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:

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

150, 170

7

Orthopaedic Implants

285

168, 170

8

Cleaning, Disinfection and Laundry

102, 204, 216, 248

 
9 Sterilization

102, 195, 204, 243

 
10

Horizontal Standards

206, 258, 316

198, 209

11 Ambulances

239

194, 210

12 Services

CHESSS, 362

 
13

Cleanrooms

243

209
14

Ostomy and Incontinence

293 173
15

Aesthetic Surgery Services

403  
16

Osteopathic Services

414  
17

EU Matters

ABHS, CEN/CLC TF3

 
18 Nanotechnologies 352 229
19 Miscellaneous

261, 424, 427

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

ISO TC 215 see draft 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

List of Published Documents, TC 62

Work Programme TC 62

SC 62A

Common Aspects of Electrical Equipment used in Medical Practice, incl. Software

List of Published Documents, TC 62A

Work Programme TC 62A

SC 62B

Diagnostic Imaging Equipment

List of Published Documents, TC 62B

Work Programme TC 62B

SC 62C

Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry

List of Published Documents, TC 62C

Work Programme TC 62C

SC 62D

Electromedical Equipment

List of Published Documents, TC 62D

Work Programme 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 all other queries please contact: mary.white@nsai.ie

Learn More

TC10 Electrical Equipment in Medical Practice | Scope / Introduction

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)

Links to Resources