SIST EN 16602-70-57:2015

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

• Status: Published
• Public Enquiry End Date: 19-Aug-2014
• Publication Date: 18-Oct-2015
• ICS: 49.140 - Space systems and operations
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Oct-2015
• Due Date: 11-Dec-2015
• Completion Date: 19-Oct-2015
• Mandate: M/496 - Mandate addressed to CEN, CENELEC and ETSI to develop standardisation regarding space industry (Phase 3 of the process)
• Ref Project: EN 16602-70-57:2015 - Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware

Overview

EN 16602-70-57:2015 - Space product assurance: Dry Heat Bioburden Reduction for Flight Hardware (CEN) defines procedures, requirements and documentation for reducing microbiological contamination of flight hardware using dry heat. The standard covers reduction of bioburden on exposed surfaces, mated surfaces and encapsulated materials, and in dry, ambient and uncontrolled humidity environments. It specifies conditioning, cycle development, equipment, monitoring and reporting needed to meet planetary protection and space product assurance objectives.

Key topics and technical requirements

• Scope of treatment: exposed, mated and encapsulated bioburden; applicable in dry, ambient (≤12 g/m3) and uncontrolled humidity conditions.
• Process steps: pre‑conditioning, heat‑up, bioburden reduction phase, cool‑down - each with defined control and monitoring parameters (time, temperature, humidity).
• D-value concept: D‑value = time to achieve 90% inactivation under stated conditions; effective D‑values address ≥4 orders of magnitude reductions (longer times required for resistant sub‑populations).
• Product requirements: verify material/process compatibility using ECSS‑Q‑ST‑70‑53; ensure particulate/molecular cleanliness of 300A per IEST‑STD‑CC1246D prior to treatment; measure initial bioburden per ECSS‑Q‑ST‑70‑55.
• Process control & release: supplier provides a Dry Heat Bioburden Reduction Proposal (Annex B) and, after processing, a Dry Heat Bioburden Reduction Report (Annex C). Customer issues the bioburden reduction specification (Annex A). Parametric release is permitted for heat (temperature/time records may suffice) but not for chemical processes.
• Equipment & validation: requirements for ovens, monitoring, cycle development and verification are defined; use of biological indicators and references (ISO 20857, ISO 11138) is noted for background guidance.
• Tailoring: the standard may be tailored per project characteristics in conformance with ECSS‑S‑ST‑00.

Practical applications

• Sterilization planning for spacecraft and payload hardware where planetary protection constraints apply.
• Developing validated dry heat cycles for desiccated electronics, structural items, harnesses, thermal blankets, and other flight hardware.
• Supplier/customer flow‑down of bioburden reduction requirements, approvals and reporting in procurement and assembly.
• Cleanroom and test laboratory procedures for executing and documenting heat‑based bioburden reduction.

Who should use this standard

• Spacecraft manufacturers, subsystem suppliers and test houses.
• Product assurance and quality engineers responsible for space product assurance and planetary protection compliance.
• Cleanroom managers, process engineers and validation teams who develop and run bioburden reduction cycles.
• Planetary protection officers and mission planners ensuring compliance with COSPAR/Outer Space Treaty guidance.

Related standards and references

• ECSS series: ECSS‑Q‑ST‑70‑53, ECSS‑Q‑ST‑70‑55, ECSS‑Q‑ST‑70‑58, ECSS‑S‑ST‑00.
• IEST‑STD‑CC1246D (product cleanliness levels).
• ISO 20857, ISO 11138 (background on heat sterilization and biological indicators).
• COSPAR planetary protection guidelines / Outer Space Treaty.

EN 16602-70-57:2015 provides the structured, auditable framework needed to plan, validate and document dry heat bioburden reduction for flight hardware, enabling mission teams to meet planetary protection and space product assurance obligations.

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
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

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
“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 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
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

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

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

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

Pre-conditioning with heat (e.g., bakeout) can be necessary for products releasing a large amount of water vapour (e.g., parachute, airbag)
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