IECEE OD-5003-F1:2021 © IEC 2021 –1– Ed. 1.

2
Template (Provisional) Equipment List 2021-02-03

TESTING AND MEASURING EQUIPMENT/ALLOWED SUBCONTRACTING

IEC 60601-1-2:2014 + AMD1:2020
Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and test

“R” Required
“S” May be s ubcontracted, s ee OD 2012
“S P ” Specialized Facility, s ee IECEE 02-2
“W ” W it ness t esting in t he c ategories “MED” and “MEAS”
“3PPS” Three Phase Power Supply required

Cl a use Me asurement/testing
7. 1. 1 E lectromagnetic E missions – c onducted
dis turbance (CISPR 11:2015+A1:2016
+ A2:2019 s ubclauses 6. 2.1 and 6.3.1)
7. 1. 1 E lectromagnetic E missions - radiated
dis turbances 150 k Hz – 30 MHz (CISPR
11: 2015+A1:2016+A2:2019 s ubclause
6. 3. 1.3)
7. 1. 1 E lectromagnetic E missions - radiated
dis turbances 30 MHz – 1 GHz (CISPR
11: 2015+A1:2016+A2:2019 s ubclauses
6. 2. 2.3 and 6.3.2.3)
Equi pment
Te sti ng / measuring equipment / material needed Cl a ssi fication
Rec eiver or Spectrum analyser + preselector + QP adapter (CISPR 16- R
1-1 c ompliant), AMN, RF Coaxial Cable, RGP, Artificial hand
High Pass Filter, Attenuator S
Loop ant enna, Rec eiver or Spectrum analyser + pres elector + QP R
adapt er (CISPR 16-1-1 c ompliant), RF Coaxial Cable, a s uitable test
s it e
At t enuator, Filter, RF Amplifier S
Bic onical Antenna and log-periodic antenna or bilog antenna, Receiver R
or Spec trum analyser + preselector + QP adapter (CISPR 16-1-1
c ompliant), RF Coaxial Cable, CMAD, Semi- or Fully- A nechoic
Chamber or Open Area Test S ite
At t enuator, Filter, RF Amplifier S

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Template (Provisional) Equipment List 2021-02-03

Equi pment
Cl a use Me asurement/testing Te sti ng / measuring equipment / material needed
Cl a ssi fication
7. 1. 1 E lectromagnetic E missions – c onducted Rec eiver or Spectrum analyser + preselector + QP adapter (CISPR 16- R
dis turbance on mains when AMN c annot be 1-1 c ompliant), Voltage probe, RF Coaxial Cable
us ed (CISPR 11:2015+A1:2016+A2:2019
s ubclause 7.3.3)
7. 1. 7 Cont inuous dis turbances – disturbance Rec eiver or Spectrum analyser + preselector + QP adapter (CISPR 16- R
volt ages - (CISPR 14-1:2016 subclause 4.3.3) 1-1 c ompliant), AMN, RF Coaxial Cable, RGP, Artificial hand
7. 1. 7 Cont inuous disturbances – disturbance power Tes t Receiver or Spectrum analyser, Absorbing Clamp R
(CISPR 14-1:2016 s ubclause 4.3.4)
7. 1. 7 Cont inuous dis t urbances – radiated power Bic onical Antenna and Log periodic antenna or bilog antenna, Receiver R
(CISPR 14-1:2016 s ubclause 4.3.4) or Spec trum analyser + pres elector + QP adapt er (CISPR 16 -1-1
c ompliant), RF Coax ial Cable, CMAD, Semi- or Fully- A nechoic
Chamber or Open Area Test S ite or TE M-Waveguide
At t enuator, Filter, RF Amplifier S
7. 1. 7 Dis continuous disturbance (CISPR 14-1:2016 AMN, Dis turbance Analyser for dis continuous dis t urbances (e.g. R
s ubclause 4.4) Clic kmeter or Receiver), Oscilloscope

7. 2. 1 Harmonic dis t ortion (IEC 61000-3- Power s ource, harmonic meter R

2: 2005+A1:2008+A2:2009) – s ubclause 6.2
7. 2. 2 Volt age fluctuations and flicker (IEC 61000-3- Power s upply, Voltage fluc tuation met er, Impedance net work, flicker R
3: 2013) – c lause 6 met er
8 Immunity t est t o electrostatic discharges (IEC ESD simulator (up t o 8 kV CD, 15 kV AD), VCP, HCP, reference ground R
61000-4-2:2008) plane
8 Immunity test to radiated electromagnetic field Signal generator (able t o provide frequency range and modulation acc. R
(IEC 61000-4-3:2006+A1:2007+A2:2010) t o t able 9 of IEC 60601-1-2:2014), RF power amplifier (able t o provide
fieldstrengh acc. to table 9 of IEC 60601-1-2:2014), Function generator,
Bic onical antenna and log periodic ant enna or bilog antenna, Horn
ant enna, Millivoltmeter (or Power Meter with Power Sensor), Isotropic
Field Probe, Direc tional c oupler, Power Amplifier (RF Amplifier
frequency range up t o 6 GHz ), Anechoic c hamber or Semi-Anechoic
c hamber, RF Coax ial Cable, Cont roller (e. g. P C and Cont roller
s oft ware)
EMI Filter, Additional absorbers S

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Template (Provisional) Equipment List 2021-02-03

Equi pment
Cl a use Me asurement/testing Te sti ng / measuring equipment / material needed
Cl a ssi fication
8 Immunity t ests t o electrical fas t t ransients / Burs t Generator (able t o provide 100 k Hz repet ition frequency), R
burs ts (IEC 61000-4-4:2012) Coupling/Decoupling Network, Capacitive Clamp, RGP, Interconnection
Cable (for Clamp t o Generator)
33 nF c apacitor for direct injection S
8 Immunity t es t t o s urges (IEC 61000-4- Surge generator, c oupling/decoupling net work for mains, reference R
5: 2014+A1:2017) ground plane
Surge generator 10/ 700 µs , c oupling/decoupling net work for SIP / S
SOPS intended t o be connected t o outdoor symmetrical communication
lines
8 Immunity t es t t o c ont inuous c onducted Signal generator, RF power amplifier, Coupler, Coupling/decoupling R
dis turbances (IEC 61000-4-6:2013) net work, RF Coax ial Cable, At tenuator, Power met er wit h Power
Sensor, EM c lamp, Current c lamp,100Ω t o 50Ω adaptor and direct
injection device, RGP
Dec oupling net work, Dec oupling devic e, Art ificial hand, 50Ω S
Termination, EMI Filter
8 Immunity t est t o power frequency magnetic Tes t Generator, Square Coil and/ or Rec tangular Coil and/ or other R
fields (IEC 61000-4-8:2009) inductive Coil, and/or Helmholtz Coil, Magnetic Field Tester, Magnetic
Field Probe
Dec oupling network, Back filter S
8 Immunity t es t t o volt age dips , s hort Tes t generator, oscilloscope R
int erruptions and voltage variations on power
s upply input lines (IEC 61000-4-
11: 2004+A1:2017)
8 Immunity t o prox imity magnetic fields (IEC Signal generator with internal or external modulation capability, power S
61000-4-39:2017 subclause 8. 5) amplifier, field generating devices – radiating loop (subclause 6.1.2.1
and 6. 1. 3.1), magnetic field s ens or loop (s ubclause 6. 1.2.3 and
6. 1. 3.2), volt meter, c urrent probe (s ubclause 6. 1. 2.2) inc luding
os c illoscope, AC volt meter or AC current meter

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Template (Provisional) Equipment List 2021-02-03

Additional te sting and me asuring e quipme nt ne eded only for ME EQUIPMENT and ME SYST EMS intended for use
HOME HEALT HCARE ENVIRONMENT with Input d.c. powe r PORT intended to be installed in passe nger cars and light
comme rcial v e hicles including ambulance s (Note 3)
Clau se M easurement/testing Te sting / me asuring e quipment / material Su b contracting
n eeded
8 Electrical t rans ient c onduction along s upply Os c illoscope or equivalent, volt age probe, t es t pulse S
Table 6 lines according ISO 7637-2:2011 generator, ground plane, power s upply, battery
Not e f)

Not e 1: This equipment list shows t est and measuring equipment for t wo out of t hree environments (Professional healthcare facility environment
and home healthcare environment). For t he t hird environment (Special) no equipment c an be defined in a general l ist, bas ed on t he fac t t hat the
t es ts and consequently t he t est equipment’s are based upon identified EM phenomena at t his s pecial environment (see IEC 60601 -1-2:2014 Annex
E)
Not e 2: It must be noted t hat t he IEC 60601 -1-2:2014 (Edition 4. 0) requirements cannot be addressed without Risk Management (ISO 14971) and
Es sential Performance, which, in it self, c annot be addressed wit hout Risk Management (ISO 14971). It als o needs t o be not ed t hat Risk
Management (ISO 14971) and Essential Performance related t o IS O 60601 Part II Particular Standards play a k ey role in t he IEC 60601-1-2:2014
(Edition 4. 0).
Not e 3: All devices need t o fulfil t echnical requirements of ISO 7637-2:2011

Di scl aimer: This do cument is co ntrolled a nd has b een release d electronically.

O n l y the version o n the I ECEE Websi te is t he current do cument version.