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Essential Requirement Checksheet - FC161

This document provides an essential requirements checklist for a hand-held fundus camera. It lists the essential requirements for medical devices according to relevant EU regulations and standards. For each requirement, it indicates whether the device meets the standard ("A") or if it is not applicable ("NA") along with the evidence, such as test reports and a clinical evaluation report. The checklist covers requirements regarding device design, manufacturing, performance, safety, biological compatibility, contamination risks, and substance incorporation.

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Jackeline Pereda
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Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
175 views14 pages

Essential Requirement Checksheet - FC161

This document provides an essential requirements checklist for a hand-held fundus camera. It lists the essential requirements for medical devices according to relevant EU regulations and standards. For each requirement, it indicates whether the device meets the standard ("A") or if it is not applicable ("NA") along with the evidence, such as test reports and a clinical evaluation report. The checklist covers requirements regarding device design, manufacturing, performance, safety, biological compatibility, contamination risks, and substance incorporation.

Uploaded by

Jackeline Pereda
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 14

1 / 14

Manufacturer Product Date Prepared by


Essential Requirements Checklist
Hand-held Fundus Camera,
– Annex I, 93/42/EEC as amended by Directive 2007/47/EC 2020/4/28 Charlotte Lee
Model FC161

Essential Requirements Appl/NA Standards Evidence of Compliance


1. The devices must be designed and manufactured in such a way that, EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
when used under the conditions and for the purposes intended, they will
not compromise the clinical condition or the safety of patients, or the EN ISO14971:2012 Risk Management File
safety and health of users or, where applicable, other persons, provided
that any risks which may be associated with their intended use
constitute acceptable risks when weighed against the benefits to the
patient and are compatible with a high level of protection of health and
safety.
A

This shall include:


- reducing, as far as possible, the risk of use error due to the EN 60601-1-6:2010 Test Report No. 22C-005
ergonomic features of the device and the environment in which the EN 62366:2008 Test Report No. 22C-006
device is intended to be used (design for patient safety), and EN60601-1:2007+A1:2012 Test Report No. CJ17-143428V
- consideration of the technical knowledge, experience, education and 7.9.1
training and where applicable the medical and physical conditions of MEDDEV2.7.1 Rev.4 Clinical Evaluation Report
intended users (design for lay, professional, disabled or other users).
2. The solutions adopted by the manufacturer for the design and EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
construction of the devices must conform to safety principles, taking 7, 8, 9, 15
account of the generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer most EN ISO14971:2012 Risk Management File
apply the following principles in the following order:
eliminate or reduce risk as far as possible A
(inherently safe design and construction)
where appropriate take adequate protection measures including alarms
if necessary, in relation to risk that cannot be eliminated,
inform users of the residual risks due to any shortcomings of the
protection measures adopted.
2 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


3. The devices must achieve the performances intended by the EN ISO13485:2016 Test Report No. SHME180600015301
manufacture and be designed, manufactured and packaged in such a
way that they are suitable for one or more of the functions referred to in A MEDDEV2.7.1 Rev.4 Clinical Evaluation Report
Article 1 (2) (a), as specified by the manufacturer.

4. The characteristics and performances referred to in Section 1, 2 and EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
3 must not be adversely affected to such a degree that the clinical
conditions and safety of the patients and, where applicable, of other
A
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 condition of use.
5. The device must be designed, manufactures and packed in such a EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
way that their characteristics and performances during their intended 7.2.17, 7.9.3.1, 15.3.7
use will not be adversely affected during transport and storage taking A EN ISO15004-1:2009 Test Report No.1404-9A
account of the instructions and information provided by the ISO9022-3:1998
manufacturer. JIS Z0200:1999
6. Any undesirable side-effect must constitute an acceptable risk EN ISO14971:2012 Risk Management File
when weighed against the performances intended. A

6a. Demonstration of conformity with the essential requirements must MEDDEV2.7.1 Rev.4 Clinical Evaluation Report
include a clinical evaluation in accordance with Annex X. A

7. Chemical, physical and biological properties


7.1 The devices must be designed and manufactured in such a way as
to guarantee the characteristics and performances referred to in Section
1 on the “General requirements”. Particular attention must be paid to :
-the choice of materials used, particularly as regards toxicity and,
where appropriate, flammability. EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
A
-the compatibility between the materials used and biological tissues, (toxicity)11.7, 13.1.2
cells and body fluids, taking account of the intended purpose of the (flammability)11.2, 11.3
device.
EN ISO10993-1:2009 Test Report No. 1803-00061
-where appropriate, the results of biophysical or modelling research
whose validity has been demonstrated beforehand.
3 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


7.2 The device must be designed, manufactured and packed in such a There is no part delivered in a sterile state.
way as to minimize the risk posed by contaminants and residues to the
persons involved in the transport, storage and use of the device and to NA
product. Particular attention must be paid to the tissues exposed and to
the duration and frequency of exposure.

7.3 The device must be designed and manufactured in such a way that EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
they can be used safely with the materials, substances and gases with 11.6.1, 11.6.6
which they enter into contact during their normal use or during routine
procedures; if the devices are intended to administer medicinal products
A
they must be designed and manufactured in such a way as to be
compatible with the medicinal products concerned according to the
provisions and restrictions governing these products and that their
performances is maintained in accordance with the intended use.
7.4 Where a device incorporates, as an integral part, a substance Such substance is not incorporated.
which, if used separately, may be considered to be a medical product as
defined in Article 1 of Directive 2001/83/EC and which is liable to act
upon the body with action ancillary to that of the device, the quality,
safety and usefulness of the substance must be verified by analogy with
the methods specified in Annex I to Directive 2001/83/EC.

For the substances referred to in the first paragraph, the notified body
shall, having verified the usefulness of the substance as part of the
medical device and taking account of the intended purpose of the
device, seek a scientific opinion from one of the competent authorities NA
designated by the Member States or the European Medicines Agency
(EMEA) acting particularly through its committee in accordance with
Regulation (EC) No 726/2004 on the quality and safety of the substance
including the clinical benefit/risk profile of the incorporation of the
substance into the device. When issuing its opinion, the competent
authority or the EMEA shall take into account the manufacturing
process and the data related to the usefulness of incorporation of the
substance into the device as determined by the notified body.
4 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


Where a device incorporates, as an integral part, a human blood Human blood derivative is not incorporated.
derivative, the notified body shall, having verified the usefulness of the
substance as part of the medical device and taking into account the
intended purpose of the device, seek a scientific opinion from the
EMEA, acting particularly through its committee, on the quality and
safety of the substance including the clinical benefit/risk profile of the
incorporation of the human blood derivative into the device. When
issuing its opinion, the EMEA shall take into account the manufacturing
process and the data related to the usefulness of incorporation of the
substance into the device as determined by the notified body.

Where changes are made to an ancillary substance incorporated in a Ancillary substance is not incorporated.
device, in particular related to its manufacturing process, the notified
body shall be informed of the changes and shall consult the relevant
medicines competent authority (i.e. the one involved in the initial
consultation), in order to confirm that the quality and safety of the
ancillary substance are maintained. The competent authority shall take
into account the data related to the usefulness of incorporation of the
substance into the device as determined by the notified body, in order to
ensure that the changes have no negative impact on the established
benefit/risk profile of the addition of the substance in the medical device.

When the relevant medicines competent authority (i.e. the one involved
in the initial consultation) has obtained information on the ancillary
substance, which could have an impact on the established benefit/risk
profile of the addition of the substance in the medical device, it shall
provide the notified body with advice, whether this information has an
impact on the established benefit/risk profile of the addition of the
substance in the medical device or not. The notified body shall take the
updated scientific opinion into account in reconsidering its assessment
of the conformity assessment procedure.
7.5 The device must be designed and manufactured in such a way as to There is no substance leaking from the device.
reduce to a minimum the risks posed by substances leaking from the NA
device.
5 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance

Special attention shall be given to substances which are carcinogenic,


mutagenic or toxic to reproduction, in accordance with Annex I to
Council Directive 67/548/EEC of 27 June 1967 on the approximation of
laws, regulations and administrative provisions relating to the
classification, packaging and labelling of dangerous substances.

If parts of a device (or a device itself) intended to administer and/or The device is not intended to administer or remove
remove medicines, body liquids or other substances to or from the medicine, body liquid or other substance to or from
body, or devices intended for transport and storage of such body fluids body.
or substances, contain phthalates which are classified as carcinogenic,
mutagenic or toxic to reproduction, of category 1 or 2, in accordance
with Annex I to Directive 67/548/EEC, these devices must be labelled
on the device itself and/or on the packaging for each unit or, where
appropriate, on the sales packaging as a device containing phthalates.

If the intended use of such devices includes treatment of children or


treatment of pregnant or nursing women, the manufacturer must
provide a specific justification for the use of these substances with
regard to compliance with the essential requirements, in particular of
this paragraph, within the technical documentation and, within the
instructions for use, information on residual risks for these patient
groups and, if applicable, on appropriate precautionary measures.
7.6 Devices must be designed and manufactured in such a way as to EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
reduce, as much as possible, risks posed by the unintentional ingress of 11.6.5
A
substances into the device taking into account the device and the
nature of the environment in which it is intended to be used.
8. Infection and microbial contamination
8.1 The devices and manufacturing processes must be designed in EN ISO14971:2012 Risk Management File
such a way as to eliminate or reduce as far as possible, the risk of Instruction Manual
infection to the patient, user and third parties. The design must allow A
easy handling and, where necessary, minimize contamination of the
device by the patient or vice versa during use.
6 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


8.2 Tissues of animal origin must originate from animals that have been The device doesn’t treat tissues of animal origin.
subjected to veterinary controls and surveillance adapted to the
intended use of the tissues. Notified bodies shall retain information on
the geographical origin of the animals. Processing, preservation, testing
and handling of tissues, cells and substances of animal origin must be
carried out so as to provide optimal security. In particular safety with NA
regard to viruses and other transmissible agents must be addressed by
implementation of validated methods of elimination or viral inactivation
in the course of the manufacturing process.

8.3 Devices delivered in a sterile state must be designed, manufactured There is no part delivered in a sterile state.
and packed in a non-reusable pack and/or according to appropriate
procedures to ensure that they are sterile when placed on the market NA
and remain sterile, under the storage and transport condition laid down,
until the protective packaging is damaged or opened.
8.4 Devices delivered in a sterile state must have been manufactured There is no part delivered in a sterile state.
NA
and sterilized by an appropriate, validated method.
8.5 Devices intended to be sterilized must be manufactured FC-161 is non-sterile device.
NA
inappropriately controlled (e.g. environmental) conditions.
8.6 Packaging system for non-sterile devices must keep the product EN ISO13485:2016 Package Drawing
without deterioration at the level of cleanliness stipulated and, if the
device are to be sterilized prior to use, minimize the risk of microbial A EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
contamination; the packaging system must be suitable taking account of 7.2.17
the methods of sterilization indicated by the manufacturer.
8.7 The packaging and/or label of the device must distinguish between The device is not sold in both sterile and non-sterile
identical or similar products sold in both sterile and non-sterile NA condition.
condition.
9. Construction and environmental properties
9.1 If the device is intended for use in combination with other devices or The device is not intended for use in combination
equipment, the whole combination, including the connection system with other devices.
must be safe and must not impair the specified performances of the NA
devices. Any restriction on use must be indicated on the label or in the
instructions for use.
7 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


9.2 Devise must be designed and manufactured in such a way as to EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
remove or minimize as for as is possible: 8.1, 9.1, 11.1, 11.2, 11.8,
-the risk of injury, in connection with their physical features, including 12.4, 13.1, 13.2, 15.3, 15.4,
the volume/pressure ratio, dimensional and where appropriate 15.5.3
ergonomic features, Test Report No. SHME180600015301
- risks connected with reasonably foreseeable environmental EN 60601-1-2:2015
conditions, such as magnetic fields, external electrical influences,
A
electrostatic discharge, pressure, temperature or variations in
pressure and acceleration,
-the risks of reciprocal interference with other devices normally used in
the investigations or for the treatment given,
-risks arising where maintenance or calibration are not possible (as
with implants), from aging of materials used or loss of accuracy of any
measuring or control mechanism.
9.3 Devices must be designed and manufactured in such a way as to EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
minimize the risks of fire or explosion during normal use and in single 11.2, 11.3
fault condition. Particular attention must be paid to devices whose A
intended use includes exposure to flammable substances or to
substances which could cause combustion.
10. Devices with a measuring function
10.1 Devices with a measuring function must be designed and EN ISO15004-1:2009 Test Report No. 1404-9A
manufactured in such a way as to provide sufficient accuracy and
stability within appropriate limits of accuracy and taking account of the A EN60601-1:2007+A1:2012 Test Report No. SHME180600015301 A
intended purpose of the device. The limits of accuracy must be 12.1, 7.9.3.1
indicated by the manufacturer.
10.2 The measurement monitoring and display scale must be designed EN 60601-1-6:2010 Test Report No. 22C-005
in line with ergonomic principles, taking account of the intended A EN 62366:2008 Test Report No. 22C-006
purpose of the device.
10.3 The measurement made by devices with a measuring function EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
must be expresses in legal units conforming to the provisions of Council 7.4.3
A 80/181/EEC
Directive 80/181/EEC. Instruction Manual

11. Protection against radiation


11.1 General
8 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


11.1.1 Devices shall be designed and manufactured in such a way that EN60601-1:2007/A1:2012 Test Report No. SHME180600015301
exposure of patients, users and other persons to radiation shall be 10.4
reduced as far as possible compatible with the intended purpose, whilst A
EN ISO15004-2:2007 Test Report No.1602-5A, 1306-29A
not restricting the application of appropriate specified levels for
therapeutic and diagnostic purposes. EN60825-1:2007 Test Report No.15069324 001
11.2 Intended radiation
11.2.1 Where devices are designed to emit hazardous levels of EN60601-1:2007/A1:2012 Test Report No. SHME180600015301
radiation necessary for a specific medical purpose the benefit of which 10.4
is considered to outweigh the risks inherent in the emissions. Such
Test Report No.1602-5A, 1306-29A
A
EN ISO15004-2:2007 EN
devices shall be designed and manufactured to ensure reproducibility Risk Management File
and tolerance of relevant variable parameters. ISO 14971:2012
11.2.2 Where devices are intended to emit potentially hazardous, visible The device is not intended to emit potentially
and/or invisible radiation, they must be fitted, where practicable, with NA hazardous radiation.
visual displays and/or audible warnings of such emissions.
11.3 Unintended radiation
11.3.1 Devise shall be designed and manufactured in such a way that There is no unintended radiation.
exposure of patients, users and other persons to the emission of NA
unintended, stray and scattered radiation is reduced as far as possible
11.4 Instructions
11.4.1 The operating instructions for devices emitting radiation must The device is Group 1 instrument.
give detailed information as to the nature of the emitted radiation, (EN ISO15004-2:2007)
NA
means of protecting the patient and the users and on ways of avoiding
misuse and of eliminating the risks inherent in installation.
11.5 Ionizing radiation
11.5.1 Devices intended to emit ionizing radiation must be designed and The device is not intended to emit ionizing radiation.
manufactured in such a way as to ensure that, when practicable, the
NA
quantity, geometry and quality of radiation emitted can be varied and
controlled taking into account the intended use.
11.5.2 Devices emitting ionizing radiation intended for diagnostic The device is not intended to emit ionizing radiation.
radiology shell be designed and manufactured in such a way as to
achieve appropriate image and/or output quality for the intended
NA
medical purpose whilst minimizing radiation exposure of the patient ad
user.
9 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


11.5.3 Devices emitting ionizing radiation, intended for therapeutic The device is not intended to emit ionizing radiation.
radiology shall be designed and manufactured in such a way as to
NA
enable reliable monitoring and control of the delivery dose, the beam
type and energy and where appropriate the quality of radiation.
12 Requirements for medical devices connected to or equipped
with an energy source
12.1 Devices incorporating electronic programmable system must be EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
designed to ensure the repeatability, reliability and performance of 14
these systems according to the intended use. In the event of a single A EN62304:2006 Test Report No. 22C-009
fault condition (in the system) appropriate means should be adopted to
eliminate or reduce as far as possible consequent risks.
12.1a For devices which incorporate software or which are medical EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
software in themselves, the software must be validated according to the 14
A Test Report No. 22C-009
state of the art taking into account the principles of development EN 62304:2006
lifecycle, risk management, validation and verification.
12.2 Devices where the safety of the patients depends on an internal EN60601-1:2007/A1:2012 Test Report No. SHME180600015301
power supply must be equipped with a means of determining the state A 15.4.4
of the power supply.
12.3 Device where the safety of the patients depends on an external External power supply is not used.
NA
power supply must include an alarm system to signal any power failure.
12.4 Devise intended to monitor one or more clinical parameters of a The device is not intended to monitor clinical
patient must be equipped with appropriate alarm system to alert the parameter.
NA
user of situations which could lead to death or severe deterioration of
the patient’s state of health.
12.5 Devices must be designed and manufactured in such a way as to EN 60601-1-2:2015 Test Report No. SHEM1806005093ME
minimize the risks of creating electromagnetic fields which could impair A
the operation of other devices or equipment in the usual environment.
12.6 Protection against electrical risks EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
Device must be designed and manufactured in such a way as to avoid, 6.2, 7.2.10, 7.9, 8, 13.1, 13.2
as for as possible, the risk of accidental electric shocks during normal
use and in single fault condition, provided the devices are installed A
correctly.
10 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


12.7 Protection against mechanical and thermal risks
12.7.1 Devices must be designed and manufactured in such a way as to EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
protect the patient and user against mechanical risks connected with, A 9.1, 15.3
for example, resistance, stability and moving parts.
12.7.2 Device must be designed and manufactured in such a way as to EN60601-1:2007/A1:2012 Test Report No. SHME180600015301
reduce to the lowest possible level the risks arising from vibration 9.6, 9.8.1
generated by the devices, taking account of technical progress and of A
the means available for limiting vibrations, particularly at source, unless
the vibration are part of the specified performance.
12.7.3 Device must be designed and manufactured in such a way as to EN60601-1:2007/A1:2012 Test Report No. SHME180600015301
reduce to the lowest possible level the risks arising from the noise 9.6
emitted, taking account or technical progress and of the means A
available to reduce noise, particularly at source, unless the noise
emitted is part of the specified performance.
12.7.4 Terminals and connectors to the electricity, gas or hydraulic and EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
pneumatic energy supplies which the user has to handle must be 8.1, 8.2, 8.4, 8.5, 8.6, 8.7,
A 8.11,
designed and constructed in such a way as to minimize all possible
risks.
12.7.5 Accessible parts of the devices (excluding the parts or areas EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
intended to supply heat or reach given temperatures) and their 11.1
A
surroundings must not attain potentially dangerous temperatures under
normal use.
12.8 Protection against the risks posed to the patient by energy
supplies or substances
12.8.1 Devices for supplying the patient with energy or substances must EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
be designed and constructed in such a way that flow-rate can be set 15.4.2, 15.4.4, 15.4.6,
A
and maintained accurately enough to guarantee the safety of the patient
and of the user.
12.8.2 Devices must be fitted with the means of preventing and/or EN60601-1:2007/A1:2012 Test Report No. SHME180600015301
indicating any inadequacies in the flow-rate which could pose a danger. 15.4.1, 15.4.4, 15.4.6, 12.4,
Device must incorporated suitable means to prevent, as far as possible, 14, 12.4
A
the accidental release of dangerous levels of energy from an energy
and/or substance source.
11 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


12.9 The function of the controls and indicators must be clearly EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
specified on the devices. 7.4, 7.9.1
Where a device bears instruction required for its operations or indicates
A
operating or adjustment parameters by means of a visual system such
information must be understandable to the user and, as appropriate, the
patient.
13 Information supplied by the manufacturer
13.1 Each device must be accompanied by the information needed to EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
use it safely and properly, taking account of the training and knowledge 7.2.2, 7.2.3, 7.9, 7.9.1, 7.9.2 Instruction Manual
of the potential users, and to identify the manufacturer.
This information comprises the details on the label and the data in the
instruction for use.
As far as practicable and appropriate, the information needed to use the
device safely must be set out on the device itself and/or on the A
packaging for each unit or, where appropriate, on the sales packaging.
If individual packaging of each unit is not practicable, the information
must be set out in the leaflet supplied with one or more devices.
Instructions for use must be included in the packaging for every device.
By way of exception, no such instructions for use are needed for device
in Class I or IIA if they can be used safely without any such instructions.
13.2 Where appropriate, this information should take the form of EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
symbols. Any symbol or identification colour used must conform to the 7.6, Annex D Instruction Manual
harmonized standards. In areas for which no standards exist, the A
symbols and colours must be described in the documentation supplied
with the device.
13.3 The label must bear the following particulars: EN ISO 15223-1:2016 Test Report No. 22C-008
(a) the name or trade name and address of the manufacturer. For
devices imported into the Community, in view of their distribution in a) EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
the Community, the label, or the outer packaging, or instructions for 7.2.2 Instruction Manual
use, shall contain in addition the name and address of the b) EN60601-1:2007+A1:2012 Label Drawing
A Package Drawing
authorised representative where the manufacturer does not have a 7.2.2
c) NA c) There is no part delivered in a sterile state
registered place of business in the Community;
(b) the details strictly necessary to identify the device and the contents d) EN60601-1:2007+A1:2012 e) There is no part having used date.
of the packaging especially for the users; 7.2.2, 7.2.4 f) There is no single used part.
e) NA g) The device is not custom-made.
12 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


(c) where appropriate, the word “STERILE”; f) NA h) The device is not intended for clinical
(d) where appropriate, the batch code, preceded by the word “LOT”, or g) NA investigations.
serial number, h) NA m) FC-161 is non-sterile device.
(e) where appropriate, an indication of the date by which the device i) EN60601-1:2007+A1:2012 n) The device is not within the meaning
7.2.17
should be used, in safety, expressed as the year and month; of Article 1(4a).
j) EN60601-1:2007+A1:2012
(f) where appropriate, an indication that the device is for single use. A 7.2, 7.3
manufacturer's indication of single use must be consistent across the k)EN60601-1:2007+A1:2012
Community; 7.2.2, 7.3
(g) if the device is custom-made, the words “custom-made device”; l) EN60601-1:2007+A1:2012
(h) if the device is intended for clinical investigations, the words 7.2.2
m)NA
“exclusively for clinical investigations”;
n) NA
(i) any special storage and/or handing conditions;
(j) any special operating instructions;
(k) any warnings and/or precaution to take;
(l) year of manufacture for active devices other than those covered by
(e). This indication may be included in the batch or serial number;
(m) where applicable, method of sterilization;
(n) in the case of a device within the meaning of Article 1(4a), an
indication that the device contains a human blood derivative.
13.4 If the intended purpose of the device is not obvious to the user, the EN60601-1:2007+A1:2012 Test Report No. SHME180600015301
manufacturer must clearly state it on the label and in the instructions for A 7.2 Instruction Manual
use. Label Drawing
13.5 Wherever reasonable and practicable, the devices and detachable There are no detachable components.
components must be identified, where appropriate in terms of batches,
NA
to allow all appropriate action to detect any potential risk posed by the
devices and detachable components.
13 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


13.6 Where appropriate, the instructions for use must contain the EN 1041:2008 Test Report No. 22C-007
following particulars:
(a) the details referred to in Section 13.3, with the exception of (d) and a) EN60601-1:2007 Test Report No. SHME180600015301
(e); +A1:2012 7.9.2, 7.9.1, 7.9.2.2, Instruction Manual
(b) the performances referred to in Section 3 and any undesirable 7.9.3.1 e) The device is not implant.
side-effects; b) Section 3 g) There is no part delivered in a sterile state.
(c) if the device must be installed with or connected to other medical c)EN60601-1:2007+A1:2012 j) The device is not used radiation.
devices or equipment in order to operate as required for its intended 7.9.1, 7.9.2.1, 7.9.2.14, 7.9.3, m) The device is not used substance.
purpose, sufficient details of its characteristics to identify the correct 14 o) The device is not used medicinal substances or
device or equipment to use in order to obtain a safe combination; d) EN60601-1:2007 human blood derivatives.
(d) all the information needed to verify whether the device is properly +A1:2012 7.9.2.9, 7.9.2.13
installed and can operate correctly and safely, plus details of the e) NA
nature and frequency of the maintenance and calibration needed to f) EN60601-1:2007/A1:2012
ensure that the devices operate properly and safely at all times; 7.9.2.2
(e) where appropriate, information to avoid certain risks in connection g) NA
with implantation of the device; h) EN60601-1:2007/A1:2012
(f) information regarding the risks of reciprocal interference posed by 7.9.2.18
A
the presence of the device during specific investigations or i) EN60601-1:2007/A1:2012
treatment; 7.9
(g) the necessary instructions in the event of damage to the sterile j) NA
packaging and, where appropriate, details of appropriate methods of k)instruction manual
resterilization; l) EN60601-1:2007+A1:2012
(h) if the device is reusable, information on the appropriate processes to 7.9
allow reuse, including cleaning, disinfection, packaging and, where m) NA
appropriate, the method of sterilization of the device to be n) EN60601-1:2007/A1:2012
resterilized, and any restriction on the number of reuses. 7.9
o) NA
Where device are supplied with the intention that they be sterilized p) EN60601-1:2007
before use, the instructions for cleaning and sterilization must be such +A1:2012 7.9
that, if correctly followed, the device will still comply with the q) EN60601-1:2007
requirements in Section I. +A1:2012 7.9

If the device bears an indication that the device is for single use,
information on known characteristics and technical factors known to the
14 / 14

Essential Requirements Appl/NA Standards Evidence of Compliance


manufacturer that could pose a risk if the device were to be re-used. If
in accordance with Section 13.1 no instructions for use are needed, the
information must be made available to the user upon request;

(i) details of any further treatment or handling needed before the device
can be used (for example sterilization, final assembly, etc);
(j) in the case of devices emitting radiation for medical purpose, details
of the nature, type, intensity and distribution of this radiation.

The instruction for use must also include details allowing the medical
staff to brief the patient on any contra-indication and any precautions to
be taken. These details should cover in particular:

(k) precautions to be taken in the event of changes in the performance


of the device;
(l) precautions to be taken as regards exposure, in reasonably
foreseeable environmental conditions, to magnetic fields, external
electrical influences, electrostatic discharge, pressure or variations
in pressure, acceleration, thermal ignition sources, etc;
(m) adequate information regarding the medical product or products
which the device in question is designed to administer, including any
limitations in the choice of substance to be delivered;
(n) precautions to be taken against any special, unusual risks related to
the disposal of the device;
(o) medicinal substances, or human blood derivatives incorporated into
the device as an integral part in accordance with Section 7.4;
(p) degree of accuracy claimed for devices with a measuring function;
(q) date of issue or the latest revision of the instructions for use.

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