Privremeno besplatno preuzimanje norma za osobnu zaštitnu opremu i medicinske proizvode - COVID-19

20.03.2020.

U skladu s Odlukom Predsjedničkog odbora europskih normizacijskih organizacija CEN-a i CENELEC-a (Decision 15/20 2020), donesenom na zahtjev Europske komisije radi olakšavanja i poticanja proizvodnje osobne zaštitne opreme i medicinskih proizvoda radi suzbijanja pandemije virusa COVID-19, Hrvatski zavod za norme (HZN) omogućuje, do
31. ožujka 2021. godine, privremeno besplatno preuzimanje norma za osobnu zaštitnu opremu i medicinske proizvode navedenih u tablici.

Oznaka norme	Naslov (HR)	Naslov (EN)
HRN EN 149:2010	Zaštitne naprave za disanje – Filtarska polumaska za zaštitu od čestica – Zahtjevi, ispitivanje, označivanje (EN 149:2001+A1:2009)	Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking (EN 149:2001+A1:2009)
HRN EN 166:2002	Osobna zaštita očiju – Specifikacije (EN 166:2001)	Personal eye-protection – Specifications (EN 166:2001)
HRN EN 455-1:2008	Medicinske rukavice za jednokratnu upotrebu – 1. dio: Zahtjevi i ispitivanje na postojanje rupa (EN 455-1:2000)	Medical gloves for single use – Part 1: Requirements and testing for freedom from holes (EN 455-1:2000)
HRN EN 455-2:2015	Medicinske rukavice za jednokratnu upotrebu – 2. dio: Zahtjevi i ispitivanje fizičkih svojstava (EN 455-2:2015)	Medical gloves for single use – Part 2: Requirements and testing for physical properties (EN 455-2:2015)
HRN EN 455-3:2015	Medicinske rukavice za jednokratnu upotrebu – 3. dio: Zahtjevi i ispitivanje za biološko vrednovanje (EN 455-3:2015)	Medical gloves for single use – Part 3: Requirements and testing for biological evaluation (EN 455-3:2015)
HRN EN 455-4:2010	Medicinske rukavice za jednokratnu upotrebu – 4. dio: Zahtjevi i ispitivanje za određivanje roka upotrebe (EN 455-4:2009)	Medical gloves for single use – Part 4: Requirements and testing for shelf life determination (EN 455-4:2009)
HRN EN 13795-1:2019	Kirurška odjeća i prekrivači – Zahtjevi i metode ispitivanja – 1. dio: Kirurški prekrivači i ogrtači (EN 13795-1:2019)	Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns (EN 13795-1:2019)
HRN EN 13795-2:2019	Kirurška odjeća i prekrivači – Zahtjevi i metode ispitivanja – 2. dio: Operacijska odijela (EN 13795-2:2019)	Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits (EN 13795-2:2019)
HRN EN 14126:2004	Zaštitna odjeća – Zahtjevi za svojstva i ispitne metode za zaštitnu odjeću od infektivnih tvari (EN 14126:2003)	Protective clothing – Performance requirements and tests methods for protective clothing against infective agents (EN 14126:2003)
HRN EN 14126:2004/AC:2005	Zaštitna odjeća – Zahtjevi za svojstva i ispitne metode za zaštitnu odjeću od infektivnih tvari (EN 14126:2003/AC:2004)	Protective clothing – Performance requirements and test methods for protective clothing against infective agents (EN 14126:2003/AC:2004)
HRN EN 14605:2010	Odjeća za zaštitu od tekućih kemikalija – Zahtjevi za svojstva odjeće sa spojevima nepropusnim za tekućinu (tip 3) ili raspršenu tekućinu (tip 4), uključujući i elemente koji štite samo dijelove tijela (tipovi PB [3] i PB [4]) (EN 14605:2005+A1:2009)	Protective clothing against liquid chemicals – Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) (EN 14605:2005+A1:2009)
HRN EN 14683:2019 povučena	Kirurške maske – Zahtjevi i metode ispitivanja (EN 14683:2019)	Medical face masks – Requirements and test methods (EN 14683:2019)
HRN EN 14683:2020	Kirurške maske – Zahtjevi i metode ispitivanja (EN 14683:2019+AC:2019)	Medical face masks – Requirements and test methods (EN 14683:2019+AC:2019)
HRN EN ISO 10993-1:2010	Biološka procjena medicinskih proizvoda – 1. dio: Procjena i ispitivanje unutar procesa upravljanja rizikom (ISO 10993-1:2009; EN ISO 10993-1:2009)	Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009; EN ISO 10993-1:2009)
HRN EN ISO 10993-1:2010 /Ispr.1:2011	Biološka procjena medicinskih proizvoda – 1. dio: Procjena i ispitivanje unutar procesa upravljanja rizikom Tehnički ispravak 1 (ISO 10993-1:2009/Cor 1:2010; EN ISO 10993-1:2009/AC:2010)	Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process -- Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010; EN ISO 10993-1:2009/AC:2010)
HRN EN ISO 374-5:2016	Rukavice za zaštitu od opasnih kemikalija i mikroorganizama – 5. dio: Nazivlje i zahtjevi za svojstva za rizike od mikroorganizama (ISO 374-5:2016; EN ISO 374-5:2016)	Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016; EN ISO 374-5:2016)
HRN EN ISO 13688:2013	Zaštitna odjeća – Opći zahtjevi (ISO 13688:2013; EN ISO 13688:2013)	Protective clothing – General requirements (ISO 13688:2013; EN ISO 13688:2013)
HRN EN ISO 22301:2019	Sigurnost i elastičnost – Sustavi upravljanja neprekidnošću poslovanja – Zahtjevi (ISO 22301:2019; EN ISO 22301:2019)	Security and resilience – Business continuity management systems – Requirements (ISO 22301:2019; EN ISO 22301:2019)
HRN ISO 31000:2018	Upravljanje rizicima – Smjernice (ISO 31000:2018)	Risk management – Guidelines (ISO 31000:2018)
ISO 22316:2017		Security and resilience – Organizational resilience – Principles and attributes
ISO 22320:2018		Security and resilience – Emergency management – Guidelines for incident management
ISO 22395:2018		Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency
HRN EN ISO 5356-1:2015	Anestetička i respiracijska oprema – Stožasti priključci – 1. dio: Stožasti utikači i utičnice (ISO 5356-1:2015; EN ISO 5356-1:2015)	Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets (ISO 5356-1:2015; EN ISO 5356-1:2015)
HRN EN ISO 10651-4:2010	Plućni ventilatori – 4. dio: Posebni zahtjevi za balone za ručnu ventilaciju pogonjene ljudskom snagom (ISO 10651-4:2002; EN ISO 10651-4:2009)	Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002; EN ISO 10651-4:2009)
HRN EN ISO 17510:2020	Medicinski proizvodi – Respiratorna terapija apneje pri spavanju – Maske i pribor za postavljanje (ISO 17510:2015; EN ISO 17510:2020)	Medical devices – Sleep apnoea breathing therapy – Masks and application accessories (ISO 17510:2015; EN ISO 17510:2020)
HRN EN ISO 18082:2014	Anestetička i respiracijska oprema – Dimenzije nezamjenjivih priključaka na navoj (NIST) niskog tlaka za medicinske plinove (ISO 18082:2014; EN ISO 18082:2014)	Anaesthetic and respiratory equipment – Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO 18082:2014; EN ISO 18082:2014)
HRN EN ISO 18082:2014/A1:2017	Anestetička i respiracijska oprema – Dimenzije nezamjenjivih priključaka na navoj (NIST) niskog tlaka za medicinske plinove (ISO 18082:2014/Amd 1:2017; EN ISO 18082:2014/A1:2017)	Anaesthetic and respiratory equipment – Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO 18082:2014/Amd 1:2017; EN ISO 18082:2014/A1:2017)
HRN EN ISO 80601-2-12: 2011 povučena	Medicinska električna oprema – Dio 2-12: Posebni zahtjevi za osnovnu sigurnost i nužne značajke opreme za pojačanu zaštitu ventilatora (ISO 80601-2-12:2011; EN ISO 80601-2-12:2011)	Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2011; EN ISO 80601-2-12:2011)
HRN EN ISO 80601-2-12:2011/Ispr.1:2013 povučena	Medicinska električna oprema – Dio 2-12: Posebni zahtjevi za osnovnu sigurnost i nužne značajke opreme za pojačanu zaštitu ventilatora – Tehnički ispravak 1 (ISO 80601-2-12:2011/Cor 1:2011; EN ISO 80601-2-12:2011/AC:2011)	Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators – Technical Corrigendum 1 (ISO 80601-2-12:2011/Cor 1:2011; EN ISO 80601-2-12:2011/AC:2011)
HRN EN ISO 80601-2-12: 2020	Medicinska električna oprema – Dio 2-12: Posebni zahtjevi za osnovnu sigurnost i bitne radne značajke ventilatora za intenzivnu njegu (ISO 80601-2-12:2020; EN ISO 80601-2-12:2020)	Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020; EN ISO 80601-2-12:2020)
HRN EN ISO 80601-2-79: 2019	Medicinska električna oprema – Dio 2-79: Posebni zahtjevi za osnovnu sigurnost i bitne radne značajke opreme za potporu disanju kod poremećaja disanja (ISO 80601-2-79:2018; EN ISO 80601-2-79:2019)	Medical electrical equipment – Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018; EN ISO 80601-2-79:2019)
HRN EN ISO 80601-2-80: 2019	Medicinska električna oprema – Dio 2-80: Posebni zahtjevi za osnovnu sigurnost i bitne radne značajke opreme za potporu disanju kod respiratorne insuficijencije (ISO 80601-2-80:2018; EN ISO 80601-2-80:2019)	Medical electrical equipment – Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018; EN ISO 80601-2-80:2019)
CWA 17553:2020		Community face coverings – Guide to minimum requirements, methods of testing and use
HRS CWA 17553:2021	Maske za lice za građanstvo – Upute za minimalne zahtjeve, metode ispitivanja i upotrebu (CWA 17553:2020)	Community face coverings – Guide to minimum requirements, methods of testing and use (CWA 17553:2020)