GB10035-2017
Air-bag type sequential external counter-pulsation device
气囊式体外反搏装置
GB 10035-2017 is a current mandatory Chinese national standard for Air-bag type sequential external counter-pulsation device. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Jul 1, 2019.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.
Compliance overview
Scope and applicability
This standard applies to air-bag type sequential external counter-pulsation devices used in medical institutions for the treatment and rehabilitation of ischemic diseases. It covers the classification, structure, and essential safety requirements for these medical devices. This standard is mandatory for all manufacturers of external counter-pulsation equipment entering the Chinese market. It references GB 9706.1 and YY 0505 for safety and electromagnetic compatibility.
Technical requirements
The standard specifies comprehensive requirements for the operation pressure and pneumatic system stability of the counter-pulsation device. It mandates specific performance criteria for the ECG monitoring component, including QRS wave detection, heart rate measurement accuracy, and common-mode rejection capabilities. Manufacturers must ensure the device effectively suppresses high T-waves to prevent false triggering. Control system requirements dictate precise timing for inflation and exsufflation sequences, ensuring synchronization with the patient's physiological signals. The standard also outlines critical protection functions, such as automatic cessation of counter-pulsation when heart rates exceed safe thresholds, premature beat protection, and emergency stop mechanisms. Devices must automatically release mechanical constraints upon power failure to ensure patient safety. Mechanical and physical requirements cover the pressure resistance and air tightness of the airbags, overall machine noise levels, and the load-bearing capacity of the counterpulsation bed. Additionally, the standard requires compliance with GB 9706.1 for basic safety and YY 0505 for electromagnetic compatibility (EMC).
Testing methods
The standard outlines specific testing procedures to verify compliance, including working pressure tests using simulated limbs and pressure gauges. It details ECG performance tests utilizing signal generators to evaluate QRS detection and noise levels. Mechanical evaluations include air tightness tests under sustained pressure, noise level measurements, and load-bearing assessments for the counterpulsation bed. All testing must be conducted under the specified normal working conditions to ensure valid results. Environmental testing follows the methodologies specified in GB/T 14710.
FAQs
What products are regulated under GB 10035-2017?
GB 10035-2017 regulates air-bag type sequential external counter-pulsation devices used in medical settings for treating ischemic diseases. It is mandatory for all such medical devices sold in China.
Are there any updates from the previous version of GB 10035?
Yes, the 2017 version replaces GB 10035-2006. It adds requirements for the pulse oximetry component, trigger signals, and electromagnetic compatibility, while removing certain electronic system clauses from the 2006 edition.
How does GB 10035-2017 address safety and electromagnetic compatibility?
The standard requires full compliance with GB 9706.1 for general safety requirements and YY 0505 for electromagnetic compatibility (EMC). Manufacturers must conduct tests according to these referenced standards to achieve certification.
The summary above provides a high-level overview of GB 10035-2017. To ensure complete compliance for your products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 10035-2017 today to access all detailed parameters, tables, and testing procedures.
Applicability hints
- Type
- Product
- CCS
- C45
- ICS
- 11.040.40
- Competent department
- National Medical Products Administration
- Technical committee
- National Technical Committee on Medical Extracorporeal Circulation Equipment of Standardization Administration of China
Relationships
Replaces:GB 10035-2006