Introduction
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 effectiveness 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.
For this reason, within Europe, many standards have been ‘harmonised’ or ‘synchronised’ in order to align their requirements with those of the European Medical Devices Directives.
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, from design to use, of medical devices, 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 three committees.
Healthcare Standards Consultative Committee (HCSC)
HCSC participates in the work of relevant Technical committees in both ISO and CEN.
Apart from members directly involved on the committee, HCSC warmly welcomes the contributions and involvement of clinicians, industry and academics, who may have a particular interest in even a small field.
This committee participates in the work of the following CEN and ISO committees:
- NSAI / TC 5 / Health Care - committee mappings (pdf)
HCSC | Subject | CEN TC | ISO TC |
1 | Dentistry | 55 | 106 |
2 |
In-Vitro Diagnostics |
140 | 212 |
3 |
Ophthalmics |
170 | 172 |
4 |
Non-Active Medical Devices |
205 | 076, 084, 157 |
5 |
Respiratory and Anaesthesia |
215 | 121 |
6 |
Implantable |
285 | |
7 |
Orthopaedic Implants |
285 | |
8 |
Cleaning, Disinfection and Laundry |
||
9 | Sterilization | ||
10 |
Horizontal Standards |
||
11 | Ambulances | ||
12 | Services | ||
13 |
Cleanrooms |
209 | |
14 |
Ostomy and Incontinence |
293 | 173 |
15 |
Aesthetic Surgery Services |
403 | |
16 |
Osteopathic Services |
414 | |
17 |
EU Matters |
||
18 | Nanotechnologies | 352 | 229 |
19 | Miscellaneous | 249 |
Health Informatics Standards Consultative Committee (HISC)
HISC participates in the work of ISO TC 215 and CEN TC 251.
Apart from members directly involved on the committee, HISC warmly welcomes the contributions and involvement of Healthcare Providers, Clinicians, IT Experts, Health Software Developers. Industry and Academics, who may have a particular interest in even a small field.
The work of the committee is broadly divided as follows:
HISC | Subject | CEN TC 251 | ISO TC 215 |
---|---|---|---|
SC 1 |
EHR Architecture and Information Models |
WG 1 |
WGs 1 & 8 |
SC 2 |
Nursing and Health Terminology |
WG 2 |
WG 3 |
SC 3 |
Network Management, Interoperability, Security and Safety |
WG 4 |
WGs 2, 4, JWG7 |
SC 4 | Pharmacy | WG 2 | WG 6 |
SC 5 |
Medical Device Software |
WG 2 |
ISO TC 210 JWGs 2, 3 / IEC TC 62A |
SC 6 | IT Network management |
IEC TC 62A (IEC 80001 Series) |
|
CEN TC 251 see draft standards and published standards |
ETC TC 10 Electrical Equipment in Medical Practice
NSAI ETC TC 10 is responsible for the standardisation of electrical equipment used in medical practice.
More information is available below on the TC 10 Electrical Equipment in Medical Practice standards.
NSAI ETC TC10 provides a national focal point for the development of the IEC 601 series of standards. The goal of the IEC 601 standards is to 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.
Apart from members directly involved on the committee, NSAI ETC TC 10 warmly welcomes the contributions and involvement of Healthcare Providers Clinicians, IT Experts, Health Software Developers, Industry and Academics, who may have a particular interest in even a small field.
Since 2017, NSAI has assumed direct responsibility for the maintenance and development of the national system of electrical installation standards.
NSAI is building upon the significant achievements of the Electro-Technical Council of Ireland Limited (ETCI Ltd.) over many years.
ETC TC 10 is responsible for the standardisation of electrical equipment used in medical practice.
The Committee participates in the work of CENELEC TC 62 and IEC TC 62 and its four subcommittees:
IEC Committee |
Subject |
Link to Published Documents |
Link to Current Work |
---|---|---|---|
TC 62 |
General aspects of Electrical Equipment in Medical Practice |
||
SC 62A |
Common Aspects of Electrical Equipment used in Medical Practice, incl. Software |
List of Published Documents, TC 62A | |
SC 62B |
Diagnostic Imaging Equipment |
List of Published Documents, TC 62B | |
SC 62C |
Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry |
List of Published Documents, TC 62C | |
SC 62D |
Electromedical Equipment |
List of Published Documents, TC 62D | |
CENELEC TC 62 |
Electrical Equipment in Medical Practice |
List of Published Documents, CLC/TC 62 | List of documents for vote, CLC/TC 62 |
ETC TC10 provides a national focal point for the development of the IEC 601 series of standards. The goal of the IEC 601 standards is to 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.
Apart from members directly involved on the committee, ETC TC 10 warmly welcomes the contributions and involvement of Healthcare Providers Clinicians, IT Experts, Health Software Developers, Industry and Academics, who may have a particular interest in even a small field.
For queries relating to Healthcare Standards please contact: linda.hendy@nsai.ie
Learn More
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
- Metrology
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: linda.hendy@nsai.ie
NSAI ETC TC 10 Electrical Equipment in Medical Practice
Scope/Introduction
NSAI ETC TC10 is responsible for the standardisation of electrical equipment used in medical practice. The Committee contributes to CENELEC TC62 and also to IEC TC62 and its four subcommittees:
- SC62A: Common Aspects of Electrical Equipment used in Medical Practice
- SC62B: Diagnostic Imaging Equipment
- SC62C: Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry
- SC62D: Electromedical Equipment
TC10 provides a national focal point for the development of the IEC 601 series of standards. The goal of the IEC 601 standards is to 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
- Health care professionals in managing the risks associated with use of these products
International/European Committees Mirrored (in full or in part)
- IEC TC62 Electrical Equipment in Medical Practice
- CENELEC TC62 Electrical Equipment in Medical Practice
- Current EU Legislation and directives
- NSAI Certification Services for medical device manufacturers
- List of all harmonized standards
- Latest News from Europe [within this site click on monthly snapshot]
- Guide to UDI Regulation for Manufacturers and Distributers
- How to become involved in the work of HISC and HCSC - Get Involved
- NSAI ISO National Mirror Committee (Experts only, password required)
- NSAI CEN National Mirror Committee (Experts only, password required)
- View and comment on draft standards on Your Standards, Your Say
- Buy a Standard from NSAI
- Biomedical & Clinical Engineering Association of Ireland (BEAI)
- GS1 Ireland Healthcare
- Health Information and Quality Authority
- Healthcare Informatics Society of Ireland
- Health Products Regulatory Authority
- Irish Cleanroom Society
- Irish Medical & Surgical Trade Association (IMSTA)
- Health Products Regulatory Authority (HPRA)
- Life Sciences Ireland