Medical device standards

Medical device standards are developed practically in all the major standardization organi-zations. The technical committee 215 on health informatics at ISO (ISO/TC215) works on standardization of health information and communications technology to allow compatibility and interoperability between independent systems. It consists of nine working groups (WG):

• WG1 Health records and modeling coordination

• WG2 Messaging and communication

• WG3 Health concept representation

• WG4 Security

• WG5 Health cards

• WG6 E-pharmacy and medicines business

• WG7 Devices

• WG8 Business requirements for Electronic Health Records

• WG9 SDO Harmonization

In Europe, health informatics standards are developed in CEN technical committee 251 (CEN/TC 251) in four workgroups:

• WG1 Information models

• WG2 Terminology and knowledge representation

• WG3 Security, safety and quality

• WG4 Technology for interoperability

In addition to these two committees, groups developing standards useful in medical devices and health information systems include:

3.2 Medical device standards and interfaces 53

• CDISC (Clinical Data Interchange Standards Consortium) - Develops and supports global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

• DICOM (Digital Imaging and Communication in Medicine) - Medical imaging communi-cation, world wide standards for radiology, ultrasound, endorsed by CEN and ISO.

• HL7 (Health Level Seven) - Works on health care messaging for clinical patient care and healthcare services. Co-operation with CEN and ISO.

• IHTSDO (International Health Terminology Standards Development Organisation) - De-velops, maintains, promotes and enables the uptake and correct use of its terminology products in health systems, services and products, notably SNOMED CT (Systematized Nomenclature of Medicine-Clinical Terms), to support safe, accurate, and effective ex-change of clinical and related health information. Focuses on enabling the implementation of semantically accurate health records that are interoperable.

• ISO/IEC JTC1 (Joint Technical Committee 1) - Development of information technology standards

• ITU-T/SG 16 - Works on multimedia communication, and also how multimedia system can support e-health applications, particularly in the area of telemedicine.

• IETF (Internet Engineering Task Force) - Development of the internet architecture.

• OMG (Object Management Group) - International not-for-profit computer industry con-sortium that develops enterprise integration standards for wide range of technologies.

Some well known specification include UML and CORBA.

• W3C (World Wide Web Consortium) - Develops interoperable technologies related to the WWW.

As the medical device field is so heterogeneous, the field of applicable standards is huge.

In Table 3.3 some of the most relevant standards for a medical-electrical device designer are presented. The proposed use and properties of the device designed define further standards which should be used.

Historically, the standardization of medical electrical devices has focused on electrical safety, which has be addressed by the IEC 1 since 1977 [Sid06]. The 2005 release of the IEC 60601-1, third edition, adds risk management (ISO 14971 standards based) to its contents [Sid06]. By applying risk management type of procedures, the third edition is designed to keep pace with the technology developments, and can be applied to new emerging technologies. This change has meant that the IEC 60601-1 has evolved from a basic safety standard to also an performance

Generic device standards

EN 980 Symbols For Use In The Labeling Of Medical Devices EN 1041 Information supplied by the manufacturer of medical devices

Safety and quality standards

EN ISO 13485 Medical Devices - Quality Management Systems - Requirements For Regula-tory Purposes. (Particular requirements for the application of EN ISO 9001) EN ISO 14971 Medical Devices - Application Of Risk Management To Medical Devices IEC 80001 Application of risk management to information technology (IT) networks

in-corporating medical devices (Note: Scheduled for approval in 2010) Medical electrical devices

IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance

IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests

IEC 60601-1-4 Medical electrical equipment Part 1-4: General requirements for safety - Col-lateral standard: Programmable electrical medical systems

IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for safety - Col-lateral standard: Usability

Medical devices with software

IEC 62304 Medical Device Software - Software Life Cycle Processes

IEC 61508-3 Functional safety of electrical/electronic/programmable safety related systems Software in health systems other than medical devices

ISO/PRF TS 29321

Health Informatics - Application of clinical risk management to the manufac-ture of health software (Note: Did not pass the vote in ISO)

ISO/IEC 12207 Information technology Software life cycle processes Patient safety

CEN CR 13694 CEN Report: Health Informatics - Safety and security related software quality standards for healthcare (SSQS)

CEN TS 15260 Health informatics - Categorization of risks from health informatics products CEN TR 15299 Health informatics - Safety procedures for identification of patients and related

objects

ISO DTS 25238 Health Informatics - Classification of safety risks from health informatics prod-ucts

ISO/TR 21730 Health informatics - Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for the management of unintentional electromagnetic interference with medical devices

Table 3.3: Medical device standards.

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standard, kind of which was lacking in the field. The combination of the IEC 60601-1 and the ISO 14971 standards is an unavoidable part any medical electrical equipment and system design [Sid06].

Medical software regulation and standardization is rather new area. The current EU direc-tives define, that “Software that is intended to be used specifically for diagnostic or therapeutic purposes will be subject to the directive’s requirements. Recital (6) of 2007/47/EC amplifies this by stating that software for general purposes when used in a healthcare setting is not a medical device.” [EU.07] The Directive 2007/47/EC will be applied from 21.3.2010. The prac-tical interpretation and scope of application of the directive has been under heavy discussion, and it seems that a more stricter interpretation will be applied, which will lead to widespread regulation of software. The practical tools and procedures for software MDD conformance are still under development, and are currently hastily being worked on.

An interesting developing standard regarding personal health monitoring at home, is the

“EN 60601-1-11 General requirements for basic safety and essential performance. Collateral standard. Requirements for medical electrical equipment and medical electrical systems used in home care applications CH/62/1”. It may have impact in the future design of home healthcare systems.

Also other non-medical standards and regulations have to be taken into account. For exam-ple, wireless devices must adhere to the RF regulations defined for the used radio frequency band and communicate as defined by the interface standard. The interface standards are discussed in the next Section.