MANUFACTURER’S DECLARATION OF CONFORMITYTechnical File Number: Plum 360™ Infusion Pump 22973519665

This is a declaration made under the sole responsibility of ICU Medical in accordance with therequirements of Council Directives 93/42/EEC of 14th June 1993, concerning medical devices;
Company Headquarters:

ICU Medical, Inc.

Issuer of Declaration

Business Address:

600 North Field Drive,
Lake Forest,
Illinois 60045, USA

EU Authorized
Representative:

ICU Medical BV
Hofspoor 33994 VZ Houten
The Netherlands

Manufacturing Sites(s):ICU Medical Costa Rica Ltd
1 Km Noreste del Centro Comercial Real Cariari
Zona Franca Global PK
La Aurora de Heredia
Costa Rica
List Number:Medical Devices:
Identification of object of thedeclaration:

30010

MDD Classification:

Class: IIb

Product Name:
GMDN code:
Plum 360™ Infusion
13215
Pump
Rule 11, according to Annex IX of theMDD

Statement of Conformity:
We, ICU Medical, Inc., declare that the products described herein comply with the Essential
Requirements and applicable provisions of:Council Directive 93/42/EEC of 14th June 1993, concerning medical devices,
The medical devices represented by this declaration are certified according to Annex II of the Council
Directive 93/42/EEC of 14th June 1993, concerning medical devices.
93/42/EEC Annex II (excluding section 4) EC Certification: Design and manufacture of Infusion
Pumps excluding accessories and administration sets
EC Certificate Number: CE 674103
Issued by: BSI Group The Netherlands B.V. (Notified Body Number 2797), Say Building, John M.
Keynesplein 9, 1066 EP Amsterdam, The Netherlands

Plum 360 Infusion Pump Single Declaration of Conformity 828042162193
Page 1 of 6

MANUFACTURER’S DECLARATION OF CONFORMITYTechnical File Number: Plum 360™ Infusion Pump 22973519665
This is a declaration made under the sole responsibility of ICU Medical in accordance with therequirements of Council Directives 93/42/EEC of 14th June 1993, concerning medical devices;Standards applied:Standard reference
EN ISO 13485:2016
EN ISO 14971:2012
EN 62304:2006/AC:2008
EN 62366:2008
EN 60601-1:2006/A1:2013
EN 60601-1-2:2015

EN 60601-1-6:2010
EN 60601-1-8:2007/AC:2010/ A11:2017

EN 60601-2-24:1998
IEC 60601-2-24:2012
EN 1041:2008 /A1:2013
EN ISO 15223-1:2016

Standard title
Medical devices - Quality management systems Requirements for regulatory purposes
Medical devices - Application of risk management tomedical devices
Medical device software - Software life-cycle
processes
Medical devices - Application of usability engineering
to medical devices
Medical electrical equipment -- Part 1: General
requirements for basic safety and essential
performance
Medical electrical equipment -- Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
Medical electrical equipment -- Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability
Medical electrical equipment -- Part 1-8: General
requirements for basic safety and essential
performance - Collateral Standard: General
requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electricalsystems
Medical electrical equipment -- Part 2-24: Particularrequirements for the safety of infusion pumps andcontrollers
Information supplied by the manufacturer of medical
devices
Medical devices — Symbols to be used with medical
device labels, labelling and information to be supplied— Part 1: General requirements

Plum 360 Infusion Pump Single Declaration of Conformity 828042162193
Page 2 of 6MANUFACTURER’S DECLARATION OF CONFORMITYTechnical File Number: Plum 360™ Infusion Pump 22973519665
This is a declaration made under the sole responsibility of ICU Medical in accordance with therequirements of Council Directive 2014/53/EU of 16 April 2014 on the harmonisation of the lawsof the Member States relating to the making available on the market of radio equipment
Company Headquarters:
Issuer of Declaration
Business Address:

ICU Medical, Inc.
600 N. Field Drive,
Lake Forest,
Illinois 60045, USA

EU Authorized
Representative:

ICU Medical B.V.
Hofspoor 3, 3994 VZ Houten,
The Netherlands

Notified Body (NB)

GMDN code:
Product Name:
Model Number:
13215
Plum 360™ Infusion
Plum 360Pump
30010
Radio Equipment
ACCESSORIES
Wireless Local Area Network
None
Siemic Laboratories, 775 Montague Expressway, Milpitas, CA 95035

NB Identification No.

2200

EU-Type Examination
certificate

RE-17053001

Products:
Identification of object ofthe declaration:

Statement of Conformity:
We, ICU Medical, Inc., declare that the products described herein comply with the Essential
Requirements and applicable provisions of:
2014/53/EU of 16th April 2014, the Radio Equipment Directive

Plum 360 Infusion Pump Single Declaration of Conformity 828042162193
Page 3 of 6

MANUFACTURER’S DECLARATION OF CONFORMITYTechnical File Number: Plum 360™ Infusion Pump 22973519665
This is a declaration made under the sole responsibility of ICU Medical in accordance with therequirements of Council Directive RED Directive 2014/53/EU of 16 April 2014 on theharmonisation of the laws of the Member States relating to the making available on the marketof radio equipment
Standards applied:Standard referenceStandard title

EN 62311:2008

Assessment of electronic and electrical equipment related to human exposurerestrictions for electromagnetic fields(0 Hz to 300 GHz)
Medical electrical equipment -- Part 1: General requirements for basic safety
and essential performance
Wideband transmission systems; Data transmission equipment operating in the2,4 GHz ISM band and using wide band modulation techniques; HarmonisedStandard covering the essential requirements of article 3.2 of Directive
2014/53/EU;
5 GHz RLAN; Harmonised Standard covering the essential requirements ofarticle 3.2 of Directive 2014/53/EU
Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment andservices; Part 1: Common technical requirements
ElectroMagnetic Compatibility (EMC) standard for radio equipment andservices; Part 17: Specific conditions for Broadband Data Transmission
Systems;
Electromagnetic compatibility (EMC). Testing and measurement techniques.
Electrostatic discharge immunity test
Electromagnetic compatibility (EMC). Testing and measurement techniques.
Radiated, radio-frequency, electromagnetic field immunity test
Electromagnetic compatibility (EMC). Testing and measurement techniques Electrical fast transient/burst immunity test
Electromagnetic Compatibility (EMC) – Testing and Measurement Techniques –Surge Immunity Test
Electromagnetic compatibility (EMC). Testing and measurement techniques.
Immunity to conducted disturbances, induced by radio-frequency fields
Electromagnetic compatibility (EMC). Testing and measurement techniques.
Voltage dips, short interruptions and voltage variations immunity tests
Electromagnetic compatibility (EMC). Limits. Limits for harmonic currentemissions (equipment input current ≤ 16 A per phase)
Electromagnetic compatibility (EMC). Limits. Limitation of voltage changes,
voltage fluctuations and flicker in public low-voltage supply systems, forequipment with rated current ≤ 16 A per phase and not subject to conditionalconnection
Electromagnetic compatibility of multimedia equipment - Emission requirements

EN 60601-1:2006/A1:2013
EN 300 328 V2.1.1

EN 301 893 V2.1.0
EN 301 489-1 V2.1.1
EN 301 489-17 V3.1.1
EN 61000-4-2:2009
EN 61000-4-3:2010
EN 61000-4-4:2012
EN 61000-4-5:2014
EN 61000-4-6:2014
EN 61000-4-11:2004
EN 61000-3-2:2014
EN 61000-3-3:2013

EN 55032:2012+AC:2013

Plum 360 Infusion Pump Single Declaration of Conformity 828042162193
Page 4 of 6

MANUFACTURER’S DECLARATION OF CONFORMITYTechnical File Number: Plum 360™ Infusion Pump 22973519665This is a declaration made under the sole responsibility of ICU Medical in accordance with therequirements of Council Directive 2011/65/EU of 8th June 2011 on the restriction of the use ofcertain hazardous substances in electrical and electronic equipment (RoHS Recast)Company Headquarters:

ICU Medical, Inc.

Issuer of Declaration

Business Address:

600 N. Field Drive,
Lake Forest,
Illinois 60045, USA

EU Authorized
Representative:

ICU Medical BV
Hofspoor 33994 VZ Houten
The Netherlands

Products:

List Number:
30010(comprising of 30011 or 30012)

Identification of object of thedeclaration:

Product Name:
Plum 360™ Infusion
Pump

GMDN code:
13215

Statement of Conformity
We, ICU Medical Inc, also declare that the electrical and electronic equipment (EEE) described hereincomply with the applicable provisions of:
2011/65/EU of 8th June 2011 on the restriction of the use of certain hazardous substances inelectrical and electronic equipment (RoHS Recast)Standards applied:Standard reference
EN 50581:2012

Standard title

Technical documentation for the assessment ofelectrical and electronic products with respect to therestriction of hazardous substances

Plum 360 Infusion Pump Single Declaration of Conformity 828042162193
Page 5 of 6

icuri l,-11•:,
edtcal,.

,1l't ·t 1u1

MANUFACTURER'S DECLARATION OF CONFORMITYTechnical File Number: Plum 360™ Infusion Pump 22973519665
This Is a declaration made under the sole responsibility of ICU Medical in accordance with therequirements of Council Directives:

1) 2012/19/EU of 4 th July 2012 on waste electrical and electronic equipment (WEEE);
2) 2006/66/EC of 6 th September 2006 on batteries and accumulators and waste batteries
and accumulators and repealing Directive 91/157/EEC

Company Headquarters:

ICU Medical, Inc.

Issuer of Declaration

Business Address:

600 N. Field Drive,lake Forest,
Illinois 60045, USA

EU Authorized
Representative:

ICU Medical BV
Hofspoor33994 VZ Houten
The Netherlands

Products:

List Number:
30010(comprising of 30011 or 30012)

Identification of object of thedeclaration:

Product Name:
Plum 360m Infusion
Pump

GMDN code:
13215

Statement of Conformity
We, ICU Medical Inc., also declare that the products described herein comply with the applicableprovisions of:2012119/EU of41h July 2012 on waste ele~trical and electronic equipment(WEEE);
2006/66/EC of 6 th September 2006 on batteries and accumulators and waste batteries
and accumulators and repealing Directive 91I157/EEC

Authorised Signatories:

Name: Yuliya Matlin
Dept: Global Regulatory Affairs~~

Name: Robert Cousineau
Dept: Research and Development

I Place of Issue:

1gnature

I Lake Forest, Illinois

Plwn 360 Infusion Pwnp Single Declaration of Conformity 828042162193
Page 6 of6_03-2-q-21>14
Date