YY/T 0841-2023 Active Industry standards-Medicine

YY/T 0841-2023 Medical electrical equipment—Recurrent test and test after repair of medical electrical equipment

YY/T 0841-2023 Medical electrical equipment—Recurrent test and test after repair of medical electrical equipment

Publish Date: 2023-09-05 Implement Date: 2025-09-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 0841-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Medical equipment

Publish Date: 2023-09-05

Implement Date: 2025-09-15

Pages: 52 pages

Scope

This document specifies the requirements for testing, or periodic testing, of medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems) and their components before delivery, during maintenance, during inspection, after repair, and during other services, in accordance with GB 9706.1.
This document does not specify the requirements for repair, component replacement, or modifications to ME equipment or ME systems.
This document applies to ME equipment and ME systems, and their components, that comply with GB 9706.1.
This document does not apply to assessing whether the design of ME equipment, ME systems, or other equipment complies with their relevant standards.
This document does not apply to the assembly of ME systems. For the assembly of ME systems, see Chapter 16 of GB 9706.1—2020.
Note: In this document, GB 9706.1 without a version specification refers to GB 9706.1—1995, GB 9706.1—2007, or GB 9706.1—2020.

Development Information

Word Count: 95 Thousand words Pages: 52 pages

Replace the following standards

YY/T 0841-2011 Medical electrical equipment—Recurrent test and test after repair of medical electrical equipment

Referenced Standards

GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB 4793.5-2001 Safety requirements for electrical equipment for measurement, control and laboratory use—Particular requirements for hand-held probe assemblies for electrical measurement and test GB 4793.5-2008 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 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 17045-1997 Protection against electric shock—Common aspects for installation and equipment GB/T 17045-2006 Protection against electric shock—Common aspects for installation and equipment GB/T 17045-2008 Protection against electric shock—Common aspects for installation and equipment GB/T 17045-2020 Protection against electric shock—Common aspects for installations and equipment GB/T 18216.1-2000 Electrical safety in low voltage distribution systems up to 1000V a.c. and 1500V d.c.—equipment for testing, measuring or monitoring of protective measuring Part 1:General requirements GB/T 18216.1-2012 Electrical safety in low voltage distribution systems up to 1 000 V a.c.and 1 500 V d.c.—Equipment for testing,measuring or monitoring of protective measures—Part 1:General requirements GB/T 18216.1-2021 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c.—Equipment for testing,measuring or monitoring of protective measures—Part 1:General requirements GB/T 18216.2-2002 Electrical safety in low voltage distribution systems up to 1000V a.c. and 1500V d.c.—Equipment for testing, measuring or monitoring of protective measuring—Part 2:Insulation resistance GB/T 18216.2-2012 Electrical safety in low voltage distribution systems up to 1 000 V a.c.and 1 500 V d.c.—Equipment for testing, measuring or monitoring of protective measures—Part 2:Insulation resistance GB/T 18216.2-2021 Electrical safety in low voltage distribution systems up to 1 000 V a.c.and 1 500 V d.c.—Equipment for testing,measuring or monitoring of protective measures—Part 2:Insulation resistance GB/T 18216.4-2007 Electrical safety in low voltage distribution systems up to 1 000 V a.c—Equipment for testing, measuring or monitoring of protective measures—Part 4:Resistance of earth connection and equipotential bonding GB/T 18216.4-2012 Electrical safety in low voltage distribution systems up to 1 000 V a.c.and 1 500 V d.c.—Equipment for testing, measuring or monitoring of protective measures—Part 4:Resistance of earth connection and equipotential bonding GB/T 18216.4-2021 Electrical safety in low voltage distribution systems up to 1 000 V a.c and 1 500 V d.c—Equipment for testing,measuring or monitoring of protective measures—Part 4:Resistance of earth connection and equipotential bonding

Adopt standards

IEC 62353:2014

Related Standards

GB 9706.8-1995 Replaced

GB 9706.8-1995 Medical electrical equipment—Part 2:Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors

Publish Date: 1995-06-02

GB 11235-1997 Replaced

GB 11235-1997 VCu intra-uterine device

Publish Date: 1997-07-24

GB/T 17257.1-1998 Replaced

GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary

Publish Date: 1998-03-18

GB/T 17257.2-1998 Replaced

GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions

Publish Date: 1998-03-18

GB/T 17257.3-1998 Replaced

GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume

Publish Date: 1998-03-18

GB/T 17257.4-1998 Replaced

GB/T 17257.4-1998 Urine collection bags—Part 4:Determination of freedom form leakage

Publish Date: 1998-03-18