Medical Device Standards

 
The Medical Device 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 (HSCS)

HSCS follows the work of every relevant Technical committee 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 follows 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 Opthalmics 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 Sterilizers 102, 204  
9 Sterilization 195, 204, 216, 243 198, 209
10 Horizontal Standards 206, 258, 316 194, 210
11 Ambulances 239  
12 Services CHESSS, TC 362  
13 Cleanrooms 243 209
14 EU Matters ABHS, CEN/CLC TF3  
       
 

Health Informatics Standards Consultative Committee (HISC)

HISC follows the work of the relevant ISO TC 215 and CEN TC 251.
Apart from members directly involved on the committee, HISC warmly welcomes the contributions and involvement of clinicians, IT Experts, 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
WG 1 Electronic Health Record WG 1 WG 1 & 8
WG 2 Nursing and Health WG 2 WG 3
WG 3 Devices Network Management CLC SAMD WG 7
WG 4 Safety and Security WG 3 WG 4
5 Terminology WG 2 WG 3
6 Interoperability WG 4 WG 2
7 Pharmacy   WG 6
CEN TC 251 Pending and Published Work ISO TC 215 Pending and Published Work  
       
 

ETCI TC 10 Electrical Equipment in Medical Practice

Within the Healthcare arena, ETCI, (Electrotechnical Council of Ireland) hosts TC 10, concerning safety of Electrical Equipment in Medical Practice.


NSAI provides technical secretariat to this committee.


ETCI TC 10 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:
 
IEC Committee Subject Link to Published Documents Link to Documents out for vote
TC 62 General aspects of Electrical Equipment in Medical Practice List of Published Documents, TC 62 List of documents out for vote, TC 62
SC 62A Common Aspects of Electrical Equipment used in Medical Practice List of Published Documents, TC 62A List of documents out for vote, TC 62A
SC 62B Diagnostic Imaging Equipment List of Published Documents, TC 62B List of documents out for vote, TC 62B
SC 62C Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry List of Published Documents, TC 62C List of documents out for vote, TC 62C
SC 62D Electromedical Equipment List of Published Documents, TC 62D List of documents out for vote, 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

ETCI 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, ETCI TC 10 warmly welcomes the contributions and involvement of clinicians, 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: chrissie.keane@nsai.ie
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