南宫28NG相信品牌力量

南宫(28NG·国际)官方网站-相信品牌力量
Our service

Centre Testing International Co., Ltd. (NG28) is the pioneer and leader in the TIC Industry which provides one-stop solutions on testing, inspection, certification, calibration, audit, training & technical services.

 
南宫(28NG·国际)官方网站-相信品牌力量
By Industry

Our service capabilties cover the upstream and downstream of the supply chain including textile and apparel,toys,electronic appliances,medical health,food...andother industries.
南宫(28NG·国际)官方网站-相信品牌力量
Specialty

Comprehensively guarantee quality and safety, promote compliance and innovation, demonstrate brand competitiveness, and achieve higher quality, healthier, safer, and greener sustainable development.
南宫(28NG·国际)官方网站-相信品牌力量
AUTHORITY & TRUST
QUALITY & VALUE
Single Failure Testing

Refers to the medical equipment's only risk reducing measure failing or exhibiting one form of abnormality. Under the state of this single fault, the medical electrical equipment still needs to maintain product safety.

Single Failure Testing

?    Service Background

Single Fault：Refers to the medical equipment's only risk reducing measure failing or exhibiting one form of abnormality. Under the state of this single fault, the medical electrical equipment still needs to maintain product safety. The Single Fault test, which evaluates quality and electrical safety characteristics, 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

  1. Testing of active medical device
  2. EMC testing and debugging service
  3. Reliability Testing
  4. NMPA registration testing service
  5. Validation of product life
  6. Failure mode analysis
  7. Biocompatibility test
  8. Software evaluation
  9. Global marketing access
  10. US agent service
  11. EU representative service
  12. 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/IEC 80601-2-49

 
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