BS EN 16602-70-53-2015 Space product assurance Materials and hardware compatibility tests for sterilization processes《航天产品保证 灭菌过程用材料和硬件兼容性试验》.pdf

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1、BSI Standards PublicationBS EN 16602-70-53:2015Space product assurance Materials and hardwarecompatibility tests forsterilization processesBS EN 16602-70-53:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation ofEN 16602-70-53:2015.The UK participation in its preparat

2、ion was entrusted to Technical Committee 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 corre

3、ct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 86585 5 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 Strateg

4、y Committee on 31 January 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16602-70-53 January 2015 ICS 49.140 English version Space product assurance - Materials and hardware compatibility tests for sterilization pro

5、cesses Assurance produit des projets spatiaux - Essais de compatibilit des matriaux et matriels pour les processus de strilisation Raumfahrtproduktsicherung - Kompatibilittstests fr Material und Hardware in Sterilisationsprozessen This European Standard was approved by CEN on 18 October 2014. CEN an

6、d CENELEC members are bound to comply 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 obtaine

7、d on application to the CEN-CENELEC 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 a

8、nd notified to the CEN-CENELEC Management 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

9、 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 United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000

10、Brussels 2015 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 16602-70-53:2015 EBS EN 16602-70-53:2015Table of contents Foreword 6 Introduction 7 1 Scope . 8 2 Normative references . 10 3 Terms, defi

11、nitions and abbreviated terms 11 3.1 Terms from other standards 11 3.2 Terms specific to the present standard . 11 3.3 Abbreviated terms. 13 4 Principles 15 4.1 Introduction to sterilization processes . 15 4.1.1 Overview . 15 4.1.2 Dry heat 16 4.1.3 Beta or gamma radiation . 16 4.1.4 Chemical steril

12、ization 17 4.1.5 Steam sterilization . 18 4.1.6 Main methods used and studied in the field of space application 18 4.2 Potential effects on hardware caused by sterilization 19 4.2.1 Direct effects . 19 4.2.2 Indirect effects . 19 4.2.3 Long duration effects . 20 4.2.4 Technology risks . 20 4.3 Quali

13、fication approach 20 5 Requirements 22 5.1 Specifying test 22 5.1.1 General provision 22 5.1.2 Specifying the test means . 22 5.1.3 Specifying the test procedure 23 5.2 Preparing and performing test 24 5.2.1 General . 24 EN 16602-70-53:2015 (E)BS EN 16602-70-53:20155.2.2 Preparation of hardware 24 5

14、.2.3 Pre and post tests . 25 5.2.4 Sterilization test . 26 5.3 Recording and reporting the test results . 27 5.3.1 Test report 27 5.3.2 Test records 27 5.3.3 Acceptance criteria 27 Annex A (normative) Request for sterilization compatibility test - DRD. 29 A.1 DRD identification . 29 A.1.1 Requiremen

15、t identification and source document 29 A.1.2 Purpose and objective . 29 A.2 Expected response . 29 A.2.1 Scope and content 29 A.2.2 Special remarks 29 Annex B (normative) Sterilization compatibility test specifications and procedures (Work Proposal) - DRD . 30 B.1 DRD identification . 30 B.1.1 Requ

16、irement identification and source document 30 B.1.2 Purpose and objective . 30 B.2 Expected response . 30 B.2.1 Scope and content 30 B.2.2 Special remarks 31 Annex C (normative) Sterilization compatibility test report - DRD 32 C.1 DRD identification . 32 C.1.1 Requirement identification and source d

17、ocument 32 C.1.2 Purpose and objective . 32 C.2 Expected response . 32 C.2.1 Scope and content 32 C.2.2 Special remarks 33 Annex D (informative) Technology risks of sterilization 34 D.1 General . 34 D.2 Polymer (organic) materials 34 D.2.1 Dry heat sterilization 34 D.2.1.1. Overview 34 D.2.1.2. Temp

18、erature limit 34 D.2.1.3. Presence of air (oxidizing) . 35 D.2.1.4. Phase change materials 35 D.2.2 Hydrogen peroxide sterilization . 35 EN 16602-70-53:2015 (E)BS EN 16602-70-53:2015D.2.3 -Radiation sterilization . 36 D.3 Metallic materials 37 D.3.1 Dry heat sterilization 37 D.3.1.1. Precipitation h

19、ardened alloys 37 D.3.1.2. Low melting point 37 D.3.1.3. Memory shape alloys 37 D.3.2 Hydrogen peroxide sterilization . 37 D.3.2.1. Oxidation . 37 D.3.3 -Radiation sterilization . 38 D.4 Ceramic materials . 38 D.4.1 Dry heat sterilization 38 D.4.2 Hydrogen peroxide sterilization . 38 D.4.3 -Radiatio

20、n sterilization . 38 D.5 Lubricants . 38 D.5.1 Dry heat sterilization 38 D.5.2 Hydrogen peroxide sterilization . 38 D.5.3 -Radiation sterilization . 38 D.6 EEE components 39 D.6.1 Overview . 39 D.6.2 Dry heat sterilization 39 D.6.3 Hydrogen peroxide sterilization . 43 D.6.4 -radiation sterilization

21、47 D.7 Batteries . 50 D.7.1 Overview . 50 D.7.2 Dry heat sterilization 50 D.7.3 Hydrogen peroxide sterilization . 50 D.7.4 -Radiation sterilization . 50 D.8 Explosive devices . 50 D.8.1 Overview . 50 D.8.2 Dry heat sterilization 50 D.8.3 Hydrogen peroxide sterilization . 51 D.8.4 -Radiation steriliz

22、ation . 51 D.9 Solar cell assemblies 51 D.9.1 Overview . 51 D.9.2 Dry heat sterilization 51 D.9.3 Hydrogen peroxide sterilization . 51 D.9.4 -Radiation sterilization . 51 D.10 PCBs, populated . 51 D.10.1 Overview . 51 EN 16602-70-53:2015 (E)BS EN 16602-70-53:2015D.10.2 Dry heat sterilization 51 D.10

23、.3 Hydrogen peroxide sterilization . 52 D.10.4 -Radiation sterilization . 52 Bibliography . 53 Figures Figure 4-1: Sterilization parameters 15 Figure 4-2: Test procedure flow diagram for sterilization 21 Figure D-1 : Relative radiation stability of polymers (see ref 1) . 36 Tables Table 4-1:Time/tem

24、perature equivalences for SAL 10-616 Table 4-2: Main sterilization methods used for space missions 19 Table D-1 : Risk identification linked to dry heat sterilization 39 Table D-2 : Risk identification linked to hydrogen peroxide sterilization . 43 Table D-3 : Risk identification linked to -radiatio

25、n sterilization 47 EN 16602-70-53:2015 (E)BS EN 16602-70-53:2015Foreword This document (EN 16602-70-53:2015) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-70-53:2015) originates from ECSS-Q-ST-70-53C. This European Sta

26、ndard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by July 2015, and conflicting national standards shall be withdrawn at the latest by July 2015. Attention is drawn to the possibility that some of the elements of this

27、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. This document has been develo

28、ped 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 countries are bound to implem

29、ent 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, Poland, Portugal, Romania,

30、Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. EN 16602-70-53:2015 (E)BS EN 16602-70-53:2015Introduction A properly formulated and executed test program for all hardware elements that have to undergo sterilization is essential to guarantee their nominal performance an

31、d to prevent any immediate or long-term detrimental effects. The detrimental effects to be anticipated during sterilization depend on the applied process and include Direct effects: Materials degradation by heat, particulate and electromagnetic radiation, chemical interaction, cracking/fracture of m

32、aterials or assemblies due to dimensional changes by expansion, out or off-gassing, etc. Indirect effects: Change in crystallinity of materials, accelerated ageing (e.g. burn-in of components), heating due to radiation, generation of secondary radiation, re-contamination after out or off-gassing, et

33、c. Long-term effects: Generation of long-lived active centres (e.g. radicals) and subsequent post-degradation reactions, etc. The objective of this Standard is to ensure a successful mission by the definition of a test protocol and acceptance criteria for the determination of hardware compatibility

34、with sterilization processes. EN 16602-70-53:2015 (E)BS EN 16602-70-53:20151 Scope This Standard describes a test protocol to determine the compatibility of materials, components, parts, and assemblies with sterilization processes. It is dedicated to test on non-flight hardware only. Any additional

35、requirements that can be imposed by the potential use of test samples as flight hardware are not covered in this document (e.g. handling requirements). This Standard covers the following: Identification of critical test parameters to establish functional integrity of the hardware. Typical test proto

36、cols. Acceptance criteria. Statements about compatibility of materials and components with sterilization processes in this document are made in general terms only. Other factors for determination of whether a material or component is suitable for a particular mission system application include: The

37、potential number of sterilization cycles to which the material/component will be subjected in their live cycle. The additional stresses on materials/components introduced when they have become part of a larger unit/equipment/system undergoing sterilization. Compatibility of sterilization processes a

38、t e.g. materials level. This compatibility does not automatically guarantee that it will perform to its requirements in an assembly. The final application and possible interactions at higher assembly level are important considerations for qualification. Qualification of hardware achieved by specific

39、 sterilization parameters. They cannot be necessarily extrapolated to other sterilization parameters, not even within the same sterilization process. The drift in performance that can be induced by sterilization processes . This drift can cause equipments to fail to meet their specified performance

40、requirements, even though each individual element/component remains within spec. An example of this is where Select-on-test components are used to operate a component over a critically narrow range its full performance. To assess ultimately the suitability/compatibility of a material or component fo

41、r an application requires a full consideration of the impact of sterilization EN 16602-70-53:2015 (E)BS EN 16602-70-53:2015processes to which it is subjected during its whole life. This includes sterilization processes it undergoes from the time it is a standalone component/material right through to

42、 when it experiences final sterilization as part of the complete system. This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00. EN 16602-70-53:2015 (E)BS EN 16602-70-53:20152 Normative references The following normative docum

43、ents contain provisions which, through reference in this text, constitute provisions of this ECSS 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

44、the possibility of applying the more recent editions of the normative documents indicated below. 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 16602-10-09 ECSS-Q-

45、ST-10-09 Space product assurance Nonconformance control system EN 16602-20 ECSS-Q-ST-20 Space product assurance Quality assurance EN 16602-20-07 ECSS-Q-ST-20-07 Space product assurance Quality assurance for test centres EN 16602-70-53:2015 (E)BS EN 16602-70-53:20153 Terms, definitions and abbreviate

46、d terms 3.1 Terms from other standards For the purpose of this Standard, the terms and definitions from ECSS-ST-00-01 apply. 3.2 Terms specific to the present standard 3.2.1 direct effect change of an intrinsic materials property that is caused by the interaction with a process parameter during appl

47、ication of a sterilization process NOTE A direct effect might not be observed immediately after sterilization, but can be manifested over longer duration, see also long duration effect. 3.2.2 D-value, D10value time or dose required to achieve inactivation of 90 % of a population of the test micro-or

48、ganism under stated conditions ISO 11139 3.2.3 exposure time period for which the process parameters are maintained within their specified tolerances ISO 11139 3.2.4 indirect effect effect that is not manifested as change in an intrinsic materials property but is the consequence of secondary interac

49、tions NOTE Typical examples include molecular contamination during chemical sterilization, formation of radiolysis gas during -sterilization, bond breakage due to CTE mismatch during thermal sterilization. effect that is caused by the interaction with a non-process parameter after application of a sterilization process EN 16602-70-53:2015 (E)BS EN 16602-70-53:2015NOTE 1 A typical example is post degradation because of interaction of oxygen from air with active centres generated during the sterilization process. NOTE 2 An indirect