On December 29, 2022, the Standardization Administration of China (SAC) issued a notice foe the publication of a new batch of mandatory national standards together with their implementation date.
The new standard batch includes a total of 54 standards and covers a variety of sectors and topics from medical device, electrical and electronics, EMC etc.
A selected list of the standards that may connect with foreign stakeholders are summarized with key takeaways as below:
· The mandatory standards for medical device in this batch are all adopted from ISO/IEC standards, which makes them easier for overseas manufacturers to implement.
· Those for electrical and electronics are latest revision for existing standards, the compliance team of relevant overseas stakeholders are advised to focus on the modifications comparing with existing versions.
No. | Standard No. | Standard Name | Standard to be Replaced | Relevant International Standard | Effective Date | |
Medical | ||||||
1 | GB 9706.255-2022 | Medical electrical equipment—Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | / | Modified adoption of ISO 80601-2-55:2018 | 2026/1/1 | |
2 | GB 9706.271-2022 | Medical electrical equipment—Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment | / | Modified adoption of IEC 80601-2-71：2015 | 2026/1/1 | |
3 | GB 9706.275-2022 | Medical electrical equipment—Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment | / | Modified adoption of IEC 60601-2-75：2017 | 2026/1/1 | |
4 | GB 9706.283-2022 | Medical electrical equipment—Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment | / | Modified adoption of IEC 60601-2-83：2019 | 2026/1/1 | |
5 | GB 9706.290-2022 | Medical electrical equipment—Part 2-90:Particular requirements for basic safety and essential performance of respiratory high flow therapy equipment | / | Modified adoption of ISO 80601-2-90:2021 | 2026/1/1 | |
Automotive | ||||||
6 | GB 15084-2022 | Motor vehicles—Device for indirect vision-Requirement of performance and installation | GB 15084-2013 | / | 2023/7/1 | |
7 | GB 29743.1-2022 | Motor vehicle coolant—Part 1: Fuel vehicle engine coolant | GB 29743-2013 | / | 2023/7/1 | |
Electrical and Electronics | ||||||
8 | GB 32030-2022 | Minimum allowable values of energy efficiency and energy efficiency grades for submersible motor-pumps | GB 32029-2015 | / | 2024/1/1 | |
9 | GB 17625.1-2022 | Electromagnetic compatibility—Limits—Part 1: Limits for harmonic current emissions (equipment input current ≤ 16A per phase) | GB 17625.1-2012 | / | 2024/7/1 | |
10 | GB 17896-2022 | Minimum allowable values of energy efficiency and energy efficiency grades of ballasts for gas discharge lamps for general lighting | GB 17896-2012 | / | 2024/1/1 | |
11 | GB 19044-2022 | Minimum allowable values of energy efficiency and energy efficiency grades of fluorescent lamps for general lighting | GB 19044-2013 | / | 2024/1/1 | |
12 | GB 31241-2022 | Lithium ion cells and batteries used in portable electronic equipments—Safety technical specification | GB 31241-2014 | / | 2024/1/1 | |
Cybersecurity | ||||||
13 | GB 42250-2022 | Information security technology—Security technical requirements for specialized cybersecurity products | / | / | 2023/7/1 | |
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