SIST EN 16602-70-53:2015
(Main)Space product assurance - Materials and hardware compatibility tests for sterilization processes
Space product assurance - Materials and hardware compatibility tests for sterilization processes
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 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 protocols.
• 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 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 at 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 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 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 for an application requires a full consideration of the impact of sterilization processes 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 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.
Raumfahrtproduktsicherung - Kompatibilitätstests für Material und Hardware in Sterilisationsprozessen
Assurance produit des projets spatiaux - Essais de compatibilité des matériaux et matériels pour les processus de stérilisation
La présente Norme décrit un protocole d'essai pour déterminer la compatibilité des matériaux, composants, pièces et assemblages avec les processus de stérilisation. Elle est dédiée aux essais sur des matériels non destinés au vol. Aucune des exigences supplémentaires pouvant être imposées par l'utilisation potentielle d'éprouvettes comme matériel de vol n'est abordée dans ce document (par exemple, les exigences de manipulation). La présente Norme couvre les points suivants :
• identification des paramètres d'essai critiques pour établir l'intégrité fonctionnelle du matériel ;
• protocoles d'essai types ;
• critères d'acceptabilité.
Les indications concernant la compatibilité des matériaux et composants avec les processus de stérilisation de ce document ne sont formulées qu'en termes généraux. Les autres facteurs servant à déterminer si un matériau ou composant est adapté à une application de système de mission particulière comprennent :
• le nombre potentiel de cycles de stérilisation auquel le matériau/composant sera soumis au cours de son cycle de vie ;
• les contraintes supplémentaires introduites sur les matériaux/composants lorsque ceux-ci font partie d'une unité/d'un équipement/d'un système soumis(e) à stérilisation ;
• la compatibilité des processus de stérilisation, au niveau des matériaux par exemple. Cette compatibilité ne garantit pas automatiquement une performance conforme aux exigences dans un assemblage. L'application finale et les interactions possibles à un niveau supérieur de l’assemblage représentent des considérations importantes pour la qualification ;
• la qualification du matériel obtenue au moyen de paramètres de stérilisation particuliers. Ceux-ci ne peuvent pas toujours être extrapolés à d'autres paramètres de stérilisation, même dans le cadre d'un processus de stérilisation identique ;
• les écarts de performance pouvant être causés par les processus de stérilisation. Ces écarts peuvent entraîner un non-respect par les équipements de leurs exigences de performance spécifiées, même si chaque élément/composant individuel reste dans les limites de la spécification. Ceci peut arriver, par exemple, quand des composants « SOT (Select-on-test) » sont utilisés pour faire fonctionner un composant sur une plage critique étroite de sa performance optimale.
Afin d'évaluer à terme l'adéquation/la compatibilité d'un matériau ou composant avec une application, il est nécessaire de prendre pleinement en compte l'impact des processus de stérilisation auquel ce matériau/composant sera soumis tout au long de sa vie. Ceci comprend les processus de stérilisation auxquels il est soumis à partir du moment où il est autonome, jusqu'au moment où il fait l'objet de la stérilisation finale dans le cadre du système complet.
La présente norme peut être adaptée aux caractéristiques et contraintes spécifiques d'un projet spatial, conformément à l'ECSS-S-ST-00.
Zagotavljanje varnih proizvodov v vesoljski tehniki - Preskušanje združljivosti materialov in strojne opreme za procese sterilizacije
Ta standard opisuje preskusni protokol za ugotavljanje združljivosti materialov, komponent, delov in sestavov s procesi sterilizacije. Namenjen je izključno preskušanju strojne opreme, ki ni namenjena letenju. Vse dodatne zahteve, ki jih je mogoče določiti s potencialno uporabo preskusnih vzorcev kot letalska strojna oprema, niso obravnavane v tem dokumentu (npr. zahteve glede ravnanja). Ta standard obravnava naslednje elemente: • identifikacijo kritičnih preskusnih parametrov, da se vzpostavi funkcionalna integriteta strojne opreme; • tipične preskusne protokole; • merila sprejemljivosti. Izjave o združljivosti materialov in komponent s procesi sterilizacije v tem dokumentu so podane samo na splošno. Med druge dejavnike za ugotavljanje, ali je material ali komponenta primerna za določeno uporabo v sistemu misije, spadajo: • potencialno število sterilizacijskih ciklov, ki jim bosta material/komponenta podvržena med življenjskim ciklom; • dodatne obremenitve uvedenih materialov/komponent, ko postanejo del večje enote/opreme/sistema, ki prestaja sterilizacijo; • združljivost procesov sterilizacije na npr. ravni materialov. Ta združljivost ne zagotavlja samodejno doseganja zahtev v sestavu. Končna uporaba in morebitni medsebojni vplivi na višji ravni sestava so pomembni premisleki za kvalifikacijo; • kvalifikacija strojne opreme, ki se doseže s posebnimi sterilizacijskimi parametri. Ni nujno, da jih je mogoče ekstrapolirati na druge sterilizacijske parametre, niti na parametre v okviru istega procesa sterilizacije; • odstopanje v lastnostih, ki ga lahko povzročijo procesi sterilizacije. Zaradi tega odstopanja lahko oprema ne dosega določenih zahtev glede zmogljivosti, čeprav vsak posamezni element/komponenta ostane znotraj specifikacij. Primer tega je, kadar se komponente za izbiro pri preskusu uporabljajo za upravljanje komponente v kritično ozkem razponu med celotnim delovanjem. Za končno oceno primernosti/združljivosti materiala ali komponente za določeno uporabo je treba v celoti upoštevati učinek procesov sterilizacije, ki jim je material ali komponenta podvržena med celotno življenjsko dobo. Sem spadajo procesi sterilizacije, ki jim je komponenta ali material podvržen od obdobja, ko deluje kot samostojna komponenta/material, do končne sterilizacije v okviru celotnega sistema. Ta standard se lahko prilagodi posameznim lastnostim in omejitvam vesoljskega projekta v skladu s standardom ECSS-S-ST-00.
General Information
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zagotavljanje varnih proizvodov v vesoljski tehniki - Preskušanje združljivosti materialov in strojne opreme za procese sterilizacijeRaumfahrtproduktsicherung - Kompatibilitätstests für Material und Hardware in SterilisationsprozessenAssurance produit des projets spatiaux - Essais de compatibilité des matériaux et matériels pour les processus de stérilisationSpace product assurance - Materials and hardware compatibility tests for sterilization processes49.140Vesoljski sistemi in operacijeSpace systems and operations11.080.99Drugi standardi v zvezi s sterilizacijo in dezinfekcijoOther standards related to sterilization and disinfectionICS:Ta slovenski standard je istoveten z:EN 16602-70-53:2015SIST EN 16602-70-53:2015en01-april-2015SIST EN 16602-70-53:2015SLOVENSKI
STANDARD
SIST EN 16602-70-53:2015
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16602-70-53
January 2015 ICS 49.140
English version
Space product assurance - Materials and hardware compatibility tests for sterilization processes
Assurance produit des projets spatiaux - Essais de compatibilité des matériaux et matériels pour les processus de stérilisation
Raumfahrtproduktsicherung - Kompatibilitätstests für Material und Hardware in Sterilisationsprozessen This European Standard was approved by CEN on 18 October 2014.
CEN and 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 obtained 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 and 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 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 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 E SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 2 Table of contents Foreword . 6 Introduction . 7 1 Scope . 8 2 Normative references . 10 3 Terms, definitions 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 sterilization . 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 Qualification 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 SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 3 5.2.2 Preparation of hardware . 24 5.2.3 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 Requirement 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 Requirement 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 document . 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. Temperature 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 SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 4 D.2.3 -Radiation sterilization . 36 D.3 Metallic materials . 37 D.3.1 Dry heat sterilization . 37 D.3.1.1. Precipitation hardened 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 -Radiation 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 . 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 sterilization . 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 SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 5 D.10.2 Dry heat sterilization . 51 D.10.3 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/temperature equivalences for SAL 10-6 . 16 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--radiation sterilization . 47
SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 6 Foreword 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 Standard 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 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 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 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, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 7 Introduction A properly formulated and executed test program for all hardware elements that have to undergo sterilization is essential to guarantee their nominal performance and 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 materials 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, etc. • 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 with sterilization processes.
SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 8 1 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 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 protocols. • 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 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 at 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 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 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 for an application requires a full consideration of the impact of sterilization SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 9 processes 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 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.
SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 10 2 Normative references The following normative documents 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 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-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
SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 11 3 Terms, definitions and abbreviated 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 application 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, D10 value time or dose required to achieve inactivation of 90 % of a population of the test micro-organism 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 interactions
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 SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 12 NOTE 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 effect might not be observed immediately after sterilization, but can be manifested over longer duration, see also ‘long duration effect’. 3.2.5 long duration effect direct or indirect effect that is not manifested immediately after sterilization or post materials investigation but only after longer duration NOTE 1 Typical examples are slow cross-linking of active centres and embrittlement of materials -sterilization or induced corrosion followed from chemical conversion after chemical sterilization. NOTE 2 The time period after which long-duration effects become observable is materials and process specific, it can be as quick as days or as slow as years. 3.2.6 micro-organism entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses [ISO 11139] 3.2.7 process parameter specified value for a process variable
NOTE
The specification for a sterilization process includes the process parameters and their tolerances. [ISO 11139] 3.2.8 sterility
state of being free from viable micro-organisms NOTE 1 In practice, no such absolute statement regarding the absence of micro-organisms can be proven. NOTE 2 The definition of sterility in the context of this standard refers to the achievement of a required sterility assurance level. [adapted from ISO 11139] 3.2.9 sterility assurance level probability of a single viable micro-organism occurring on an item after sterilization SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 13 NOTE
The term SAL takes a quantitative value, generally 10º\ or 10ºY. When applying this quantitative value to assurance of sterility, an SAL of 10º\ has a lower value but provides a greater assurance of sterility than an SAL of 10ºY. [ISO 11139] 3.2.10 sterilization validated process used to render product free from viable micro-organisms NOTE
In a sterilization process, the nature of microbial inactivation is exponential and thus the survival of a micro-organism on an individual item can be expressed in terms of probability. While this probability can be reduced to a very low number, it can never be reduced to zero. [ISO 11139] 3.2.11 sterilization process series of actions or operations needed to achieve the specified requirements for sterility NOTE
This series of actions includes pre-treatment of product (if necessary), exposure under defined conditions to the sterilizing agent and any necessary post treatment. The sterilization process does not include any cleaning, disinfection or packaging operations that precede sterilization. [ISO 11139] 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 CTE coefficient of thermal expansion DSM Deutsche Sammlung von Mikroorganismen (German Collection of Microorganisms) DML declared materials list DMPL declared mechanical parts list DPL declared process list EEE electrical, electronic, electromechanical ESCC European Space Components Coordination SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 14 ETFE ethylene tetrafluoroethylene ETO ethylene oxide GSE ground support equipment HDPE high density polyethylene IPA isopropyl alcohol ISO International Organization for Standardization LDPE low density polyethylene MIL-DTL military detail specification MIL-PRF military performance specification PCB printed circuit board PEEK polyetheretherketone PET polyethylene terephthalate PI polyimide POM polyoxymethylene PP polypropylene PPS polyphenylene sulfide PTFE polytetrafluoroethylene PUR polyurethane PVF polyvinyl fluoride OIT oxygen induction time OITP oxygen induction temperature SAL sterility assurance level UV ultraviolet
SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 15 4 Principles 4.1 Introduction to sterilization processes 4.1.1 Overview Sterilization is a process killing all microorganisms. If there are survivors it is a bioburden reduction method. Sterilization processes are qualified in terms of probability to find one reference microorganism after their application, using the common and most resistant organism with respect to the sterilization method, named the SAL (Sterility Assurance Level). Independently of the method used - radiation, heat, gas - the reduction of microorganisms in time is in general a logarithmic curve, and follows ideally a straight line in a log diagram (see Figure 4-1). The sterilization parameter typically used for each process is D10, the time necessary to divide the microbial population by a factor of ten (10% survivor, also commonly called 1 log reduction, or one decimal reduction). Knowing the initial population (for example 104 microorganisms) and the specification to reach (for example SAL 10-6, meaning one microorganism for 106 items, or a 10-6 probability to find one microorganism on an item), the duration/dose will be 10 x D10. A 6 log reduction is the typical SAL for medical applications. 0.0000010.000010.00010.0010.010.11101001000100001000001000000Time (heat, chemical, radiation)Population-6-5-4-3-2-10123456Log of survivors10% Survivors (1 log reduction)D10: Time to reduce the population by factor 10
Figure 4-1: Sterilization parameters SIST EN 16602-70-53:2015
EN 16602-70-53:2015 (E) 16 In the following clauses a selection of potential sterilization processes for space hardware are described. 4.1.2 Dry heat Dry heat is a bulk sterilization method. The effects of thermal sterilization on microorganisms depend on temperature, humidity and time. Typical parameters used for medical sterilization are given in Table 4-1. Qualified sterilization parameters to be used on flight hardware ca
...
SLOVENSKI STANDARD
kSIST FprEN 16602-70-53:2014
01-julij-2014
Zagotavljanje varnih proizvodov v vesoljski tehniki - Preskušanje združljivosti
materialov in strojne opreme za procese sterilizacije
Space product assurance - Materials and hardware compatibility tests for sterilization
processes
Raumfahrtproduktsicherung - Kompatibilitätstests für Material und Hardware in
Sterilisationsprozessen
Assurance produit des projets spatiaux - Essais de compatibilité des matériaux et
matériels pour les processus de stérilisation
Ta slovenski standard je istoveten z: FprEN 16602-70-53
ICS:
11.080.99 Drugi standardi v zvezi s Other standards related to
sterilizacijo in dezinfekcijo sterilization and disinfection
49.140 Vesoljski sistemi in operacije Space systems and
operations
kSIST FprEN 16602-70-53:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST FprEN 16602-70-53:2014
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kSIST FprEN 16602-70-53:2014
EUROPEAN STANDARD
FINAL DRAFT
FprEN 16602-70-53
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2014
ICS
English version
Space product assurance - Materials and hardware compatibility
tests for sterilization processes
Assurance produit des projets spatiaux - Essais de Raumfahrtproduktsicherung - Kompatibilitätstests für
compatibilité des matériaux et matériels pour les processus Material und Hardware in Sterilisationsprozessen
de stérilisation
This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical
Committee CEN/CLC/TC 5.
If this draft becomes a European Standard, CEN and 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.
This draft European Standard was established by CEN and CENELEC 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 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,
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© 2014 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. FprEN 16602-70-53:2014 E
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Members.
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Table of contents
Foreword . 6
Introduction . 7
1 Scope . 8
2 Normative references . 10
3 Terms, definitions 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 sterilization . 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 Qualification 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
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5.2.2 Preparation of hardware . 24
5.2.3 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 Requirement 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 Requirement 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 document . 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. Temperature 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
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D.2.3 γ-Radiation sterilization . 36
D.3 Metallic materials . 37
D.3.1 Dry heat sterilization . 37
D.3.1.1. Precipitation hardened 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 γ-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 γ-Radiation sterilization . 38
D.5 Lubricants . 38
D.5.1 Dry heat sterilization . 38
D.5.2 Hydrogen peroxide sterilization . 38
D.5.3 γ-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 γ-radiation sterilization . 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 γ-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 γ-Radiation sterilization . 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 γ-Radiation sterilization . 51
D.10 PCBs, populated . 51
D.10.1 Overview . 51
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D.10.2 Dry heat sterilization . 51
D.10.3 Hydrogen peroxide sterilization . 52
D.10.4 γ-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
-6
Table 4-1:Time/temperature equivalences for SAL 10 . 16
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 γ-radiation sterilization . 47
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Foreword
This document (FprEN 16602-70-53:2014) has been prepared by Technical
Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN
(Germany).
This document (FprEN 16602-70-53:2014) originates from ECSS-Q-ST-70-53C.
This document is currently submitted to the Unique Acceptance Procedure.
This document has been developed to cover specifically space systems and will
the-refore have precedence over any EN covering the same scope but with a
wider do-main of applicability (e.g. : aerospace).
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Introduction
A properly formulated and executed test program for all hardware elements
that have to undergo sterilization is essential to guarantee their nominal
performance and 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
materials 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, etc.
• 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 with sterilization processes.
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1
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 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 protocols.
• 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 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 at 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 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 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 for
an application requires a full consideration of the impact of sterilization
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processes 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 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.
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2
Normative references
The following normative documents 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 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-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
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3
Terms, definitions and abbreviated 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 application 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, D value
10
time or dose required to achieve inactivation of 90 % of a population of the test
micro-organism 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 interactions
NOTE Typical examples include molecular
contamination during chemical sterilization,
formation of radiolysis gas during γ-
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
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NOTE 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 effect might not be observed
immediately after sterilization, but can be
manifested over longer duration, see also ‘long
duration effect’.
3.2.5 long duration effect
direct or indirect effect that is not manifested immediately after sterilization or
post materials investigation but only after longer duration
NOTE 1 Typical examples are slow cross-linking of
active centres and embrittlement of materials
after γ-sterilization or induced corrosion
followed from chemical conversion after
chemical sterilization.
NOTE 2 The time period after which long-duration
effects become observable is materials and
process specific, it can be as quick as days or as
slow as years.
3.2.6 micro-organism
entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses
[ISO 11139]
3.2.7 process parameter
specified value for a process variable
NOTE The specification for a sterilization process
includes the process parameters and their
tolerances.
[ISO 11139]
3.2.8 sterility
state of being free from viable micro-organisms
NOTE 1 In practice, no such absolute statement
regarding the absence of micro-organisms can
be proven.
NOTE 2 The definition of sterility in the context of this
standard refers to the achievement of a
required sterility assurance level.
[adapted from ISO 11139]
3.2.9 sterility assurance level
probability of a single viable micro-organism occurring on an item after
sterilization
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NOTE The term SAL takes a quantitative value,
−6 −3
generally 10 or 10 . When applying this
quantitative value to assurance of sterility, an
−6
SAL of 10 has a lower value but provides a
−3
greater assurance of sterility than an SAL of 10 .
[ISO 11139]
3.2.10 sterilization
validated process used to render product free from viable micro-organisms
NOTE In a sterilization process, the nature of
microbial inactivation is exponential and thus
the survival of a micro-organism on an
individual item can be expressed in terms of
probability. While this probability can be
reduced to a very low number, it can never be
reduced to zero.
[ISO 11139]
3.2.11 sterilization process
series of actions or operations needed to achieve the specified requirements for
sterility
NOTE This series of actions includes pre-treatment of
product (if necessary), exposure under defined
conditions to the sterilizing agent and any
necessary post treatment. The sterilization
process does not include any cleaning,
disinfection or packaging operations that
precede sterilization.
[ISO 11139]
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
coefficient of thermal expansion
CTE
Deutsche Sammlung von Mikroorganismen
DSM
(German Collection of Microorganisms)
declared materials list
DML
declared mechanical parts list
DMPL
declared process list
DPL
electrical, electronic, electromechanical
EEE
European Space Components Coordination
ESCC
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ethylene tetrafluoroethylene
ETFE
ethylene oxide
ETO
ground support equipment
GSE
high density polyethylene
HDPE
isopropyl alcohol
IPA
International Organization for Standardization
ISO
low density polyethylene
LDPE
military detail specification
MIL-DTL
military performance specification
MIL-PRF
printed circuit board
PCB
polyetheretherketone
PEEK
polyethylene terephthalate
PET
polyimide
PI
polyoxymethylene
POM
polypropylene
PP
polyphenylene sulfide
PPS
polytetrafluoroethylene
PTFE
polyurethane
PUR
polyvinyl fluoride
PVF
oxygen induction time
OIT
oxygen induction temperature
OITP
sterility assurance level
SAL
ultraviolet
UV
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4
Principles
4.1 Introduction to sterilization processes
4.1.1 Overview
Sterilization is a process killing all microorganisms. If there are survivors it is a
bioburden reduction method. Sterilization processes are qualified in terms of
probability to find one reference microorganism after their application, using
the common and most resistant organism with respect to the sterilization
method, named the SAL (Sterility Assurance Level). Independently of the
method used - radiation, heat, gas - the reduction of microorganisms in time is
in general a logarithmic curve, and follows ideally a straight line in a log
diagram (see Figure 4-1). The sterilization parameter typically used for each
process is D10, the time necessary to divide the microbial population by a factor
of ten (10% survivor, also commonly called 1 log reduction, or one decimal
4
reduction). Knowing the initial population (for example 10 microorgani
...
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