Context Sensitive Design of Medical Devices, Alma Mater Studiorum Università Di Bologna

Medical Devices Standards and Quality System

ER
STU
D
M
ALMA
UNIVERSITA
DI BOLOGNA
IORUM
A. D. 1088
CESENA
ALMA MATER STUDIORUM
UNIVERSITÀ DI BOLOGNA
CAMPUS DI CESENA
93924
CONTEXT SENSITIVE DESIGN
OF MEDICAL DEVICES
Medical Devices
Standards and Quality System
Johan de Bie
Department of Electrical, Electronic, and Information
Engineering "Guglielmo Marconi"How do we define the state of the art?

Harmonized Standards for Medical Devices

Article 8: Harmonized Standards
Devices that are in conformity with the relevant harmonized standards, or
the relevant parts of those standards, the references of which have been
published in the Official Journal of the European Union, shall be presumed
to be in conformity with the requirements of this Regulation covered by
those standards or parts thereof.
Also applies to system or process requirements ... , including those relating
to quality management systems, risk management, post-market
surveillance systems, clinical investigations, clinical evaluation or post-
market clinical follow-up
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02020D0437-20210415

International and European Standards Organizations

International Standards Organization
IEC
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ISO
International
Organization for
Standardization
European Standards Organization
cen
CENELEC
Official Journal
of the European Union
L 117
Volume 60
English edition
Legislation
5 May 2017
Contents
Legislative Acts
REGULATIONS

• Regulation (EU) 2017/745 of the European Parliament and of the Council of $ April 2017 on
  medical devices, amending Directive 2001/83/EC. Regulation (EC) No 178/2002 and
  Regulation (EC) No 1223/2009 and repealing Council Directives 90/185/FEC and 93/42/EEC ()
• Regulation (EU)) 2017/746 of the European Parliament and of the Council of 5 April 2017 on
  in vitro diagnostic medical devices and repealing Directive 98/70/EC and Commission Decision
  2010,227/EU(1)
  176
  RUM
  GNA
  CAMPUS DI CESENA

Medical Device Standards Overview

Standards and EU Harmonization

Standards
there are many standards
In practice, there can be long delays between publication of the
international standard and EU harmonization (publication in EU Journal)
and use of the international newer version is acceptable / preferred.
Standard clauses need to be mapped to MDR Annex I Requirements.
The use of standards is voluntary, but ....
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02020D0437-20210415
https://bsol.bsigroup.com/

Key Medical Device Standards

UDIORUM
DI BOLOGNA
1058
ENA
STUDIORUM
DI BOLOGNA
CAMPUS DI CESENA

Standard Example Index: Electrical Hazards

Standard example index
8
/.y ACCOMPANYING DOCUMENTS
by

• Protection against electrical HAZARDS from ME EQUIPMENT
  75
  8.1
  Fundamental rule of protection against electric shock
  75
  8.2
  Requirements related to power sources
  76
  8.3
  Classification of APPLIED PARTS
  77
  8.4
  Limitation of voltage, current or energy
  77
  8.5
  Separation of parts
  80
  8.6
• Protective earthing, functional earthing and potential equalization of
  ME EQUIPMENT
  90
  8.7
  LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
  93
  8.8
  Insulation
  115
  8.9
• CREEPAGE DISTANCES and AIR CLEARANCES
  121
  8.10 Components and wiring
  138
  8.11 MAINS PARTS, components and layout
  140
• Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
  146
  9.1
  MECHANICAL HAZARDS of ME EQUIPMENT
  146
  9.2
• MECHANICAL HAZARDS associated with moving parts
  146
  9.3
• MECHANICAL HAZARD associated with surfaces corners and edges
  152
  ATER STUD
  ALMA MAT
  UNIVERSITA
  UDIORUM
  DI BOLOGNA
  4.D. 1088
  CESENA
  ALMA MATER STUDIORUM
  UNIVERSITÀ DI BOLOGNA
  CAMPUS DI CESENA
  9

Standard Example Clause: Protective Earth Connections

Standard example clause
8.6.4
Impedance and current-carrying capability
a) * PROTECTIVE EARTH CONNECTIONS shall be able to carry fault currents reliably and without
excessive voltage drop.
For PERMANENTLY INSTALLED ME EQUIPMENT, the impedance between the PROTECTIVE EARTH
TERMINAL and any part that is PROTECTIVELY EARTHED shall not exceed 100 m22, except as
allowed by 8.6.4 b).
For ME EQUIPMENT with an APPLIANCE INLET the impedance between the earth pin in the
APPLIANCE INLET and any part that is PROTECTIVELY EARTHED shall not exceed 100 m22,
except as allowed by 8.6.4 b).
For ME EQUIPMENT with a non-DETACHABLE POWER SUPPLY CORD the impedance between the
protective earth pin in the MAINS PLUG and any part that is PROTECTIVELY EARTHED shall not
exceed 200 ml2, except as allowed by 8.6.4 b).
Compliance is checked by the following test:
A current of 25 A or 1,5 times the highest RATED current of the relevant circuit(s),
whichever is greater (± 10 %), from a current source with a frequency of 50 Hz or 60 Hz
and with a no-load voltage not exceeding 6 V, is passed for 5 s to 10 s through the
PROTECTIVE EARTH TERMINAL or the protective earth contact in the APPLIANCE INLET or the
protective earth pin in the MAINS PLUG and each PROTECTIVELY EARTHED part.
The voltage drop between the parts described is measured and the impedance determined
from the current and voltage drop.
Where the product of the test current as specified above and the total impedance (i.e. the
impedance being measured plus the impedance of the test leads and the contact
impedances) would exceed 6 V, the impedance is first measured with a no-load voltage not
exceeding 6 V.
If the measured impedance is within the permitted limit, either the impedance measure-
ment is then repeated using a current source with a no-load voltage sufficient to deliver the
specified current into the total impedance, or the current-carrying ability of the relevant
nententive north conductor and intentive north connection is confirmed his chorbing that
ER
STUD
ALMA MA
UNIVERSITA
UDIORUM
DI BOLOGNA
A.D. 1088
CESENA
ALMA MATER STUDIORUM
UNIVERSITÀ DI BOLOGNA
CAMPUS DI CESENA

Standard Example Index: Annexes and Figures

Standard example index -2
Annex A (informative) General guidance and rationale
218
Annex B (informative) Sequence of testing
331
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS
335
Annex D (informative) Symbols on marking
338
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT
347< Annex F (informative) Suitable measuring supply circuits
349
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures.
352
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation
367
Annex I (informative) ME SYSTEMS aspects
380
Annex J (informative) Survey of insulation paths
386
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams
389
Annex L (normative) Insulated winding wires for use without interleaved insulation
392
Annex M (normative) Reduction of pollution degrees
395
Bibliography
396
INDEX OF ABBREVIATIONS AND ACRONYMS
400
INDEX
402
Figure 1 - Detachable mains connection
23
Figure 2 - Example of the defined terminals and conductors
25
Finura 2
Euamain af
no
ER
STUD
ALMA MAT
UNIVERSITA
IDIORUM
DI BOLOGNA
A.D. 1088
CESENA
ALMA MATER STUDIORUM
UNIVERSITÀ DI BOLOGNA
CAMPUS DI CESENA

Compliance and Quality Management

Achieving Standard Compliance

Compliance with a standard
1. Compliance by testing samples or prototypes
2. Accredited laboratory is usually best, but expensive
3. Manufacturer can do test but needs certified and calibrated
equipment, traceable to standard units
4. Rules for test reports; may specify national variants of standards
5. "Process" standard compliance is often done by Notified Bodies
through assessment of processes, procedures and documentation.
Both the general system and the application on a specific product is
audited.
6. Many labs and NB's provide test reports and certificates for multiple
legislations, like EU, US, Australia, Canada. China requires in-country
testing.
ER
STUD
ALMA MAT
UNIVERSITA
IDIORUM
DI BOLOGNA
4.0. 1088
CESENA
ALMA MATER STUDIORUM
UNIVERSITÀ DI BOLOGNA
CAMPUS DI CESENA

Quality Management System Requirements

Quality Management System (article 10(9))
should govern all part of the company
Quality = ability to consistently meet or exceed expectations
Manufacturers of devices .. shall establish, document, implement,
maintain, keep up to date and continually improve a quality
management system that shall ensure compliance with this Regulation in
the most effective manner and in a manner that is proportionate to the risk
class and the type of device.
The quality management system shall cover all parts and elements of a
manufacturer's organization dealing with the quality of processes,
procedures and devices. It shall govern the structure, responsibilities,
procedures, processes and management resources required to
implement the principles and actions necessary to achieve compliance
with the provisions of this Regulation.
Changes in device design or characteristics and changes in the
harmonised standards or CS by reference to which the conformity of a
device is declared shall be adequately taken into account in a timely
manner
The manufacturer shall ensure the application of the quality management
DRUM
BOLOGNA
system .. and shall be subject to audit .. and to surveillance ..
UNIVERSIT
4.D. 1088
CESENA
EN ISO 13485:2016 Medical devices -- Quality management systemsR STUOLORW
CAMPUS DI CESENA

Quality Management System Elements

Quality Management System (article 10(9))
(a) a strategy for regulatory compliance ...
(b) identification of applicable general safety and performance requirements and
exploration of options to address those requirements
(c) responsibility of the management
(d) resource management, including selection and control of suppliers and sub-
contractors
(e) risk management as set out in Section 3 of Annex I
(f) clinical evaluation in accordance with Article 61 and Annex XIV ...
(g) product realization, including planning, design, development, production and
service provision
(h) verification of the UDI assignments ...
(i) setting-up, implementation and maintenance of post-market surveillance system ..
(j) handling communication with competent authorities, notified bodies, other
economic operators, customers ...
(k) processes for reporting of serious incidents and field safety corrective actions in the
context of vigilance
(l) management of corrective and preventive actions and verification of their
effectiveness
(m) processes for monitoring and measurement of output, data analysis and product
improvement.
ALMA MAY
UNIVERSITA
DIORUM
DI BOLOGNA
A.D. 1088
CESENA
ALMA MATER STUDIORUM
UNIVERSITÀ DI BOLOGNA
CAMPUS DI CESENA