COVID-19 ile mücadele için ISO ve IEC standartları ücretsiz

ISO COVID-19 ile mücadele için standartları ücretsiz sunuyor
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ISO (The International Organization for Standardization) ve IEC (International Electrotechnical Commission), COVID-19 ile mücadele kapsamında eldiven, ventilatör, tıbbi cihazlar, koruyucu kıyafetler, tıbbi elektronik ekipmanlar, güvenlik, risk yönetimi ile ilgili standartlarını ücretsiz olarak paylaşıma açtı. Ücretsiz olarak sunulan bu standartlara ISO’nun COVID-19 sayfasından erişilebiliyor. IEC’nin standartlarına erişebilmek için ise (haberin devamında yer alan aşağıdaki adrese) e-posta göndermek gerekiyor.

ISO’nun COVID-19 ile mücadele kapsamında ücretsiz olarak edinilebilecek standartları şunlar:

  • ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk
  • ISO 10651-3:1997, Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators
  • ISO 10651-4:2002, Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
  • ISO 10651-5:2006, Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators
  • ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
  • ISO 13485:2016, Medical devices — Quality management systems – Requirements for regulatory purposes
  • ISO 13688:2013, Protective clothing – General requirements
  • ISO 17510:2015, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
  • 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]
  • ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
  • ISO 18562-2:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
  • ISO 18562-3:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)
  • ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
  • ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics
  • ISO 20395:2019, Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR
  • ISO 22301:2019, Security and resilience – Business continuity management systems –Requirements
  • ISO 22395:2018, Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency
  • ISO 22320:2018, Security and resilience – Emergency management – Guidelines for incident management
  • ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes
  • ISO 31000:2018, Risk management – Guidelines
  • ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
  • ISO 80601-2-12:2020, Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
  • ISO 80601-2-13:2011, 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]
  • 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
  • ISO 80601-2-74:2017, Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
  • 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
  • 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
  • ISO/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8: Ergonomic factors

IEC standartları imalatçılar için ücretsiz

IEC de sitesinde sağlık için kritik cihaz geliştiren ya da üreten işletmelere bazı standartlarını ücretsiz olarak paylaşacağının bilgisini verdi. Buna göre IEC şu standartları paylaşıma açtı:

IEC 60601-1:2005+AMD1:2012 CSV, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

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

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

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

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

Kaynak: IEC

IEC’ye e-posta göndermek gerekiyor

COVID-19 hastalarına yardımcı olmak için yoğun bakım ventilatörü geliştiren veya imalatını yapan şirketlerin, IEC’nin paylaşıma açtığı yukarıdaki standartları temin etmek için sales@iec.ch e-posta adresine Şirket İsmi, Markası, e-posta adresi ve ülke bilgisini de ekleyerek e-posta göndermeleri isteniyor:

In this case, the IEC Standards will be provided with the following settings:

Print restrictions
Text copy prevention
Watermark

Enterprises who are developing or manufacturing critical care ventilators for use by Covid-19 patients may access these standards free of charge. To receive the above-mentioned IEC Standards please click here (do not forget to mention your company name, end-user name, email and country).

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