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Healthcare Standards

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 host 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 285 150, 170
7 Orthopaedic Implants 285 168, 170
8 Cleaning, Disinfection and Laundry 102, 204, 216, 248  
9 Sterilization 102, 195, 204, 243 198, 209
10 Horizontal Standards 206, 258, 316 194, 210
11 Ambulances 239  
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, 427, 424 249 

 

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 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 out 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.

Links to Resources:

External Links 

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

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