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Mold Pressing Testing

Mould stress relief is to ensure the thermoplastic shells of medical electrical products, formed through mold pressing or injection molding, are well constructed. Any shrinkage or deformation stemming from internal stress during the process of mold pressing or injection molding cannot lead to any unacceptable risks. The Mould stress relief test, which evaluates the safety characteristics of the products' outer shell, is one of the most important tests for safety of medical electrical products.

? Service Background

Mould stress relief: Mould stress relief is to ensure the thermoplastic shells of medical electrical products, formed through mold pressing or injection molding, are well constructed. Any shrinkage or deformation stemming from internal stress during the process of mold pressing or injection molding cannot lead to any unacceptable risks. The way of testing is putting a sample, either the whole medical equipment or just the shell with supporting frames, into an oven with air circulating at a specific temperature. After the test when the sample is cooled back to room temperature, the shell should shrink or deform without causing unacceptable risks. The Mould stress relief test, which evaluates the safety characteristics of the products' outer shell, is one of the most important tests for safety of medical electrical products.

Medical device testing is the basis for medical devices to enter the global market. If a product is to be exported to the European Union or the United States, then corresponding tests will need to be done to meet the EU or US standards.

? Other Services of Medical Devices

Testing of active medical device
EMC testing and debugging service
Reliability Testing
NMPA registration testing service
Validation of product life
Failure mode analysis
Biocompatibility test
Software evaluation
Global marketing access
US agent service
EU representative service
Training Service

? Medical Device Testing Standards

In Vitro Diagnostic Medical Devices

SN	Title	International Standard	National Standard
1	Electrical Equipment For Measurement, Control, and Laboratory Use	IEC/EN 61010-1	GB4793.1
2	Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment	IEC/EN 61010-2-101	YY 0648
3	Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes	IEC/EN 61010-2-081	GB4793.9
4	Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements	IEC/EN 61326-1	GB/T 18268.1
5	Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment	IEC/EN 61326-2-6	GB/T18268.26

Medical Device Testing Standards List

SN	Title	International Standard	National Standard
1	Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements	IEC/EN 60601-2-25	GB 10793
2	Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type	EN ISO /ISO 81060-1
3	Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems	EN 1060-3
4	Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems	IEC/EN 60601-1-1	GB 9706.15
5	Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment	IEC/EN 60601-2-27	GB 9706.25
7	Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs	IEC/EN 60601-2-26:2012 IEC 80601-2-26：2019	GB 9706.26
8	Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement	ISO/ EN ISO 80601-2-56
9	Non-invasive automated sphygmomanometers	ANSI/AAMI SP10	YY 0670
10	Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use	IEC/EN 60601-2-57
11	Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories	IEC/EN/EN IEC 60601-2-2	GB 9706.4
12	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance	ANSI/AAMI ES60601-1 EN /IEC60601-1	GB9706.1
13	Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators	IECC/EN 60601-2-10	YY 0607
14	Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers	IEC/EN 80601-2-30	YY 0667
15	Medical electrical equipment-Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment	IEC/EN 60601-2-49/

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