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BULETINUL STANDARDIZĂRII Publicaţie Oficială a Organismului Naţional De Standardizare BULETINUL STANDARDIZĂRII Publicaţie oficială a Organismului Naţional de Standardizare Noiembrie 2018 CUPRINS Direcţia Comercială Șef Serviciu: Eduard Laurențiu Ioan Redactare şi tehnoredactare: Serviciul Producţie STANDARDIZAREA NAŢIONALĂ ......................... 1 Management Informatic: Dumitriana Bănică, Standarde aprobate ������������������������������������������������������������������������ 1 Monica Marin, Ştefania Kraus Standarde anulate ���������������������������������������������������������������������������12 Standarde europene adoptate iniţial prin filă de confirmare sau notă de confirmare pentru care se publică versiunea română ������������������������21 Modificări în organizarea şi structura comitetelor tehnice �����������������������������������������������������������������������25 STANDARDIZAREA EUROPEANĂ ...................... 26 Standarde europene CEN aprobate �������������������������������������26 Standarde europene CENELEC aprobate �������������������������31 Standarde europene ETSI aprobate �������������������������������������33 Proiecte de standarde europene CEN supuse anchetei publice �������������������������������������������������������������47 Proiecte de standarde europene CENELEC supuse anchetei publice �������������������������������������������������������������51 Proiecte de standarde europene ETSI supuse anchetei publice �������������������������������������������������������������53 STANDARDIZAREA INTERNAŢIONALĂ ............. 54 Standarde internaţionale ISO aprobate �����������������������������54 Standarde internaţionale IEC aprobate �����������������������������59 Proiecte de standarde internaţionale ISO supuse anchetei publice �������������������������������������������������������������60 Proiecte de standarde internaţionale IEC supuse anchetei publice �������������������������������������������������������������64 © Toate drepturile rezervate Asociaţiei de Standardizare din România Potrivit Legii 163/2015 privind standardizarea naţională în România, ASRO beneficiază de protecţia drepturilor de autor asupra standardelor naţionale în condiţiile Legii privind drepturile de autor şi drepturile conexe. Reproducerea sau utilizarea integrală sau parţială a standardelor naţionale sau a conţinutului publicaţiilor organismului naţional de standardizare prin orice procedeu (electronic, mecanic, fotocopiere, microfilmare) este interzisă, dacă nu există în prealabil, acordul ASRO. ISSN 2559-4230 Buletinul Standardiz ării – Noiembrie 2018 Publica ţie finan ţat ă de MINISTERUL ECONOMIEI STANDARDIZAREA NA ŢIONAL Ă STANDARDE APROBATE Standardele române de mai jos au fost aprobate în luna octombrie 2018. Standardele europene şi interna ţionale sunt adoptate ca standarde române prin metoda versiunii române ( T), metoda filei de confirmare (FC ) sau metoda notei de confirmare ( A). Eratele la standardele europene şi interna ţionale sunt notate cu simbolul ( ER ). Standardele române originale sunt notate cu E. Sub indicativul standardului este indicat num ărul comitetului tehnic ( CT ) responsabil. Pentru standardele adoptate prin metoda filei de confirmare sau metoda notei de confirmare, textul standardului nu este publicat în versiune român ă. Versiunile originale ale acestor standarde pot fi consultate sau procurate de la Asocia ţia de Standardizare din România. În aceast ă rubric ă sunt cuprinse, de asemenea, amendamente şi erate ale standardelor române. În cazul în care un standard aprobat înlocuie şte şi anuleaz ă unul sau mai multe standarde existente, indicativul/indicativele acestora sunt indicate după titlul standardului respectiv. Informa ţii privind standardele anulate sunt date în rubrica STANDARDE ANULATE. 01 GENERALIT ĂȚI, TERMINOLOGIE, STANDARDIZARE. 03 SERVICII. ORGANIZAREA ÎNTREPRINDERII, DOCUMENTARE MANAGEMENT ȘI CALITATE. ADMINISTRARE. 01.040 Vocabulare TRANSPORT. SOCIOLOGIE 01.040.03 Servicii. Organizarea întreprinderilor, 03.080 Servicii management și calitate. Administrare. 03.080.10 Servicii de mentenan ță. Managementul Transport. Sociologie. (Vocabulare) infrastructurii SR EN ISO 41011:2018 A SR EN ISO 41001:2018 A CT 365 CT 365 Managementul facilit ăților. Vocabular Managementul facilit ăților. Sisteme de management. Cerin țe Inlocuieste: SR EN 15221 -1:2007 cu îndrum ări pentru utilizare 01.040.25 Tehnici de f abricare (Vocabulare) SR EN ISO 41011:2018 A CT 365 SR EN ISO 4885:2018 A Managementul facilit ăților. Vocabular CT 42 Inlocuieste: SR EN 15221 -1:2007 Materiale feroase. Tratamente termice. Vocabular Inlocuieste: SR EN ISO 4885:2017 03.100 Organizarea i managementul întreprinderii. ș Sisteme de management 01.040.77 Metalurgie (Vocabulare) 03.100.70 Sisteme de management SR EN ISO 4885:2018 A SR EN 9100:2018 A CT 42 CT 72 Materiale feroase. Tratamente termice. Vocabu lar Sisteme de management al calit ății. Cerin țe ale organiza țiilor Inlocuieste: SR EN ISO 4885:2017 pentru avia ție, spa țiu și ap ărare Inlocuieste: SR EN 9100:2010 01.080 Simboluri grafice 01.080.20 Simboluri grafice utilizate pe echipamente SR EN 9101:2018 A specifice CT 72 Sisteme de management al calit ății. Cerin țe de audit pentru SR EN ISO 9687:2015/A1:2018 A organisme de avia ție, spa țiale și de ap ărare CT 377 Inlocuieste: SR EN 9101:2016 Stomatologie. Simboluri grafice pentru echipament stomatologic SR EN 9110:2018 A CT 72 Sisteme de management al calit ății. Cerin țe pentru organismele de între ținere din industria aeronautic ă Inlocuieste: SR EN 9110:2015 Buletinul Standardiz ării – Noiembrie 2018 SR EN 9120:2018 A SR EN ISO 14607:2018 A CT 72 CT 377 Sisteme de management al calit ății. Cerin țe pentru Implanturi chirurgicale neactive. Implanturi mamare. Cerin țe distribuitorii din industria aeronautic ă, aerospa țial ă și de particulare ap ărare Inlocuieste: SR EN ISO 14607:2009 Inlocuieste: SR EN 9120:2010 11.040.50 Echipament radiologic SR EN ISO 41001:2018 A CT 365 SR EN 60601 -2-43:2011/A1:2018 A Managementul facilit ăților. Sisteme de management. Cerin țe CT 22 cu îndrum ări pentru utilizare Aparate el ectromedicale. Partea 2-43: Cerin țe particulare de securitate de baz ă și performan țe esen țiale pentru aparate cu 03.120 Calitate raze X pentru proceduri interven ționale 03.120.10 Managementul calit ății și asigurarea calit ății 11.040.70 Echipament oftalmologic SR EN 9100:2018 A CT 72 SR EN ISO 11979 -10:2018 A Sisteme de management al calit ății. Cerin țe ale organiza țiilor CT 230 pentru avia ție, spa țiu și ap ărare Implanturi oftalmice. Lentile intraoculare. Partea 10: Inlocuie ste: SR EN 9100:2010 Investiga ții clinice ale lentilelor intraoculare pentru corectarea ametropiei ochilor phakic SR EN 9101:2018 A Inlocuieste: SR EN ISO 11979 -10:2007 SR EN ISO 11979 -10:2007/A1:2015 CT 72 Sisteme de management al calit ății. Cerin țe de audit pentru organisme de avia ție, spa țiale și de ap ărare SR EN ISO 11979 -7:2018 A Inlocuieste: SR EN 9101:2016 CT 230 Implanturi oftalmice. Lentile intraoculare. Partea 7: Investiga ții SR EN 9110:2018 A clinice ale lentile intraoculare pentru corectarea afakiei CT 72 Inlocuieste: SR EN ISO 11979 -7:2015 Sisteme de management al calit ății. Cerin țe pentru SR EN ISO 11979 -9:2007 SR EN ISO 11979 -9:2007/A1:2015 organismele de între ținere din industria aeronautic ă Inlocuieste: SR EN 9110:2015 SR EN ISO 12870:2018 A SR EN 9120:2018 A CT 230 CT 72 Optic ă oftalmic ă. Rame de ochelari. Cerin țe și metode de Sisteme de management al calit ății. Cerin țe pentru încercare Inlocuieste: SR EN ISO 12870:2015 distribuitorii din industria aeronautic ă, aerospa țial ă și de ap ărare Inloc uieste: SR EN 9120:2010 11.060 Stomatologie 11.060.10 Materiale dentare SR EN 9136:2018 A SR EN ISO 6872:2015/A1:2018 A CT 72 CT 377 Serie aerospa țial ă. Analiza cauzei principale și solu ționarea problemei (metodologie 9S) Stomatologie. Materiale ceramice 03.120.20 Certificarea produselor și a întreprinderilor. SR EN ISO 10139 -1:2018 A Evaluarea conformit ății CT 377 Stomatologie. Materiale moi de c ăptu șire pentru proteze SR EN 9101:2018 A dentare mobile. Partea 1: Materiale pentru utilizare pe termen CT 72 scurt Sisteme de management al calit ății. Cerin țe de audit pentru Inlocuieste: SR EN ISO 10139 -1:2005 SR EN ISO 10139 -1:2005/AC:2006 organisme de avia ție, spa țiale și de ap ărare Inlocuieste: SR EN 9101:2016 SR EN ISO 28319:2018 A 11 MEDICIN Ă CT 377 11.040 Echipament medical Stomatologie. Sudur ă cu lase r și materiale de umplere Inlocuieste: SR EN ISO 28319:2010 11.040.30 Instrumente și materiale chirurgicale SR EN IEC 60601 -2-2:2018 A 11.060.20 Echipament stomatologic CT 22 Aparate electromedicale. Partea 2 -2: Cerin țe particulare de SR EN ISO 7488:2018 A securitate de baz ă și performan țe esen țiale pentru aparatele CT 377 de electrochirurgie cu curen ți de înalt ă frecven ță și pentru Stomatologie. Amestec ătoare pentru amalgam stomatologic accesoriile de electrochirurgie cu curen ți de înalt ă fre cven ță Inlocuieste: SR EN ISO 7488:2003 Inlocuieste: SR EN 60601 -2-2:2009 SR EN 60601 -2-2:2009/A11:2012 SR EN ISO 9687:2015/A1:2 018 A CT 377 11.040.40 Implanturi chirurgicale, proteze și orteze Stomatologie. Simboluri grafice pentru echipament stomatologic SR EN ISO 5832 -2:2018 A CT 377 SR EN ISO 20608:2018 A Implanturi chirurgicale. Produse metalice. Partea 2: Titan CT 377 nealiat Stomatologie. Pulberi și piese de m ână pentru pulverizare Inlocuieste: SR EN ISO 5832 -2:2012 2 Buletinul Standardiz ării – Noiembrie 2018 13 MEDIU. PROTEC ȚIA S ĂNĂTĂȚII. SECURITATE SR EN 54 -7:2018 A 13.040 Calitatea aerului CT 216 13.040.30 Aerul la locul de munc
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