SIST EN 16602-70-56:2015
(Main)Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware
Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware
This standard specifies procedures for the reduction of microbiological contamination of flight hardware using hydrogen peroxide vapour.
The procedures specified in this standard cover:
• Reduction of microbiological contamination on exposed surfaces.
• Reduction of microbiological contamination in controlled ambient and vacuum environments.
This standard also specifies 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-00C.
Raumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei Dampfphase für Flughardware
Assurance produit des projets spatiaux - Réduction en phase gazeuse de la charge microbienne des matériels de vol
Zagotavljanje varnih proizvodov v vesoljski tehniki - Zmanjšanje biološke obremenitve v parni fazi za letalsko strojno opremo
Ta standard določa postopke za zmanjšanje mikrobiološke onesnaženosti letalske strojne opreme s hlapi vodikovega peroksida. Postopki, določeni v tem standardu, vključujejo: • zmanjšanje mikrobiološke onesnaženosti izpostavljenih površin; • zmanjšanje mikrobiološke onesnaženosti v nadzorovanih zunanjih in vakuumskih 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-00C.
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 - Zmanjšanje biološke obremenitve v parni fazi za letalsko strojno opremoRaumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei Dampfphase für FlughardwareAssurance produit des projets spatiaux - Réduction en phase gazeuse de la charge microbienne des matériels de volSpace product assurance - Vapour Phase Bioburden Reduction for Flight Hardware49.140Vesoljski sistemi in operacijeSpace systems and operationsICS:Ta slovenski standard je istoveten z:EN 16602-70-56:2015SIST EN 16602-70-56:2015en,fr,de01-november-2015SIST EN 16602-70-56:2015SLOVENSKI
STANDARD
SIST EN 16602-70-56:2015
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16602-70-56
September 2015 ICS 49.140
English version
Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware
Assurance produit des projets spatiaux - Réduction en phase gazeuse de la charge microbienne des matériels de vol
Raumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei Dampfphase 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 16602-70-56:2015 E SIST EN 16602-70-56:2015
EN 16602-70-56:2015 (E) 2 Table of contents European foreword . 3 Introduction . 3 1 Scope . 5 2 Normative references . 6 3 Terms and abbreviated terms . 7 3.1 Terms from other standards . 7 3.2 Terms specific to the present standard . 7 3.3 Abbreviated terms. 8 3.4 Nomenclature . 9 4 Principles . 10 5 Requirements . 12 5.1 General requirements . 12 5.2 Product requirements . 12 5.2.1 Product compatibility with process . 12 5.2.2 Product cleanliness . 12 5.2.3 Product packaging . 13 5.2.4 Product release . 13 5.3 Process requirements . 14 5.3.1 Procedure requirements . 14 5.3.2 Bioburden reduction cycle requirements . 15 5.4 Equipment requirements . 15 Annex A (normative) Hydrogen peroxide bioburden reduction specification - DRD . 17 Annex B (normative) Hydrogen peroxide bioburden reduction proposal - DRD . 19 Annex C (normative) Hydrogen peroxide bioburden reduction report - DRD . 21 Bibliography . 23
Figures Figure 4-1: Hydrogen peroxide bioburden reduction process overview . 11
SIST EN 16602-70-56:2015
EN 16602-70-56:2015 (E) 3 European foreword This document (EN 16602-70-56:2015) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-70-56:2015) originates from ECSS-Q-ST-70-56C. 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 16602-70-56:2015
EN 16602-70-56:2015 (E) 4 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 16602-70-56:2015
EN 16602-70-56:2015 (E) 5 1 Scope This standard specifies procedures for the reduction of microbiological contamination of flight hardware using hydrogen peroxide vapour. The procedures specified in this standard cover: • Reduction of microbiological contamination on exposed surfaces. • Reduction of microbiological contamination in controlled ambient and vacuum environments. This standard also specifies 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-00C. SIST EN 16602-70-56:2015
EN 16602-70-56:2015 (E) 6 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 - Nonconformance control system 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 16602-70-56:2015
EN 16602-70-56:2015 (E) 7 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 biological indicators viable microorganisms providing a defined resistance to a specific process NOTE
The process is a hydrogen peroxide bioburden reduction. 3.2.2 controlled ambient conditions 1000 hPa pressure, temperature from 25 °C to 45 °C and relative humidity from 3 % to 50 %, as measured at 35 °C 3.2.3 controlled vacuum conditions temperature from 25 °C to 45 °C and pressure from 1,3 hPa to 13,3 hPa 3.2.4 cycle sequence of individual steps
NOTE
For the purpose of this standard, the individual steps are preconditioning, bioburden reduction Ct-value and venting. Each step has associated control and monitoring parameters like time and hydrogen peroxide vapour concentration. SIST EN 16602-70-56:2015
EN 16602-70-56:2015 (E) 8 3.2.5 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. 3.2.6 overkill equivalent to a 12 order of magnitude bioburden reduction 3.2.7 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 bioburden reduction using chemicals (biological test for process monitoring is mandatory). 3.2.8 positive control testing the viability of biological indicators and the quality of the culture medium 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 BIs biological indicators cfu colony forming unit COSPAR Committee on Space Research Ct time integrated (hydrogen peroxide) concentration ESD electrostatic discharge L litre (volume in controlled environment) mg
milligram (hydrogen peroxide) NCR nonconformance report sec seconds
SIST EN 16602-70-56:2015
EN 16602-70-56:2015 (E) 9 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 16602-70-56:2015
EN 16602-70-56:2015 (E) 10 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-70-57 together with the present standard describe the currently approved bioburden reduction processes, i.e. dry heat and vapour hydrogen peroxide, 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 hydrogen peroxide 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 biological indicators can be found in ISO 11138. SIST EN 166
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zagotavljanje varnih proizvodov v vesoljski tehniki - Zmanjšanje biološke obremenitve v parni fazi za letalsko strojno opremoRaumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei Dampfphase für FlughardwareAssurance produit des projets spatiaux - Réduction en phase gazeuse de la charge microbienne des matériels de volSpace product assurance - Vapour Phase Bioburden Reduction for Flight Hardware49.140Vesoljski sistemi in operacijeSpace systems and operationsICS:Ta slovenski standard je istoveten z:FprEN 16602-70-56kSIST FprEN 16602-70-56:2014en,fr,de01-julij-2014kSIST FprEN 16602-70-56:2014SLOVENSKI
STANDARD
kSIST FprEN 16602-70-56:2014
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN 16602-70-56
May 2014 ICS 49.140
English version
Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware
Assurance produit des projets spatiaux - Réduction en phase gazeuse de la charge microbienne des matériels de vol
Raumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei Dampfphase 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 16602-70-56:2014 E kSIST FprEN 16602-70-56:2014
FprEN 16602-70-56:2014 (E) 2 Table of contents Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references . 6 3 Terms and abbreviated terms . 7 3.1 Terms from other standards . 7 3.2 Terms specific to the present standard . 7 3.3 Abbreviated terms. 8 3.4 Nomenclature . 9 4 Principles . 10 5 Requirements . 12 5.1 General requirements . 12 5.2 Product requirements . 12 5.2.1 Product compatibility with process . 12 5.2.2 Product cleanliness . 12 5.2.3 Product packaging . 13 5.2.4 Product release . 13 5.3 Process requirements . 14 5.3.1 Procedure requirements . 14 5.3.2 Bioburden reduction cycle requirements . 15 5.4 Equipment requirements . 15 Annex A (normative) Hydrogen peroxide bioburden reduction specification - DRD . 17 Annex B (normative) Hydrogen peroxide bioburden reduction proposal - DRD . 19 Annex C (normative) Hydrogen peroxide bioburden reduction report - DRD . 21 Bibliography . 23
Figures Figure 4-1: Hydrogen peroxide bioburden reduction process overview . 11
kSIST FprEN 16602-70-56:2014
FprEN 16602-70-56:2014 (E) 3 Foreword This document (FprEN 16602-70-56:2014) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN (Germany). This document (FprEN 16602-70-56:2014) originates from ECSS-Q-ST-70-56C. 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 16602-70-56:2014
FprEN 16602-70-56:2014 (E) 4 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 16602-70-56:2014
FprEN 16602-70-56:2014 (E) 5 1 Scope This standard specifies procedures for the reduction of microbiological contamination of flight hardware using hydrogen peroxide vapour. The procedures specified in this standard cover: • Reduction of microbiological contamination on exposed surfaces. • Reduction of microbiological contamination in controlled ambient and vacuum environments. This standard also specifies 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-00C. kSIST FprEN 16602-70-56:2014
FprEN 16602-70-56:2014 (E) 6 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 - Nonconformance control system 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 16602-70-56:2014
FprEN 16602-70-56:2014 (E) 7 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 biological indicators viable microorganisms providing a defined resistance to a specific process NOTE
The process is a hydrogen peroxide bioburden reduction. 3.2.2 controlled ambient conditions 1000 hPa pressure, temperature from 25 °C to 45 °C and relative humidity from 3 % to 50 %, as measured at 35 °C 3.2.3 controlled vacuum conditions temperature from 25 °C to 45 °C and pressure from 1,3 hPa to 13,3 hPa 3.2.4 cycle sequence of individual steps
NOTE
For the purpose of this standard, the individual steps are preconditioning, bioburden reduction Ct-value and venting. Each step has associated control and monitoring parameters like time and hydrogen peroxide vapour concentration. kSIST FprEN 16602-70-56:2014
FprEN 16602-70-56:2014 (E) 8 3.2.5 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. 3.2.6 overkill equivalent to a 12 order of magnitude bioburden reduction 3.2.7 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 bioburden reduction using chemicals (biological test for process monitoring is mandatory). 3.2.8 positive control testing the viability of biological indicators and the quality of the culture medium 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 BIs biological indicators cfu colony forming unit COSPAR Committee on Space Research Ct time integrated (hydrogen peroxide) concentration ESD electrostatic discharge L litre (volume in controlled environment) mg
milligram (hydrogen peroxide) NCR nonconformance report sec seconds
kSIST FprEN 16602-70-56:2014
FprEN 16602-70-56:2014 (E) 9 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 16602-70-56:2014
FprEN 16602-70-56:2014 (E) 10 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-70-57 together with the present standard describe the currently approved bioburden reduction processes, i.e. dry heat and vapour hydrogen peroxide, 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 hydrogen peroxide 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 biological indicators can be found in ISO 11138. kSIST FprEN 16602-70-56:2014
FprEN 16602-70-56:2014 (E) 11 Specifying process Preparing and performing processQuality 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
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