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China
ESS CHN X-RAY Device
X ray; X ray devices; Radiation; Ionizing radiation; Emit radiation; Radiation emitting device

89.00 € NET

30-Tages-Lizenz

Anwendungsbereich des Regulatory Essentials

This ESSENTIAL describes the legal obligations for manufacturers and the regulatory requirements for electronic product radiation in China.

Stakeholder:

Manufacturer, Importer

Geltende Rechtsvorschriften:

The Law is enacted to prevent and control radioactive pollution, protect the environment, ensure human health, and promote the development and peaceful use of nuclear energy and technology. Chapter I General provisions Chapter II Supervision over prevention and control of radioactive pollution Chapter III Prevention and control of radioactive pollution from nuclear facilities Chapter IV Prevention and control of radioactive pollution from utilization of nuclear technology Chapter V Prevention and control of radioactive pollution from development and utilization of uranium (Thorium) mines and associated radioactive mines Chapter VI Administration of radioactive wastes Chapter VII Legal liabilities Chapter VIII Supplementary provisions The Law came into force on 1 October 2003. The Regulations govern the production, sale and use of radioisotopes and radiation devices as well as the transfer, import and export of radioisotopes. An entity producing, selling or using radioisotope and ray devices shall obtain the relevant licenses. Chapter I General Provisions Chapter II Licensing and Filing Chapter III Safety and Protection Chapter IV Emergency Response to Radiation Accidents Chapter V Supervision and inspection Chapter VI Legal liabilities Chapter VII Supplementary provisions The Regulations entered into force on 29 July 2005. The purpose of these Provisions is to strengthen the safety and protection management of radiation of radioisotopes and ray devices. Chapter I General Provisions Chapter II Workplace Safety and Protection Chapter III Personnel Safety and Protection Chapter IV Management of Waste Radioactive Sources and Goods Contaminated by Radiation Chapter V Supervision and Inspection Chapter VI Emergency Reporting and Handling Chapter VII Exemption Management Chapter VIII Legal Liability Chapter IX Supplementary Provisions The measures came into force on May 1, 2011. GB 18871-2002 - Basic Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources This standard specifies the basic requirements of ionizing radiation protection and radiation source safety. Appendixes A, B, C, D, E, F, J are normative (mandatory). 1 Scope 2 Definitions 3 General Requirements 4 Major Requirement for Practice 5 Major Requirement for Intervention 6 Control of Occupational Exposure 7 Control of Medical Exposure 8 Control of Public Exposure 9 Control of Potential Exposure——Safety of Source 10 Intervention of Emergency Exposure Condition 11 Intervention of Prolonged Exposure Condition Annex A (Normative) Exemptions Annex B (Normative) Dose Limits and Control Level of Surface Contamination Annex C (Normative) Classification of Working Spaces with Unsealed Sources Annex D (Normative) Toxicity Grouping of Radionuclides Annex E (Normative) Dose Level of Expected Intervention in Any Case and the Intervention Level and Action Level Under Emergency Exposure Condition Annex F (Normative) Sign and Warning Sign of Ionizing Radiation Annex G (Informative) Guidance Level for Medical Exposure of Radiodiagnosis and Nuclear Medicine Diagnosis Annex H (Informative) Action Level under Prolonged Exposure Condition Annex J (Normative) Terms and Definitions

Nationale Anwendungsebene:

Radioisotope, Radiation-emitting Device

Länder:

 

China

Status:

Published 2023-03-28 by Inken Green and Torsten Sahm
Last change 2024-03-14 by Torsten Sahm: Penalty by this legislation, X-Ray

ID:

#ix6v


Inhalt des Regulatory Essentials

Scope of legislation
Mandatory standard like legislation:
GB 18871-2002
3.1.1.
The practice applicable to this standard shall include:
a) Source production and radiation or radioactive substance application in medical, industry, agriculture or teaching and research, including various activities related to application involved or possibly involved in radiation or radioactive substance exposure
3.1.2.1 The source applicable to the requirements of this standard for practice shall include:
a) Radioactive substance and component containing radioactive substance or generating radiation, including consumer product, sealed source, unsealed source and radiation generator;
b) Device and facility with radioactive substance and equipment generating radiation, including irradiation installations, mine or mill processing radioactive ores, installation processing radioactive substances, nuclear installation and radioactive waste management facility;
c) Other sources specified by regulatory authority

Article 68 of the Radioisotope and radiation device safety and protection regulations
- Radioactive isotope, refers to a radioactive decay of an element with the same atomic number but different mass nuclide
- Radioactive devices, refers to X-ray machines, gas pedals, neutron generators and devices containing radioactive sources.
- With the generation of X-rays electrical products, is not to generate X-rays for the purpose, but in the production or use of the process of generating X-rays of electrical products.


Article 37 The radiation protection equipment, equipment containing radioactive isotopes and radiation devices, as well as products containing radioactive substances and electrical products accompanied by the generation of X-rays, should meet the radiation protection requirements.
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Responsible actors
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Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)
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What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Penalty by this legislation
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What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?

Exemption clauses
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Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
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E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU
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Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
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Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)
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Hints
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Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
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Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
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[Yes/No]

Hints
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Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Approval process (conformity assessment procedure)
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Means each legally required approval process prior placing on the market, importation or putting into service

Is the IECEE CB Scheme accepted by the authority/approval body?
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"[Yes/ No / no information available] [Text] Information (website)"

Conformance document(s) to show compliance to the authority
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e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal
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Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?
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e .g. formal application

Is a factory inspection legally required
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Hints
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Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing
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e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards
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e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Source for standards for conformity assessment
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Is in-country testing legally required?
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Acceptance of foreign test reports
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Hints
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Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)
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e. g. product label

Regulatory e-labelling allowed?
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e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging
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e. g. address of the manufacturer/importer, serial number

User instructions language(s)
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Regulated by the legal provisions

User instruction requirements and specific compliance notes
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Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Digital user documentation allowed?
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User instructions allowed by QR-Code/internet or digital medium or integrated in device with display? Safety instruction allowed by QR-Code or digital medium?

Warnings, symbols
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e. g. ANSI Z 535.4

Hints
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Specific recommendations, information or most common mistakes


Allgemeine Informationen

   
China

Code, Kontinent, Wirtschaftsraum

CHN, Asia

Wirtschaftsraum

APEC (Asia-Pacific Economic Cooperation)

Offizielle Amtssprache

Chinese (Mandarin) - Law of the People's Republic of China on the Standard Spoken and Written Chinese Language | http://www.npc.gov.cn/zgrdw/englishnpc/Law/2007-12/11/content_1383540.htm

Normen Institut

Standardization Administration of China (SAC) | https://www.sac.gov.cn/

HS Codemitglied

Yes

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