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60601-1-11 2015 - Amd1 2020-Interim El

The document outlines the provisional equipment list for testing and measuring equipment in accordance with IEC 60601-1-11:2015/AMD1:2020, focusing on medical electrical equipment used in home healthcare. It specifies requirements for environmental conditions, mechanical strength, ingress protection, and electromagnetic compatibility, along with classifications for required and subcontracted equipment. The document is controlled and the current version is available on the IECEE website.

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Mirna Ristovski
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97 views2 pages

60601-1-11 2015 - Amd1 2020-Interim El

The document outlines the provisional equipment list for testing and measuring equipment in accordance with IEC 60601-1-11:2015/AMD1:2020, focusing on medical electrical equipment used in home healthcare. It specifies requirements for environmental conditions, mechanical strength, ingress protection, and electromagnetic compatibility, along with classifications for required and subcontracted equipment. The document is controlled and the current version is available on the IECEE website.

Uploaded by

Mirna Ristovski
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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IECEE OD-5003-F1 2024 © IEC 2024 –1– Ed.1.

3
Template (Provisional) Equipment List 2024-06-26

TESTING AND MEASURING EQUIPMENT/ALLOWED SUBCONTRACTING


IEC 60601-1-11:2015/AMD1:2020
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment

Abbreviations to be used at the column “Equipment Classification”:


“R” Required
“S” May be subcontracted, see OD 2012
“SP” Specialized Facility, see IECEE 02-2
“W” Witness testing in the categories “MED” and “MEAS”
“3PPS” Three Phase Power Supply required

Equipment
Clause Measurement/testing Testing / measuring equipment / material needed
Classification
4.2.1, - Environmental conditions of transport and Cycling Environmental chamber: Temperature range: R
storage between uses – 25 °C to + 5 °C
4.2.2, - Environmental operating conditions +5°C to +35°C at a relative humidity up to 90%, non-condensing; and
4.2.3 - Environmental shock to TRANSIT- >35°C to + 70 °C at a water vapour pressure up to 50hPa;
OPERABLE ME EQUIPMENT With timer capability of least 6 hours.(monitoring and trending)
Click here
to enter Click here to enter text. Relative humidity (rh) range : less than or equal to 15 % rh ± 3 % to and
text. greater than or equal to 90 % rh -0% +6%
– An atmospheric pressure range of 700 hPa to 1 060 hPa. W
5 General requirements for testing ME Small finger probe 5.6 mm diameter (Figure 1) or as per IEC 61032 figure R
EQUIPMENT/ Accessible parts 13
8.3.1 Ingress of water or particulate matter into ME IEC 60529:1989 – Tests apparatus according to IP22 and IP21 W
EQUIPMENT / IP testing
8.3.2 Ingress of water or particulate matter into ME IEC 60529 test equipment W
SYSTEMS / IP Testing

Disclaimer: This document is controlled and has been released electronically.


Only the version on the IECEE Website is the current document version.
Ed.1.3 –2– IECEE OD-5003-F1:2025 © IEC 2025
2025-01-01

Equipment
Clause Measurement/testing Testing / measuring equipment / material needed
Classification
10.1.2 Requirements for Mechanical strength for Shock test in accordance with IEC 60068-2-27:2008 – test type 1, 2 S
NON-TRANSIT-OPERABLE ME EQUIPMENT Broad-band random vibration test in accordance with IEC 60068-2-64:2008
/ Shock and Vibration
10.1.3 Requirements for Mechanical strength for Shock test in accordance with IEC 60068-2-27:2008 – test type 1, 2 S
TRANSIT-OPERABLE ME EQUIPMENT / Broad-band random vibration test in accordance with IEC 60068-2-64:2008
Shock and Vibration Free fall in accordance with IEC 60068-2-31:2008 - PROCEDURE 1
12.1 Additional requirements for Class B according to CISPR 11:2009. S
electromagnetic compatibility of ME
EQUIPMENT and ME SYSTEMS / Emissions
classification
13.1 Additional requirement for generation of Sound measurement equipment according requirements of S
ALARM SIGNALS / Alarm signal IEC 60601-1-8:2006 clauses 6.3.1 and 6.3.3.2.
13.2 Additional requirement for ALARM SIGNAL
volume / Alarm volume

Disclaimer: This document is controlled and has been released electronically.


Only the version on the IECEE Website is the current document version.

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