Health and Pandemics - The role of Standards


The European Policy context: strategies and legislation


Pandemics are epidemic episodes that spread worldwide and have characterised human history since the dawn of time. They often result from the sudden increase of a localised illness propelled by viral/bacterial vectors, affecting many people. Several vector-borne diseases can pose significant health threats at different geographical scales, and only a wide range of community measures can help prevent or mitigate pandemic episodes. These include social distancing, appropriate hygienic measures, social distancing and vaccinations.

While several pandemic episodes have occurred throughout human history, the spread of vaccines and modern medicine has allowed humankind to contain infectious diseases and minimise their impacts. However, the recent spread of COVID-19 posed unprecedented challenges to our entangled globalised world.

The European Union (EU) and its member states experienced the national and regional consequences of the spread of COVID-19 in their socioeconomic orders. Despite these challenges, the EU has mobilised many resources to assist member states in their national responses. Examples include information and vaccination campaigns, several containment measures (social distancing, travel restrictions), and economic reparations to mitigate the social consequences brought by the pandemic. Evidence of this coordinated effort was the establishment of a coronavirus response team coordinated directly by president Ursula von der Leyen.

The current COVID-19 pandemic was also an occasion to create solidarity among member states through donations and assistance to the countries most in need. Most notably, the donation of protective equipment such as masks, cross-border treatments of ill patients and coordinated efforts to bring stranded citizens home.


The role of standardisation


The COVID-19 pandemic has led to the development of various sets of standards to contrast the outbreak of future pandemic episodes. These aim to contain the spread of infectious diseases through several measures, with particular attention to healthcare workers continuously exposed to viral and bacterial vectors.

Current ISO standards aimed at preventing pandemics are:

  • ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms (part 5: terminology and performance requirements for micro-organisms risk);
  • ISO 5356-1:2015, Anaesthetic and respiratory equipment – Conical connectors (Part 1: Cones and sockets);
  • 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/TS 16976-8:2013, Respiratory protective devices – Human factors (Part 8: Ergonomic factors);
  • 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;
  • 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);
  • ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications (Part 4: Tests for leachable 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 22316:2017, Security and resilience – Organisational 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;
  • ISO 22609:2004, Clothing for protection against infectious agents – Medical face masks – Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected);
  • ISO 31000:2018, Risk management – Guidelines;
  • ISO 45003:2021, Occupational health and safety management – Psychological health and safety at work – Guidelines for managing psychosocial risk;
  • ISO/PAS 45005:2020, Occupational health and safety management – General guidelines for safe working during the COVID-19 pandemic;
  • ISO 80601-2-90:2021, Medical electrical equipment — Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (e.g., ventilators for medical emergencies, technical support).

Moreover, in recent times, the ISO technical committee ISO/TC 304, Healthcare organisation management, established a working group (WG 4 - Pandemic preparation response) to develop standards to run safe tests, rapidly quarantine and treat patients and focus on quickly cutting the chain of transmission.

The COVID-19 pandemic has revealed the importance of developing and maintaining healthcare systems that cannot only handle such crises but can spring into immediate action to reduce the spread of infectious diseases quickly and effectively at the first signs of an outbreak.

Pandemics and Covid-19 Standardisation