CE-024 Essential Principles (EP) Checklist 基本原则清单

Essential Principles Checklist

Identity of IVD medical device:

Blood glucose monitoring system（URIT-25、URIT-26、URIT-28）

Essential Principle Applicable to

the device?

A General Requirements

A1 Medical devices should be designed and

manufactured in such a way that, when used under

the conditions and for the purposes intended and,

where applicable, by virtue of the technical

knowledge, experience, education or training, and the

medical and physical conditions of intended users,

they will perform as intended by the manufacturer

and not compromise the clinical condition or the

safety of patients, or the safety and health of users or,

where applicable, other persons, provided that any

risks which may be associated with their use

YES

Method Method Reference Reference to

Used to Supporting Controlled

Demonstrate Documents

Conformity

Recognised

EN ISO 14971:2012 CE-019

standard

EN 61010-2-101:2002

EN ISO 15197:2003

CE-013

CE-021

1

constitute acceptable risks when weighed against the

benefits to the patient and are compatible with a high

level of protection of health and safety.

A2 The solutions adopted by the manufacturer for the

design and manufacture of the devices should

conform to safety principles, taking account of the

generally acknowledged state of the art. When risk

reduction is required, the manufacturer should

control the risks so that the residual risk associated

with each hazard is judged acceptable. The

manufacturer should apply the following principles

in the priority order listed:

• identify known or foreseeable hazards and estimate

the associated risks arising from the intended use

and foreseeable misuse;

YES

Recognised

standard

EN ISO 14971:2012

EN 61010-2-101:2002

EN ISO 15197:2003

EN 62366:2008

EN ISO 18113-4:2011

EN ISO 18113-5:2011

CE-019-1，CE-019-2，CE-019-3

CE-013

CE-021

CE-017

CE-011

MANUAL

(URIT G25 / URIT G26 /

URIT G28)

(URIT-25/URIT-26/URIT-28)

OPERATING

• eliminate risks as far as reasonably

practicable through inherently safe design and

manufacture;

reduce as far as reasonably practicable the

remaining risks by taking adequate protection

measures, including alarms; and

inform users of any residual risks.

YES

•

•

A3 Medical devices should achieve the performance

Recognised

EN ISO 15197:2003 CE-021

2

intended by the manufacturer and be designed and

manufactured in such a way that, during normal

conditions of use, they are suitable for their intended

purpose.

A4 The

characteristics and performances referred to in Clauses

YES

A1, A2 and A3 should not be adversely affected to such a degree

that the health or safety of the patient or the user and, where

applicable, of other persons are compromised during the lifetime of

the device, as indicated by the manufacturer, when the device is

subjected to the stresses which can occur during normal conditions

of use and has been properly maintained in accordance with the

manufacturer’s instructions.

standard

EN 62366:2008

EN 62304:2006

CE-017

CE-016

Recognised

standard

EN13612:2002

CE-022

A5

Medical devices should be designed, manufactured and

YES

packaged in such a way that their characteristics and performances

during their intended use will not be adversely affected by transport

and storage conditions (for example, fluctuations of temperature

and humidity) taking account of the instructions and information

provided by the manufacturer.

Recognised

standard

EN ISO 15197:2003

CE-021

A6 All known and foreseeable risks, and any undesirable effects,

YES

should be minimised and be acceptable when weighed against the

benefits of the intended performance of medical devices during

normal conditions of use.

Recognised

standard

EN ISO 14971:2012 CE-019

B Essential Principles applicable to Medical Devices

/

other than IVD Medical Devices

C Essential Principles applicable to IVD Medical

/

/

/

3

Devices

C1 Chemical, physical and biological properties

C1.1 The IVD medical devices should be designed and manufactured in such a

way as to ensure the characteristics and performance referred to in Section 6.

Particular attention should be paid to the possibility of impairment of analytical

performance due to incompatibility between the materials used and the

specimens and/or analyte (measurand) to be detected (such as biological

tissues, cells, body fluids and micro-organisms), taking account of its intended

purpose.

C1.2 The IVD medical devices should be designed, manufactured and

packaged in such a way as to minimize the risk posed by contaminants and

residues to the persons involved in the transport, storage and use of the devices

and to patients, taking account of the intended purpose of the device.

C1.3 The IVD medical devices should be designed and manufactured in such a

way as to reduce as far as reasonably practicable and appropriate the risks

posed by substances that may leach or leak from the IVD medical device.

Special attention should be given to substances which are carcinogenic,

mutagenic or toxic to reproduction.

YES

EN ISO 14971:2012

CE-019

Recognised

standard

YES

Recognised

standard

EN ISO 14971:2012 CE-019

NO. This device

does not have

the transudates

or leakages

which are

carcinogenic,

mutagenic or

toxic to

reproduction.

4

C1.4 IVD medical devices should be designed and manufactured in such a way

YES

as to reduce as far as reasonably practicable and appropriate risks posed by the

unintentional ingress or egress of substances into or from the IVD medical

device taking into account the device and the nature of the environment in

which it is intended to be used.

Recognised

standard

EN ISO 14971:2012 CE-019

C2 Infection and microbial contamination

C2.1 The IVD medical devices and manufacturing

processes should be designed in such a way as to

eliminate or to reduce as far as reasonably

practicable and appropriate the risk of infection to

user, professional or lay, or, where applicable,

other person . The design should:

• allow easy and safe handling;

YES

EN ISO 14971:2012

CE-019

Recognised

standard

and, where necessary:

• reduce as far as reasonably practicable and

appropriate any microbial leakage from the

IVD medical device and/or microbial exposure

during use; and

prevent microbial contamination of the IVD

medical device or specimen where applicable,

by the user, professional or lay, or other person.

NO This

does

device

not

•

C2.2 IVD medical devices labelled either as sterile or as having a special

microbiological state should be designed, manufactured and packaged to

5

ensure they remain so when placed on the market and remain so under the

transport and storage conditions specified by the manufacturer, until the

protective packaging is damaged or opened.

C2.3 IVD medical devices labelled either as sterile or as having a special

microbiological state should have been processed, manufactured and, if

applicable, sterilized by appropriate, validated methods.

C2.4 IVD medical devices intended to be sterilized should be manufactured in

appropriately controlled (e.g. environmental) conditions.

contain

microbes.

NO This device

does not

contain

microbes.

This device

does not

contain

microbes.

This device

does not

contain

microbes.

This device

does not

contain

biological

source

materials

NO

C2.5 Packaging systems for non sterile IVD medical devices should maintain

the integrity and cleanliness of the device.

NO

C3 IVD medical devices incorporating materials of biological origin

C3.1 Where IVD medical devices include tissues, cells and substances

originating from animals, the processing, preservation, testing and handling of

tissues, cells and substances of animal origin should be carried out so as to

provide optimal safety for user, professional or lay, or other person.

In particular, safety with regard to viruses and other transmissible agents

should be addressed by implementation of validated methods of elimination or

inactivation in the course of the manufacturing process. This may not apply

to certain IVD medical devices if the activity of the virus and other

transmissible agent are integral to the intended purpose of the IVD medical

device or when such elimination or inactivation process would compromise the

NO

6

performance of the IVD medical device.

National regulations may require that the manufacturer and/or the Regulatory

Authority retain information on the geographical origin of the animals.

C3.2 Where IVD medical devices include human tissues, cells and substances,

the selection of sources, donors and/or substances of human origin, the

processing, preservation, testing and handling of tissues, cells and substances

of such origin should be carried out so as to provide optimal safety for user,

professional or lay, or other person.

In particular, safety with regard to viruses and other transmissible agents

should be addressed by implementation of validated methods of elimination or

inactivation in the course of the manufacturing process. This may not apply

to certain IVD medical devices if the activity of the virus and other

transmissible agent are integral to the intended purpose of the IVD medical

device or when such elimination or inactivation process would compromise the

performance of the IVD medical device.

C3.3 Where IVD medical devices include cells and substances of microbial

origin, the processing, preservation, testing and handling of cells and

substances should be carried out so as to provide optimal safety for user,

professional or lay, or other person.

In particular, safety with regard to viruses and other transmissible agents

should be addressed by implementation of validated methods of elimination or

inactivation in the course of the manufacturing process. This may not apply

to certain IVD medical devices if the activity of the virus and other

transmissible agent are integral to the intended purpose of the IVD medical

device or when such elimination or inactivation process would compromise the

performance of the IVD medical device.

NO This device

does not

contain

biological

source

materials

NO This device

does not

contain

biological

source

materials

7

C4 Environmental properties

C4.1 If the IVD medical device is intended for use in combination with other

devices or equipment, the whole combination, including the connection system

should not impair the specified performance of the devices. Any restrictions

on use applying to such combinations should be indicated on the label and/or in

the instructions for use.

YES

EN ISO 14971:2012

CE-019

Recognised

standard

C4.2 IVD medical devices should be designed and manufactured in such a way

as to remove or reduce as far as reasonably practicable and appropriate:

C4.2.1

C4.2.2

C4.2.3

the risk of injury to user, professional or lay, or other person in

the risk of use error due to the ergonomic features, human factors

risks connected with reasonably foreseeable external influences or

EN ISO 14971:2012

CE-019

YES

YES

YES

connection with their physical and ergonomic features;

and the environment in which the IVD medical device is intended to be used;

environmental conditions, such as magnetic fields, external electrical and

electromagnetic effects, electrostatic discharge, pressure, humidity, temperature

or variations thereof;

C4.2.4 the risks associated with the use of the IVD medical device when it

Recognised

standard

Recognised

standard

Recognised

standard

EN ISO 14971:2012

EN ISO 14971:2012

CE-019

CE-019

CE-012

CE-013

CE-019

EN 61326-2-6:2006

EN 61010-2-101:2002

EN ISO 14971:2012

YES

comes into contact with materials, liquids, and gases to which it is exposed

during normal conditions of use;

C4.2.5 the risk associated with the possible negative interaction between

software and the environment within which it operates and interacts;

C4.2.6 the risks of accidental penetration of substances into the IVD medical

device;

Recognised

standard

Recognised

standard

Recognised

standard

YES

EN ISO 14971:2012 CE-019

YES

EN ISO 14971:2012 CE-019

8

C4.2.7 the risk of incorrect identification of specimens/samples;

C4.2.8 the risks of reasonably foreseeable interference with other devices such

as carry over between IVD medical devices.

C4.3 IVD medical devices should be designed and manufactured in such a

way as to minimize the risks of fire or explosion during normal use and in

single fault condition. Particular attention should be paid to IVD medical

devices whose intended use includes exposure to or use in association with

flammable substances or substances which could cause combustion.

C4.4 IVD medical devices should be designed and manufactured in such a

way that adjustment, calibration, and maintenance, where such is necessary to

achieve the performances intended, can be done safely.

C4.5 IVD medical devices should be designed and manufactured in such a

way as to facilitate the safe disposal of any waste substances.

C5 Performance characteristics

YES

YES

Recognised

standard

Recognised

standard

Recognised

standard

EN ISO 14971:2012 CE-019

EN ISO 14971:2012 CE-019

YES

EN 61010-2-101:2002 CE-013

YES

Recognised

standard

EN 61010-2-101:2002 CE-013

YES

Recognised

standard

EN ISO 14971:2012 CE-019

EN ISO 15197:2003

EN13612:2002

C5.1 IVD medical devices should be designed and

manufactured in such a way that the performance

characteristics support the intended use, based on

appropriate scientific and technical methods. In

particular, where appropriate, the design should

address sensitivity, specificity, accuracy which is

trueness and precision (repeatability and

YES

Recognised

standard

CE-021

CE-014

9

reproducibility), control of known relevant

interference and limits of detection.

These performance characteristics need to be maintained

during the lifetime of the IVD medical device as indicated

by the manufacturer.

C5.2 Where the performance of devices depends on the

use of calibrators and/or control materials, the

traceability of values assigned to such calibrators

and/or control materials should be assured through

available reference measurement procedures and/or

available reference materials of a higher order.

C5.3 Wherever possible values expressed numerically

should be in commonly accepted, standardised

units, and understood by the users of the device.

C6 Protection against radiation

C6.1 IVD medical devices should be designed,

manufactured and packaged in such a way that

exposure of user, professional or lay, or other

person to the emitted radiation (intended,

unintended, stray or scattered) is reduced as far as

reasonably practicable and appropriate.

C6.2 When IVD medical devices are intended to emit

YES

Recognised

standard

EN ISO 15197:2003

CE-006

YES

Recognised

standard

EN ISO 15197:2003

CE-021

CE-012

YES

Recognised

standard

EN 61326-2-6:2006

NO。 This device does

10

potentially hazardous, visible and/or invisible

radiation, they should as far as reasonably

practicable and appropriate be:

• designed and manufactured in such a way

as to ensure that the characteristics and

the quantity of radiation emitted can be

controlled and/or adjusted; and

fitted with visual displays and/or audible

warnings of such emissions.

not intend to emit

radiation.

•

C7 IVD medical devices that incorporate software

and standalone IVD medical device software

C7.1 For IVD medical devices which incorporate

software or for standalone software that are IVD

medical devices in themselves, the software must

be validated according to the state of the art taking

into account the principles of development

lifecycle, risk management, verification and

validation.

C8 IVD medical devices connected to, or equipped

with, an energy source

C8.1 IVD medical devices where the safety of the patient

depends on an internal power supply in the IVD

YES

Recognised

standard

EN ISO 14971:2012

EN 62304:2006

CE-019

CE-016

YES

Recognised

standard

EN ISO 14971:2012

CE-019

CE-021

11

medical device, should be equipped with a means

of determining the state of the power supply.

C8.2 IVD medical devices should be designed and

manufactured in such a way as to reduce as far as

reasonably practicable and appropriate the risks of

creating electromagnetic interference which could

impair the operation of this or other devices or

equipment in the usual environment.

C8.3 IVD medical devices should be designed and

manufactured in such a way as to provide an

adequate level of intrinsic immunity to

electromagnetic disturbance to enable them to

operate as intended.

C8.4 IVD medical devices should be designed and

manufactured in such a way as to avoid, as far as

reasonably practicable, the risk of accidental

electric shocks to the user, professional or lay, or

other person both during normal use of the device

and in the event of a single fault condition in the

device, provided the IVD medical device is

installed and maintained as indicated by the

manufacturer.

YES

Recognised

standard

EN 61326-2-6:2006

CE-012

YES

Recognised

standard

EN 61326-2-6:2006

CE-012

YES

Recognised

standard

EN 61010-2-101:2002 CE-013

12

C9 Protection against mechanical and thermal risks

C9.1 IVD medical devices should be designed and

manufactured in such a way as to protect the user,

professional or lay, or other person against

mechanical risks connected with, for example,

resistance to movement, instability and moving

parts.

C9.2 Where there are risks due to the presence of moving

parts, risks due to break-up or detachment, or

leakage of substances, then appropriate protection

means must be incorporated.

C9.3 IVD medical devices should be designed and

manufactured in such a way as to reduce to the

lowest practicable level the risks arising from

vibration generated by the devices, taking account

of technical progress and of the means available for

limiting vibrations, particularly at source, unless the

vibrations are part of the specified performance.

C9.4 IVD medical devices should be designed and

manufactured in such a way as to reduce to the

lowest practicable level the risks arising from the

noise emitted, taking account of technical progress

EN ISO 14971:2012

CE-019

YES

Recognised

standard

YES

Recognised

standard

EN 61010-2-101:2002 CE-013

YES

Recognised

standard

EN 61010-2-101:2002 CE-013

YES

Recognised

standard

EN 61010-2-101:2002 CE-013

13

and of the means available to reduce noise,

particularly at source.

C9.5 Terminals and connectors to the electricity, gas or

hydraulic and pneumatic energy supplies which the

user, professional or lay, or other person has to

handle should be designed and constructed in such

a way as to minimize all possible risks.

C9.6 IVD medical devices should be designed and

manufactured in such a way as to reduce to the

lowest practicable level, the risk of error when

certain parts within the device are intended to be

connected or reconnected before or during use.

C9.7 Accessible parts of the IVD medical devices

(excluding the parts or areas intended to supply heat

or reach given temperatures) and their surroundings

should not attain potentially dangerous

temperatures under normal use.

C10 Protection against the risks posed by IVD

medical devices for self-testing

C10.1 IVD medical devices for self-testing should be

designed and manufactured in such a way that they

perform appropriately for their intended purpose

NO。 This device does

not contain these

terminals

connectors.

or

YES

Recognised

standard

EN ISO 14971:2012

CE-019

YES

Recognised

standard

EN 61010-2-101:2002

CE-013

YES

Recognised

standard

EN 62366:2008

EN13612:2002

CE-017

CE-014 性能测试报告

14

taking into account the skills and the means

available to lay persons and the influence resulting

from variation that can reasonably be anticipated in

the lay person’s technique and environment. The

information and instructions provided by the

manufacturer should be easy for the lay person to

understand and apply.

C10.2 IVD medical devices for self-testing should be

designed and manufactured in such a way as to

reduce as far as reasonably practicable the risk of

error by the lay person in the handling of the device

and, if applicable, the specimen, and also in the

interpretation of results.

C10.3 IVD medical devices for self-testing should, where

reasonably possible, include a procedure by which

the lay person can verify that, at the time of use, the

product will perform as intended by the

manufacturer.

C11 Label and Instructions for Use

C11.1 Users should be provided with the information

needed to identify the manufacturer, to use the

device safely and to ensure the intended

performance, taking account of their training and

YES

Recognised

standard

EN 62366:2008

EN13612:2002

CE-017

CE-014

YES

Recognised

standard

EN 62366:2008

EN ISO 15197:2003

CE-017

CE-011

EN ISO 15197:2003

YES

Recognised

standard

CE-011

15

knowledge. This information should be easily

understood.

C12 Performance evaluation including analytical

performance and, where appropriate, clinical

performance

C12.1 For an IVD medical device a performance

evaluation should be conducted in accordance with

GHTF guidance. The performance evaluation

should review analytical performance data and,

where appropriate, clinical performance data in the

form of any:

•

•

•

YES

Recognised

standard

EN13612:2002

CE-014

literature;

performance study reports; and

experience gained by routine diagnostic testing.

to establish that the IVD medical device achieves its

intended performance during normal conditions of use and

that the known, and foreseeable risks, and any undesirable

effects, are minimised and acceptable when weighed

against the benefits of the intended performance.

C12.2 Clinical performance studies using specimens from

human subjects should be carried out in accordance

with the spirit of the Declaration of Helsinki. This

NO Performance

studies

venous

using

blood

samples are come

16

includes every step in the clinical performance

study from first consideration of the need and

justification of the study to publication of the

results. In addition, some countries may have

specific regulatory requirements for informed

consent.

from the hospital;

and the users are

voluntary

evaluation.

to

perform the user

Compiled by：

Reviewed by：

Approved by：

17