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

Status
Published
Public Enquiry End Date
30-Jul-2014
Publication Date
04-Mar-2015
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
19-Feb-2015
Due Date
26-Apr-2015
Completion Date
05-Mar-2015

Buy Standard

Standard
SIST EN 16602-70-53:2015 - BARVE na PDF-strani 17,38
English language
53 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

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

...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.