Eurofins | Newsflash - January 2019 | Electrical & Electronics
Eurofins Product Service GmbH has updated its scope for medical devices
The Certification Body scope for the National Certification Body and Certification Body Testing Laboratory Eurofins Product Service GmbH was updated. Following Medical electrical Device standards for Safety were added to the scope.
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Medical Devices |
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Reference |
Title |
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IEC 60601-1-9:2007 IEC 60601-1-9:2007/AMD1:2013 |
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design. |
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IEC 60601-1-10:2007 IEC 60601-1-10:2007/AMD1:2013 |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers. |
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IEC 60601-1-12:2014 |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. |
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IEC 80601-2-60:2012 |
Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment. |
European product database for Energy Labelling
Energy Labelling Regulation (EU) 2017/1369 establishes a framework to allow, within others:
- The introduction of a product registration database to support market surveillance activities by the Member States
- A public database containing all energy efficiency labels, giving consumers a better tool to compare the energy efficiency of household appliances.
Article 4 of this regulation concerning obligations of suppliers in relation to the product database shall apply from 1 January 2019.
Within this framework, from 1st January 2019, suppliers (manufacturers, importers or authorised representatives) need to register their appliances subject to energy labelling requirements in the European Product Database for Energy Labelling (EPREL), before selling them on the European market (according to the regulation,).
The information to be entered in the product database is described in Annex I of Energy Labelling Regulation such as: energy label, energy efficiency class and other parameters of the label, technical documentation.
For products placed on the EU market between 1 August 2017 and 1 January 2019, their registration can be done until 1 July 2019.
For products placed on the EU market before 1 August 2017, their registration is made on a voluntary basis.
Extract from Energy Labelling Regulation, Article 4:
Article 4- Obligations of suppliers in relation to the product database
- As from 1 January 2019, the supplier shall, before placing on the market a unit of a new model covered by a delegated act, enter in the public and compliance parts of the product database the information for that model, as set out in Annex I.
- Where units of models covered by a delegated act are placed on the market between 1 August 2017 and 1 January 2019, the supplier shall, by 30 June 2019, enter in the product database the information set out in Annex I in relation to those models.
Until data entry in the product database, the supplier shall make an electronic version of the technical documentation available for inspection within 10 days of a request received from market surveillance authorities or the Commission.
- The supplier may enter in the product database the information for models, as set out in Annex I, the units of which were exclusively placed on the market before 1 August 2017.
- A product for which changes are made that are relevant for the label or the product information sheet shall be considered to be a new model. The supplier shall indicate in the database when it no longer places on the market units of a model.
(…)
Click here for getting more information from European Commission’s website.
Regulatory updates
Below a summary table with some recent European regulation proposals notified to World Trade Organization:
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Notification number |
Date |
Title |
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21/11/2018 |
Draft Commission Regulation laying down ecodesign requirements for refrigerating appliances with a direct sales function pursuant to Directive 2009/125/EC of the European Parliament and of the Council. |
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21/11/2018 |
Draft Commission Delegated Regulation supplementing Regulation (EU) 2017/1369 of the European Parliament and of the Council with regard to energy labelling of refrigerating appliances with a direct sales function. |
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23/11/2018 |
Draft Commission Regulation laying down ecodesign requirements for welding equipment pursuant to Directive 2009/125/EC of the European Parliament and of the Council. |
Regulatory proposals notified to WTO
Below a summary table with some recent legislative proposals notified to World Trade Organization by different countries worldwide:
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Notification number |
Country |
Title |
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Canada |
Consultation: Radio Standard Specification RSS-246, Issue 1, Ultra-Low Power (ULP) Wireless Medical Endoscopy Devices Operating in the 430-440 MHz Band. |
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Japan |
Partial amendment of Regulations for Radio Equipment. |
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Japan |
Partial amendment of Regulations for Enforcement of the Radio Law. |
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China |
Announcement on the Issuance of Compulsory Certification Management for Large Refrigerators with the Volume higher than 500L. |
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Korea |
A draft revision of Electrical appliances and Consumer products Act. |
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Korea |
Technical Requirements for the Telecommunication Terminal Equipment. |
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Korea |
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Australia |
Greenhouse and Energy Minimum Standards (Refrigerated Cabinets) Determination. |
Other worldwide regulatory updates
Below a summary table with some recent updates in legislations (non-exhaustive):
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Date |
Country |
Update |
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18/09/2018 |
Electricity Safety Amendment (Electrical Equipment Safety Scheme) Act 2018 -No. 43 of 2018. |
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10/10/2018 |
Regulations Amending the Energy Efficiency Regulations, 2016: SOR/2018-201. |
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22/10/2018 |
As published in the Official Journal No. 42.186 of 22 October 2018, Approves the safety test protocol, PE Nº 5/21, to certify and test LED lamps with Built-In ballast for use in public, commercial and industrial lighting. |
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16/11/2018 |
Proposal revision of the Electromagnetic Compatibility Test Method. |
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4/12/2018 |
As published in Official Gazette No. 024 of 4 December 2018: “Amendment to the Minimum Energy Performance Standard and Inspection for Self-ballasted LED Lamps”. |
Standards Updates
Below a summary table with some recent standards updates and upcoming dates of withdrawal (non-exhaustive):
(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.
(**) Date of availability: date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat.
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RoHS related |
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Reference |
Title |
Date of Withdrawal (*) |
Supersedes |
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Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances |
2023-12-07 |
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Reference |
Title |
Date of Availability (*) |
Supersedes |
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Steels and cast irons - Determination of substances listed in the directives 2011/65/EU (RoHS) and 2000/53/EC (ELV) - Limitations |
2018-11-14 |
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Rotating machinery and Switches |
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Reference |
Title |
Date of Withdrawal (*) |
Supersedes |
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Rotating electrical machines - Part 14: Mechanical vibration of certain machines with shaft heights 56 mm and higher - Measurement, evaluation and limits of vibration severity |
2021-09-21 |
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Reference |
Title |
Date of Availability (**) |
Supersedes |
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Switches for household and similar fixed electrical installations - Part 1: General requirements |
2018-11-16 |
- |
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Lighting |
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Reference |
Title |
Date of Withdrawal (*) |
Supersedes |
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Self-ballasted LED lamps for general lighting services with supply voltages > 50 V - Performance requirements |
2021-09-14 |
- |
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Light and lighting - Measurement and presentation of photometric data of lamps and luminaires - Part 5: Presentation of data for luminaires used for road lighting |
2019-05-31 |
- |
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Digital addressable lighting interface - Part 102: General requirements - Control gear |
2021-11-02 |
- |
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Digital addressable lighting interface - Part 103: General requirements - Control devices |
2021-11-02 |
- |
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Measurement, Control and Laboratory equipment |
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Reference |
Title |
Date of publication |
Reference |
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Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 3-2: Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety) - Industrial applications with specified electromagnetic environment |
2021-11-30 |
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Batteries |
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Reference |
Title |
Date of publication |
Reference |
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Lead-acid starter batteries - Part 1: General requirements and methods of test |
2021-11-30 |
- |
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Lead-acid starter batteries - Part 6: Batteries for Micro-Cycle Applications |
2021-11-30 |
- |
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Others |
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Reference |
Title |
Date of publication |
Reference |
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Coupling capacitors and capacitor dividers - Part 4: DC and AC single-phase capacitor dividers |
2021-11-23 |
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Connectors for electrical and electronic equipment - Tests and measurements - Part 1: Generic specification |
2021-11-26 |
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