Healthcare and Lifescience Standards

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	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 Lastest newsletter
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 queries relating to Healthcare Standards please contact: linda.hendy@nsai.ie