YY/T 0841-2023 English PDF (YYT0841-2023)

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YY/T 0841-2023: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
YY/T 0841-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
CCS C 30
Replacing YY/T 0841-2011
Medical electrical equipment – Recurrent test and test after
repair of medical electrical equipment
(IEC 62353:2014, MOD)
ISSUED ON: SEPTEMBER 05, 2023
IMPLEMENTED ON: SEPTEMBER 15, 2025
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 Requirements ... 18
4.1 * General requirements ... 18
4.2 Testing before putting into service, after modifications, and after repair ... 20
4.3 * Recurrent test ... 20
5 * Tests ... 21
5.1 General ... 21
5.2 Visual inspection ... 21
5.3 Measurements ... 22
5.4 Functional test ... 36
6 Results of test and evaluation ... 37
6.1 Reporting of results ... 37
6.2 Evaluation ... 37
Annex A (Informative) General guidance and rationale ... 39
Annex B (Informative) Sequence of testing ... 50
Annex C (Normative) Requirements for the measurement equipment and for
measurement circuits for protective earth resistance and leakage currents ... 52
Annex D (Informative) Patient environment ... 56
Annex E (Normative) Allowable values for leakage currents from GB 9706.1 ... 57
Annex F (Informative) Testing intervals ... 61
Annex G (Informative) Example of test documentation ... 63
Annex H (Informative) Notes on testing ME systems ... 64
Bibliography ... 66
Foreword
This document is drafted in accordance with the rules provided in GB/T 1.1-2020
Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents.
This document replaces YY/T 0841-2011 Medical electrical equipment - Recurrent test
and test after repair of medical electrical equipment. Compared with YY/T 0841-2011,
in addition to structural adjustment and editorial modification, the main technical
revisions are as follows:
-- Add the definitions of “configuration” and “line-to-earth voltage” (see 3.8 and
3.17);
-- Add some terms in GB 9706.1-2020 (see 3.28, 3.31, 3.33, 3.35);
-- Delete the definition of “normal condition” (see 3.26 of the 2011 edition);
-- Change the measuring of protective earth resistance to adapt to the test of ME
systems in GB 9706.1-2020 (see 5.3.2; 5.3.2 of the 2011 edition);
-- Add the measurement of insulation resistance (see 5.3.3);
-- Add the method of measuring the equipment leakage currents, and explain the
relevant contents (see 5.3.4.1);
-- Add some required values (see Table 2).
This document adopts IEC 62353:2014 Medical electrical equipment – Recurrent test
and test after repair of medical electrical equipment by modification.
The technical differences between this document and IEC 62353:2014 and their reasons
are as follows:
-- Use the normatively referenced GB 9706.1 to replace IEC 60601-1:2005 and
IEC 60601-1:2005+AMD 1:2012 to adapt to our country's technical conditions;
-- Use the normatively referenced GB 4793.1 to replace IEC 61010-1 (see Annex
C) to adapt to our country's technical conditions;
-- Use the normatively referenced GB 4793.5 to replace IEC 61010-031 (see
Annex C) to adapt to our country's technical conditions;
-- Use the normatively referenced GB/T 17045 to replace IEC 61140 (see 6.2) to
adapt to our country's technical conditions;
-- Use the normatively referenced GB/T 18216.1 to replace IEC 61557-1 (see
Annex C) to adapt to our country's technical conditions;
Medical electrical equipment – Recurrent test and test after
repair of medical electrical equipment
1 Scope
This document specifies testing of medical electrical equipment and medical electrical
system (hereafter referred to as ME equipment and ME systems) or parts of such
equipment or systems, which comply with GB 9706.1, before putting into service,
during maintenance, during inspection, after repair and in other services, or on occasion
of recurrent tests.
This document does not define requirements for repair, exchange of components and
modification of ME equipment or ME systems.
This document applies to ME equipment and ME systems conforming to GB 9706.1
and their parts.
This document is not suitable to assess whether ME equipment or ME systems or any
other equipment comply with the relevant standards for their design.
This document is not applicable to the assembly of ME systems. For assembling ME
systems, see Clause 16 of GB 9706.1-2020.
Note: In this document, GB 9706.1 without version indication refers to GB 9706.1-
1995, GB 9706.1-2007 or GB 9706.1-2020.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this
document and are indispensable for its application. For dated references, only the
edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
GB 4793.1, Safety requirements for electrical equipment for measurement,
control and laboratory use - Part 1: General requirements (GB 4793.1-2007, IEC
61010-1:2001, IDT)
GB 4793.5, Safety requirements for electrical equipment for measurement,
control and laboratory use - Part 5: Safety requirements for hand-held probe
assemblies for electrical measurement and test (GB 4793.5-2008, IEC 61010-
031:2002, IDT)