they imply descriptive text. BS EN 16602-70-57:2015EN 16602-70-57:2015 (E) 11 4 Pr

47、inciples It is expected that every project specifies the high level planetary protection requirements (as needed). NOTE For example: for all ESA projects, those requirements are specified in ESSB-ST-U-001. The following series of ECSS standards describe the processes and procedures to respond to tho

48、se bioburden requirements: ECSS-Q-ST-70-56 together with the present standard describe the currently approved bioburden reduction processes, i.e. vapour hydrogen peroxide and dry heat, respectively. ECSS-Q-ST-70-58 describes how to operate a bioburden controlled environment, like a cleanroom, for th

49、e assembly and testing of bioburden controlled flight hardware. ECSS-Q-ST-70-55 describes how to measure the biological contamination on flight hardware and in bioburden controlled environments. ECSS-Q-ST-70-53 describes how to evaluate the material compatibility with different bioburden reduction processes. The activities related to dry heat bioburden reduction are shown in Figure 4-1. The related requirements are captured in clause 5. The process can be summarized as follows: The customer issues a “bioburden reduction specification” used as an input for the