Title: IVDD Essential Requirements Checklist for Atellica VTLi hs-cTnI

Document Identifier: DX032851 Ver: 04 Page 1 of 30

Product Name: Atellica VTLi Immunoassay Analyzer

Atellica VTLi Docking Station

Atellica VTLi Immunoassay Analyzer (*Starter Kit 1 –

English, French, German, Dutch, Italian)

Atellica VTLi Immunoassay Analyzer (*Starter Kit 2 –

Danish, Norwegian, Swedish, Finnish)

Atellica VTLi Immunoassay Analyzer (*Starter Kit 3 –

Spanish, Portuguese)

Atellica VTLi hs-cTnI Reagent Cartridge

Document Title: IVDD Essential Requirements Checklist for Atellica VTLi hs-
cTnI

Document Identifier: DX032851

Version: 04

Prepared By: Julie Benedict

Revised By: Julie Benedict

* Additional Descriptors

REVISION HISTORY
Location Revision Description Rev. Date
(YYYY/MM/DD)

See KVP for

All Initial Version 01
Dates

Revised SMN and product names to match labeling.

See KVP for
All Added more detail to the product description. 02
Dates
Added RoHS Standard and supporting documents.

See KVP for

All Updated product description 03
Dates

See KVP for

All Updated based on CIA 2021-EDW-02726 04
Dates

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APPROVALS
Function Name (Print) Signatures and Dates

Regulatory Affairs Amy Goldberg

Core Team Lead Marcel Jacobs

R&D Femke de Theije See KVP file for Signatures and Dates.

R&D Alexander van Reenen

Quality Selina Kok

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PRODUCT INFORMATION SUMMARY

1. Product Identification

Product Name: Product Catalog Siemens

Type: Number Material
(REF) Number (SMN)
Atellica VTLi Immunoassay Analyzer Instrument 11555589 11555589
Atellica VTLi Docking Station Instrument 11555591 11555591
Atellica VTLi Immunoassay Analyzer (Starter Kit 1 - Instrument 11555586 11555586
English, French, German, Dutch, Italian)
Atellica VTLi Immunoassay Analyzer (Starter Kit 2 – Instrument 11555587 11555587
Danish, Norwegian, Swedish, Finnish)
Atellica VTLi Immunoassay Analyzer (Starter Kit 3 – Instrument 11555588 11555588
Spanish, Portuguese)

Atellica VTLi hs-cTnI Reagent Cartridge Reagent 11555609 11555609

2. Manufacturer and Establishments Associated with the Device

Legal Manufacturer Siemens Healthcare Diagnostics Inc.

(as listed on the labeling):
511 Benedict Avenue
Tarrytown, NY 10591-5097 USA
Place of Manufacture: Instrument:
LRE Medical
Hofer Strasse 5,
86720 Noerdlingen, Germany

Reagent:
Siemens Healthcare Diagnostics Inc
430 South Beiger St
Mishawaka, IN 46544-3207
Development Site: Siemens Healthineers Nederland B.V.
Point of Care Business
High Tech Campus 29
5656 AE Eindhoven, the Netherlands
EU Authorized Representative: Siemens Healthcare Diagnostics Manufacturing Ltd.
Chapel Lane
Swords, Co. Dublin, Ireland
Notified Body: N/A

3. Classification Information

EU Classification: General IVD

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EU Conformity Assessment Route: Annex III

GHTF Classification: Instrument: Class A
Reagent: Class C
GMDN Code: Instrument: 61726
Reagent: 61716
GMDN Term: Instrument: Point-of-care multiplex analyzer IVD
Reagent: Troponin I IVD, kit, magnetic immunoassay)

4. Quality Management System Certification

Applicable Standard: EN ISO 13485:2016/AC:2018

Registrar: TUV Rheinland LGA Products GmbH
Tillystrasse 2, 90431 Nuremberg,
Germany

5. Description of the Device and the Intended Use

Description: The System consists of the following products and

components:

Atellica VTLi hs-cTnI Reagent Cartridge

The Cartridge is the disposable system element that contains
all required reagents to perform a single test.

Atellica VTLi Immunoassay Analyzer

This is the system element that executes the measurement
sequence inside the Cartridge and measures the outcome.
The Analyzer generates a test result with minimal sample
handling. The Analyzer can make a wireless Ethernet
connection to the hospital IT network.

Atellica VTLi Software – Considered part of Analyzer

The Service Software runs on a standard Windows PC
(already available or to be provided by the hospital) and
allows service personnel and hospital technicians to
configure the Analyzer to meet the specific requirements of
the user.

Atellica VTLi Docking Station

The Analyzer can be docked onto the Docking Station for
charging of the battery and making a wired Ethernet
connection to the hospital IT network.

Instrument Intended Use: The Atellica VTLi Immunoassay Analyzer is intended to be

used by healthcare professionals in clinical laboratories and
(Includes Docking Station and point-of-care settings, to measure the concentration of bio-
Starter Kits) markers in whole blood or plasma using disposable cartridges.

The Atellica VTLi Immunoassay Analyzer is a solution for the

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quantitative evaluation of immunoassays using Magnotech

technology.
Reagent Intended Use: Atellica VTLi hs-cTnI Reagent Cartridges are for in vitro
diagnostic use in the quantitative measurement of cardiac
troponin I (cTnI) in human capillary (fingerstick) whole blood,
and lithium-heparinized venous whole blood or plasma, using
the Atellica® VTLi Immunoassay Analyzer. The reagent
cartridges are to be used by healthcare professionals at the
point of care (POC) as well as in the clinical laboratory.
The reagent cartridges are to be used as an aid in the
diagnosis of myocardial infarction (MI).

6. Product History Summary

The Atellica VTLi analyzer is a multi-assay POC analyzer designed for use with Atellica VTLi
assays. The only assay currently available for use with the Atellica VTLi Immunoassay Analyzer is
the Atellica VTLi hs-cTnI Reagent Cartridge. All of the analytical and clinical performance
characteristics of the Atellica VTLi hs-cTnI Reagent Cartridges were evaluated on the Atellica VTLi
Immunoassay Analyzer.
The Atellica VTLi System was formerly known as Minicare. Minicare, previously owned by Philips,
was acquired by Siemens in 2019. The Atellica VTLi System has been developed under the project
name “Moose”. As the project was acquired mid-development it is referred to by a number of
different names in the project and product development documentation including but not limited to
the following:
 Minicare
 Siemens POC
 Moose
 Atellica
All of the product labeling and labels refer to the correct product names and will match the names
called out in this Essential Requirements Checklist and the Declaration of Conformity.

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7. Performance Summary

Performance Characteristics: The following analytical performance characteristics were

evaluated for the Atellica VTLi hs-cTnI: precision, detection
capability (LoB, LoD, LoQ), cross-reactivity, interferences,
linearity, and high-dose hook effect. The following clinical
performance characteristics were evaluated for the Atellica
VTLi hs-cTnI: clinical sensitivity, clinical specificity, positive
predictive value, negative predictive value, 99th percentile
healthy individual reference interval.
Comparison Method: An analytical method comparison is not applicable for this
assay.
The clinical performance of the Atellica VTLi hs-cTnI was
compared to patient diagnoses.
Standardization: The Atellica VTLi hs-cTnI reagent cartridge is standardized to
an internal standard manufactured using human heart
homogenate. Assigned values for calibrators are traceable to
this standardization.

8. Compliance with Essential Requirements of the IVDD and Technical Standards That Apply

Compliance to applicable Essential Requirements is described below. Compliance to applicable

standards is described below and in Appendix 1.

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Compliance with Essential Requirements of Annex I of IVD Directive 98/79/EC

Note: The information contained herein is subject to updates. Modifications are included in the change documentation system for the product or
other referenced documentation system.

Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence

A. General Requirements
A.1 The devices must be designed and manufactured in such a way that, when EN 13641:2002 Applicable Platform: Documentum
used under the conditions and for the purposes intended, they will not EN ISO 14971:2012
compromise, directly or indirectly, the clinical condition or the safety of the EN 62366:2008 Product Risk Management Process
patients, the safety or health of users or, where applicable, other persons, or (DQSP-00017)
the safety of property. Any risks which may be associated with their use Usability Engineering Policy (DQSP-
must be acceptable when weighed against the benefits to the patient and be 00041)
compatible with a high level of protection of health and safety.
Hazard Analysis for Atellica VTLi SAP P41
Platform (DX032966)
Risk Report Atellica VTLi Platform
(DX032964)
Atellica VTLi Usability Verification
Summary Report (DX032262)
Atellica VTLi Design Validation
Report – Supplemental Usability
Validation (DX032863)
Atellica VTLi Usability Engineering
File (DX029702)
Moose Usability Specification
(DX026236)

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
A.2 The solutions adopted by the manufacturer for the design and construction EN 13641:2002 Applicable See A.1 See A.1
of the devices must conform to safety principles, taking account of the EN ISO 14971:2012
generally acknowledged state of the art. EN 62366:2008
In selecting the most appropriate solutions, the manufacturer must apply the
following principles in the following order:
— eliminate or reduce risks as far as possible (inherently safe design and
construction),
— where appropriate take adequate protection measures in relation to risks
that cannot be eliminated,
— inform users of the residual risks due to any shortcomings of the
protection measures adopted.

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
A.3 The devices must be designed and manufactured in such a way that they EN 13612:2002/AC:2002 Applicable Platform: SAP P41
are suitable for the purposes referred to in Article 1(2) (b), as specified by EN ISO 17511:2003
the manufacturer, taking account of the generally acknowledged state of the EN ISO 18153:2003 Design Input Requirements Atellica
art. They must achieve the performances, in particular, where appropriate, VTLi System (DX027272)
in terms of analytical sensitivity, diagnostic sensitivity, analytical specificity, Reagents:
diagnostic specificity, accuracy, repeatability, reproducibility, including
control of known relevant interference, and limits of detection, stated by the Design Input Requirements Atellica
manufacturer. VTLi hs-ctnI (DX028974)
The traceability of values assigned to calibrators and/or control materials Requirements Traceability Matrix
must be assured through available reference measurement procedures Atellica VTLi hs cTnI assay
and/or available reference materials of a higher order. (DX029611)
Atellica VTLi hs-cTnI Design
Verification Summary (DX031267)
Atellica VTLi hs-cTnI 99th Percentile
Report (DX033769)
Atellica VTLi hs-cTnI Clinical Study
Report (DX032843)
Instrument:
Design Input Requirements Atellica
VTLi Analyzer (DX027273)
Requirements for Atellica VTLi
Embedded Software (DX027526)
Sub-System Requirements for the
Integrated hs-cTnI Cartridge and hs-
cTnI Cartridge Type File
(DX029001)
Analyzer Requirements Traceability
Matrix (DX027276)
Software Test Report for Moose
Embedded Software v2.0
(DX033628)
Atellica VTLi hs cTnI Design
Verification Report Cartridge Type
File hs-cTnI v1.1 (DX036060)
Minicare System V2 Design
Verification Report (DX033081)

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
A.4 The characteristics and performances referred to in sections 1 and 3 must EN 13612:2002/AC:2002 Applicable Reagent: SAP P41
not be adversely affected to such a degree that the health or the safety of EN ISO 23640:2015
the patient or the user and, where applicable, of other persons, are Minicare hs-cTnI Analytical Studies
compromised during the lifetime of the device as indicated by the Result – Robustness (DX032242)
manufacturer, when the device is subjected to the stresses which can occur Instrument:
during normal conditions of use. When no lifetime is stated, the same
applies for the lifetime reasonably to be expected of a device of that kind, Analyzer Lifetime (DX034123)
having regard to the intended purpose and the anticipated use of the device.

A.5 The devices must be designed, manufactured and packed in such a way EN ISO 23640:2015 Applicable Reagent: SAP P41
that their characteristics and performances during their intended use will not
be adversely affected under storage and transport conditions (temperature, Packing Readiness Report Assay
humidity, etc.) taking account of the instructions and information provided by (DX032852)
the manufacturer. Instrument:
Atellica VTLi Packaging and
Shipping Report (DX034422)

B. Design and Manufacturing Requirements

B.1 Chemical and physical properties

B.1.1 The devices must be designed and manufactured in such a way as to EN 13612:2002/AC:2002 Applicable The assay has been designed and SAP P41
achieve the characteristics and performances referred to in section A on the EN 50581:2012 validated for use with human
‘General requirements’. Particular attention must be paid to the possibility of capillary (fingerstick) whole blood
impairment of analytical performance due to incompatibility between the and lithium heparin Venous Whole
materials used and the specimens (such as biological tissues, cells, body Blood and Plasma.
fluids and micro-organisms) intended to be used with the device, taking
account of its intended purpose. Sample Stability Report (DX027881)
Interim Real Time Stability Report
(DX034006)
Atellica hs-cTnI Statement of
Biological and Chemical Safe
Design Statement (DX034035)

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.1.2 The devices must be designed, manufactured and packed in such a way as EN 50581:2012 Applicable Reagent: SAP P41
to reduce as far as possible the risk posed by product leakage,
contaminants and residues to the persons involved in the transport, storage Atellica hs-cTnI Statement of
and use of the devices, taking account of the intended purpose of the Biological and Chemical Safe
products. Design Statement (DX034035)
Interim Real Time Stability Report
(DX034006)
Packing Readiness Report Assay
(DX032852)
Atellica VTLi Packaging and
Shipping Report (DX034422)
Safety Data Sheets 11555609
Instrument:
RoHS Compliance Statement for
Analyzer and Docking Station
(DX034168)
REACH Compliance Statement for
Analyzer and Docking Station
(DX034169)

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.2 Infection and microbial contamination

B.2.1 The devices and their manufacturing processes must be designed in such a EN 13641:2002 Applicable Reagent: SAP P41
way as to eliminate or reduce as far as possible the risk of infection to the EN 13612:2002/AC:2002
user or other persons. The design must allow easy handling and, where EN 50581:2012 Atellica hs-cTnI Statement of
necessary, reduce as far as possible contamination of and leakage from, the EN 61010-1:2010 Biological and Chemical Safe
device during use and, in the case of specimen receptacles, the risk of EN 61010-2-101:2002 Design Statement (DX034035)
contamination of the specimen. The manufacturing processes must be Interim Real Time Stability Report
appropriate for these purposes. (DX034006)
Packing Readiness Report Assay
(DX032852)
Atellica VTLi Packaging and
Shipping Report (DX034422)
Safety Data Sheets 11555609
Instrument:
RoHS Compliance Statement for
Analyzer and Docking Station
(DX034168)
REACH Compliance Statement for
Analyzer and Docking Station
(DX034169)
B.2.2 Where a device incorporates biological substances; the risks of infection EN 13641:2002 Applicable See B.2.1 SAP P41
must be reduced as far as possible by selecting appropriate donors and
appropriate substances and by using appropriate, validated inactivation,
conservation, test and control procedures.
B.2.3 Devices labelled either as ‘STERILE’ or as having a special microbiological N/A Not Applicable Not a sterile device.
state must be designed, manufactured and packed in an appropriate pack,
according to procedures suitable for ensuring that they remain in the
appropriate microbiological state indicated on the label when placed on the
market, under the storage and transport conditions specified by the
manufacturer, until the protective packaging is damaged or opened.
B.2.4 Devices labelled either as ‘STERILE’ or as having a special microbiological N/A Not Applicable Not a sterile device. Does not have a
state must have been processed by an appropriate, validated method. special microbiological state.

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.2.5 Packaging systems for devices other than those referred to in section 2.3 EN 13641:2002 Applicable Packing Readiness Report Assay SAP P41
must keep the product without deterioration at the level of cleanliness (DX032852)
indicated by the manufacturer and, if the devices are to be sterilized prior to
use, reduce as far as possible the risk of microbial contamination. Atellica VTLi Packaging and
Shipping Report (DX034422)
Steps must be taken to reduce as far as possible microbial contamination
during selection and handling of raw materials, manufacture, storage and Handheld Analyzer Cleaning
distribution where the performance of the device can be adversely affected Validation Report (DX034205)
by such contamination.
B.2.6 Devices intended to be sterilized must be manufactured in appropriately N/A Not Applicable Not a sterile device.
controlled (e.g. environmental) conditions.
B.2.7 Packaging systems for non-sterile devices must keep the product without N/A Applicable Packing Readiness Report Assay SAP P41
deterioration at the level of cleanliness stipulated and, if the devices are to (DX032852)
be sterilized prior to use, minimize the risk of microbial contamination; the
packaging system must be suitable taking account of the method of Atellica VTLi Packaging and
sterilization indicated by the manufacturer. Shipping Report (DX034422)
Interim Real Time Stability Report
(DX034006)

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.3 Manufacturing and environmental properties

B.3.1 If the device is intended for use in combination with other devices or EN ISO 18113-2:2011 Applicable All performance data were SAP P41
equipment, the whole combination, including the connection system, must EN 50581:2012 generated with the complete system
be safe and must not impair the specified performances of the devices. Any EN 61010-1:2010 (combination of instrument,
restrictions on use must be indicated on the label and/or in the instructions EN 61010-2-101:2002 software, reagents, and controls).
for use.
Atellica VTLi Usability Verification
Summary Report (DX032262)
Atellica VTLi Design Validation
Report – Supplemental Usability
Validation (DX032863)
Atellica VTLi hs-cTnI Information for
Use (11538069)
Atellica VTLi Immunoassay Analyzer
Quick Reference Guide (11538070)
Atellica VTLi Immunoassay Analyzer
User Guide (11538071)
Atellica VTLi Immunoassay Analyzer
Advanced User Guide (11538072)
Acceptance Test: SRS Connection
to Atellica VTLi IS Service Software
(DX034153)
RoHS Compliance Statement for
Analyzer and Docking Station
(DX034168)
REACH Compliance Statement for
Analyzer and Docking Station
(DX034169)
Specific Absorption Rate (SAR)
Compliance Statement for Atellica
VTLi Immunoassay Analyzer
(DX034170)
Electromagnetic compatibility (EMC)
Compliance Statement for Atellica
VTLi Immunoassay Analyzer
(DX034171)

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.3.2 Devices must be designed and manufactured in such a way as to reduce as EN 61010-1:2010 Applicable See B.3.1 SAP P41
far as possible the risks linked to their use in conjunction with materials, EN 61010-2-101:2002
substances and gases with which they may come into contact during normal
conditions of use.
B.3.3 Devices must be designed and manufactured in such a way as to remove or EN 61010-1:2010 Applicable See B.3.1 SAP P41
reduce as far as possible: EN 61010-2-101:2002
— the risk of injury linked to their physical features (in particular aspects of
volume x pressure, dimension and, where appropriate, ergonomic
features),
— risks linked to reasonably foreseeable external influences, such as
magnetic fields, external electrical effects, electrostatic discharge,
pressure, humidity, temperature or variations in pressure or acceleration
or accidental penetration of substances into the device.
Devices must be designed and manufactured in such a way as to provide an
adequate level of intrinsic immunity of electromagnetic disturbance to
enable them to operate as intended.
B.3.4 Devices must be designed and manufactured in such a way as to reduce as EN 61010-1:2010 Applicable See B.3.1 SAP P41
far as possible the risks of fire or explosion during normal use and in single EN 61010-2-101:2002
fault condition. Particular attention must be paid to devices whose intended
use includes exposure to or use in association with flammable substances or
substances which could cause combustion.

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.3.5 Devices must be designed and manufactured in such a way as to facilitate EN 50581:2012 Applicable Atellica hs-cTnI Statement of SAP P41
the management of safe waste disposal. EN 61010-2-101:2002 Biological and Chemical Safe
Design Statement (DX034035)
PREP Assessment Form
(DX029820)
Atellica VTLi hs-cTnI Information for
Use (11538069)
Atellica VTLi Immunoassay Analyzer
Quick Reference Guide (11538070)
Atellica VTLi Immunoassay Analyzer
User Guide (11538071)
Atellica VTLi Immunoassay Analyzer
Advanced User Guide (11538072)
Safety Data Sheets, 11555609
RoHS Compliance Statement for
Analyzer and Docking Station
(DX034168)
REACH Compliance Statement for
Analyzer and Docking Station
(DX034169)
B.3.6 The measuring, monitoring or display scale (including color change and EN 61010-1:2010 Applicable Atellica VTLi Usability Verification SAP P41
other visual indicators) must be designed and manufactured in line with EN 61010-2-101:2002 Summary Report (DX032262)
ergonomic principles, taking account of the intended purpose of the device.
Atellica VTLi Design Validation
Report – Supplemental Usability
Validation (DX032863)
B.4 Devices which are instruments or apparatus with a measuring function

B.4.1 Devices which are instruments or apparatus having a primary analytical EN 13612:2002/AC:2002 Applicable Atellica VTLi hs-cTnI Design SAP P41
measuring function must be designed and manufactured in such a way as to Verification Summary (DX031267)
provide adequate stability and accuracy of measurement within appropriate
accuracy limits, taking into account the intended purpose of the device and Minicare Design Verification Report -
of available and appropriate reference measurement procedures and Analytical Specificity (DX029615)
materials. The accuracy limits have to be specified by the manufacturer. Atellica VTLi hs cTnI Design
Verification Report Analytical
Studies – Precision (DX029619)

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.4.2 When values are expressed numerically, they must be given in legal units N/A Applicable The instrument reports troponin I N/A
conforming to the provisions of Council Directive 80/181/EEC of 20 results in ng/L.
December 1979 on the approximation of the laws of the Member States
relating to units of measurement.
B.5 Protection against radiation

B.5.1 Devices shall be designed; manufactured and packaged in such a way that EN 60825-1:2014 Applicable Specific Absorption Rate (SAR) SAP P41
exposure of users and other persons to the emitted radiation is minimized. EN 61010-1:2010 Compliance Statement for Atellica
EN 61010-2-101:2002 VTLi Immunoassay Analyzer
(DX034170)
Electromagnetic compatibility (EMC)
Compliance Statement for Atellica
VTLi Immunoassay Analyzer
(DX034171)
B.5.2 When devices are intended to emit potentially hazardous, visible and/or EN 60825-1:2014 Applicable Specific Absorption Rate (SAR) SAP P41
invisible radiation, they must as far as possible be: EN 61010-1:2010 Compliance Statement for Atellica
EN 61010-2-101:2002 VTLi Immunoassay Analyzer
— designed and manufactured in such a way as to ensure that the (DX034170)
characteristics and the quantity of radiation emitted can be controlled Electromagnetic compatibility (EMC)
and/or adjusted, Compliance Statement for Atellica
— fitted with visual displays and/or audible warnings of such emissions. VTLi Immunoassay Analyzer
(DX034171)

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.5.3 The operating instructions for devices emitting radiation must give detailed EN 60825-1:2014 Applicable Specific Absorption Rate (SAR) SAP P41
information as to the nature of the emitted radiation, means of protecting the EN 61010-1:2010 Compliance Statement for Atellica
user, and on ways of avoiding misuse and of eliminating the risks inherent in EN 61010-2-101:2002 VTLi Immunoassay Analyzer
installation. (DX034170)

Electromagnetic compatibility (EMC)

Compliance Statement for Atellica
VTLi Immunoassay Analyzer
(DX034171)

Atellica VTLi hs-cTnI Information for

Use (11538069)

Atellica VTLi Immunoassay Analyzer

Quick Reference Guide (11538070)

Atellica VTLi Immunoassay Analyzer

User Guide (11538071)

Atellica VTLi Immunoassay Analyzer

Advanced User Guide (11538072)

Atellica VTLi hs-cTnI Design

Verification Summary (DX031267)
Minicare Design Verification Report -
Analytical Specificity (DX029615)
B.6 Requirements for medical devices connected to or equipped with an
energy source
B.6.1 Devices incorporating electronic programmable systems, including software, EN 13612:2002/AC:2002 Applicable Moose Software Verification and SAP P41
must be designed to ensure the repeatability, reliability and performance of EN 62304:2006/AC:2008 Validation Report (DX033627)
these systems according to the intended use.
B.6.2 Devices must be designed and manufactured in such a way as to minimize EN 61326-1:2013 Applicable Electromagnetic compatibility (EMC) SAP P41
the risks of creating electromagnetic perturbation which could impair the EN 61326-2-6:2016 Compliance Statement for Atellica
operation of other devices or equipment in the usual environment. VTLi Immunoassay Analyzer
(DX034171)

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.6.3 Devices must be designed and manufactured in such a way as to avoid, as EN 61010-1:2010 Applicable Specific Absorption Rate (SAR) SAP P41
far as possible, the risk of accidental electric shocks during normal use and EN 61010-2-101:2002 Compliance Statement for Atellica
in single fault condition, provided the devices are installed and maintained VTLi Immunoassay Analyzer
correctly. (DX034170)
Electromagnetic compatibility (EMC)
Compliance Statement for Atellica
VTLi Immunoassay Analyzer
(DX034171)
B.6.4 Protection against mechanical and thermal risks

B.6.4.1 Devices must be designed and manufactured in such a way as to protect the EN 61010-1:2010 Applicable See B.6.3 SAP P41
user against mechanical risks. Devices must be sufficiently stable under the EN 61010-2-101:2002
foreseen operating conditions. They must be suitable to withstand stresses
inherent in the foreseen working environment, and to retain this resistance
during the expected life of the devices, subject to any inspection and
maintenance requirements as indicated by the manufacturer.
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.
Any guards or other means included with the device to provide protection, in
particular against moving parts, must be secure and must not interfere with
access for the normal operation of the device, or restrict routine
maintenance of the device as intended by the manufacturer.
B.6.4.2 Devices must be designed and manufactured in such a way as to reduce to EN 61010-1:2010 Applicable See B.6.3 SAP P41
the lowest possible level the risks arising from vibration generated by the EN 61010-2-101:2002
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.
B.6.4.3 Devices must be designed and manufactured in such a way as to reduce as EN 61010-1:2010 Applicable See B.6.3 SAP P41
far as possible the risks arising from the noise emitted, taking account of EN 61010-2-101:2002
technical progress and of the means available to reduce noise, particularly
at source, unless the noise emitted is part of the specified performance.
B.6.4.4 Terminals and connectors to electricity, gas or hydraulic and pneumatic EN 61010-1:2010 Applicable See B.6.3 SAP P41
energy supplies which the user has to handle must be designed and EN 61010-2-101:2002
manufactured in such a way as to minimize all possible risks.
B.6.4.5 Accessible parts of the devices (excluding the parts of areas intended to EN 61010-1:2010 Applicable See B.6.3 SAP P41
supply heat or reach given temperatures) and their surroundings must not EN 61010-2-101:2002
attain potentially dangerous temperatures under normal use.

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.7 Requirements for devices for self-testing

Devices for self-testing must be designed and manufactured in such a way N/A Note Applicable Not a Self-Test Device N/A
that they perform appropriately for their intended purpose taking into account
the skills and the means available to users and the influence resulting from
variation that can reasonably be anticipated in users’ technique and
environment. The information and instructions provided by the manufacturer
should be easily understood and applied by the user.
B.7.1 Devices for self-testing must be designed and manufactured in such a way N/A Not Applicable Not a Self-Test Device N/A
as to:
— ensure that the device is easy to use by the intended lay user at all
stages of the procedure, and
— reduce as far as practicable the risk of user error in the handling of the
device and in the interpretation of the results.
B.7.2 Devices for self-testing must, where reasonably possible, include user N/A Not Applicable Not a Self-Test Device N/A
control, i.e. a procedure by which the user can verify that, at the time of use,
the product will perform as intended.

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.8 Information supplied by the manufacturer

B.8.1 Each device must be accompanied by the information needed to use it EN ISO 15223-1:2016 Applicable Specific Absorption Rate (SAR) SAP P41
safely and properly, taking account of the training and knowledge of the EN ISO 18113-1:2011 Compliance Statement for Atellica
potential users, and to identify the manufacturer. EN ISO 18113-2:2011 VTLi Immunoassay Analyzer
EN ISO 18113-3:2011 (DX034170)
This information comprises the data on the label and in the instructions for EN 61010-1:2010
use. Electromagnetic compatibility (EMC)
EN 61010-2-101:2002 Compliance Statement for Atellica
As far as practicable and appropriate, the information needed to use the VTLi Immunoassay Analyzer
device safely and properly must be set out on the device itself and/or, where (DX034171)
appropriate, on the sales packaging. If individual full labeling of each unit is
not practicable, the information must be set out on the packaging and/or in Atellica VTLi hs-cTnI Design
the instructions for use supplied with one or more devices. Verification Summary (DX031267)
Instructions for use must accompany or be included in the packaging of one Minicare Design Verification Report -
or more devices. Analytical Specificity (DX029615)
In duly justified and exceptional cases no such instructions for use are
needed for a device if it can be used properly and safely without them. Atellica VTLi hs-cTnI Information for
Use (11538069)
The decision whether to translate the instructions for use and the label into
one or more languages of the European Union shall be left to the Member Atellica VTLi Immunoassay Analyzer
States, except that, for devices for self-testing, the instructions for use and Quick Reference Guide (11538070)
the label must include a translation into the official language(s) of the
Member State in which the device for self-testing reaches its final user. Atellica VTLi Immunoassay Analyzer
User Guide (11538071)

Atellica VTLi Immunoassay Analyzer

Advanced User Guide (11538072)

Safety Data Sheets, 11555609

B.8.2 Where appropriate, the information to be supplied should take the form of EN ISO 15223-1:2016 Applicable See B.8.1 SAP P41
symbols. Any symbol and identification color used must conform to the EN ISO 18113-1:2011
harmonized standards. In areas for which no standards exist, the symbols EN ISO 18113-2:2011
and color used must be described in the documentation supplied with the EN ISO 18113-3:2011
device. EN 61010-1:2010
EN 61010-2-101:2002

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.8.3 In the case of devices containing or a preparation which may be considered EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
as being dangerous, taking account of the nature and quantity of its EN 61010-1:2010
constituents and the form under which they are present, relevant danger EN 61010-2-101:2002
symbols and labeling requirements of Directive 67/548/EEC1 and Directive
88/379/EEC2 shall apply. Where there is insufficient space to put all the NOTE: 88/379/EEC was
information on the device itself or on its label, the relevant danger symbols repealed by 1999/45/EC.
shall be put on the label and the other information required by those 67/548/EEC and
Directives shall be given in the instructions for use. 1999/45/EC were
repealed by Regulation
The provisions of the aforementioned Directives on the safety data sheet (EC) No 1272/2008. IVD
shall apply, unless all relevant information as appropriate is already made medical devices are
available by the instructions for use. excluded from
Regulation (EC) No
1272/2008. Therefore,
no relevant Directive or
Regulation on dangerous
preparations currently
applies to IVD medical
devices.
B.8.4 The label must bear the following particulars which may take the form of
symbols as appropriate:
B.8.4(a) the name or trade name and address of the manufacturer. For devices EN ISO 15223-1:2016 Applicable See B.8.1 SAP P41
imported into the Community with a view to their distribution in the EN ISO 18113-2:2011
Community, the label, the outer packaging, or the instructions for use shall EN ISO 18113-3:2011
contain in addition the name and address of the authorized representative of EN 61010-1:2010
the manufacturer; EN 61010-2-101:2002
B.8.4(b) the details strictly necessary for the user to uniquely identify the device and EN ISO 15223-1:2016 Applicable See B.8.1 SAP P41
the contents of the packaging; EN ISO 18113-2:2011
EN ISO 18113-3:2011
EN 61010-1:2010
EN 61010-2-101:2002
B.8.4(c) where appropriate, the word ‘STERILE’ or a statement indicating any special N/A Not Applicable Not a sterile device. Does not have a
microbiological state or state of cleanliness; special microbiological state.

1 1
Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances
(OJ 196, 16.8.1967, p. 1). Directive as last amended by Commission Directive 97/69/EC (OJ L 343, 13.12.1997, p. 19).
2 2
Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labeling of
dangerous preparations (OJ L 187, 16.7.1988, p. 14). Directive as last amended by Commission Directive 96/65/EC (OJ L 265, 18.10.1996, p. 15).

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.8.4(d) the batch code, preceded by the word ‘LOT’, or the serial number; EN ISO 15223-1:2016 Applicable See B.8.1 SAP P41
EN ISO 18113-2:2011
EN ISO 18113-3:2011
EN 61010-1:2010
EN 61010-2-101:2002
B.8.4(e) if necessary, an indication of the date by which the device or part of it should EN ISO 15223-1:2016 Applicable See B.8.1 SAP P41
be used, in safety, without degradation of performance, expressed as the EN ISO 18113-2:2011
year, the month and, where relevant, the day, in that order; EN ISO 23640:2015
B.8.4(f) in case of devices for performance evaluation, the words ‘for performance N/A Not Applicable Device not intended for Performance
evaluation only’; Evaluation
B.8.4(g) where appropriate, a statement indicating the in vitro use of the device; EN ISO 15223-1:2016 Applicable See B.8.1 SAP P41
EN ISO 18113-2:2011
EN ISO 18113-3:2011
B.8.4(h) any particular storage and/or handling conditions; EN ISO 15223-1:2016 Applicable See B.8.1 SAP P41
EN ISO 18113-2:2011
EN ISO 23640:2015
B.8.4(i) where applicable, any particular operating instructions; EN ISO 15223-1:2016 Applicable See B.8.1 SAP P41
B.8.4(j) appropriate warnings and/or precautions to take; EN 13641:2002 Applicable See B.8.1 SAP P41
EN ISO 15223-1:2016
EN ISO 18113-1:2011
EN ISO 18113-2:2011
EN ISO 18113-3:2011
B.8.4(k) if the device is intended for self-testing, that fact must be clearly stated. N/A Not Applicable Not a Self-Test Device SAP P41
B.8.5 If the intended purpose of the device is not obvious to the user, the EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
manufacturer must clearly state the intended purpose in the instructions for EN ISO 18113-3:2011
use and, if appropriate, on the label.
B.8.6 Wherever reasonable and practicable, the devices and separate EN ISO 15223-1:2016 Applicable See B.8.1 SAP P41
components must be identified, where appropriate in terms of batches, to EN ISO 18113-2:2011
allow all appropriate action to detect any potential risk posed by the devices EN ISO 18113-3:2011
and detachable components.
B.8.7 Where appropriate, the instructions for use must contain the following
particulars:
B.8.7(a) the details referred to in section 8.4 with the exception of points (d) and (e); EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
EN ISO 23640:2015
EN ISO 18113-3:2011

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.8.7(b) composition of the reagent product by nature and amount or concentration EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
of the active ingredient(s) of the reagent(s) or kit as well as a statement,
where appropriate, that the device contains other ingredients which might
influence the measurement;
B.8.7(c) the storage conditions and shelf life following the first opening of the primary EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
container, together with the storage conditions and stability of working EN ISO 23640:2015
reagents;
B.8.7(d) the performances referred to in section 3 of part A; EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
EN ISO 18113-3:2011
B.8.7(e) an indication of any special equipment required including information EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
necessary for the identification of that special equipment for proper use; EN ISO 18113-3:2011
B.8.7(f) the type of specimen to be used, any special conditions of collection, pre- EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
treatment and, if necessary, storage conditions and instructions for the EN ISO 18113-3:2011
preparation of the patient;
B.8.7(g) a detailed description of the procedure to be followed in using the device; EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
EN ISO 18113-3:2011
B.8.7(h) the measurement procedure to be followed with the device including as EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
appropriate: EN ISO 18113-3:2011
— the principle of the method,
— the specific analytical performance characteristics (e.g. sensitivity,
specificity, accuracy, repeatability, reproducibility, limits of detection and
measurement range, including information needed for the control of
known relevant interferences), limitations of the method and information
about the use of available reference measurement procedures and
materials by the user,
— the details of any further procedure or handling needed before the
device can be used (for example, reconstitution, incubation, dilution,
instrument checks, etc.),
— the indication whether any particular training is required;
B.8.7(i) the mathematical approach upon which the calculation of the analytical EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
result is made; EN ISO 18113-3:2011
B.8.7(j) measures to be taken in the event of changes in the analytical performance EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
of the device; EN ISO 18113-3:2011

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.8.7(k) information appropriate to users on: EN ISO 17511:2003 Applicable See B.8.1 SAP P41
EN ISO 18113-2:2011
— internal quality control including specific validation procedures, EN ISO 18153:2003
EN ISO 18113-3:2011
— the traceability of the calibration of the device;
B.8.7(l) the reference intervals for the quantities being determined, including a EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
description of the appropriate reference population;
B.8.7(m) if the device must be used in combination with or installed with or connected EN ISO 18113-2:2011 Applicable See B.8.1 SAP P41
to other medical devices or equipment in order to operate as required for its EN ISO 18113-3:2011
intended purpose, sufficient details of its characteristics to identify the
correct devices or equipment to use in order to obtain a safe and proper
combination;
B.8.7(n) all the information needed to verify whether the device is properly installed EN ISO 18113-3:2011 Applicable See B.8.1 SAP P41
and can operate correctly and safely, plus details of the nature and
frequency of the maintenance and calibration needed to ensure that the
device operates properly and safely; information about safe waste disposal;
B.8.7(o) details of any further treatment or handling needed before the device can be N/A Applicable See B.8.1 SAP P41
used (for example, sterilization, final assembly, etc.);
B.8.7(p) the necessary instructions in the event of damage to the protective EN ISO 18113-3:2011 Applicable See B.8.1 SAP P41
packaging and details of appropriate methods of resterilization or
decontamination;
B.8.7(q) if the device is reusable, information on the appropriate processes to allow EN ISO 18113-3:2011 Applicable See B.8.1 SAP P41
reuse, including cleaning, disinfection, packaging and resterilization or
decontamination, and any restriction on the number of reuses;
B.8.7(r) precautions to be taken as regards exposure, in reasonably foreseeable EN ISO 18113-3:2011 Applicable See B.8.1 SAP P41
environmental conditions, to magnetic fields, external electrical influences,
electrostatic discharge, pressure or variations in pressure, acceleration,
thermal ignition sources, etc.;
B.8.7(s) precautions to be taken against any special, unusual risks related to the use EN 13641:2002 Applicable See B.8.1 SAP P41
or disposal of the device including special protective measures; where the EN ISO 18113-2:2011
device includes substances of human or animal origin, attention must be EN ISO 18113-3:2011
drawn to their potential infectious nature;

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Essential Requirement (ER) Associated Applicable / Title of Documentary Evidence Storage

Standard(s) Not Applicable (Document Identifier and/or Location of
Version and/or Date) Evidence
B.8.7(t) specifications for devices for self-testing: N/A Not Applicable Not a Self-Test Device
— the results need to be expressed and presented in a way that is readily
understood by a lay person; information needs to be provided with
advice to the user on action to be taken (in case of positive, negative or
indeterminate result) and on the possibility of false positive or false
negative result,
— specific particulars may be omitted provided that the other information
supplied by the manufacturer is sufficient to enable the user to use the
device and to understand the result(s) produced by the device,
— the information provided must include a statement clearly directing that
the user should not take any decision of medical relevance without first
consulting his or her medical practitioner,
— the information must also specify that when the device for self-testing is
used for the monitoring of an existing disease, the patient should only
adapt the treatment if he has received the appropriate training to do so;
B.8.7(u) date of issue or latest revision of the instructions for use. EN 13641:2002 Applicable See B.8.1 SAP P41
EN ISO 14971:2012
EN 62366:2008

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Appendix 1 – Summary of Referenced Standards

The following standards are referenced in the above Essential Requirements Checklist:

Standard Number and Title Applicable Essential Name, Address and Accreditations of Comments
(International Standard) Requirement(s) Third-Party Certification Organization
EN ISO 13485:2016/AC:2016 Applies to overall Quality Name N/A
Medical devices - Quality Management System Address
management systems -
Requirements for regulatory Relevant Accreditations:
purposes (ISO 13485:2016) ISO/IEC 17021:2011
CAN-P-16:2011
CAN-P-1517:2013
EN 13612:2002/AC:2002 A.3, A.4, B.1.1, B.2.1 N/A N/A
Performance evaluation of in vitro
diagnostic medical devices
EN 13641:2002 A.1, A.2, B.2.1, B.2.2, B.2.5, N/A N/A
Elimination or reduction of risk of B.8.4(j), B.8.7(s)
infection related to in vitro diagnostic
reagents
EN ISO 14971:2012 A.1, A.2 N/A N/A
Medical devices – Application of risk
management to medical devices (ISO
14971:2007)
EN ISO 15223-1:2016 B.8.1, B.8.2, B.8.4(a), B.8.4(b), N/A N/A
Medical devices -- Symbols to be B.8.4(d), B.8.4(e), B.8.4(g),
used with medical device labels, B.8.4(h), B.8.4(i), B.8.4(j), B.8.6
labelling and information to be
supplied – Part 1: General
requirements (ISO 15223-1:2016)
EN ISO 17511:2003 A.3, B.8.7(k) N/A N/A
In vitro diagnostic medical devices –
Measurement of quantities in
biological samples – Metrological
traceability of values assigned to
calibrators and control materials (ISO
17511:2003)

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Standard Number and Title Applicable Essential Name, Address and Accreditations of Comments
(International Standard) Requirement(s) Third-Party Certification Organization
EN ISO 18113-1:2011 B.8.1, B.8.2, B.8.4(j) N/A N/A
In vitro diagnostic medical devices –
Information supplied by the
manufacturer (labelling) – Part 1:
Terms, definitions and general
requirements (ISO 18113-1:2009)
EN ISO 18113-2:2011 B.3.1, B.8.1, B.8.2, B.8.3, B.8.4(a), N/A N/A
In vitro diagnostic medical devices – B.8.4(b), B.8.4(d), B.8.4(e),
Information supplied by the B.8.4(g), B.8.4(h), B.8.4(j), B.8.5,
manufacturer (labelling) – Part 2: In B.8.6, B.8.7(a), B.8.7(b), B.8.7(c),
vitro diagnostic reagents for B.8.7(d), B.8.7(e), B.8.7(f),
professional use (ISO 18113-2:2009) B.8.7(g), B.8.7(h), B.8.7(i), B.8.7(j),
B.8.7(k), B.8.7(l), B.8.7(m), B.8.7(s)
EN ISO 18113-3:2011 B.8.1, B.8.2, B.8.4(a), B.8.4(b), N/A N/A
In vitro diagnostic medical devices – B.8.4(d), B.8.4(g), B.8.4(j), B.8.5,
Information supplied by the B.8.6, B.8.7(a), B.8.7(d), B.8.7(e),
manufacturer (labelling) – Part 3: In B.8.7(f), B.8.7(g), B.8.7(h), B.8.7(i),
vitro diagnostic instruments for B.8.7(j), B.8.7(k), B.8.7(m),
professional use (ISO 18113-3:2009) B.8.7(n), B.8.7(p), B.8.7(q),
B.8.7(r), B.8.7(s)
EN ISO 23640:2015 A.4, A.5, B.8.4(e), B.8.4(h), N/A N/A
In vitro diagnostic medical devices -- B.8.7(a), B.8.7(c)
Evaluation of stability of in vitro
diagnostic reagents (ISO
23640:2011)
EN 50581:2012 B.1.1, B.1.2, B.2.1, B.3.1, B.3.5 N/A N/A
Technical Documentation for the
assessment of electrical and electric
products with respect to the
restriction of hazardous substances
EN 61010-1:2010 B.2.1, B.3.1, B.3.2, B.3.3, B.3.4, Name N/A
Safety requirements for electrical B.3.6, B.5.1, B.5.2, B.5.3, B.6.3, Address
equipment for measurement, control, B.6.4.1, B.6.4.2, B.6.4.3, B.6.4.4,
and laboratory use – Part 1: General B.6.4.5, B.8.1, B.8.2, B.8.3, Relevant Accreditations:
requirements (IEC 61010-1:2010) B.8.4(a), B.8.4(b), B.8.4(d), ISO/IEC 17025:2005
B.8.4(g)

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 Title: IVDD Essential Requirements Checklist for Atellica VTLi hs-cTnI
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Standard Number and Title Applicable Essential Name, Address and Accreditations of Comments
(International Standard) Requirement(s) Third-Party Certification Organization
EN 61010-2-101:2002 B.2.1, B.3.1, B.3.2, B.3.3, B.3.4, Name Assessed according to EN 61010-2-101:2017
Safety requirements for electrical B.3.5, B.3.6, B.5.1, B.5.2, B.5.3, Address (Safety requirements for electrical equipment for
equipment for measurement, control, B.6.3, B.6.4.1, B.6.4.2, B.6.4.3, measurement, control and laboratory use - Part 2-
and laboratory use — Part 2-101: B.6.4.4, B.6.4.5, B.8.1, B.8.2, Relevant Accreditations: 101: Particular requirements for in vitro diagnostic
Particular requirements for in vitro B.8.3, B.8.4(a), B.8.4(b), B.8.4(d), ISO/IEC 17025:2005 (IVD) medical equipment) (IEC 61010-2-
diagnostic (IVD) medical equipment B.8.4(g) 101:2015).
(IEC 61010-2-101:2002) (Modified) This standard encompasses all requirements of
EN 61010-2-101:2002.
EN 61326-1:2013 B.6.2 Name N/A
Electrical equipment for Address
measurement, control and laboratory
use – EMC requirements – Part 1: Relevant Accreditations:
General requirements (IEC 61326- ISO/IEC 17025:2005
1:2012)
EN 61326-2-6:2006 B.6.2 Name Assessed according to EN 61326-2-6:2013
Electrical equipment for Address (Medical devices -- Part 1: Application of usability
measurement, control and laboratory engineering to medical devices) (IEC 61326-
use - EMC requirements - Part 2-6: Relevant Accreditations: 1:2012).
Particular requirements - In vitro ISO/IEC 17025:2005 This standard encompasses all requirements of
diagnostic (IVD) medical equipment EN 61326-2-6:2006.
(IEC 61326-2-6:2005)
EN 62304:2006/AC:2008 B.6.1 N/A N/A
Medical device software — Software
life-cycle processes (IEC
62304:2006)
EN 62366:2008 A.1, A.2 N/A Assessed according to IEC 62366-1:2015
Medical devices -- Application of (Medical devices -- Part 1: Application of usability
usability engineering to medical engineering to medical devices).
devices (IEC 62366:2007/A1:2014) This standard is an administrative update to IEC
62366:2007/A1:2014.

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 Title: IVDD Essential Requirements Checklist for Atellica VTLi hs-cTnI
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Appendix 2 – Supplemental References

No Supplement References added.

DQSP-00069-T1 Version: 4.0 Effective: 2019-Jan-18

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Print Date 2024-04-06