SIST EN 45502-2-3:2010

Active implantable medical devices - Part 2-3: Particular requirements for cochlear implant systems

This Part 2-3 of EN 45502 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance.

Aktive implantierbare Medizingeräte - Teil 2-3: Besondere Festlegungen für Cochlea-Implantate

Dispositifs médicaux implantables actifs - Partie 2-3: Exigences particulières pour les systèmes d'implant cochléaire

Aktivni medicinski vsadki (za implantacijo) - 2-3. del: Posebne zahteve za sisteme s polžkovim vsadkom

Ta del 2-3 EN 45502 določa zahteve, ki veljajo za AKTIVNE MEDICINSKE VSADKE (ZA IMPLANTACIJO), ki so namenjeni zdravljenje slušnih okvar z električno stimulacijo slušnih poti. Naprave, ki ne zdravijo slušne okvare z električno stimulacijo, temveč na druge načine, niso zajete v tem evropskem standardu. Preskusi, ki so določeni v EN 45502, so tipski preskusi in so izvedeni na vzorcih naprave za dokaz skladnosti.

General Information

• Status: Published
• Publication Date: 03-Mar-2010
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 24-Feb-2010
• Due Date: 01-May-2010
• Completion Date: 04-Mar-2010
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Mandate: BC/CLC/02-89 - BC/CLC/02-89
• Ref Project: EN 45502-2-3:2010 - Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 45502-2-3:2010
01-april-2010
Aktivni medicinski vsadki (za implantacijo) - 2-3. del: Posebne zahteve za sisteme
s polžkovim vsadkom
Active implantable medical devices - Part 2-3: Particular requirements for cochlear
implant systems
Aktive implantierbare Medizingeräte - Teil 2-3: Besondere Festlegungen für Cochlea-
Implantate
Dispositifs médicaux implantables actifs - Partie 2-3: Exigences particulières pour les
systèmes d'implant cochléaire
Ta slovenski standard je istoveten z: EN 45502-2-3:201
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN 45502-2-3:2010 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 45502-2-3:2010

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SIST EN 45502-2-3:2010

EUROPEAN STANDARD
EN 45502-2-3

NORME EUROPÉENNE
February 2010
EUROPÄISCHE NORM

ICS 13.320


English version


Active implantable medical devices -
Part 2-3: Particular requirements for cochlear and auditory brainstem
implant systems



Dispositifs médicaux implantables actifs - Aktive implantierbare Medizingeräte -
Partie 2-3: Exigences particulières Teil 2-3: Besondere Festlegungen
pour les systèmes d'implant cochléaire für Cochlea-Implantatsysteme
et les systèmes d'implant auditif und auditorische
du tronc cérébral Hirnstammimplantatsysteme





This European Standard was approved by CEN and CENELEC on 2010-02-01. CEN and CENELEC members
are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the CEN-CENELEC Management Centre or to any CENELEC member

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of
Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

CEN/CENELEC




CEN-CENELEC Management Centre: Avenue Marnix 17, B - 1000 Brussels



Ref. No. EN 45502-2-3:2010 E

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SIST EN 45502-2-3:2010
EN 45502-2-3:2010 – 2 –
Foreword
This European Standard was prepared by the CEN/CENELEC Joint Working Group AIMD, Active
Implantable Medical Devices. Members of the Joint Working Group were nominated by one of the
members of either CEN or CENELEC. The lead has been given to CENELEC.
The text of the draft was submitted to a second formal vote and was approved by CEN and CENELEC as
EN 45502-2-3 on 2010-02-01.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented

at national level by publication of an identical

national standard or by endorsement
(dop) 2011-02-01

– latest date by which the national standards conflicting

with the EN have to be withdrawn
(dow) 2013-02-01
The requirements of this particular standard supplement or modify those of the General Standard
EN 45502-1:1997, Active implantable medical devices – Part 1: General requirements for safety, marking
and information to be provided by the manufacturer.
This European Standard has been prepared under a mandate given to CEN and CENELEC by the
European Commission and the European Free Trade Association and covers essential requirements of
EC Directive 90/385/EEC. See Annexes AA and BB.
Although both this European Standard and the Directive deal with the same range of products, the
structure and purpose of the two documents are different. Annex AA, BB, CC are rationales, providing
some further explanation of particular subclauses of this European Standard. All three annexes are
informative.
__________

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Contents
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Definitions . 7
4 Symbols and abbreviations (optional) . 9
5 General requirements for non-implantable parts. 9
6 Inspection and measurement . 9
7 General arrangement of the packaging .10
8 General markings for active implantable medical devices .10
9 Markings on the SALES PACKAGING .10
10 Construction of the SALES PACKAGING .11
11 Markings on the sterile pack.11
12 Construction of the non-reusable pack .12
13 Markings on the active implantable medical device .12
14 Protection from unintentional biological effects being caused by the active implantable medical
device .12
15 Protection from harm to the patient or user caused by external physical features of the active
implantable medical device .13
16 Protection from harm to the patient caused by electricity .13
17 Protection from harm to the patient caused by heat .13
18 Protection from ionizing radiation released or emitted from the active implantable medical device 14
19 Protection from unintended effects caused by the device .14
20 Protection of the device from damage caused by external defibrillators .15
21 Protection of the device from changes caused by high power electrical fields applied directly to
the patient .15
22 Protection of the active implantable medical device from changes caused by miscellaneous
medical treatments .16
23 Protection of the active implantable medical device from mechanical forces .18
24 Protection of the active implantable medical device from damage caused by electrostatic
discharge .23
25 Protection of the active implantable medical device from damage caused by atmospheric
pressure changes .24
26 Protection of the active implantable medical device from damage caused by temperature
changes .24
27 Protection of the active implantable medical device from electromagnetic non-ionising radiation .24
28 Accompanying documentation .27
Annex AA (informative) Notes on EN 45502-2-3 .30
Annex BB (informative) Notes on theoretical modelling to demonstrate compliance to Clause 27 .38
Annex CC (informative) Notes on EMI measurements to demonstrate compliance to Clause 27 .40
Bibliography .44

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SIST EN 45502-2-3:2010
EN 45502-2-3:2010 – 4 –
Figures
Figure 101 – Measurement of output signal amplitude and load impedance . 10
Figure 102 – Test set-up for proof of protection from high frequency currents caused by surgical
equipment . 15
Figure 103 – Test set-up for proof of protection from harmful output during MRI scanning . 17
Figure 104 – Stimulator drop test . 20
Figure 105 – Flex test fixture . 21
Figure 106 – Interference signal at 16 Hz and 50 Hz . 26
Figure 107 – Interference signal at frequencies above 1 kHz . 26
Figure CC.101 – Head simulator for EMI measurements . 41
Tables
Table 101 – Peak magnetic field strength H . 25
P
Table 102 – Peak electric field strength E . 26
P
Table CC.101 – Peak net dipole power . 43

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Introduction
This European Standard specifies particular requirements for those ACTIVE IMPLANTABLE MEDICAL DEVICES
that are intended to treat hearing impairment via electrical stimulation (for EXAMPLE COCHLEAR IMPLANT
SYSTEMS or AUDITORY BRAINSTEM IMPLANT SYSTEMS), to provide basic assurance of safety for both patients
and users.
A COCHLEAR IMPLANT SYSTEM or AUDITORY BRAINSTEM IMPLANT SYSTEM is an ACTIVE IMPLANTABLE MEDICAL
DEVICE comprising implantable and NON-IMPLANTABLE PARTS (external parts). The power source may be
externally derived or from an internal battery. The IMPLANT SYSTEM is designed to restore hearing via
electrical stimulation of the auditory pathways. Externally or internally processed acoustic information is
converted to electrical stimulation signals which are delivered via one or more electrodes. The working
parameters of the device may be adjusted via a non-implantable accessory.
This European Standard is relevant to all parts of IMPLANT SYSTEMS, including accessories.
The requirements of this European Standard supplement or modify those of EN 45502–1:1997, Active
implantable medical devices – Part 1: General requirements for safety, marking and information to be
provided by the manufacturer, hereinafter referred to as Part 1. The requirements of this European
Standard take priority over those of Part 1.
Figures or tables that are additional to those of Part 1 are numbered starting from 101; additional annexes
are lettered AA, BB, etc.

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SIST EN 45502-2-3:2010
EN 45502-2-3:2010 – 6 –
1 Scope
This Part 2-3 of EN 45502 specifies requirements that are applicable to those ACTIVE IMPLANTABLE
MEDICAL DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory
pathways. Devices which treat hearing impairment via means other than electrical stimulation are not
covered by this European Standard.
The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device
to show compliance.
This Part of EN 45502 is also applicable to NON-IMPLANTABLE PARTS and accessories of the devices (see
NOTE 1).
The electrical characteristics of the IMPLANTABLE PART shall be determined by either the appropriate
method detailed in this particular standard or by any other method demonstrated to have an accuracy
equal to, or better than, the method specified. In the case of dispute, the method detailed in this particular
standard shall apply.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a
combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to
be either partially or totally implantable, but there is a need to specify some requirements of NON-IMPLANTABLE PARTS and
accessories if they could affect the safety or performance of the implantable part.
NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive
90/385/EEC.
NOTE 3 In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is
used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.
2 Normative references
This clause of Part 1 applies except as follows:
Additional references:
1)
EN ISO 14971 2007 Medical devices - Application of risk management to medical devices
(ISO 14971:2007)
EN 1593 1999 Non-destructive testing - Leak testing - Bubble emission techniques
EN 13185 2001 Non-destructive testing - Leak testing – Tracer gas method
EN 45502-1 1997 Active implantable medical devices - Part 1: General requirements
for safety, marking and information to be provided by the
manufacturer
EN 55011 2007 Industrial, scientific and medical (ISM) radio-frequency equipment -
+ A2 2007 Electromagnetic disturbance characteristics - Limits and methods of
measurement (CISPR 11:2003, mod. + A1:2004, mod. + A2:2006)
2)
EN 60068-2-27 1993 Basic environmental testing procedures - Part 2: Tests - Test Ea and
guidance: Shock (IEC 60068-2-27:1987)
3)
EN 60068-2-31 2008 Basic environmental testing procedures - Part 2: Tests - Test Ec:
Drop and topple, primarily for equipment-type specimens
(IEC 60068-2-31:1969 + A1:1982)

1)
Superseded by EN ISO 14971:2009 “Medical devices - Application of risk management to medical devices” (ISO 14971:2007).
2)
Will be superseded by EN 60068-2-27:2009 “Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock”
(IEC 60068-2-27:2008) at the dow of the latter, i.e. 2012-05-01.

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EN 60068-2-47 2005 Environmental testing - Part 2-47: Tests - Mounting of specimens for
vibration, impact and similar dynamic tests (IEC 60068-2-47:2005)
EN 60068-2-64 2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration,
broadband random and guidance (IEC 60068-2-64:2008)
EN 60068-2-75 1997 Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests
(IEC 60068-2-75:1997)
EN 60118-6 1999 Hearing aids - Part 6: Characteristics of electrical input circuits for
hearing aids (IEC 60118-6:1999)
EN 60601-1 2006 Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance (IEC 60601-1:2005)
EN 60601-1-2 2007 Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests
(IEC 60601-1-2:2007, mod.)
4)
EN 60801-2 1993 Electromagnetic compatibility for industrial-process measurement
and control equipment - Part 2: Electrostatic discharge requirements
(IEC 60801-2:1991)
3 Definitions
This clause of Part 1 applies except as follows:
Additional definitions:
3.3.1
cochlear implant system
(CIS)
active implantable medical device, comprising implantable and NON-IMPLANTABLE PARTS, intended to treat
hearing impairment via electrical stimulation of the cochlea
3.3.2
auditory brainstem implant system
(BIS)
ACTIVE IMPLANTABLE MEDICAL DEVICE, comprising implantable and NON-IMPLANTABLE PARTS, intended to
treat hearing impairment via electrical stimulation of the auditory brainstem
3.3.3
implant system
either COCHLEAR IMPLANT SYSTEM or AUDITORY BRAINSTEM IMPLANT SYSTEM
3.3.4
non-implantable part
external part of the IMPLANT SYSTEM
NOTE Examples would include but are not limited to: sound processor, microphone, coil or power source.
3.3.5
stimulator
implantable part of the IMPLANT SYSTEM containing electronic circuitry required to produce electrical
stimulation

3)
Will be superseded by EN 60068-2-31:2008 “Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks,
primarily for equipment-type specimens” (IEC 60068-2-31:2008) at the dow of the latter, i.e. 2011-07-01.
4)
Superseded by EN 61000-4-2:1995, “Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques -
Electrostatic discharge immunity test” (IEC 61000-4-2:1995).

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EN 45502-2-3:2010 – 8 –
3.3.6
body-worn
NON-IMPLANTABLE PART of the IMPLANT SYSTEM and worn on the body (e.g. belt or ear level)
3.5.1
electrode contact
electrically conducting part which is designed to form an interface with body tissue or body fluid
3.5.2
electrode array
DISTAL part of a LEAD containing more than one ELECTRODE CONTACT
3.5.3
reference electrode
electrically conducting part designed as return path for electrical stimulation current
3.5.4
distal
located away from the point of attachment to the STIMULATOR
3.5.5
proximal
located closest to the point of attachment to the STIMULATOR
3.9.1
model designation
name and/or a combination of letters and numbers used by a manufacturer to distinguish, by function or
type, one device from another
3.9.2
serial number
unique combination of letters and/or numbers, selected by the manufacturer, intended to distinguish a
device from other devices with the same MODEL DESIGNATION
3.20.1
output signal
electrical output, either pulsatile or analogue of an IMPLANT SYSTEM intended to stimulate the auditory
pathways
3.20.2
pulse
specified electrical OUTPUT SIGNAL (voltage or current) of a specified amplitude and duration
3.20.3
biphasic pulse
PULSE which has both negative and positive going phases
3.22.1
use-before-date
date after which the manufacturer recommends that the IMPLANT SYSTEM should not be implanted
3.22.2
magnet
component producing an external magnetic flux

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4 Symbols and abbreviations (optional)
NOTE There are no requirements specified in this Part of EN 45502. However this does not preclude the use of symbols defined in
other standards nor special symbols defined in the accompanying documentation.
5 General requirements for non-implantable parts
5.1 This subclause of part 1 applies.
5.2 Replacement
The IMPLANT SYSTEM shall meet the requirements of EN 60601-1-2:2007 for Group 1 equipment as
specified in EN 55011:2007.
Compliance shall be checked by review of the test results and documentation provided by the
manufacturer.
6 Inspection and measurement
If this standard refers to inspection of design analysis documentation provided by the manufacturer it shall
include an inspection of the risk management file as required by EN ISO 14971.
6.1 Measurement of output signal characteristics
The measurement shall be performed with the implantable part of the IMPLANT SYSTEM at a temperature of
(37 ± 2) °C. The IMPLANT SYSTEM shall be configured to use its maximum number of outputs and each
output shall be programmed to its maximum value (amplitude and pulse width). An input signal equivalent
to 70dB SPL shall be applied to the microphone. Where applicable the transcutaneous link shall operate
over a distance of (5 ± 1) mm. Where the IMPLANT SYSTEM provides alternative OUTPUT SIGNALS each shall
be measured and listed separately. To facilitate connection the test sample may be unfinished. The
accuracy of the amplitude measurement shall be better than ± 5 % taking all errors into consideration.
6.2 Measurement of the OUTPUT SIGNAL amplitude and pulse width
A representative sample of the IMPLANT SYSTEM shall have each output connected to a 1 kΩ (± 1 %) load
resistor (see Figure 101) and configured per 6.1. An oscilloscope shall be adjusted to display the full
output at its maximum resolution. The measurement shall be made in the peak of the OUTPUT SIGNAL.
Each output shall be in turn connected to the oscilloscope and the amplitude and pulse width shall be
measured. The median of the amplitudes and pulse widths and their range shall be recorded and the
result shall be expressed in µA and µs.
6.3 Impedance measurement accuracy
Where the IMPLANT SYSTEM allows an impedance measurement (either by telemetry or direct
measurement) the manufacturer shall specify the accuracy of the impedance measurement for a 10 kΩ
load resistor. The measurement conditions shall be chosen to reflect normal clinical practice. The
measurement shall be repeated on every output (see Figure 101). The accuracy of the impedance
measurement shall be expressed as a percentage.

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SIST EN 45502-2-3:2010
EN 45502-2-3:2010 – 10 –

NOTE Ground is connected to the external reference electrode, if available.
Figure 101 – Measurement of output signal amplitude and load impedance
7 General arrangement of the packaging
7.1 This subclause of Part 1 applies.
7.2 This subclause of Part 1 applies.
8 General markings for active implantable medical devices
8.1 This subclause of Part 1 applies.
8.2 This subclause of Part 1 applies.
9 Markings on the SALES PACKAGING
9.1 This subclause of Part 1 applies.
9.2 This subclause of Part 1 applies except as follows:
Replacement:
The SALES PACKAGING shall bear the name and address of the manufacturer, the address including at
least the city and country. The SALES PACKAGING shall bear the name and address of the authorized
representative, if the manufacturer does not have a registered place of business in the European
Community
Compliance is checked by inspection.
9.3 This subclause of Part 1 applies.
9.4 This subclause of Part 1 applies.
9.5 This subclause of Part 1 applies.
9.6 This subclause of Part 1 applies.

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9.7 The SALES PACKAGING of implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall bear the
USE-BEFORE-DATE, as expressed in 9.6.
Compliance shall be checked by inspection.
9.8 This subclause of Part 1 applies.
9.9 This subclause of Part 1 applies.
9.10 This subclause of Part 1 applies.
9.11 This subclause of Part 1 applies.
9.12 Additional subclause
Where an implant system is supplied in separate sub-assembly packaging, each individual sales
packaging shall bear a description of the contents of the packaging, the model designation or part number
and, if applicable the batch number or the serial number.
Compliance shall be checked by inspection.
10 Construction of the SALES PACKAGING
10.1 This subclause of Part 1 applies
10.2 This subclause of Part 1 applies.
10.3 This subclause of Part 1 applies.
Additional note:
NOTE Removable stickers, which provide supplementary information exceeding the information specified in Clause 9, need not to
be subjected to the test specified in 10.3.
10.4 This subclause of Part 1 applies.
11 Markings on the sterile pack
11.1 This subclause of Part 1 applies.
11.2 This subclause of Part 1 applies.
11.3 This subclause of Part 1 applies.
11.4 This subclause of Part 1 applies.
11.5 This subclause of Part 1 applies.
11.6 This subclause of Part 1 applies.
11.7 This subclause of Part 1 applies.
11.8 This subclause of Part 1 applies.

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EN 45502-2-3:2010 – 12 –
11.9 This subclause of Part 1 applies.
NOTE This subclause can be fulfilled using an unambiguous symbol.
12 Construction of the non-reusable pack
12.1 This subclause of Part 1 applies except as follows:
Replacement:
The NON-REUSEABLE PACK shall comply with EN ISO 11607-1.
Compliance shall be checked by inspection and by review of records provided by the manufacturer.
12.2 This subclause of Part 1 applies.
12.3 This subclause of Part 1 applies.
13 Markings on the active implantable medical device
13.1 This subclause of Part 1 applies.
13.2 This subclause of Part 1 applies.
13.3 Replacement
Implantable parts of an IMPLANT SYSTEM shall be unequivocally identifiable (particularly with regard to the
model designation of the device), when necessary, without the need for a surgical intervention.
Compliance shall be confirmed by inspection of the procedure defined by the manufacturer in the
instructions for use (see 28.6).
13.4 This subclause of Part 1 applies.
14 Protection from unintentional biological effects being caused by the active
implantable medical device
14.1 This subclause of Part 1 applies.
14.2 Any implantable part of the ACTIVE IMPLANTABLE MEDICAL DEVICE, intended in normal use to be in
contact with body fluids, shall cause no unacceptable release of particulate matter when the device is
used as intended by the manufacturer.
Test: The implantable part of the IMPLANT SYSTEM shall be removed aseptically from the NON-
REUSABLE PACK. The implantable part shall be immersed in a bath of saline solution, approximately 9 g/l
and suitable for injection in a neutral glass container. The volume of the saline in millilitres (ml) shall be
2
5 ± 0,5 times the numerical value of the surface area of the implantable part expressed in cm . The
container shall be covered with a glass lid and maintained at (37 ± 2) °C for between 8 h and 18 h, the
bath being agitated throughout the period. A reference sample of similar volume shall be prepared from
the same batch of saline, maintained and agitated in a similar way to the specimen. A sample of liquid
from the specimen bath and from the reference bath shall be compared using apparatus suitable for
measurement of particle size, such as apparatus operating on the light blockage principle (see
method V.5.7.1 of the European Pharmacopoeia) or the electrical zone sensing principle (the Coulter
principle, see Appendix XIII of the British Pharmacopoeia).
Compliance shall be confirmed if the excess average count of unintentional particles from the specimen
compared to the reference sample does not exceed 100 per ml greater than 5,0 µm and does not exceed
5 per ml greater than 25 µm.

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14.3 Replacement
This subclause of Part 1 applies with addition that EN ISO 10993 series shall be used.
14.4 This subclause of Part 1 applies.
15 Protection from harm to the patient or user caused by external physical features of
the active implantable medical device
15.1 This subclause of Part 1 applies.
15.2 Replacement
Implantable parts of an IMPLANT SYSTEM shall have no surface features, such as sharp corners or edges
that could cause excessive reaction or inflammation beyond that caused by the implanting procedure, or
rough surfaces which are not required for the correct functioning of the device.
Compliance shall be confirmed if records provided by the manufacturer establish that the safety of the
physical characteristics has been verified with appropriate methods.
1
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