Covid-19 ile mücadele kapsamında Türk Standardları Enstitüsü (TSE), CEN (Avrupa Standardizasyon Komitesi) ve CENELEC (Avrupa Elektroteknik Standardizasyon Komitesi) ISO ve IEC ile birlikte, tıbbi cihazlar ve kişisel koruyucu ekipmanlarda dâhil olmak üzere bir dizi Avrupa Standardını (EN) ve ISO/IEC standartlarını salgınla mücadele çabalarını desteklemek üzere ilgili taraflara web üzerinden ücretsiz erişilebilir hale getirmiştir.

Bu kapsamda ücretsiz erişim sağlanabilecek aşağıda listelenmiş olup standartlar ikinci bir duyuruya kadar ilgililerine erişilebilir olacaktır.

https://intweb.tse.org.tr//Yetki/Login/Login.aspx?Durum=Cikis adresinden kaydınız yoksa kurumsal veya bireysel abonelik gerçekleştirerek listedeki standartları arayıp bilgisayarınıza indirebilirsiniz.

Sisteme kayıt olma aşamasında yardımcı olmak için aşağıda linki verilen “Abone olma” kılavuzundan faydalanabilirsiniz.

https://statik.tse.org.trhttps://statik.tse.org.tr/upload//tr/dosya/icerikyonetimi/7590/13022020181732-2.pdf

CEN-CENELEC

1. EN 149:2001 + A1:2009 Respiratory protective devices – Filtering half masks to protect against particles - Requirements, testing, marking (commonly referred to as ‘FFP masks’)

(TS EN 149+A1:2010 Solunumla ilgili koruyucu cihazlar - Parçacıklara karşı koruma amaçlı filtreli yarım maskeler - Özellikler, deneyler ve işaretleme)

2. EN 14683:2019  Medical face masks - Requirements and test methods

TS EN 14683+AC:2019 (İngilizce Metin) Tıbbi yüz maskeleri – Gereklilikler ve deney yöntemleri

3. EN 166:2001 Personal eye-protection – Specifications

(TS 5560 EN 166:2005 Kişisel göz koruması – Özellikler)

4. EN 14126:2003 + AC 2004 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents

(TS EN 14126:2004 Koruyucu giyecekler - Patojen organizmalara karşı - Performans özellikleri ve deney metotları)

5. EN 14605:2009 + 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

(TS EN 14605+A1:2010 Koruyucu giyecekler - Sıvı kimyasal maddelere karşı - Vücudun sadece bir kısmına koruma sağlayanlar (tip pb [3] ve tip pb [4]) dâhil, bağlantı yerleri sıvı geçirmez (tip 3) veya sprey geçirmez (tip 4) giyecekler için performans özellikleri)

6. EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

7. EN 13795-2:2019 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods

(TS EN 13795-2:2019 Cerrahi giysiler ve örtüler – Gereklilikler ve deney yöntemleri – Bölüm 2: Temiz hava giysileri)

8. EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD)

(TS EN 455-1:2004 Tıbbî eldivenler - Bir kullanımlık - Bölüm 1: Özellikler ve delik bulunmaması deneyi)

9. EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD)

TS EN 455-2:2015 (İngilizce Metin) Tek kullanımlık tıbbî eldivenler - Bölüm 2: Fiziksel özellikler için kurallar ve deneyler

10. EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD)

(TS EN 455-3: 2015 (İngilizce Metin) Tıbbî eldivenler- Bir kullanımlık- Bölüm 3: Biyolojik değerlendirme için özellikler ve deneyler

11. EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)

(TS EN 455-4: 2010 Tek kullanımlık tıbbi eldivenler - Bölüm 4: Raf ömrünün tayini için kurallar ve deneyler)

12. EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks

(TS EN ISO 374-5:2016 (İngilizce Metin) Tehlikeli kimyasallara ve mikroorganizmalara karşı koruyucu eldivenler - Bölüm 5: Mikroorganizmal riskler için terimler ve performans kuralları)

13. EN ISO 13688:2013 Protective clothing - General requirements

(TS EN ISO 13688:2013 Koruyucu giyecekler-Genel özellikler)

14. EN ISO 10993-1:2009 + AC 2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

(TS EN ISO 10993-1:2011 Tıbbi gereçlerin biyolojik Değerlendirilmesi - Bölüm 1: Bir risk yönetim sürecinde değerlendirme ve deney)

15. EN ISO 22301:2019 Security and resilience — Business continuity management systems — Requirements

(TS EN ISO 22301:2020 (İngilizce Metin) Güvenlik ve esneklik - İş sürekliliği yönetim sistemleri – Gereksinimler)

ISO

Aşağıdaki standartlar, www.iso.org/covid19 sayfası üzerinden okuma amaçlı temin edilebilir.

1. ISO 22395:2018 Security and resilience — Community resilience — Guidelines for supporting vulnerable persons in an emergency
2. ISO 22320:2018 Security and resilience — Emergency management — Guidelines for incident management
3. ISO 22316:2017 Security and resilience — Organizational resilience — Principles and attributes
4. ISO 31000:2018 Risk management — Guidelines
5. ISO 22320:2018, Security and resilience – Emergency management – Guidelines for incident management
6.  ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes

7. ISO 10651-3:1997, Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators

8. ISO 10651-4:2002, Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators

9. ISO 10651-5:2006, Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators

10. ISO 13485:2016, Medical devices — Quality management systems - Requirements for regulatory purposes

11. ISO 17510:2015, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

12. ISO 18082:2014, Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including ISO 18082:2014/AMD 1:2017, AMENDMENT 1]

13. ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

14. ISO 18562-2:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter

15. ISO 18562-3:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)

16. ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate

17. ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics

18. ISO 20395:2019, Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR

19. ISO 22301:2019, Security and resilience – Business continuity management systems –Requirements

20. ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

21. ISO 80601-2-12:2020, Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

22. ISO 80601-2-13:2011, Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: ISO 80601-2-13:2011/Amd.1:2015, AMENDMENT 1 and ISO 80601-2-13:2011/Amd.2:2018, AMENDMENT 2]

23. ISO 80601-2-70:2015, Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

24. ISO 80601-2-74:2017, Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

25. ISO 80601-2-79:2018, Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

26. ISO 80601-2-80:2018, Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

27. ISO/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8: Ergonomic factors

IEC

Aşağıdaki IEC standartlarına bu linkten talep edilmesi halinde erişim verilecektir.

1. IEC 60601-1:2005+AMD1:2012 CSV, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
2. IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
3. IEC 60601-1-6:2010+AMD1:2013 CSV, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
4. IEC 60601-1-8:2006+AMD1:2012 CSV, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
5. IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

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