New challenges in Edition 4.0 of the medical EMC standard IEC 60601-1-2Wilko de GraafPhilips Healthcare - Best NLJune 21st, 2016

Prevent hazards

Part of IEC 60601 group

IEC 60601-1-2 Edition 4.0: 2014

Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral Standard: Electromagnetic disturbances –Requirements and tests

Philips Healthcare - Best NL2

Prevent hazards

Not equal to compatibility

IEC 60601-1-2 Edition 4.0: 2014

Emission: CISPR 11 (unchanged)

Immunity:• BASIC SAFETY = freedom from unacceptable

RISK directly caused by physical HAZARDS when ME EQUIPMENT is used under NORMAL CONDITION and SINGLE FAULT CONDITION

• ESSENTIAL PERFORMANCE = performance of a clinical function, other than that related to BASIC SAFETY, where loss or degradation beyond the limits specified by the MANUFACTURER results in an unacceptable RISK

Philips Healthcare - Best NL3

Environments of INTENDED USE

Philips Healthcare - Best NL4

e.g. residences, shops, cars, hotels, museums, etc.

e.g. hospitals, clinics, birthing centers, dental offices, etc.

e.g. nearby HF SURGICAL EQUIPMENT, inside shielded room of MRI, military areas, heavy industrial areas, etc.

Risk management in IEC 60601-1-2 ed. 4

• Determine INTENDED USE.

• Risk analysis: what HAZARD could possibly happen due to EMI,

in the intended EM Environment?

• Risk evaluation: what is acceptable, and what is not?

• Risk reduction: robust concept, fail-safe, instruction.

• Derive performance criteria.

• Determine location of intended use.

• Derive applicable test levels.

Philips Healthcare - Best NL5

Risk management in IEC 60601

• Perform immunity tests

• at applicable test levels.

• Verify whether performance criteria are met.

Philips Healthcare - Best NL6

Immunity test levels:subject to change by risk managementESD• ±8 kV contact discharge• ±2 kV, ±4 kV, ±8 kV, ±15 kV air discharge• Including connectors that can be touched by standard test finger

Electrical Fast Transients / Bursts• ±2 kV a.c./d.c. power ports• ±1 kV signal input/output ports• Repetition frequency: 100 kHz

Surges• ±0.5 kV, ±1 kV line-to-line• ±0.5 kV, ±1 kV, ±2 kV line-to-ground• At four phase angles

Philips Healthcare - Best NL7

Immunity test levels:subject to change by risk managementPower Frequency Magnetic Fields• 30 A/m• Only for products with magnetically sensitive components

Voltage Dips and Interruptions• 0%, 0.5 cycle, at eight phase angles• 0%, 1 cycle at 0°• 70%, 0.5 second• 0%, 5 seconds

Philips Healthcare - Best NL8

Immunity test levels:subject to change by risk managementConducted Immunity• 3 V, 0.15-80 MHz• 6 V at ISM bands (professional healthcare facility environment)• 6 V at ISM and amateur radio bands (HOME HEALTHCARE ENVIRONMENT)

Radiated Immunity• 3 V/m, 80-2700 MHz (professional healthcare facility environment)• 10 V/m, 80-2700 MHz (HOME HEALTHCARE ENVIRONMENT)• Including intentional receiving frequency

Philips Healthcare - Best NL9

Immunity test levels:subject to change by risk management• Proximity fields from RF wireless communications equipment

Philips Healthcare - Best NL10

Service Test frequency Amplitude ModulationTETRA 400 385 MHz 27 V/m PM, 18 Hz

GMRS 460, FRS 460

450 MHz 28 V/m FM ± 5 kHz dev., 1 kHz sine

LTE band 13, 17 710, 745, 780 MHz 9 V/m PM, 217 Hz

GSM, TETRA, CDMA, etc.

810, 870, 930 MHz 28 V/m PM, 18 Hz

GSM, DECT, UMTS, Bluetooth,WLAN, etc.

1720, 1845, 1970, 2450 MHz

28 V/m PM, 217 Hz

WLAN 802.11 5240, 5500, 5785 MHz

9 V/m PM, 217 Hz

Immunity test

• Proximity fields from RF wireless communications equipment

tested according IEC 61000-4-3

Philips Healthcare - Best NL11

Documentation

• New requirements for test plan

• New requirements for test report

• Requirements for product documentation renewed

Philips Healthcare - Best NL12

Transition period edition 3 to edition 4

Publication of IEC 60601-1-2 edition 4:• 2014-02

EU:• Dow 2018-12-31 (all products on the market)

USA:• 2017-04-01 (new products on the market)

Other parts of the world:• May differ per country

Philips Healthcare - Best NL13