DIN EN 16602-70-56-2015 Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware English version EN 16602-70-56 2015《航天产品保证 飞行硬件的气相生物负荷减少 英文版本EN 16602-70-56-2.pdf

1、Dezember 2015DEUTSCHE NORM Preisgruppe 13DIN 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?“2353528www.din.deDIN EN 16602-70-56Raumfahrtproduktsicherung Reduktion

2、der Gesamtkeimzahl bei Dampfphase fr Flughardware;Englische Fassung EN 166027056:2015Space product assurance Vapour Phase Bioburden Reduction for Flight Hardware;English version EN 166027056:2015Assurance produit des projets spatiaux Rduction en phase gazeuse de la charge microbienne des matriels de

3、 vol;Version anglaise EN 166027056:2015Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 Berlin www.beuth.deGesamtumfang 27 SeitenDDIN-Normenausschuss Luft- und Raumfahrt (NL)DIN EN 16602-70-56:2015-12 2 Nationales Vorwort Dieses Dokument (EN 16602-70-56:2015) wurde vom Technischen Komitee CEN

4、/CLC/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). Diese

5、s Dokument (EN 16602-70-56:2015) basiert auf ECSS-Q-ST-70-56C. Dieses Dokument enthlt unter Bercksichtigung des DIN-Prsidialbeschlusses 1/2004 nur die englische Originalfassung von EN 16602-70-56:2015. Dieses Dokument wurde speziell zur Behandlung von Raumfahrtsystemen erarbeitet und hat daher Vorra

6、ng vor jeglicher Europischer Norm, da es denselben Anwendungsbereich hat, jedoch ber einen greren Geltungsbereich (z. B. Luft- und Raumfahrt) verfgt. DIN EN 16602-70-56:2015-12 3 Nationaler Anhang NA (informativ) 3 Begriffe und Abkrzungen 3.1 Begriffe aus anderen Normen Fr die Anwendung dieser Norm

7、gelten die Begriffe nach ECSS-S-ST-00-01. Fr die Anwendung dieser Norm gelten die folgenden Begriffe nach ECSS-M-ST-40, ECSS-Q-ST-70-01, ECSS-Q-ST-70-55 und ECSS-Q-ST-70-58: Keimbelastung Verringerung der Gesamtkeimzahl Sauberkeitsniveau Produktteil 3.2 Fr diese Norm spezifische Begriffe 3.2.1 biolo

8、gische Indikatoren lebensfhige Mikroorganismen, die gegen einen spezifischen Prozess einen definierten Widerstand leisten ANMERKUNG Der Prozess ist eine Wasserstoffperoxyd-Keimbelastungsverringerung. 3.2.2 kontrollierte Auenbedingungen 1 000 hPa Druck, Temperatur von 25 C bis 45 C und relative Luftf

9、euchte von 3 % bis 50 %, gemessen bei 35 C 3.2.3 kontrollierte Vakuumbedingungen Temperaturen von 25 C bis 45 C und Drcke von 1,3 hPa bis 13,3 hPa 3.2.4 Zyklus Abfolge einzelner Schritte ANMERKUNG Zum Zweck dieser Norm bestehen die einzelnen Schritte aus einer Prkonditionierung, einem Gesamt-keimzah

10、lverringerungs-CT-Wert und einer Entlftung. Jeder Schritt weist damit in Verbindung stehende Kontroll- und berwachungsparameter auf, wie zum Beispiel Zeit und Wasserstoffperoxydkonzentration. 3.2.5 exponierte Oberflchen interne und externe Oberflchen, auf denen ein freier Gasaustausch stattfinden ka

11、nn ANMERKUNG Beispiele: Ein freier Gasaustausch kann zum Beispiel auf den Auenoberflchen, den Innenoberflchen von Kisten mit Luftlchern, den Oberflchen der Bienenwabenzellen, den Oberflchen der ueren und inneren Lagen der mehrlagigen Isolation und dem offenen Zellschaum stattfinden. DIN EN 16602-70-

12、56:2015-12 4 3.2.6 Keimabttung ber das bliche Ma hinaus quivalent einer Keimbelastungsverringerung der 12. Grenordnung 3.2.7 parametrische Freigabe Erklrung, dass ein Produkt ein bestimmtes Keimbelastungsniveau aufweist, basierend auf Aufzeichnungen, die nachweisen, dass die Prozessparameter innerha

13、lb spezifizierter Toleranzen erbracht wurden ANMERKUNG Eine parametrische Freigabe kann fr das Erreichen einer Keimbelastungsverringerung mit Hitze verwendet werden (Temperatur- und Zeitaufzeichnung reichen aus, ein biologischer Test ist nicht erforderlich), sie ist aber nicht akzeptabel fr die Verw

14、endung von Chemikalien (eine biologische Prfung zur Prozessberwachung ist obligatorisch). 3.2.8 positive Kontrolle Prfung der Lebensfhigkeit der biologische Indikatoren und der Qualitt des Kulturmediums 3.3 Abkrzungen Fr die Anwendung dieser Norm gelten die Abkrzungen in ECSS-S-ST-00-01 und die folg

15、enden Abkrzungen: Abkrzung Bedeutung BIs biologische Indikatoren (en: biological indicators) cfu Kolonie-formende Einheit (en: colony forming unit) COSPAR Ausschuss fr Weltraumforschung (en: Committee on Space Research) Ct zeitintegrierte (Wasserstoffperoxyd-)Konzentration (en: time integrated (hydr

16、ogen peroxide) concentration) ESD elektrostatische Entladung (en: electrostatic discharge) L Liter (Volumen in kontrollierter Umgebung) (en: litre (volume in controlled environment) mg Milligramm (Wasserstoffperoxyd) (en: milligram (hydrogen peroxide) NCR Abweichungsbericht (en: nonconformance repor

17、t) sec Sekunden (en: seconds) EUROPEAN 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 produit des projets spatiaux - Rduction en phase gazeuse de la charge micr

18、obienne 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 with the CEN/CENELEC Internal Regulations which stipulate the conditions for

19、 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 exi

20、sts 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 mem

21、bers 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,

22、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 natio

23、nal Members and for CENELEC Members. Ref. No. EN 16602-70-56:2015 EEN 16602-70-56:2015 (E) 2 Table of contents European foreword 3 Introduction 3 1 Scope . 5 2 Normative references . 6 3 Terms and abbreviated terms 7 3.1 Terms from other standards 7 3.2 Terms specific to the present standard . 7 3.3

24、 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 cleanliness . 12 5.2.3 Product packaging 13 5.2.4 Product release . 13 5.3 Process requirements . 14 5.3.

25、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 (normative) Hydrogen peroxide bioburden reduction proposal - DRD 19 Annex C (normative) Hydrogen pero

26、xide bioburden reduction report - DRD . 21 Bibliography . 23 Figures Figure 4-1: Hydrogen peroxide bioburden reduction process overview . 11 DIN EN 16602-70-56:2015-12 EN 16602-70-56:2015 (E) 3 European foreword This document (EN 16602-70-56:2015) has been prepared by Technical Committee CEN/CLC/TC

27、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 publication of an identical text or by endorsement, at the latest by March 2016, and conflictin

28、g 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 not be held responsible for identifying any or all such patent rights. This document has

29、 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 over any EN covering the same scope but with a wider domain of applicability (e.g. : aeros

30、pace). 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, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Fran

31、ce, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 16602-70-56:2015-12 EN 16602-70-56:2015 (E) 4 Introduction The UN Outer S

32、pace 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 shall pursue studies of outer space, including the Moon and other celestial bodies, an

33、d 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 defin

34、ed 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 requirement

35、s on spaceflight missions according 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. DIN EN 16602-70-56:2015-12 EN

36、16602-70-56:2015 (E) 5 1 Scope This standard specifies procedures for the reduction of microbiological contamination of flight hardware using hydrogen peroxide vapour. The procedures specified in this standard cover: Reduction of microbiological contamination on exposed surfaces. Reduction of microb

37、iological contamination in controlled ambient and vacuum environments. This standard also specifies 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 fo

38、r the specific characteristics and constraints of a space project in conformance with ECSS-S-ST-00C. DIN EN 16602-70-56:2015-12 EN 16602-70-56:2015 (E) 6 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this E

39、CSS 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 indicated belo

40、w. 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 16601-40 ECSS-M-ST-40 Space project management - Configuration and information management EN 16602-10-09 ECSS-Q

41、-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 - Microbial examination of flight hardware and clea

42、nrooms 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 DIN EN 16602-70-56:2015-12 EN 16602-70-56:2015 (E) 7 3 Terms and abbreviat

43、ed 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-Q-ST-70-55 and ECSS-Q-ST-70-58 apply, and in particular the following:

44、Bioburden Bioburden reduction Cleanliness level Product 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 bioburden reduction. 3.2.2 controlled ambient conditi

45、ons 1000 hPa pressure, temperature from 25 C to 45 C and relative humidity from 3 % 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

46、individual steps are preconditioning, bioburden reduction Ct-value and venting. Each step has associated control and monitoring parameters like time and hydrogen peroxide vapour concentration. DIN EN 16602-70-56:2015-12 EN 16602-70-56:2015 (E) 8 3.2.5 exposed surfaces internal and external surfaces

47、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. 3.2.6 overkill equivalent to a 12 order of magnitude bi

48、oburden reduction 3.2.7 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 reduction with heat (temperature an

49、d time record sufficient, no need for biological test) but is not acceptable for bioburden reduction using chemicals (biological test for process monitoring is mandatory). 3.2.8 positive control testing the viability of biological indicators and the quality of the culture medium 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 BIs biological indicators cfu colony forming unit COSPAR Committee on Space Re