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Eurofins | Newsflash - January 2019 | Electrical & Electronics

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Tuesday, January 8, 2019

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Eurofins newsflash Electrical and electronics

 

Germany

 

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.

 

Medical Devices

Reference

Title

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.

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.

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.

IEC 80601-2-60:2012

Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment.

 

Europe

 

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

  1. 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.
  2. 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.

  1. 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.
  2. 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.

 

Europe

 

Regulatory updates

 

Below a summary table with some recent European regulation proposals notified to World Trade Organization:

 

Notification number

Date

Title

G/TBT/N/EU/620

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.

G/TBT/N/EU/621

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.

G/TBT/N/EU/622

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.

 

International

 

Regulatory proposals notified to WTO

 

Below a summary table with some recent legislative proposals notified to World Trade Organization by different countries worldwide:

 

Notification number

Country

Title

G/TBT/N/CAN/570

Canada

Consultation: Radio Standard Specification RSS-246, Issue 1, Ultra-Low Power (ULP) Wireless Medical Endoscopy Devices Operating in the 430-440 MHz Band.

G/TBT/N/JPN/612

Japan

Partial amendment of Regulations for Radio Equipment.

G/TBT/N/JPN/613

Japan

Partial amendment of Regulations for Enforcement of the Radio Law.

G/TBT/N/CHN/1300

China

Announcement on the Issuance of Compulsory Certification Management for Large Refrigerators with the Volume higher than 500L.

G/TBT/N/KOR/802

Korea

A draft revision of Electrical appliances and Consumer products Act.

G/TBT/N/KOR/804

Korea

Technical Requirements for the Telecommunication Terminal Equipment.

G/TBT/N/KOR/806

Korea


Amended Safety Standards for Secondary lithium cells.

G/TBT/N/AUS/109

Australia

Greenhouse and Energy Minimum Standards (Refrigerated Cabinets) Determination.

 

International

 

Other worldwide regulatory updates

 

Below a summary table with some recent updates in legislations (non-exhaustive):

 

Date

Country

Update

18/09/2018

Australia (Victoria)

Electricity Safety Amendment (Electrical Equipment Safety Scheme) Act 2018 -No. 43 of 2018.

10/10/2018

Canada

Regulations Amending the Energy Efficiency Regulations, 2016: SOR/2018-201.

“Energy Efficiency Regulations, 2016 (SOR/2016-311)”

22/10/2018

Chile

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.

16/11/2018

South Korea

Proposal revision of the Electromagnetic Compatibility Test Method.

4/12/2018

Taiwan

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”.

 

Europe / International

 

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.

 

RoHS related

Reference

Title

Date of Withdrawal (*)

Supersedes

EN IEC 63000:2018

Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances

2023-12-07

EN 50581:2012

Reference

Title

Date of Availability (*)

Supersedes

CEN/TR 10364:2018

Steels and cast irons - Determination of substances listed in the directives 2011/65/EU (RoHS) and 2000/53/EC (ELV) - Limitations

2018-11-14

CEN/TR 10364:2016

 

Rotating machinery and Switches

Reference

Title

Date of Withdrawal (*)

Supersedes

EN IEC 60034-14:2018

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

EN 60034-14:2004
EN 60034-14:2004/A1:2007

Reference

Title

Date of Availability (**)

Supersedes

EN 60669-1:2018/AC:2018-11

Switches for household and similar fixed electrical installations - Part 1: General requirements

2018-11-16

-

 

Lighting

Reference

Title

Date of Withdrawal (*)

Supersedes

EN 62612:2013/A2:2018

Self-ballasted LED lamps for general lighting services with supply voltages > 50 V - Performance requirements

2021-09-14

-

EN 13032-5:2018

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

-

EN 62386-102:2014/A1:2018

Digital addressable lighting interface - Part 102: General requirements - Control gear

2021-11-02

-

EN 62386-103:2014/A1:2018

Digital addressable lighting interface - Part 103: General requirements - Control devices

2021-11-02

-

 

Measurement, Control and Laboratory equipment

Reference

Title

Date of publication

Reference

EN IEC 61326-3-2:2018

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

EN 61326-3-2:2008

 

Batteries

Reference

Title

Date of publication

Reference

EN 50342-1:2015/A1:2018

Lead-acid starter batteries - Part 1: General requirements and methods of test

2021-11-30

-

EN 50342-6:2015/A1:2018

Lead-acid starter batteries - Part 6: Batteries for Micro-Cycle Applications

2021-11-30

-

 

Others

Reference

Title

Date of publication

Reference

EN IEC 60358-4:2018

Coupling capacitors and capacitor dividers - Part 4: DC and AC single-phase capacitor dividers

2021-11-23

HD 597 S1:1992
HD 597 S1:1992/corrigendum Mar. 1992

EN IEC 60512-1:2018

Connectors for electrical and electronic equipment - Tests and measurements - Part 1: Generic specification

2021-11-26

EN 60512-1:2001