EN 16602-70-58-2015 en Space product assurance - Bioburden control of cleanrooms《航天产品保证 洁净室微生物控制》.pdf

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1、BSI Standards PublicationBS EN 16602-70-58:2015Space product assurance Bioburden control ofcleanroomsBS EN 16602-70-58:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 16602-70-58:2015.The UK participation in its preparation was entrusted to Technical Commit

2、tee ACE/68, Space systems and operations.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards

3、 Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 86590 9 ICS 49.140 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2015.Ame

4、ndments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 16602-70-58:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16602-70-58 September 2015 ICS 49.140 English version Space product assurance - Bioburden control of cleanrooms Assurance produit des projets spatiaux - C

5、ontrle de la charge microbienne des salles blanches Raumfahrtproduktsicherung - Kontrolle der Gesamtkeimzahl in Reinrumen This European Standard was approved by CEN on 25 October 2014. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condition

6、s 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 Management Centre or to any CEN and CENELEC member. This European Standar

7、d 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 Centre has the same status as the official versions. CEN and CENELE

8、C 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, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembo

9、urg, 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

10、national Members and for CENELEC Members. Ref. No. EN 16602-70-58:2015 EBS EN 16602-70-58:2015EN 16602-70-58:2015 (E) 2 Table of contents European foreword 5 Introduction 5 1 Scope . 7 2 Normative references . 8 3 Terms, definitions and abbreviated terms 9 3.1 Terms defined in other standards . 9 3.

11、2 Terms specific to the present standard . 9 3.3 Abbreviated terms. 11 4 Principles 12 5 Requirements 13 5.1 Bioburden control . 13 5.1.1 Formal system 13 5.1.2 Action and alert levels . 14 5.2 Operational requirements . 15 5.2.1 Cleanroom class . 15 5.2.2 Applicability of bioburden control . 16 5.2

12、.3 Restrictions . 16 5.2.4 Bioburden monitoring of cleanroom environment 17 5.2.5 Sampling plan . 17 5.2.6 Training . 19 5.2.7 Personnel 19 5.2.8 Cleanroom garments . 20 5.3 Cleanroom commissioning 20 Annex A (normative) Bioburden control formal system description - DRD. 21 A.1 DRD identification .

13、21 A.1.1 Requirement identification and source document 21 A.1.2 Purpose and objective . 21 A.2 Expected response . 21 BS EN 16602-70-58:2015EN 16602-70-58:2015 (E) 3 A.2.1 Scope and content 21 A.2.2 Special remarks 23 Annex B (normative) Request for cleanroom commissioning - DRD . 24 B.1 DRD identi

14、fication . 24 B.1.1 Requirement identification and source document 24 B.1.2 Purpose and objective . 24 B.2 Expected response . 24 B.2.1 Scope and content 24 B.2.2 Special remarks 24 Annex C (normative) Cleanroom commissioning specifications and procedures (Work Proposal) - DRD . 25 C.1 DRD identific

15、ation . 25 C.1.1 Requirement identification and source document 25 C.1.2 Purpose and objective . 25 C.2 Expected response . 25 C.2.1 Scope and content 25 C.2.2 Special remarks 26 Annex D (normative) Cleanroom commissioning report - DRD 27 D.1 DRD identification . 27 D.1.1 Requirement identification

16、and source document 27 D.1.2 Purpose and objective . 27 D.2 Expected response . 27 D.2.1 Scope and content 27 D.2.2 Special remarks 27 Annex E (informative) Cleanroom operation 28 E.1 Commissioning activities. 28 E.1.1 Elements . 28 E.2 Action and alert level events . 29 E.2.1 Investigation 29 E.2.2

17、 Sampling error 29 E.2.3 Inconclusive findings . 29 E.2.4 Microorganism Identity 30 E.2.5 Frequency . 30 E.3 Training programme . 30 E.3.1 Overview . 30 E.3.2 Training levels . 30 BS EN 16602-70-58:2015EN 16602-70-58:2015 (E) 4 E.3.3 Sampling and analysis 31 E.3.4 Training verification . 31 E.3.5 Tr

18、aining content 31 E.4 General guidelines for cleanroom design and operation . 31 E.4.1 Design; general . 31 E.4.2 Airflow . 32 E.4.3 Access 32 E.4.4 Layout design 33 E.4.5 Storage space . 33 E.4.6 Monitoring . 34 E.5 Operational guidelines 34 E.5.1 Surveillance 34 E.5.2 Communications . 34 E.5.3 Pac

19、kaging . 34 E.5.4 Flight hardware . 34 E.5.5 Maintenance . 34 E.5.6 Personnel access records . 35 E.5.7 Task planning 35 E.5.8 Garments 35 E.5.9 Microbiological laboratory 35 E.5.10 Cleanroom bioburden sampling. 35 E.5.11 Medical monitoring of personnel 35 E.5.12 Bioburden monitoring 36 E.5.13 Gowni

20、ng 36 E.5.14 Entering cleanroom . 38 E.5.15 Cleanroom cleaning 39 E.6 Cleanroom working disciplines . 40 E.6.1 Overview . 40 E.6.2 Access control . 41 E.6.3 Working practises . 42 Bibliography . 44 Figures Figure 4-1: (Bioburden Control in Cleanrooms) examination process overview 12 Figure E-1 : Cle

21、anroom environment schematic . 32 BS EN 16602-70-58:2015EN 16602-70-58:2015 (E) 5 European foreword This document (EN 16602-70-58:2015) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-70-58:2015) originates from ECSS-Q-S

22、T-70-58C. 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 withdrawn at the latest by March 2016. Attention is drawn to the possibility that

23、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 given to CEN by the European Commission and the European Free Trade Association.

24、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-CENELEC Internal Regulations, the national standards organizations of the following

25、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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway

26、, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16602-70-58:2015EN 16602-70-58:2015 (E) 6 Introduction The UN Outer Space Treaty of 1967 sets up the general principles applicable to the exploration and use of outer space. Article IX o

27、f 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 to avoid their harmful contamination and also adverse changes in the environment

28、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, including organic-constituents, to protect the environment in order to allow future e

29、xobiology 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 to target body/mission type combinations. The objective of this Standard is to en

30、sure that the proper procedures to control the microbiological contamination in controlled environments are in place to meet the planetary protection constraints. BS EN 16602-70-58:2015EN 16602-70-58:2015 (E) 7 1 Scope This standard establishes the principles and basic methodology for microbiologica

31、l control of cleanrooms and associated controlled environments with planetary protection constraints. This standard does not address: the microbiological contamination control of spaceflight hardware; molecular contamination control. Reference is made to other documents; fire and safety regulations;

32、 for these, see regulatory requirements and other national or local documentation. This standard does not lay down the methods for determining the microbiological and particulate cleanliness levels. Reference is made to other documents. This standard may be tailored for the specific characteristic a

33、nd constrains of a space project in conformance with ECSS-S-ST-00. BS EN 16602-70-58:2015EN 16602-70-58:2015 (E) 8 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this ECSS Standard. For dated references, sub

34、sequent 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 references, the latest e

35、dition 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-20 Space product assurance Quality assurance EN

36、16602-20-07 ECSS-Q-ST-20-07 Space product assurance Quality assurance for test centres EN 16602-70-55 ECSS-Q-ST-70-55 Space product assurance - Microbial Examination of Flight Hardware and Cleanrooms ISO 14644 part 1:1999 Cleanrooms and associated controlled environments - Part 1:Classification of a

37、ir cleanliness ISO 14644 part 2:2000 Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 BS EN 16602-70-58:2015EN 16602-70-58:2015 (E) 9 3 Terms, definitions and abbreviated terms 3.1 Terms defined in ot

38、her standards For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01 apply. 3.2 Terms specific to the present standard 3.2.1 action level level set by the user in the context of controlled environment, and associated to specific requirements in the case that it is exceeded

39、3.2.2 alert level level set by the user in the context of controlled environments, giving early warning of a drift from normal conditions, which, when exceeded, increased attention to the process is expected 3.2.3 aseptic state of being free from all living microorganisms (i.e. free of bioburden) NO

40、TE In practice, it is usually described as a probability. 3.2.4 biobarrier(s) barrier surrounding an item which prevents biological recontamination subsequent to microbial reduction procedures 3.2.5 bioburden quantity of viable microorganisms measured with a specified assay 3.2.6 bioburden controlle

41、d defined zone or facility in which bioburden is controlled by specified means 3.2.7 bioburden reduction process or processes used to reduce the viable microbial population on an item to an acceptable limit BS EN 16602-70-58:2015EN 16602-70-58:2015 (E) 10 3.2.8 biocontamination contamination of mate

42、rials, devices, individuals, surfaces, liquids, gases or air with viable particles 3.2.9 biodiversity identification of species of micro-organism, measured with specified assays 3.2.10 commissioning planned and documented series of inspections, adjustments and tests carried out systematically to set

43、 the installation into the specified technical operation 3.2.11 controlled environment defined zone in which contamination is controlled by specified means 3.2.12 disinfection a process which destroys vegetative forms of microorganisms NOTE Disinfection does not necessarily sterilize a surface or ob

44、ject. 3.2.13 formal system system of biocontamination control with established and documented procedures 3.2.14 occupancy states condition where the installation is complete with all services connected and functioning, but with no production equipment, materials or personnel present 3.2.15 occupancy

45、 states condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present 3.2.16 occupancy states condition where the installation is functioning in the specified manner, with the specified number o

46、f personnel present and working in the manner agreed upon 3.2.17 planetary protection policy and the technical implementations to prevent forward and backward contamination 3.2.18 sporicide substance capable of destroying bacterial spores BS EN 16602-70-58:2015EN 16602-70-58:2015 (E) 11 3.2.19 steri

47、le state of being free from all living microorganisms (i.e. free of bioburden) NOTE In practice, it is usually described as a probability. 3.2.20 sterilization validated process used to render product free from viable micro-organisms ISO 11139 3.3 Abbreviated terms For the purpose of this Standard,

48、the abbreviated terms from ECSS-S-ST-00-01 and the following apply: Abbreviation Meaning AIV assembly, integration, and verification CFU colony forming unit COSPAR Committee On Space Research DHMR dry heat microbial reduction ESA European Space Agency ESD electrostatic discharge EGSE electrical grou

49、nd support equipment FMECA failure mode effects and critical analysis GSE ground support equipment HEPA high efficiency particulate air HVAC heating, ventilation, air conditioning, and cooling IPA isopropyl alcohol (isopropanol) ISO International Organization for Standardization MGSE mechanical ground support equipment NASA National Aeronautics and Space Administration PP planetary protection WFI water for injection BS EN 16602-70-58:2015EN 16602-70-58:2015 (E) 12 4 Principles The activities related to requirements for bioburden control in cleanrooms, specifications,