MEDICAL EQUIPMENT

STANDARDS AND REGULATIONS

Based to WHO
World Health Organization
What are standards

 We need to understand the standards systems, the process in development of

standards and their use. Also the conformity assessment/process has become
essential in establishing medical device regulations
 According to ISO: Standards are defined as documented agreements
containing technical specifications or other precise criteria to be used
consistently as rules, guidelines or definitions of characteristics, to ensure
that materials, products, process and services are fit for their purpose.
Types of specifications in standards

Standards can establish a wide range of specifications for products, processes and services
1. Prescriptive specifications obligate product characteristics, e.g. device dimensions,
biomaterials, test or calibration procedures, as well as definitions of terms and
terminologies.
2. Design specifications set out the specific design or technical characteristics of a
product, e.g. operating room facilities or medical gas systems.
3. Performance specifications ensure that a product meets a prescribed test, e.g.
strength requirements, measurement accuracy, battery capacity, or maximum
defibrillator energy.
4. Management specifications set out requirements for the processes and procedures
companies put in place, e.g. quality systems for manufacturing or environmental
management systems.
Why do we need standards

1. Provide reference criteria that a product, process or service must meet.

2. Provide information that enhances safety, reliability and performance of

products, processes and services.

3. Assure consumers about reliability or other characteristics of goods or services

provided in the marketplace.

4. Give consumers more choice by allowing one firm’s products to be substituted

for, or combined with, those of another.
Voluntary and mandatory standards

 Most standards are voluntary. However, a standard may be mandated by a

company, professional society, industry, government or trade agreement. A
standard may be called a regulation when it becomes mandatory. This
mandate may, or may not, have a legal basis.

When a standard is mandated by a government or an international trade
agreement, it normally becomes legally obligatory based on regulations or a
law established by the government or the contracts between international
bodies. Countries that are considering making standards mandatory should
take into account the potential consequences under international agreements
on technical barriers to trade.
Typical process for standards
development
Advantage of Standards development
Process
 In general, good standards have the following attributes:
1. Their development has been overseen by a recognized body, thus ensuring that the process
is transparent and not dominated by vested interests.
2. The development process has been open to input from all interested parties and the
resulting document based on consensus. Consensus, in a practical sense, means that
significant agreement among the stakeholders is reached in the preparation of the
standard, including steps taken to resolve all objections. This process implies more than
the votes of a majority, but not necessarily unanimity.
3. Develops Good technical standards which are based on consolidated results of science,
technology and experience, and are aimed at the promotion of optimum community
benefits.
4. Periodic review of standard allow to remain tuned with technological advancement and
the standards also do not hinder innovations
Conformity assessment with standards
 There are four common industrial methods for assessing conformity to a standard.

1. TESTING - A product’s conformity to standards is commonly assessed by direct testing.

2. AUDITING - A process can be assessed by audit. Certification organizations or regulatory authorities attest that
products or processes conform to a standard by authorizing the display of their certification mark.

3. REGISTRATION - The conformity to management standard by an organization is known as management systems

registration, a relatively new term used primarily in North America. Formally established audit procedures are
followed by certified auditors who are supported by technical experts of the domain under audit. Management
System Registration bodies (Registrars) issue registration certificates to companies that meet a management
standard such as ISO9000, or to medical device manufacturers that meet the ISO13485/ISO9001 standards.

4. ACCREDITATION - Accreditation is used by an authoritative body to give formal recognition that an

organization or a person is competent to carry out a specific task. For example, in Europe, Notified Bodies are
notified or accredited by the relevant State Competent Authority to carry out conformity assessment of medical
devices.
National and international standards
systems
 A country may have many voluntary standards bodies. However, normally
there is one official national organization that coordinates and accredits
the standards development bodies in the country. This official national
organization would have the authority to endorse a document as a national
standard in accordance with official criteria, and it also represents the
country in the various international standards organizations.
 Examples are like United States, the American National Standards Institute
(ANSI), Tanzania Bureau of Standards (TBS), Standards Council of Canada
(SCC)
 For developing countries, reference to a standards system not only helps
medical device administration, it is also important for other industrial and
economic developments. Because standardized infrastructure is a basic
requirement for the success of economic policies that will improve
productivity, market competitiveness and export capability.
 MAJOR INTERNATIONAL STANDARDIZATION ORGANIZATIONS

1. International Electro-technical Commission

(IEC) – based on Electrical and Electronics standards
2. International Telecommunication Union (ITU) – Based on telecommunication
standards
3. International Organization for Standardization (ISO) – Based on other remaining
section of safety, management etc. standards

NB: Any grouping of five member countries can also propose a standard to be
considered by ISO for adoption as an international standard.
Identification of standards

 Standards are generally designated by an alphabetical prefix and a number. The

letters (e.g. ISO, IEC, ANSI, CAN, EN, DIN) indicate the body that has approved
them, while the numbers identify the specific standard and the year in which it
was finalized. The standard reference code often gives an indication of
adoption where standards are equivalent.
 Standard bodies-Number specifying standard – Year
Example:
 CAN/CSA-Z386-94 means a standard developed in 1994 by the Canadian
Standards Association (CSA, one of four accredited Canadian standards
development organizations) and designated by the Standards Council of Canada
(SCC) as a Canadian national standard.
Cont…

 ANSI/AAMI/ISO 15223:2000 means the international standard ISO 15223

(established in 2000) adopted by the Association for the Advancement of
Medical Instrumentations in the United States, which in turn is designated by
the American National Standards
Institute (ANSI) as an American national standard.
 UNI EN ISO 9001 indicates an Italian national standard (UNI) which is an
adoption of a European standard (EN), which is itself an adoption of the
International Standard ISO9001.
 Current trends in the use of standards in medical device
regulations

 Although a standard can be set and mandated by an authority,

the current trend is for the adoption of voluntary standards
established by consensus from all interested parties (the
stakeholders).
 The using voluntary standards provides much specifications and
detailed requirements for the multitude of devices presents
and gives enormous task for regulatory authorities. Fortunately,
the wealth of voluntary standards already existing or being
developed provide such precise specifications.
 ADVANTAGE IN USING OF VOLUNTARY/CONSENSUS
STANDARDS

1. They are normally developed by experts with access to the vast resources available in
the professional and industrial communities.

2. By taking advantage of such existing resources, the government can overcome its own
limited resources for providing product specific technical requirements and
characteristics.

3. Conformity to standards can also be assessed by an accredited third party (such as a

notified body in Europe), which is a well-established industrial practice around the world.

4. The use of international standards facilitates harmonized regulatory processes and

world trade, and thus improves global access to new technology.

5. Timely development and periodic revision by expert groups make medical device
standards effective and efficient tools for supporting health care. As technology
advances, it is much easier to update standards than to change regulations.

6. Manufacturers have the flexibility to choose appropriate standards or other means to

demonstrate compliance with regulatory requirements as they are not mandatory when
classified as Voluntary
 GOVERNMENTAL REGULATION IMPLEMENTATION OF MEDICAL
DEVICES STANDARDS

 How governments can fulfil part of their duties through the implementation of
regulations.

 Critical elements for regulatory attention

 Pre-market review contributes to product control, and post-market surveillance

ensures that medical devices in use continue to be safe and effective.
Cont..

 There is an important third element, which is the representation of the

product to the user.

 It involves labelling and advertising of the product

Stages of Governmental regulatory
control

 Pre-market control is performed on the device to ensure that the product to

be placed on market complies with regulatory requirements.
 Labelling and advertising control is maintained for correct product
representation.
 Placing-on-market control ensures establishment registration, device listing
and after-sale obligations.
 Post-market surveillance/vigilance ensures the continued safety and
performance of devices in use.
Cont..
Control of Regulations
 Product control - different authorities have different systems of pre-market review,
they all apply the risk management philosophy. All medical devices must satisfy
safety and performance, quality system (some low-risk devices may be exempt) and
labelling requirements. However, the degree of regulatory scrutiny increases with
the potential risks of the medical device, as evidenced by the risk-based device
classification system.
 Vendor establishment control - Vendor information facilitates governments in
tracking medical device vendors. Any individual or company wishing to sell medical
devices must apply for permission to obtain an establishment licence.
 Post-market surveillance/vigilance - It is critically important that the safety and
performance of medical devices are continually assessed when they are in use, as
these characteristics can only be proven if one measures how a device stands up in
these conditions. No amount of rigour in the pre-marketing review process can
predict all possible device failures or incidents arising from device misuses.
It is through actual use that unforeseen problems related to safety and performance
can occur.
 Role of Government and Private Sector
in Medical Standard Development
ROLE OF PRIVATE SECTOR IN STANDARDS DEVELOPMENT
 Private sector are the one who mostly develop standards at the level of
voluntary and depending on sections that they are of interest.
 Non-government standards development organizations use many stages in the
development process of standards, whether it’s a medical device standard or
not.
 For example ISO’s International standards are developed using a six-stage
process:
ISO Standard Development stages

Stage 1: Proposal stage

Stage 2: Preparatory stage

Stage 3: Committee stage

Stage 4: Enquiry stage

Stage 5: Approval stage

Stage 6: Publication stage

 Stage 1: Proposal stage
Involves confirming that there is a need for such standard.
o In order to initiate this first stage of proposal, the members of the
relevant technical committees or subcommittees submit a
new work item proposal for a vote.
o The proposal will only be accepted if the majority of the votes are
in its favor and if at least five participating members commit to
participate actively in the project.
o Once the proposal has been accepted a project leader responsible
for the work item is appointed

 Stage 2: Preparatory stage

At this stage, the appointed project leader chairs a group of
experts, which is set up by the technical committees and
subcommittees, for the preparation of a working draft. Afterwards,
the draft is forwarded to the working group's parent committee for
the consensus-building phase
 Stage 3: Committee stage
Once a committee draft is available, it is registered by the ISO Central
Secretariat.
It is then, distributed for comment and voting (if required), by the participating
members of the technical committees and subcommittees. Once agreement has
been reached, the text is finalized for submission as an International Standard
Draft (DIS).
 Stage 4: Enquiry stage
At this stage, the ISO Central Secretariat circulates the International Standard
Draft (DIS) for a period of five months to all ISO member bodies for voting and
comment. It is approved for submission as a final draft International Standard
(FDIS). If a two-thirds majority of the participating members of the technical
committees and subcommittees are in favor and not more than one-quarter of
the total number of votes
cast are negative it will be approved
 Stage 5: Approval stage
At this stage the final International Standard Draft (FDIS) is circulated to all ISO
member bodies by the ISO Central Secretariat for a final Yes or No vote within a
period
of two months (ISO). If a two-thirds majority of the participating members of the
technical committees and subcommittees are in favor and not more than one-
quarter of the total number of votes cast are negative it will be approved.
However, if the approval criteria are not met, the text is again returned to the
originating technical committees and subcommittees for reconsideration.

 Stage 6: Publication stage

After a final International Standard Draft has been approved, the final text is sent
to the ISO Central Secretariat, which publishes the International Standard. All
International Standards are reviewed at the least three years after publication and
every five years after the first review by all the ISO member bodies. A majority
vote of the participating members of the technical committees and subcommittees
decides whether an International Standard should be confirmed, revised or
withdrawn.
 ROLE OF GOVERNMENT IN STANDARD DEVELOPMENT
• Ensure safety, effectiveness, and quality of medical devices.
• Enforce implementation of standard and regulations.
• Formulate national standard bodies.
• Ensure policies and frame work are in place and acted on.
• Facilitating the recognition of national and international medical device
standards.