Türk Standartları Enstitüsü’nden Ücretsiz Standartlar

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)

Ücretsiz  TSE Standartları 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

Ücretsiz  TSE Standartları 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

Ücretsiz  TSE Standartları yazımız ile beraber https://www.ekaynaklar.com/sae-internationaldan-ucretsiz-standart-erisimi/ adresindeki yazımızı da inceleyebilirsiniz.