EN 16602-70-58:2015
(Main)Space product assurance - Bioburden control of cleanrooms
Space product assurance - Bioburden control of cleanrooms
This standard establishes the principles and basic methodology for microbiological control of cleanrooms and associated controlled environments with planetary protection constraints.
This standard does not address:
• the microbiological contamination control of spaceflight hardware;
• molecular contamination control. Reference is made to other documents;
• fire and safety regulations; for these, see regulatory requirements and other national or local documentation.
This standard does not lay down the methods for determining the microbiological and particulate cleanliness levels. Reference is made to other documents.
This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00.
Raumfahrtproduktsicherung - Kontrolle der Gesamtkeimzahl in Reinräumen
Assurance produit des projets spatiaux - Contrôle de la charge microbienne des salles blanches
La présente norme établit les principes et la méthodologie de base pour le contrôle microbiologique des salles blanches et des milieux contrôlés associés avec des contraintes de protection planétaire.
La présente norme ne traite pas :
• du contrôle de la contamination microbiologique du matériel de vol ;
• du contrôle de la contamination moléculaire. D'autres documents sont cités ;
• des règlements en matière d'incendie et de sécurité ; voir les exigences règlementaires et autres documentations nationales ou locales.
La présente norme ne spécifie pas les méthodes de détermination des niveaux de propreté microbiologique ou particulaire. D'autres documents sont cités.
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 - Kontrola biološke obremenitve čistih prostorov
Ta standard vzpostavlja načela in osnovno metodologijo za mikrobiološki nadzor čistih sob in povezanih nadziranih okolij z omejitvami planetarne zaščite. Ta standard ne obravnava: • nadzora mikrobiološke onesnaženosti strojnih delov vesoljskih plovil; • nadzora molekularne onesnaženosti. Vključeni so sklici na druge dokumente; • predpisov o požarni varnosti (glej regulativne zahteve in drugo nacionalno ali lokalno dokumentacijo). Ta standard ne določa metod za ugotavljanje ravni mikrobiološke čistosti in ravni čistosti delcev. Vključeni so sklici na druge dokumente. 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.RORãNHRaumfahrtproduktsicherung - Kontrolle der Gesamtkeimzahl in ReinräumenAssurance produit des projets spatiaux - Contrôle de la charge microbienne des salles blanchesSpace product assurance - Bioburden control of cleanrooms49.140Vesoljski sistemi in operacijeSpace systems and operations13.040.35Brezprašni prostori in povezana nadzorovana okoljaCleanrooms and associated controlled environmentsICS:Ta slovenski standard je istoveten z:EN 16602-70-58:2015SIST EN 16602-70-58:2015en,fr,de01-november-2015SIST EN 16602-70-58:2015SLOVENSKI
STANDARD
SIST EN 16602-70-58:2015
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16602-70-58
September 2015 ICS 49.140
English version
Space product assurance - Bioburden control of cleanrooms
Assurance produit des projets spatiaux - Contrôle de la charge microbienne des salles blanches
Raumfahrtproduktsicherung - Kontrolle der Gesamtkeimzahl in Reinräumen This European Standard was approved by CEN on 25 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 16602-70-58:2015 E SIST EN 16602-70-58:2015
EN 16602-70-58:2015 (E) 2 Table of contents European foreword . 5 Introduction . 5 1 Scope . 7 2 Normative references . 8 3 Terms, definitions and abbreviated terms . 9 3.1 Terms defined in other standards . 9 3.2 Terms specific to the present standard . 9 3.3 Abbreviated terms. 11 4 Principles . 12 5 Requirements . 13 5.1 Bioburden control . 13 5.1.1 Formal system . 13 5.1.2 Action and alert levels . 14 5.2 Operational requirements . 15 5.2.1 Cleanroom class . 15 5.2.2 Applicability of bioburden control . 16 5.2.3 Restrictions . 16 5.2.4 Bioburden monitoring of cleanroom environment . 17 5.2.5 Sampling plan . 17 5.2.6 Training . 19 5.2.7 Personnel .
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