SIST EN 16602-70-57:2015
(Main)Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware
Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware
This standard defines procedures for the reduction of microbiological contamination of flight hardware using heat.
The procedures described in this standard cover:
• Reduction of microbiological contamination on exposed surfaces, mated surfaces and encapsulated in materials.
• Reduction of microbiological contamination in dry, ambient and uncontrolled humidity environments.
This standard also sets requirements for the conditioning of the flight hardware, bioburden reduction cycle development, and equipment to be used for applying a bioburden reduction procedure.
This standard may be tailored for the specific characteristics and constraints of a space project in conformance with ECSS-S-ST-00.
Raumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei trockener Hitze für Flughardware
La présente norme spécifie les procédures relatives à la réduction de la contamination microbiologique du matériel de vol par utilisation de la chaleur.
Les procédures spécifiées dans la présente norme couvrent :
• la réduction de la contamination microbiologique sur les surfaces exposées, sur les surfaces de jointement et encapsulée dans les matériaux ;
• la réduction de la contamination microbiologique dans des milieux secs, ambiants et à humidité non contrôlée.
La présente norme spécifie également les exigences pour le conditionnement du matériel de vol, le développement de cycles de réduction de la charge microbienne et l'équipement à utiliser pour l'application de procédures de réduction de la charge microbienne.
La présente norme peut être adaptée aux caractéristiques et contraintes spécifiques d'un projet spatial, conformément à la norme ECSS-S-ST-00.
Assurance produit des projets spatiaux - Réduction par chaleur sèche de la charge microbienne des matériels de vol
Zagotavljanje varnih proizvodov v vesoljski tehniki - Zmanjšanje biološke obremenitve s suho vročino za letalsko strojno opremo
Ta standard določa postopke za zmanjšanje mikrobiološke onesnaženosti letalske strojne opreme s toploto. Postopki, opisani v tem standardu, vključujejo: • zmanjšanje mikrobiološke onesnaženosti izpostavljenih površin, matiranih površin in v materialih; • zmanjšanje mikrobiološke onesnaženosti v suhih, zunanjih in nenadzorovanih vlažnih okoljih. Ta standard določa tudi zahteve za staranje letalske strojne opreme, razvoj cikla zmanjševanja biološke obremenitve in opremo za izvajanje postopka zmanjšanja biološke obremenitve. 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.ELRORãNHRaumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei trockener Hitze für FlughardwareAssurance produit des projets spatiaux - Réduction par chaleur sèche de la charge microbienne des matériels de volSpace product assurance - Dry Heat Bioburden Reduction for Flight Hardware49.140Vesoljski sistemi in operacijeSpace systems and operationsICS:Ta slovenski standard je istoveten z:EN 16602-70-57:2015SIST EN 16602-70-57:2015en,fr,de01-november-2015SIST EN 16602-70-57:2015SLOVENSKI
STANDARD
SIST EN 16602-70-57:2015
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16602-70-57
September 2015 ICS 49.140
English version
Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware
Assurance produit des projets spatiaux - Réduction par chaleur sèche de la charge microbienne des matériels de vol
Raumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei trockener Hitze für Flughardware This European Standard was approved by CEN on 16 November 2014.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for 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 16602-70-57:2015 E SIST EN 16602-70-57:2015
EN 16602-70-57:2015 (E) 2 Table of contents European foreword . 4 Introduction . 4 1 Scope . 6 2 Normative references . 7 3 Terms and abbreviated terms . 8 3.1 Terms from other standards . 8 3.2 Terms specific to the present standard . 8 3.3 Abbreviated terms. 10 3.4 Nomenclature . 10 4 Principles . 11 5 Requirements . 13 5.1 General requirements . 13 5.2 Product requirements . 13 5.2.1 Product compatibility with process . 13 5.2.2 Product cleanliness . 13 5.2.3 Product packaging . 14 5.2.4 Product release . 14 5.3 Process requirements . 14 5.3.1 Procedure requirements . 14 5.3.2 Bioburden reduction cycle requirements . 17 5.4 Equipment requirements . 17 Annex A (normative) Dry heat bioburden reduction specification - DRD . 19 Annex B (normative) Dry heat bioburden reduction proposal - DRD . 21 Annex C (normative) Dry heat bioburden reduction report - DRD . 23 Annex D (informative) D-values for 2 to 3 orders of magnitude reduction . 25 Annex E (informative) Effective D-values for 4 to 6 orders of magnitude reduction . 27 SIST EN 16602-70-57:2015
EN 16602-70-57:2015 (E) 3 Bibliography . 29
Figures Figure 4-1: Dry heat bioburden reduction process overview . 12 Figure D-1 : D-values for 2 to 3 orders of magnitude reduction. 25 Figure E-1 : Effective D-values for 4 to 6 orders of magnitude surface reduction . 27
Tables Table D-1 : D-values for 2 to 3 orders of magnitude reduction . 26 Table E-1 : Effective D-values for 4 to 6 orders of magnitude surface reduction . 28
SIST EN 16602-70-57:2015
EN 16602-70-57:2015 (E) 4 European foreword This document (EN 16602-70-57:2015) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-70-57:2015) originates from ECSS-Q-ST-70-57C. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be withdrawn at the latest by March 2016. Attention is drawn to the possibility that 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 16602-70-57:2015
EN 16602-70-57:2015 (E) 5 Introduction The UN Outer Space Treaty of 1967 sets up the general principles applicable to the exploration and use of outer space. Article IX of the Outer Space Treaty constitutes the primary statement of international law:
“States parties shall pursue studies of outer space, including the Moon and other celestial bodies, and conduct exploration of them so as to avoid their harmful contamination and also adverse changes in the environment of the Earth resulting from the introduction of extraterrestrial matter and, when necessary, adopt appropriate measures for this purpose.”
Harmful contamination in that sense is defined as biological contamination, including organic-constituents, to protect the environment in order to allow future exobiology research. The Committee On Space Research (COSPAR) has established some planetary protection guidelines, based on the Outer Space Treaty. These guidelines impose requirements on spaceflight missions according to target body/mission type combinations.
The objective of this Standard is to ensure that proper procedures for reducing the microbiological contamination on flight hardware are in place to meet the planetary protection constraints. SIST EN 16602-70-57:2015
EN 16602-70-57:2015 (E) 6 1 Scope This standard defines procedures for the reduction of microbiological contamination of flight hardware using heat. The procedures described in this standard cover: • Reduction of microbiological contamination on exposed surfaces, mated surfaces and encapsulated in materials. • Reduction of microbiological contamination in dry, ambient and uncontrolled humidity environments. This standard also sets requirements for the conditioning of the flight hardware, bioburden reduction cycle development, and equipment to be used for applying a bioburden reduction procedure. This standard may be tailored for the specific characteristics and constraints of a space project in conformance with ECSS-S-ST-00. SIST EN 16602-70-57:2015
EN 16602-70-57:2015 (E) 7 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 16601-40 ECSS-M-ST-40 Space project management - Configuration and information management EN 16602-10-09 ECSS-Q-ST-10-09 Space product assurance - Nonconformances control system EN 16602-70-01 ECSS-Q-ST-70-01 Space product assurance - Cleanliness and contamination control EN 16602-70-53 ECSS-Q-ST-70-53 Space product assurance - Materials and hardware compatibility tests for sterilization processes EN 16602-70-55 ECSS-Q-ST-70-55 Space product assurance - Microbial examination of flight hardware and cleanrooms EN 16602-70-58 ECSS-Q-ST-70-58 Space product assurance - Bioburden control of cleanrooms
IEST-STD-CC1246D Institute of environmental science and technology - product cleanliness levels and contamination control program
SIST EN 16602-70-57:2015
EN 16602-70-57:2015 (E) 8 3 Terms and abbreviated terms 3.1 Terms from other standards For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01 apply. For the purpose of this Standard, the terms and definitions from ECSS-M-ST-40, ECSS-Q-ST-70-01, ECSS-Q-ST-70-55 and ECSS-Q-ST-70-58 apply, and in particular the following: Bioburden Bioburden reduction Cleanliness level Product item 3.2 Terms specific to the present standard 3.2.1 ambient humidity absolute humidity of no more than 12 g/m3
NOTE
This is equivalent to 70 % relative humidity at 20 °C and 1000 hPa pressure. 3.2.2 cycle sequence of individual steps
NOTE
For the purpose of this standard, the individual steps are preconditioning, heat-up, bioburden reduction as defined by the selected procedure, cool-down. Each steps has associated control and monitoring parameters like time and temperature. 3.2.3 D-value time required to achieve inactivation of 90 % of a population of the test microorganisms under stated conditions SIST EN 16602-70-57:2015
EN 16602-70-57:2015 (E) 9 3.2.4 dry humidity absolute humidity of no more than 1,2 g/m3
NOTE
This is equivalent to 25 % relative humidity at 0 °C and 1000 hPa pressure or to 7 % relative humidity at 20 °C and 1000 hPa pressure 3.2.5 effective D-value used for bioburden reduction of ≥ 4 orders of magnitudes
NOTE 1 Example: One effective D-value is 4 orders of magnitude reduction, 2 times effective D-value is 5 order of magnitude reduction, 3 times effective D-value is 6 order of magnitude reduction. NOTE 2 Attention: There is a substantial difference in the time required between 3 orders of magnitude reduction and 4 orders of magnitude reduction. NOTE 3 Reason for the longer time period necessary for ≥ 4 orders of magnitude reduction is a sub-population of typical cleanroom bioburden that is more resistant to heat than the average population. 3.2.6 encapsulated bioburden bioburden inside bulk non-metallic materials NOTE
Examples: bioburden inside of paints, coatings, adhesives, inserts, ablative material. 3.2.7 exposed surfaces internal and external surfaces free for gas exchange NOTE
Examples: Free for gas exchange are e.g., exterior surfaces, interior surfaces of boxes with venting holes, surfaces of honeycomb cells, surfaces of the outer and inner plies of multi-layer insulation, open cell foam. 3.2.8 mated bioburden surfaces joined by fasteners rather than by adhesives 3.2.9 parametric release declaration that a product is at a certain bioburden level, based on records demonstrating that the process parameters were delivered within specified tolerances NOTE
Parametric release can be used for achieving bioburden reduction with heat (temperature and time record sufficient, no need for biological test) but is not acceptable for SIST EN 16602-70-57:2015
EN 16602-70-57:2015 (E) 10 bioburden reduction using chemicals (biological test for process monitoring is mandatory). 3.2.10 uncontrolled humidity humidity level that is either not measured or does not conform to ambient humidity or dry humidity 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 COSPAR Committee on Space Research ESD electrostatic discharge
3.4 Nomenclature The following nomenclature apply throughout this document: a. The word “shall” is used in this standard to express requirements. All the requirements are expressed with the word “shall”. b. The word “should” is used in this standard to express recommendations. All the recommendations are expressed with the word “should”. NOTE
It is expected that, during tailoring, all the recommendations in this document are either converted into requirements or tailored out. c. The words “may” and “need not” are used in this standard to express positive and negative permissions respectively. All the positive permissions are expressed with the word “may”. All the negative permissions are expressed with the words “need not”. d. The word “can” is used in this standard to express capabilities or possibilities, and therefore, if not accompanied by one of the previous words, it implies descriptive text. NOTE
In ECSS “may” and “can” have a complete different meaning: “may” is normative (permission) and “can” is descriptive. e. The present and past tense are used in this standard to express statement of fact, and therefore they imply descriptive text. SIST EN 16602-70-57:2015
EN 16602-70-57:2015 (E) 11 4 Principles It is expected that every project specifies the high level planetary protection requirements (as needed). NOTE
For example: for all ESA projects, those requirements are specified in ESSB-ST-U-001.
The following series of ECSS standards describe the processes and procedures to respond to those bioburden requirements: • ECSS-Q-ST-70-56 together with the present standard describe the currently approved bioburden reduction processes, i.e. vapour hydrogen peroxide and dry heat, respectively. • ECSS-Q-ST-70-58 describes how to operate a bioburden controlled environment, like a cleanroom, for the assembly and testing of bioburden controlled flight hardware.
• ECSS-Q-ST-70-55 describes how to measure the biological contamination on flight hardware and in bioburden controlled environments. • ECSS-Q-ST-70-53 describes how to evaluate the material compatibility with different bioburden reduction processes.
The activities related to dry heat bioburden reduction are shown in Figure 4-1. The related requirements are captured in clause 5. The process can be summarized as follows: • The customer issues a “bioburden reduction specification” used as an input for the supplier “work proposal for bioburden reduction”. • Subject for customer approval the supplier prepares and performs the process taking as inputs the hardware requiring bioburden reduction, the quality requirements and the work proposal (output of the previous activity). • Then the supplier will record and produce a report by comparing the results against the work proposal for bioburden reduction.
Background information for using heat for bioburden reduction and the use of biological indicators for such a process can be found in ISO 20857 and ISO 11138. SIST EN 16602-70-57:2015
EN 16602-70-57:2015 (E) 12 Specifying process Preparing and performing process, including process verificationQuality RequirementsRecording and reporting process Work Proposal for the bioburden reduction including process description (Annex B) Bioburden reduction results (including identified deviations, if any)Bioburden reduction report (Annex C) Bioburden reduction specification (Annex A) Customer approvalNCR (if any identified deviation)HardwareBioburden reduced hardwareTask nInput to Task nOutput from Task n(and possible input to next Task)ActorNecessary conditionLegend:SupplierSupplierSupplierSpecifying bioburden requirementsCustomer Figure 4-1: Dry heat bioburden reduction process overview SIST EN 16602-70-57:2015
EN 16602-70-57:2015 (E) 13 5 Requirements 5.1 General requirements a. The bioburden reduction agent shall be heat. b. The customer shall provide a dry heat bioburden reduction specification in conformance with the DRD in Annex A. c. The supplier shall provide a dry heat bioburden reduction proposal in conformance with the DRD in Annex B for the customer approval. d. Upon approval by the customer, the supplier shall implement the dry heat bioburden reduction. e. The supplier shall provide a dry heat bioburden reduction report in conformance with the DRD in Annex C. 5.2 Product requirements 5.2.1 Product compatibility with process a. ECSS-Q-ST-70-53 shall be used to evaluate product compatibility with dry heat bioburden reduction. NOTE
Pre-conditioning with heat (e.g., bakeout) can be necessary for products releasing a large amount of water vapour (e.g., parachute, airbag)
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.ELRORãNHRaumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei trockener Hitze für FlughardwareAssurance produit des projets spatiaux - Réduction par chaleur sèche de la charge microbienne des matériels de volSpace product assurance - Dry Heat Bioburden Reduction for Flight Hardware49.140Vesoljski sistemi in operacijeSpace systems and operationsICS:Ta slovenski standard je istoveten z:FprEN 16602-70-57kSIST FprEN 16602-70-57:2014en,fr,de01-julij-2014kSIST FprEN 16602-70-57:2014SLOVENSKI
STANDARD
kSIST FprEN 16602-70-57:2014
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN 16602-70-57
May 2014 ICS 49.140
English version
Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware
Assurance produit des projets spatiaux - Réduction par chaleur sèche de la charge microbienne des matériels de vol
Raumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei trockener Hitze für Flughardware 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2014 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. FprEN 16602-70-57:2014 E kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 2 Table of contents Foreword . 4 Introduction . 5 1 Scope . 6 2 Normative references . 7 3 Terms and abbreviated terms . 8 3.1 Terms from other standards . 8 3.2 Terms specific to the present standard . 8 3.3 Abbreviated terms. 10 3.4 Nomenclature . 10 4 Principles . 11 5 Requirements . 13 5.1 General requirements . 13 5.2 Product requirements . 13 5.2.1 Product compatibility with process . 13 5.2.2 Product cleanliness . 13 5.2.3 Product packaging . 14 5.2.4 Product release . 14 5.3 Process requirements . 14 5.3.1 Procedure requirements . 14 5.3.2 Bioburden reduction cycle requirements . 17 5.4 Equipment requirements . 17 Annex A (normative) Dry heat bioburden reduction specification - DRD . 19 Annex B (normative) Dry heat bioburden reduction proposal - DRD . 21 Annex C (normative) Dry heat bioburden reduction report - DRD . 23 Annex D (informative) D-values for 2 to 3 orders of magnitude reduction . 25 Annex E (informative) Effective D-values for 4 to 6 orders of magnitude reduction . 27 kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 3 Bibliography . 29
Figures Figure 4-1: Dry heat bioburden reduction process overview . 12 Figure D-1 : D-values for 2 to 3 orders of magnitude reduction. 25 Figure E-1 : Effective D-values for 4 to 6 orders of magnitude surface reduction . 27
Tables Table D-1 : D-values for 2 to 3 orders of magnitude reduction . 26 Table E-1 : Effective D-values for 4 to 6 orders of magnitude surface reduction . 28
kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 4 Foreword This document (FprEN 16602-70-57:2014) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN (Germany). This document (FprEN 16602-70-57:2014) originates from ECSS-Q-ST-70-57C. 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). kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 5 Introduction The UN Outer Space Treaty of 1967 sets up the general principles applicable to the exploration and use of outer space. Article IX of the Outer Space Treaty constitutes the primary statement of international law:
“States parties shall pursue studies of outer space, including the Moon and other celestial bodies, and conduct exploration of them so as to avoid their harmful contamination and also adverse changes in the environment of the Earth resulting from the introduction of extraterrestrial matter and, when necessary, adopt appropriate measures for this purpose.”
Harmful contamination in that sense is defined as biological contamination, including organic-constituents, to protect the environment in order to allow future exobiology research. The Committee On Space Research (COSPAR) has established some planetary protection guidelines, based on the Outer Space Treaty. These guidelines impose requirements on spaceflight missions according to target body/mission type combinations.
The objective of this Standard is to ensure that proper procedures for reducing the microbiological contamination on flight hardware are in place to meet the planetary protection constraints. kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 6 1 Scope This standard defines procedures for the reduction of microbiological contamination of flight hardware using heat. The procedures described in this standard cover: • Reduction of microbiological contamination on exposed surfaces, mated surfaces and encapsulated in materials. • Reduction of microbiological contamination in dry, ambient and uncontrolled humidity environments. This standard also sets requirements for the conditioning of the flight hardware, bioburden reduction cycle development, and equipment to be used for applying a bioburden reduction procedure. This standard may be tailored for the specific characteristics and constraints of a space project in conformance with ECSS-S-ST-00. kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 7 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 16601-40 ECSS-M-ST-40 Space project management - Configuration and information management EN 16602-10-09 ECSS-Q-ST-10-09 Space product assurance - Nonconformances control system EN 16602-70-01 ECSS-Q-ST-70-01 Space product assurance - Cleanliness and contamination control EN 16602-70-53 ECSS-Q-ST-70-53 Space product assurance - Materials and hardware compatibility tests for sterilization processes EN 16602-70-55 ECSS-Q-ST-70-55 Space product assurance - Microbial examination of flight hardware and cleanrooms EN 16602-70-58 ECSS-Q-ST-70-58 Space product assurance - Bioburden control of cleanrooms
IEST-STD-CC1246D Institute of environmental science and technology - product cleanliness levels and contamination control program
kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 8 3 Terms and abbreviated terms 3.1 Terms from other standards For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01 apply. For the purpose of this Standard, the terms and definitions from ECSS-M-ST-40, ECSS-Q-ST-70-01, ECSS-Q-ST-70-55 and ECSS-Q-ST-70-58 apply, and in particular the following: Bioburden Bioburden reduction Cleanliness level Product item 3.2 Terms specific to the present standard 3.2.1 ambient humidity absolute humidity of no more than 12 g/m3
NOTE
This is equivalent to 70 % relative humidity at 20 °C and 1000 hPa pressure. 3.2.2 cycle sequence of individual steps
NOTE
For the purpose of this standard, the individual steps are preconditioning, heat-up, bioburden reduction as defined by the selected procedure, cool-down. Each steps has associated control and monitoring parameters like time and temperature. 3.2.3 D-value time required to achieve inactivation of 90 % of a population of the test microorganisms under stated conditions kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 9 3.2.4 dry humidity absolute humidity of no more than 1,2 g/m3
NOTE
This is equivalent to 25 % relative humidity at 0 °C and 1000 hPa pressure or to 7 % relative humidity at 20 °C and 1000 hPa pressure 3.2.5 effective D-value used for bioburden reduction of ≥ 4 orders of magnitudes
NOTE 1 Example: One effective D-value is 4 orders of magnitude reduction, 2 times effective D-value is 5 order of magnitude reduction, 3 times effective D-value is 6 order of magnitude reduction. NOTE 2 Attention: There is a substantial difference in the time required between 3 orders of magnitude reduction and 4 orders of magnitude reduction. NOTE 3 Reason for the longer time period necessary for ≥ 4 orders of magnitude reduction is a sub-population of typical cleanroom bioburden that is more resistant to heat than the average population. 3.2.6 encapsulated bioburden bioburden inside bulk non-metallic materials NOTE
Examples: bioburden inside of paints, coatings, adhesives, inserts, ablative material. 3.2.7 exposed surfaces internal and external surfaces free for gas exchange NOTE
Examples: Free for gas exchange are e.g., exterior surfaces, interior surfaces of boxes with venting holes, surfaces of honeycomb cells, surfaces of the outer and inner plies of multi-layer insulation, open cell foam. 3.2.8 mated bioburden surfaces joined by fasteners rather than by adhesives 3.2.9 parametric release declaration that a product is at a certain bioburden level, based on records demonstrating that the process parameters were delivered within specified tolerances NOTE
Parametric release can be used for achieving bioburden reduction with heat (temperature and time record sufficient, no need for biological test) but is not acceptable for kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 10 bioburden reduction using chemicals (biological test for process monitoring is mandatory). 3.2.10 uncontrolled humidity humidity level that is either not measured or does not conform to ambient humidity or dry humidity 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 COSPAR Committee on Space Research ESD electrostatic discharge
3.4 Nomenclature The following nomenclature apply throughout this document: a. The word “shall” is used in this standard to express requirements. All the requirements are expressed with the word “shall”. b. The word “should” is used in this standard to express recommendations. All the recommendations are expressed with the word “should”. NOTE
It is expected that, during tailoring, all the recommendations in this document are either converted into requirements or tailored out. c. The words “may” and “need not” are used in this standard to express positive and negative permissions respectively. All the positive permissions are expressed with the word “may”. All the negative permissions are expressed with the words “need not”. d. The word “can” is used in this standard to express capabilities or possibilities, and therefore, if not accompanied by one of the previous words, it implies descriptive text. NOTE
In ECSS “may” and “can” have a complete different meaning: “may” is normative (permission) and “can” is descriptive. e. The present and past tense are used in this standard to express statement of fact, and therefore they imply descriptive text. kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 11 4 Principles It is expected that every project specifies the high level planetary protection requirements (as needed). NOTE
For example: for all ESA projects, those requirements are specified in ESSB-ST-U-001.
The following series of ECSS standards describe the processes and procedures to respond to those bioburden requirements: • ECSS-Q-ST-70-56 together with the present standard describe the currently approved bioburden reduction processes, i.e. vapour hydrogen peroxide and dry heat, respectively. • ECSS-Q-ST-70-58 describes how to operate a bioburden controlled environment, like a cleanroom, for the assembly and testing of bioburden controlled flight hardware.
• ECSS-Q-ST-70-55 describes how to measure the biological contamination on flight hardware and in bioburden controlled environments. • ECSS-Q-ST-70-53 describes how to evaluate the material compatibility with different bioburden reduction processes.
The activities related to dry heat bioburden reduction are shown in Figure 4-1. The related requirements are captured in clause 5. The process can be summarized as follows: • The customer issues a “bioburden reduction specification” used as an input for the supplier “work proposal for bioburden reduction”. • Subject for customer approval the supplier prepares and performs the process taking as inputs the hardware requiring bioburden reduction, the quality requirements and the work proposal (output of the previous activity). • Then the supplier will record and produce a report by comparing the results against the work proposal for bioburden reduction.
Background information for using heat for bioburden reduction and the use of biological indicators for such a process can be found in ISO 20857 and ISO 11138. kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 12 Specifying process Preparing and performing process, including process verificationQuality RequirementsRecording and reporting process Work Proposal for the bioburden reduction including process description (Annex B) Bioburden reduction results (including identified deviations, if any)Bioburden reduction report (Annex C) Bioburden reduction specification (Annex A) Customer approvalNCR (if any identified deviation)HardwareBioburden reduced hardwareTask nInput to Task nOutput from Task n(and possible input to next Task)ActorNecessary conditionLegend:SupplierSupplierSupplierSpecifying bioburden requirementsCustomer Figure 4-1: Dry heat bioburden reduction process overview kSIST FprEN 16602-70-57:2014
FprEN 16602-70-57:2014 (E) 13 5 Requirements 5.1 General requirements a. The bioburden reduction agent shall be heat. b. The customer shall provide a dry heat bioburden reduction specification in conformance with the DRD in Annex A. c. The supplier shall provide a dry heat bioburden reduction proposal in conformance with the DRD in Annex B for the customer approval. d. Upon approval by the customer, the supplier shall implement the dry heat bioburden reduction. e. The supplier shall provide a dry heat bioburden reduction report in conformance with the DRD in Annex C. 5.2 Product requirements 5.2.1 Product compatibility with process a. ECSS-Q-ST-70-53 shall be used to evaluate product compatibility with dry heat bioburden reduction. NOTE
Pre-conditioning with heat (e.g., bakeout) can be necessary for products releasing a large amount of water vapour (e.g., parachute, airbag) in order to meet the humidity parameter specified in the dry heat bioburden reduction procedure. 5.2.2 Product cleanliness a. The product shall have a measured particulate and molecular cleanliness level of 300A, in conformance with requirements from the IEST-STD-CC1246D, before the bioburden reduction process is applied. NOTE
Pre-conditi
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