farbbalken
United Kingdom
ESS GBR X-RAY Health/Safety
X ray; X ray devices; Radiation; Ionizing radiation; Emit radiation; Radiation emitting device

89.00 € NET

30-Tages-Lizenz

Anwendungsbereich des Regulatory Essentials

Stakeholder:

Manufacturer, Importer, Operator

Geltende Rechtsvorschriften:

The Ionising Radiations Regulations 2017 (IRR17) apply to a large range of workplaces where radioactive substances and electrical equipment emitting ionising radiation are used. They also apply to work with natural radiation, including work in which people are exposed to naturally occurring radon gas and its decay products. Any employer who undertakes work with ionising radiation must comply with IRR17. The IRR17 requires employers to keep exposure to ionising radiations as low as reasonably practicable. Exposures must not exceed specified dose limits. Restriction of exposure should be achieved first by means of engineering control and design features. The Radiation (Emergency Preparedness and Public Information) Regulations 2019 (REPPIR) (S. I. 2019 No. 703) apply to operators of premises who carry out work with ionising radiation, and to those who transport radioactive sources through public places – other than by standard forms of transport – in excess of specified levels. The main aim of the regulations is to establish whether a radiation emergency is foreseeable and to mitigate the consequences, should one occur.

Nationale Anwendungsebene:

x-ray, ionizing radiation

Länder:

 

United Kingdom

Status:

Published 2023-03-22 by Inken Green and Torsten Sahm
Last change 2024-03-14 by Torsten Sahm: Link/Reference to other reference document(s), X-Ray

ID:

#w76s


Inhalt des Regulatory Essentials

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)

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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(Zugang nur mit erweiterter ATERIOS Lizenz)

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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(Zugang nur mit erweiterter ATERIOS Lizenz)

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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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

Warnings, symbols
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e. g. ANSI Z 535.4


Allgemeine Informationen

   
United Kingdom

Code, Kontinent, Wirtschaftsraum

GBR, Europe

Wirtschaftsraum

Offizielle Amtssprache

English (plus 6 regional official languages) De facto official language of the United Kingdom is English. Welsh, an official language in Wales, and the only de jure official language in any part of the UK and Scots

Normen Institut

BSI - British Standards Institution | https://www.bsigroup.com/en-US/Standards/

HS Codemitglied

Yes, since 1952

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