The Healthcare Standardization industry is highly regulated in order to ensure the safety of the devices and their effectiveness for use. Regulators depend on published international standards to define the detail that products must comply with in order to satisfy their essential safety and performance requirements. Since standards are the ‘currency’ or ‘language’ of requirements, it follows that compliance with standards is a vital means of compliance with requirements of European Medical Devices Directives and other international regulations.
The European Commission has mandated the development of many standards to support the following regulations:
- Regulation (EU) 2017/745 on medical devices (MDR)
- Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR)
Once cited in the Official Journal of the EU (OJEU) these standards become harmonised and give a presumption of conformance to the general safety and performance requirements in the above regulations.
Standards are constantly subject to review and change to keep up-to-date with emerging technologies and regulatory requirements. It is essential, that all involved in the design and manufacture of medical devices, to clinical users and patients are aware of applicable standards and current changes. This can be facilitated through involvement in NSAI’s Standard Consultative Committees.
Within the Healthcare arena NSAI hosts 3 committees:
- NSAI/TC 5 – Healthcare Standards Committee (HCSC)
- NSAI/TC 21 – Health Informatic Standards Committee (HISC)
- NSAI/ETC/TC 10 – Electrical Equipment in Medical Practice
Within the Lifesciences area NSAI hosts 1 committee:
- NSAI/TC 62 – Biotechnology
Membership of NSAI standard committees is open to anyone based in Ireland. For more information see about what is involved see Committee training and Frequently Asked Questions.
For more information on the scope and international standard committee’s monitored by the NSAI Healthcare and lifescience committees see the Learn More tabs below.
Join a Standards Committee today
Having regard to the protection of the health and safety of patients and users of healthcare products and to assist manufacturers and all involved in the supply of healthcare products, the Healthcare Standards Committee (HCSC) provides the national forum for review of standard developments for healthcare and medical devices.
As a consultative committee under NSAI, TC 5 fulfils the following roles:
• Provide inputs and recommendations as necessary in relation to medical device standardization
- Monitor and participate as appropriate in the development of standards generally with particular focus on the European harmonization programme which supports European regulations for the sector;
- Consult and disseminate information to national stakeholders on healthcare standard developments that might impact the sector nationally; &
- Advise and assist NSAI as necessary with related developments e.g. EC Directives, Mandates, GMP Guidelines etc.
There are several ISO & CEN Technical Committees monitored by NSAI/TC 5.
Further details on the committee structure and mapping are available in the following link: TC 5 committee structure and mapping.
For more information or queries relating to NSAI/TC5 HCSC contact – Linda Hendy, NSAI Standards Officer
Electrical Equipment in Medical Practice | NSAI/ETC/TC 10
NSAI/ETC/TC 10 provides a national focal point for the development of the IEC 60601 series of standards. The goal of the IEC 60601 standards is to improve safety in the use of Medical equipment by providing a body of standards to assist manufacturers, users and patients alike. ETC/TC 10 is responsible for co-ordinating national participation in the work of IEC/TC 62 and its 4 sub-committees and CLC/TC 62. Another function of ETC/TC 10 is to provide expertise and assist in developments of IEC 60364 Part 7-710 Requirements for special installations or locations - Medical locations and developments of National rules for electrical installations.
IEC 60601 standards improve safety in the use of medical electrical equipment by providing a body of standards that assist:
- Manufacturers in designing and assembling safe medical electrical equipment and systems.
- Manufacturers, test houses and regulatory authorities in assessing compliance with requirements set forth in the standard and
- Health care professionals in managing the risks associated with use of these products.
International/European Committees Mirrored (in full or in part)
- IEC/TC 62 – Electrical equipment in medical practice
- IEC/SC 62A - Common aspects of electrical equipment used in medical practice
- IEC/SC 62B – Diagnostic imaging equipment
- IEC/SC 62C – Equipment for radiotherapy, nuclear medicine and radiation dosimetry
- IEC/SC 62D – Electromedical equipment
- CLC/TC 62 - Electrical equipment in medical practice
For more information or queries relating to NSAI/ETC/TC 10 contact – Jonathan Quigley, NSAI Standards Officer
The NSAI Health Informatics Standards Committee (HISC) provides a representative and strategic forum through which Ireland’s participation and contribution to international standards development is coordinated.
This NSAI committee monitors the work of the following:
Areas of interest nationally include:
- Genomic Informatics
- Architecture, Framework and Models.
- Systems and device interoperability
- Security, safety and privacy
- Pharmacy and medicine business
- Safe, effective and secure health software & health IT systems
- AI technologies
- Personalised digital health
The Health Informatics Standards Committee plays an important role in ensuring national stakeholders are informed about the development of relevant health informatic standards – ensuring Irish stakeholder are aware of international standard that can improve quality, reliability and security of health data and health informatics.
For more information or queries relating to NSAI/TC 21 HISC contact – Linda Hendy, NSAI Standards Officer
Biotechnology, defined by the OECD as the application of scientific and engineering principles to the processing of materials by biological agents, is an important emerging area of Ireland's economy. As an enabling technology with potentially multiple applications, biotechnology plays an increasingly significant role in the development of Ireland’s key industries of Pharmaceutical and Healthcare; Agriculture, Food and Marine; and Medical Devices and Diagnostics.
NSAI TC 62 – Biotechnology is the Standards Consultative Committee providing a representative and strategic forum through which Ireland's participation in International Standards Organization (ISO) ISO TC 276 - Biotechnology.
ISO TC 276 – Biotechnology was established in 2013 to develop standards addressing the following:
- Terms and definitions
- Biobanking and bioresources
- Analytical methods
- Data processing including annotation, analysis, validation, comparability and integration
Click the link to access the ISO TC 276 current work programme.
Read the latest NSAI TC 62 newsletter (pdf), providing an update on standard developments in this area.
For queries relating to biotechnology standards and NSAI TC 62 please contact: firstname.lastname@example.org
- Medical device regulation (MDR) (2017/745/EU)
- In vitro diagnostic medical devices regulation (IVDR) (2017/746/EU)
- NSAI Medical Device Certification
- List of all harmonized standards per directive
- Guide to UDI Regulation for Manufacturers and Distributers
- ISO portal (Experts only, password required)
- CEN Portal (Experts only, password required)
- View and comment on draft standards on Your Standards, Your Say
- Biomedical & Clinical Engineering Association of Ireland (BEAI)
- GS1 Ireland Healthcare
- Health Information and Quality Authority (HIQA)
- Healthcare Informatics Society of Ireland (HISI)
- Irish Cleanroom Society
- Irish Medical & Surgical Trade Association (IMSTA)
- Health Products Regulatory Authority (HPRA)
- Enterprise Ireland Life Science Sector